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There are currently 81 names in this directory beginning with the letter A.

A1 Antigen

Specimen Requirements Specimen Collection: Blood Container(s): 6 mL Pink Top (EDTA) or 3 mL Lavender Top (EDTA) Preferred Volume to Collect: 6.0 mL Minimum Volume to Collect: 1.0 mL Neonate Volume to Collect: 0.5 mL Capillary Collect Acceptable? Yes Collection Instructions: Gently invert EDTA tube(s) 8 - 10 times after collection. BB 2 Signers: Specimens for Blood Bank must have 2 signatures on the specimen written in ink that is resistant to smearing: User ID's or initials of collectors/witnesses One of the two collectors/witnesses must be a lab staff member unless specimen is collected in surgery, SH Infusion Center, SH Special Care Hospital or Cord Blood for Labor and Deliver (LDR) suite. Outpatient collection: The patient may serve as witness and initial the tube label. Policytech reference #6476 Specimen must be labeled in the presence of the patient with: Patient's first and last name Unique identification number (MRN) Date of collection If there is any question as to the validity of the specimen identification or an inconsistency between current and previous results, a new specimen must be collected. Processing Instructions (Laboratory, Outpatient or Off-site collection) Processed Specimen: Whole Blood EDTA Centrifuge/Spin: No Aliquot: No Transport Temperature: Ambient or Refrigerate Specimen Stability Ambient: 24 hours Refrigerate: 10 days Laboratory Retention: 10 days Test Frequency Available 24 hours, usual TAT 1 day Reference Range Not available Performing Department BLOOD BANK Performing Department Laboratory Location Spectrum Health Big Rapids Laboratory, Big Rapids, MI Spectrum Health Blodgett Laboratory, Grand Rapids, MI Spectrum Health Butterworth Laboratory. Grand Rapids, MI Methodology Tube Technique

ABO Grouping and Rho(D) Typing

Synonyms Blood Grouping and Rh Typing Blood Type Group and Type Type and Rh Test Includes ABO blood grouping and Rh typing Special Instructions If a CBC and/or an antibody screening test is ordered with this test, please submit a separate 4 mL specimen for each test. Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Rh-hr Genotype With ABO Grouping Related Documents Sample Report Specimen Requirements Specimen Whole blood Volume 4 mL Minimum Volume 1 mL Container Lavender-top (EDTA) tube Storage Instructions Specimens should be tested as soon as possible. Samples that cannot be tested immediately should be stored at 2°C to 8°C. Do not freeze red cells. Stability Requirements Temperature Period Room temperature 7 days Refrigerated 7 days Causes for Rejection Gross hemolysis; bacterial or other contamination Test Details Use Determination of ABO blood group and Rh type for transfusion candidates. Group and typing of expectant mothers and newborns may indicate potential for ABO hemolytic disease of the fetus/newborn. Rh typing is used to determine Rh immune globulin candidacy for prenatal and postpartum patients. Limitations Abnormal plasma proteins, cold autoagglutinins, positive direct antiglobulin test, and, in some cases, bacteremia may interfere with test interpretation. Variable testing results may be observed with partial antigens, which are rare variants of the D antigen. Methodology Hemagglutination

Acetylcholine Receptor (AChR) Antibodies, Complete Profile

Synonyms Acetylcholine Receptor Complete Antibody Profile Myasthenia Gravis Evaluation Complete Profile Test Includes Acetylcholine receptor-binding antibody; acetylcholine receptor-blocking antibody; acetylcholine receptor-modulating antibody Expected Turnaround Time 5 - 8 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Acetylcholine Receptor (AChR)-binding Antibodies Acetylcholine Receptor (AChR)-binding Antibodies With Reflex to AChR-modulating Antibody Acetylcholine Receptor (AChR)-blocking Antibodies Myasthenia Gravis Complete Antibody Profile Myasthenia Gravis Evaluation Profile Myasthenia Gravis Profile I Myasthenia Gravis Profile II Myasthenia Gravis Profile III Myasthenia Gravis Profile With Reflex Specimen Requirements Specimen Serum Volume 3 mL Minimum Volume 1 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Collection Separate serum from cells within 45 minutes of collection. Send serum in plastic transport tube. Storage Instructions Refrigerate (cool pack) Stability Requirements Temperature Period Room temperature 7 days Refrigerated 14 days Frozen 14 days Causes for Rejection Improper labeling; gross microbial contamination; specimen contaminated with anticoagulants; chylous serum; plasma specimen Test Details Use Diagnose myasthenia gravis (MG); monitor response to treatment of myasthenia gravis Limitations False positives can occur in patients with serum drawn within 48 hours of administration of general anesthesia and muscle relaxants. Antibodies to α-bungarotoxin may sometimes be found in patients treated with snake venom. Recently administered radioisotopes may interfere with the assay in unpredictable ways. Acetylcholine receptor autoantibodies are not typically found in congenital myasthenia gravis. Results of this test are for research purposes only by the assay's manufacturer. The performance characteristics of this product have not been established. Results should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. Methodology AChR-binding assay and blocking antibody: radioimmunoassay (RIA); AChR-modulating antibody: cell culture based radioimmunoassay (RIA) Additional Information Myasthenia gravis is an autoimmune disorder manifested by muscle weakness caused by the loss or dysfunction of acetylcholine receptors (AChR) of skeletal muscle. Autoantibodies (binding, blocking, and/or modulating) to postsynaptic AChRs are detectable in the serum of 90% of patients with generalized MG and in 55% to 70% of patients with ocular myasthenia. These autoantibodies interfere with normal neuromuscular function, causing muscle weakness and fatigue. Receptor antibody levels tend to rise several weeks before symptoms increase in patients with established MG. Remission after thymectomy is associated with a progressive decline in antibody levels. Consequently, measurements of AChR antibodies can be used in monitoring disease progression as well as the effects of treatment. Modulating antibodies are responsible for the degradation of AChR at the muscle cell surface. Modulating antibodies bind to two receptor molecules on the cell surface and accelerate internalization, triggering endocytosis and degradation. The relative increase in this degradation rate closely corresponds to the disease severity.

Acetylcholine Receptor (AChR)-binding Antibodies

Synonyms AChR-binding Antibodies ACRAB Myasthenia Gravis Antibody Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Acetylcholine Receptor (AChR)-blocking Antibodies Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.3 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Collection If a red-top tube is used, transfer separated serum to a plastic transport tube. Storage Instructions Refrigerate. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation No isotopes administered 24 hours prior to venipuncture Causes for Rejection Excessive hemolysis; chylous serum; recently administered radioisotopes; plasma specimen Test Details Use In vitro diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma. This assay is the primary test for confirming the diagnosis of acquired myasthenia gravis.1 Limitations Antibodies are not found in congenital myasthenia. Methodology This assay measures antibodies that precipitate solublized muscle AChR that has been complexed with radiolabeled alpha-bungarotoxin (αBTX). Antibodies that bind to the receptor regions that are not sterically blocked by the αBTX are detected. Contraindications Recent radioactive scan Reference Interval • Negative: 0.00−0.24 nmol/L • Borderline: 0.25−0.40 nmol/L • Positive: >0.40 nmol/L Additional Information Myasthenia gravis is an acquired disorder of neuromuscular transmission characterized by use-associated muscle weakness and fatigability.1 This condition frequently involves the extraocular muscles and has a strong association with tumor of the thymus (thymoma). The disease has a prevalence of approximately 5 per 100,000 individuals and can occur at any age. In women, the disease usually presents between the ages of 20 and 40 years, while disease onset in men typically occurs later in life. Autoantibodies to postsynaptic acetylcholine receptors are detectable in the serum of 90% of patients with generalized myasthenia gravis and approximately 70% of patients with ocular myasthenia.1 These autoantibodies interfere with normal neuromuscular function, causing muscle weakness and fatigue. Antibody titers tend to be higher in females and a correlation between antibody titer and degree of muscle weakness has been observed in individual patients. Receptor antibody titers tend to rise several weeks before exacerbations in patients with established myasthenia gravis. Remission after thymectomy is associated with a progressive decline in antibody titers. Consequently, serial measurements of acetylcholine receptor antibodies can be useful in monitoring disease progression as well as the effects of treatment. (Myasthenia gravis is often associated with striational antibody.) AChR-binding antibodies can also be positive in uncomplicated thymoma, Lambert-Eaton myasthenic syndrome, primary lung cancer, and in patients with autoimmune liver disease.1

Acid-fast (Mycobacteria) Smear and Culture With Reflex to Identification

Synonyms Blood Mycobacteria Culture Culture, Acid-Fast (Sputum, Tissue, Urine, and Gastric Contents) Culture, Blood, Mycobacteria Mycobacteria Culture (Sputum, Tissue, Urine, and Gastric Contents) Test Includes Specimen processing (ie, N-acetyl-L-cystine-sodium hydroxide treatment or equivalent, concentration, grinding, both or neither), mycobacterial culture, and smear when appropriate (smears are not performed on blood or when there is less than 2 mL of fluid). Identification by DNA probes or sequencing will be performed at an additional charge. This culture will often detect Nocardia species and other aerobic actinomyces, and identification appropriate for these organisms will be included. Expected Turnaround Time 43 - 56 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Acid-fast Organism Identification by DNA Probe and/or Sequencing Acid-fast Organism Identification by DNA Probe and/or Sequencing With Reflex to Susceptibility Testing Mycology, Mycobacteriology, and Other Reference Microbiology Testing Related Documents Sample Report Specimen Requirements Specimen First morning sputum (not saliva) (three separate specimens from three separate days are recommended), fasting gastric aspirate, induced sputum, whole blood, tissue, biopsy, bronchial aspirate, urine, skin, cerebrospinal fluid (CSF), bone marrow, body fluid, stool. Swabs of exudate from skin sources are acceptable, otherwise swab specimens should not be submitted. Collect aspirate using sterile, nonbacteriostatic saline or other noninhibitory medium. Do not send syringe; it will be rejected. Volume 5 mL sputum or respiratory aspirate, 10 mL whole blood, 2 cm³ tissue, 5 mL CSF, 5 cc bone marrow (or as much as possible), 50 mL body fluid (eg, gastric aspirate/lavage, urine, pleural, pericardial, chronic peritoneal dialysate), 10 mL stool, biopsy of skin Container Sterile container with tight screw-cap seal or green-top (sodium heparin) tube or Isolator™ Storage Instructions Refrigerate. If sample is to be split for other tests, specimen should be divided at the time of collection so that each portion is transported at the appropriate temperature. Causes for Rejection Inadequate quantity of specimen, including swab specimen without visible evidence of tissue present; specimen received in expired transport media or inappropriate transport device; specimen received after prolonged delay (usually >72 hours); specimen received after leaking out of transport container into the specimen bag (trach-suction devices will often leak if the cap with tubing is not removed and replaced by a solid cap); syringe with attached needle; unlabeled specimen or name discrepancy between specimen and request label; lithium heparin tube; specimen submitted with eSwab device Test Details Use Isolate and identify mycobacteria Limitations Biopsy or body fluid: Transbronchial biopsy cultures may be of assistance in diagnosing tuberculosis in sputum smear-negative cases; however, sputum and bronchial washing cultures have a higher yield.1,2 In one study, only 2 out of 12 (16%) transbronchial biopsies were positive, and in those cases the biopsy was not the only source of culture-positive material.1 Mycobacterium marinum may cause a localized cutaneous lesion that may be nodular, verrucous, ulcerative, or sporotrichoid and which may rarely involve deeper structures. If it is suspected, the laboratory must be notified so that the culture may be incubated at an appropriate temperature (30°C).3 Mycobacterium marinum infection occurs in patients who have been exposed to the organism following cutaneous abrasion or penetrating injury while cleaning aquariums, clearing barnacles, and with other aquatic exposures. Likewise, there are two additional mycobacterial pathogens requiring special conditions for laboratory culture. Mycobacterium haemophilum, which causes a cutaneous, joint, or pulmonary infection in immunocompromised patients and lymphadenitis in children, requires special growth media and incubation temperature. Mycobacterium genavense has been recovered from disseminated infections in AIDS patients. It requires special acidulated media and extended incubation conditions. If either of these mycobacteria is suspected, the laboratory must be notified so that appropriate cultivation conditions can be initiated. Sputum: Bronchial washings are frequently diluted with topical anesthetics and irrigating fluids, but bronchoscopy still provides a high yield of positive specimens. Postbronchoscopy expectorated specimens may provide a better yield of organisms than those obtained during the procedure. The yield of prebronchoscopy sputum was 75%, bronchial washings 66%, and postbronchoscopy sputum 58%. Bronchoscopy can, however, be an important adjunct to serial sputum collection in the definitive diagnosis of pulmonary infection due to mycobacteria.4,5 Gastric aspirates yield organisms in 90% are culture positive. The diagnosis of vertebral tuberculosis should be considered in all cases of unexplained spondylitis. Cases of sternal wound infection, early prosthetic valve endocarditis, infections complicating mammary augmentation surgery, and other cutaneous/subcutaneous infections have been attributed to rapidly growing mycobacteria.10,11 M fortuitum is the most commonly implicated Mycobacterium in these infections, which are thought to be caused by local environmental strains rather than contaminated commercial surgical materials or devices. Rapidly growing mycobacteria often grow on routine bacterial culture media within the time allotted to incubating routine bacterial cultures. Such organisms may be misidentified as "diphtheroids" and disregarded as contaminants. Pleural effusions frequently yield positive cultures in cases of pulmonary tuberculosis. The diagnosis of peritoneal tuberculosis is difficult and is usually made at laparotomy or after a considerable delay. Tuberculosis should be considered in any patient with ascitic fluid and chronic abdominal pain.12 Peritoneal tuberculosis accounted for 11% of a series of cases of extrapulmonary tuberculosis reported by Alvarez and McCabe.13 Pericardial tuberculosis accounts for <5% of extrapulmonary tuberculosis and frequently requires biopsy for diagnosis. See table. Predisposing Clinical Conditions and Site of Involvement of Non-M tuberculosis Mycobacterial Infections Site Predisposing Clinical Conditions Species Disseminated Immunodeficiency/malignancy M avium complex M kansasii Gastrointestinal tract/disseminated Acquired immunodeficiency syndrome M avium complex Lung Chronic pulmonary disease M avium complex M kansasii Lymph nodes Pediatric age group M avium complex M scrofulaceum Peritonitis Chronic ambulatory peritoneal dialysis M fortuitum M chelonae Skeleton Immunodeficiency/malignancy M avium complex M kansasii Skin and soft tissue Percutaneous trauma/abrasion M fortuitum M chelonae Immunodeficiency/malignancy M haemophilum Sputum: Tuberculosis decreased in incidence in the United States in the 1970s and 1980s, but the incidence of tuberculosis in the United States increased from 1986-1994. High-incidence populations exist in depressed inner city areas, some rural areas, amongst new immigrants, in prison inmates, and in HIV-positive patients. The emergence of M tuberculosis and M avium complex infections complicating the acquired immunodeficiency syndrome was striking. When tuberculosis occurs as a first or case-defining opportunistic infection, 75% to 100% of patients of HIV-positive patients have pulmonary disease. After the diagnosis of AIDS has been made, 25% to 70% of HIV-associated tuberculosis patients have an extrapulmonary site of infection.14 In an ambulatory inner city population, two specimens processed for acid-fast stain and culture identified all cases of active tuberculosis within the time required for culture. The most infectious cases were identified immediately by the acid-fast stain. Tuberculin tests and chest x-rays were also performed but did not significantly increase the number of cases identified in this population.15 M kansasii is uncommon as an environmental contaminant. Implication of M avium complex as a pathogen usually requires at least one of the following criteria: • Clinical evidence of a disease process that can be explained by nontuberculous mycobacterial infection • Repeated isolation of the same mycobacterial species from sputum over a period of weeks to months • Exclusion of other possible etiologies • Biopsy demonstrating acid-fast bacilli or diagnostic histopathologic changes16 Endobronchial tuberculosis has been increasingly recognized because of its incidence in association with the acquired immunodeficiency syndrome and because it may mimic carcinoma.17,18 Nosocomial transmission of multidrug-resistant Mycobacterium tuberculosis has been noted to occur from patient to patient and from patient to health care worker. Acid-fast bacilli isolation precautions and adherence to appropriate infection control procedures are recommended until at least three smears from specimens collected on different days are negative.19,20 While M tuberculosis is contagious and is usually transmitted from person to person, most of the other disease-causing mycobacteria are not characterized by person-to-person spread, are found in the environment, and are considered opportunistic pathogens. They may be called potentially pathogenic environmental (PPE) mycobacteria. They include M avium, M intracellulare, M asiaticum, M flavescens M fortuitum complex, M haemophilum, M kansasii, M malmoense, M marinum, M scrofulaceum, M simiae, M genavense, and M xenopi. They are correlated with HIV.16,21 Urine: Although it has been thought that tuberculosis of the urinary tract should be suspected when hematuria and pyuria (sterile pyuria) occur without recovery by routine culture of usual urinary tract pathogens, concomitant infections with ordinary pathogens are not rare. Mycobacteria cultures of the urine are approximately 90% sensitive. The kidney is the most frequent site of infection; prostate, salpinx, and endometrial involvement also occurs. Continuing tuberculous bacilluria may cause cystitis with frequency. Genitourinary infections with PPE mycobacteria, particularly M kansasii and M avium complex, occur.16 Recovery of M bovis BCG from the urine of patients undergoing BCG treatment for bladder cancer can be expected. Stool: The increasing recognition of mycobacterial infections in patients with the acquired immunodeficiency syndrome (AIDS) has resulted in increased awareness of the potential to recover clinically significant mycobacteria from stool. Seven of 132 AIDS patients studied for intestinal infection were found to harbor M avium complex.22 Isolation of mycobacteria from stool indicates disseminated disease, and cultures from blood, bone marrow, and lymph nodes are usually also positive for the same mycobacterial isolate.23

Acid-fast (Mycobacteria) Smear and Culture With Reflex to Identification and Susceptibility Testing

Synonyms Blood Mycobacteria Culture Culture, Acid-Fast (Sputum, Tissue, Urine, and Gastric Contents) Culture, Blood, Mycobacteria Mycobacteria Culture (Sputum, Tissue, Urine, and Gastric Contents) Test Includes Specimen processing (ie, N-acetyl-L-cystine-sodium hydroxide treatment or equivalent, concentration, grinding, both or neither), mycobacterial culture, and smear when appropriate (smears are not performed on blood or when there is less than 2 mL of fluid). Identification by DNA probes or sequencing and susceptibility to antimicrobial antibiotics that are appropriate to the organism will be performed at an additional charge. This culture will often detect Nocardia species and other aerobic actinomyces and identification, and susceptibility appropriate for these organisms will be included. Special Instructions Specimen processing (ie, N-acetyl-L-cystine-sodium hydroxide treatment or equivalent, concentration, grinding, both or neither), mycobacterial culture, and smear when appropriate (smears are not performed on blood or when there is less than 2 mL of fluid). Identification by DNA probes or sequencing will be performed at an additional charge. This culture will often detect Nocardia species and other aerobic actinomyces, and identification appropriate for these organisms will be included. Expected Turnaround Time 43 - 56 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Acid-fast Organism Identification by DNA Probe and/or Sequencing Acid-fast Organism Identification by DNA Probe and/or Sequencing With Reflex to Susceptibility Testing Mycology, Mycobacteriology, and Other Reference Microbiology Testing Related Documents Sample Report Specimen Requirements Specimen First morning sputum (not saliva) (three separate specimens from three separate days are recommended), fasting gastric aspirate, induced sputum, whole blood, tissue, biopsy, bronchial aspirate, urine, skin, cerebrospinal fluid (CSF), bone marrow, body fluid, stool. Swabs of exudate from skin sources are acceptable, otherwise swab specimens should not be submitted. Collect aspirate using sterile, nonbacteriostatic saline or other noninhibitory medium. Do not send syringe; it will be rejected. Volume 5 mL sputum or respiratory aspirate, 10 mL whole blood, 2 cm3 tissue, 5 mL CSF, 5 cc bone marrow (or as much as possible), 50 mL body fluid (eg, gastric aspirate/lavage, urine, pleural, pericardial, chronic peritoneal dialysate), 10 mL stool, biopsy of skin Container Sterile container with tight screw-cap seal or green-top (sodium heparin) tube or Isolator™ Storage Instructions Refrigerate. If sample is to be split for other tests, specimen should be divided at the time of collection so that each portion is transported at the appropriate temperature. Causes for Rejection Inadequate quantity of specimen, including swab specimen without visible evidence of tissue present; specimen received in expired transport media or inappropriate transport device; specimen received after prolonged delay (usually >72 hours); specimen received after leaking out of transport container into the specimen bag (trach-suction devices will often leak if the cap with tubing is not removed and replaced by a solid cap); syringe with attached needle; unlabeled specimen or name discrepancy between specimen and request label; lithium heparin tube; specimen submitted with eSwab device Test Details Use Isolate and identify mycobacteria and determine susceptibility to antimycobacterial drugs Limitations Susceptibilities cannot be reported if the organism fails to grow in the test medium. Susceptibilities cannot be performed on mixed cultures. Biopsy or body fluid: Transbronchial biopsy cultures may be of assistance in diagnosing tuberculosis in sputum smear-negative cases; however, sputum and bronchial washing cultures have a higher yield.1,2 In one study, only 2 out of 12 (16%) transbronchial biopsies were positive, and in those cases the biopsy was not the only source of culture positive material.1 Mycobacterium marinum may cause a localized cutaneous lesion that may be nodular, verrucous, ulcerative, or sporotrichoid and which may rarely involve deeper structures. If it is suspected, the laboratory must be notified so that the culture may be incubated at an appropriate temperature (30°C).3 Mycobacterium marinum infection occurs in patients who have been exposed to the organism following cutaneous abrasion or penetrating injury while cleaning aquariums, clearing barnacles, and with other aquatic exposures. Likewise, there are two additional mycobacterial pathogens requiring special conditions for laboratory culture. Mycobacterium haemophilum, which causes a cutaneous, joint, or pulmonary infection in immunocompromised patients and lymphadenitis in children, requires special growth media and incubation temperature. Mycobacterium genavense has been recovered from disseminated infections in AIDS patients. It requires special acidulated media and extended incubation conditions. If either of these mycobacteria is suspected, the laboratory must be notified so that appropriate cultivation conditions can be initiated. Sputum: Bronchial washings are frequently diluted with topical anesthetics and irrigating fluids, but bronchoscopy still provides a high yield of positive specimens. Postbronchoscopy expectorated specimens may provide a better yield of organisms than those obtained during the procedure. The yield of prebronchoscopy sputum was 75%, bronchial washings 66%, and postbronchoscopy sputum 58%. Bronchoscopy can, however, be an important adjunct to serial sputum collection in the definitive diagnosis of pulmonary infection due to mycobacteria.4,5 Gastric aspirates yield organisms in 90% are culture positive. The diagnosis of vertebral tuberculosis should be considered in all cases of unexplained spondylitis. Cases of sternal wound infection, early prosthetic valve endocarditis, infections complicating mammary augmentation surgery, and other cutaneous/subcutaneous infections have been attributed to rapidly growing mycobacteria.10,11 M fortuitum is the most commonly implicated Mycobacterium in these infections, which are thought to be caused by local environmental strains rather than contaminated commercial surgical materials or devices. Rapidly growing mycobacteria often grow on routine bacterial culture media within the time allotted to incubating routine bacterial cultures. Such organisms may be misidentified as "diphtheroids" and disregarded as contaminants. Pleural effusions frequently yield positive cultures in cases of pulmonary tuberculosis. The diagnosis of peritoneal tuberculosis is difficult and is usually made at laparotomy or after a considerable delay. Tuberculosis should be considered in any patient with ascitic fluid and chronic abdominal pain.12 Peritoneal tuberculosis accounted for 11% of a series of cases of extrapulmonary tuberculosis reported by Alvarez and McCabe.13 Pericardial tuberculosis accounts for <5% of extrapulmonary tuberculosis and frequently requires biopsy for diagnosis. See table in listing for Acid-fast (Mycobacteria) Smear and Culture With Reflex to Identification [183753]. Sputum: Tuberculosis decreased in incidence in the United States in the 1970s and 1980s, but the incidence of tuberculosis in the United States increased from 1986-1994. High-incidence populations exist in depressed inner city areas, some rural areas, amongst new immigrants, in prison inmates, and in HIV-positive patients. The emergence of M tuberculosis and M avium complex infections complicating the acquired immunodeficiency syndrome was striking. When tuberculosis occurs as a first or case-defining opportunistic infection, 75% to 100% of patients of HIV-positive patients have pulmonary disease. After the diagnosis of AIDS has been made, 25% to 70% of HIV-associated tuberculosis patients have an extrapulmonary site of infection.14 In an ambulatory inner city population, two specimens processed for acid-fast stain and culture identified all cases of active tuberculosis within the time required for culture. The most infectious cases were identified immediately by the acid-fast stain. Tuberculin tests and chest x-rays were also performed but did not significantly increase the number of cases identified in this population.15 M kansasii is uncommon as an environmental contaminant. Implication of M avium complex as a pathogen usually requires at least one of the following criteria: • Clinical evidence of a disease process that can be explained by nontuberculous mycobacterial infection • Repeated isolation of the same mycobacterial species from sputum over a period of weeks to months • Exclusion of other possible etiologies • Biopsy demonstrating acid-fast bacilli or diagnostic histopathologic changes16 Endobronchial tuberculosis has been increasingly recognized because of its incidence in association with the acquired immunodeficiency syndrome and because it may mimic carcinoma.17,18 Nosocomial transmission of multidrug-resistant Mycobacterium tuberculosis has been noted to occur from patient to patient and from patient to health care worker. Acid-fast bacilli isolation precautions and adherence to appropriate infection control procedures are recommended until at least three smears from specimens collected on different days are negative.19,20 While M tuberculosis is contagious and is usually transmitted from person to person, most of the other disease-causing mycobacteria are not characterized by person-to-person spread, are found in the environment, and are considered opportunistic pathogens. They may be called potentially pathogenic environmental (PPE) mycobacteria. They include M avium, M intracellulare, M asiaticum, M flavescens, M fortuitum complex, M haemophilum, M kansasii, M malmoense, M marinum, M scrofulaceum, M simiae, M genavense, and M xenopi. They are correlated with HIV.16,21 Urine: Although it has been thought that tuberculosis of the urinary tract should be suspected when hematuria and pyuria (sterile pyuria) occur without recovery by routine culture of usual urinary tract pathogens, concomitant infections with ordinary pathogens are not rare. Mycobacteria cultures of the urine are approximately 90% sensitive. The kidney is the most frequent site of infection; prostate, salpinx, and endometrial involvement also occurs. Continuing tuberculous bacilluria may cause cystitis with frequency. Genitourinary infections with PPE mycobacteria, particularly M kansasii and M avium complex, occur.16 Mycobacterial genitourinary tract infections represented about 20% of extrapulmonary tuberculosis cases.13 Recovery of M bovis BCG from the urine of patients undergoing BCG treatment for bladder cancer can be expected. Stool: The increasing recognition of mycobacterial infections in patients with the acquired immunodeficiency syndrome (AIDS) has resulted in increased awareness of the potential to recover clinically significant mycobacteria from stool. Seven of 132 AIDS patients studied for intestinal infection were found to harbor M avium complex.22 Isolation of mycobacteria from stool indicates disseminated disease, and cultures from blood, bone marrow, and lymph nodes are usually also positive for the same mycobacterial isolate.23

Actin (Smooth Muscle) Antibody (ASMA)

Synonyms Antiactin Smooth Muscle Antibodies Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.3 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination; heat-treated specimen; specimen with preservative added Test Details Use Detection of antibodies aids in the diagnosis of autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC) Limitations Antiactin antibodies have been reported at low levels in 3% to 18% of sera from the general healthy population. The presence of immune complexes in the patient's sample may produce false positives in this assay. Not all smooth muscle positive samples will have actin antibodies. Methodology Enzyme-linked immunosorbent assay (ELISA) Reference Interval • Negative: 0−19 • Weak positive: 20−30 • Moderate to strong positive: >30 Additional Information Actin antibodies are found in 52% to 85% of patients with autoimmune hepatitis or chronic active hepatitis and in 22% of patients with primary biliary cirrhosis.

Activated Protein C Resistance (APCR)

Synonyms APCR Special Instructions If the patient's hematocrit exceeds 55%, the volume of citrate in the collection tube must be adjusted. Refer to Coagulation Collection Procedures for directions. Expected Turnaround Time 2 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Factor V Leiden Mutation Analysis Genetic Thrombophilia Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Plasma, frozen Volume 1 mL Container Blue-top (sodium citrate) tube Collection Citrated plasma samples should be collected by double centrifugation. Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood to anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples, except when using a winged blood collection device (ie, "butterfly"), in which case a discard tube should be used.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge for 10 minutes and carefully remove 2/3 of the plasma using a plastic transfer pipette, being careful not to disturb the cells. Deliver to a plastic transport tube, cap, and recentrifuge for 10 minutes. Use a second plastic pipette to remove the plasma, staying clear of the platelets at the bottom of the tube. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp No. 49482). Freeze immediately and maintain frozen until tested. Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume. Storage Instructions Freeze Patient Preparation Do not draw from an arm with a heparin lock or heparinized catheter. Ideally, the patient should not be on anticoagulant therapy. Avoid warfarin (Coumadin®) therapy for two weeks prior to the test and heparin (direct Xa and thrombin inhibitor therapies) for about three days prior to testing. Causes for Rejection Gross hemolysis; clotted specimen; frozen specimen thawed in transit; tubes <90% full; improper labeling; specimen collected in tube other than 3.2% citrate Test Details Use Screening test for the factor V Leiden gene mutation and other causes of activated protein C resistance Limitations This assay detects thrombotic risk factors other than factor V Leiden. This test should not be performed on individuals with extended baseline aPTT values due to the presence of lupus anticoagulants.6 This test should not be used for patients receiving thrombin inhibitors such as hirudin and argatroban.6 In some cases, this test will fail to distinguish individuals who are heterozygous for the factor V Leiden mutation from normals.7 Genetic testing may be required to distinguish between heterozygous and homozygous factor V Leiden mutation.7 Elevated factor VIII levels, as can be seen in acute phase reaction, can normalize the aPTT and effectively reduce the anticoagulant effect of aPC.7 Abnormal results can also be seen in pregnancy, especially during the third trimester, due to decreased levels of protein S and increased levels of factors V and VIII.7 Methodology This assay measures the effect of adding aPC on the activated partial thromboplastin time (aPTT) of the patient sample.8,9 An aPTT is performed twice, once with and again without added aPC. The ratio of the two clotting times is reported. The patient sample is diluted with factor V-deficient plasma. This serves to correct for any factor deficiencies in the patient sample and allows the test to be used for patients on oral anticoagulants. The reaction mixture also contains a heparin neutralizer to allow this test to be performed on patients receiving heparin therapy. Additional Information Activated protein C (aPC), in a complex with protein S, inactivates procoagulant factors Va and VIIIa by proteolytic cleavage at specific arginine residues.7,10,11 This serves to control coagulation and limit the extent of thrombus formation. The functionality of the aPC inhibitory system in a given individual can be assessed through an in vitro clotting assay. Addition of aPC to a patient's plasma serves to extend the activated partial thromboplastin time (aPTT) for individuals who are sensitive to aPC. Individuals are considered to be aPC resistant when addition of aPC fails to extend the time to clot formation in this assay. More than 95% of cases of aPC resistance are caused by a specific polymorphism in the factor V gene that is referred to as factor V Leiden.8 This single point mutation results in a substitution of glutamine for arginine at amino acid number 506 of factor V. Arginine number 506 is an aPC cleavage site of normal factor V, making factor V Leiden resistant to inactivation by aPC. Heterozygous factor V Leiden mutation occurs in 3% to 7% of persons of Northern European descent. However, this mutation is essentially absent in Asian, African, and Mediterranean populations.8 Individuals with heterozygous factor V Leiden have a three- to tenfold increased risk of thrombosis.8 The risk of thrombosis is approximately 80-fold increased in individuals who are homozygous for factor VLeiden.8 The incidence of factor V Leiden in unselected individuals experiencing their first venous thrombosis or pulmonary embolism is approximately 20%. In patients with a family history of thrombophilia, the likelihood of factor VLeiden being the cause reaches as high as 50%.8 Risk of thrombosis is further increased if the factor V Leiden mutation is accompanied by other prothrombotic conditions (ie, antithrombin, protein C or protein S deficiency, prothrombin G20210, pregnancy, oral contraceptive usage, prolonged immobilization, or surgery). While factor V Leiden is, by far, the most common genetic cause of aPC resistance, other polymorphisms can produce this condition.9 aPC resistance can occur due to an elevated factor VIII level, in itself a risk factor for thrombosis.9 Factor V Cambridge, a very rare mutation at another arginine residue of factor V, can produce aPC resistance.7,8 The HR2 haplotype, also referred to as A4070G mutation, is another rarely observed genetic cause of aPC resistance.7

Acylcarnitine Profile, Quantitative, Plasma

Expected Turnaround Time 3 - 7 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Plasma, frozen Volume 0.5 mL Minimum Volume 0.1 mL (Note: This volume does not allow for repeat testing) Container Green-top (sodium heparin) tube Collection Transfer plasma to a plastic transport tube and freeze. To avoid delays in turnaround time when requesting multiple tests on frozen specimens, please submit separate frozen specimens for each test requested. Storage Instructions Freeze Causes for Rejection Specimen thawed or not frozen; gross hemolysis; specimen type other than frozen plasma Test Details Use Used in the diagnosis and monitoring of inherited disorders of fatty acid oxidation and organic acidurias. May be used as a follow-up test to some abnormal newborn screen results. Limitations False-negative results can occur with acylcarnitine profiling, especially when the patient is carnitine deficient, is affected with a milder variant of a disorder, or when clinical condition or dietary supplementation causes secondary changes to the profile. Results of acylcarnitine profiling should be interpreted in the context of clinical presentation as well as other laboratory tests, which may include urine organic acid analysis and molecular testing. This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Flow injection/tandem mass spectrometry

Adalimumab and Anti-Adalimumab Antibody (Serial Monitor), DoseASSURE™ ADL

Synonyms Anti-TNF-α Drug DoseASSURE Humira® Test Includes Adalimumab concentration; antiadalimumab antibody level; serial monitoring Expected Turnaround Time 6 - 10 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Inflammatory Bowel Disease Biologics Flyer Rheumatoid Arthritis Brochure Rheumatic Biologics Flyer Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Brochure Rheumatologist Services Brochure Inflammatory Bowel Disease Brochure Sample Report Specimen Requirements Specimen Serum Volume 2 mL Minimum Volume 1 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Collection Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Refrigerate or freeze. Stability Requirements Temperature Period Room temperature 7 days Refrigerated 7 days Frozen 308 days Freeze/thaw Cycle Stable x6 Causes for Rejection Plasma specimen received Test Details Use Monitor antiadalimumab therapy for individuals with Crohn's disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides adalimumab drug concentration levels as well as the level of antiadalimumab antibodies. Methodology Electrochemiluminescence immunoassay (ECLIA) Reference Interval • Adalimumab drug level: − Quantitation limit: <0.6 μg/mL − Results ≥0.6 μg/mL indicate detection of adalimumab. In the presence of antiadalimumab antibody, the adalimumab drug level reflects the antibody-unbound fraction of adalimumab concentration in serum. • Antiadalimumab antibody: − Quantitation limit: 30 μg/mL). Failure of adalimumab therapy may not always be due to the presence of antiadalimumab antibodies. In addition, the absence of antiadalimumab antibodies does not guarantee positive response to treatment.

ADAMTS13 Antibody

Expected Turnaround Time 3 - 9 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information ADAMTS13 Activity ADAMTS13 Activity Reflex Profile Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Plasma, frozen Volume 0.5 mL Container Blue-top (sodium citrate) tube Collection Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood-to-anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Serum gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge and carefully remove the plasma using a plastic transfer pipette, being careful not to disturb the cells. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N° 49482). The specimen should be frozen immediately and maintained frozen until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Freeze. Causes for Rejection Nonfrozen sample received; noncitrate plasma received; sample left on cells Test Details Use Differentiating congenital from autoimmune ADAMTS13 deficiency Limitations Results for this test are for research purposes only by the assay's manufacturer. The performance characteristics of this product have not been established. Results should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. Methodology Enzyme-linked immunosorbent assay (ELISA) using microtiter plates coated with a recombinant form of ADAMTS13 protease Additional Information ADAMTS13 (a disintegrin and metalloprotease with thrombospondin 1 repeats) cleaves von Willebrand factor (vWF) between a tyrosine-1605 and methionine-1606 under circulatory conditions of high-shear stress.6-14 ADAMTS13 has also been referred to as von Willebrand factor-cleaving protease. Congenital or acquired deficiency of ADAMTS13 is characterized by the presence in plasma of unusually large vWF factor multimers which are more platelet-adhesive than the smaller multimers found in normal plasma. Congenital ADAMTS13 deficiency, also referred to as Upshaw-Schulman syndrome, is an autosomal recessive disorder that is associated with ADAMTS13 activity levels below the level of detection of activity assays (ie, >10% for the assay used by LabCorp.6-9 ADAMTS13 deficiency (both congenital and autoimmune) is associated with the formation of platelet-rich thrombi in the microcirculation in a clinical condition referred to as thrombotic thrombocytopenic purpura (TTP). Diagnosis of TTP involves documentation of thrombocytopenia and microangiopathic haemolytic anemia, evident on a blood smear. TTP is a life-threatening disease characterized by moderate to severe consumptive thrombocytopenia, red cell fragmentation, and elevated LDH levels (due to red cell destruction) and, ultimately, end-organ ischemia.8-10 Renal insufficiency and neurologic damage are end stage manifestations of TTP that are rarely seen in countries with advanced medical care.6-9 TTP is more common in women than men and can be present at any age, but the peak is between 30 and 40 years.14 Most patients with TTP present with nonspecific constitutional symptoms, such as weakness, abdominal pain, nausea, and vomiting. When these symptoms are associated with laboratory evidence of disseminated microvascular thrombi (also referred to as thrombomicroangiopathy or TMA) with thrombocytopenia and/or hemolytic anemia, schistocytes and elevated LDH, TTP should be considered in the differential diagnosis.9 Antibody to ADAMTS13 is not usually detected in patients with congenital deficiency. Most TTP cases are idiopathic and are associated antibodies to ADAMTS13 that reduce circulating functional enzyme levels. Acquired TTP is caused by autoantibodies that inhibit the proteolytic activity of ADAMTS13 and/or bind to ADAMTS13 and accelerate its clearance from plasma.11,13-18 Studies have shown that quantitative immunoassays for IgG-specific autoantibodies to ADAMTS13 are more sensitive than the functional (ie, inhibition) assays for detecting antibodies against ADAMTS13.16-18 Measurement of ADAMTS13 can play a role in differentiating TTP from a number of clinically similar conditions that have different underlying causes.7-9 These syndromes, which can be associated with pregnancy, organ transplantation, and certain medications, generally do not exhibit significantly reduced ADAMTS13 activity levels.8 Hemolytic uremic syndrome (HUS) is clinically similar to TTP, but is associated with acute renal failure.7 Diarrhea-associated HUS accounts for most cases and is usually by infection with Shiga-toxin-producing Escherichia coli (O157:H7). Diarrhea-negative or atypical HUS (aHUS) is thought to be caused by uncontrolled complement activation occurring in both children and adults and shares many of the clinical features of TTP.7,10-20; however, aHUS is not associated with severe reduction (ie, <10%) of ADAMTS13 activity.10 Disease classification based on clinical features alone can be unreliable and can result in inappropriate treatment or delay in the initiation of effective treatment.7 In patients exhibiting laboratory evidence of thrombocytopenia and microangiopathic hemolysis, therefore, the measurement of ADAMTS13 activity can be invaluable in differentiating TTP from other clinically similar conditions.7 Severe deficiency of ADAMTS13 (<10% activity for the LabCorp assay) is a relatively specific finding in patients with a clinical diagnosis of either hereditary or acquired TTP.11,21 An ADAMTS13 activity level greater than 10% (the diagnosis threshold for severe deficiency) does not completely exclude clinical diagnosis of TTP. As many as 40% of patients with clinically diagnosed TTP have ADAMTS13 levels greater than 10%.11,21 Other conditions that could have normal or mild-to-moderate deficiency of ADAMTS13 activity include hemolytic uremic syndrome (HUS), atypical hemolytic uremic syndrome (aHUS), and other thrombotic microangiopathies associated with hematopoietic stem cell and solid organ transplantation, liver disease, DIC, sepsis, pregnancy, or effects of certain medications (eg, ticlopidine, clopidogrel, cyclosporine, mitomycin C, quinine, etc).22

Adrenocorticotropic Hormone (ACTH), Plasma

Synonyms ACTH Corticotropin Special Instructions Instructions for suppression/stimulation tests involving ACTH measurement can be found in the online endocrine appendices ACTH Stimulation and Corticotropin-releasing Hormone Stimulation. This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample. Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information ACTH Stimulation Test Corticotropin-releasing Hormone Stimulation Dexamethasone Suppression Screening for Cushing Disease/Syndrome Related Documents Sample Report Specimen Requirements Specimen Plasma, frozen Volume 0.8 mL Minimum Volume 0.3 mL (Note: This volume does not allow for repeat testing.) Container Plastic or siliconized glass lavender-top (EDTA) tube Collection ACTH should be drawn between 7 AM and 10 AM. Collect into iced plastic or siliconized glass lavender-top (EDTA) tube, noting time of collection. After venipuncture, immediately immerse the tubes in an ice bath. Separate plasma from cells by centrifugation within one hour after venipuncture.1,2 Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N° 49482) immediately. Freeze immediately and maintain frozen until tested. Contact LabCorp's supply department for special tubes. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Freeze immediately. Stability Requirements Temperature Period Room temperature Unstable Refrigerated Unstable Frozen 14 days Freeze/thaw cycles Stable x1 Causes for Rejection Thawed specimen; serum or heparinized plasma specimen; specimen collected in nonsiliconized glass tube Test Details Use Pituitary function test useful in the differential diagnosis of Cushing syndrome, ectopic ACTH syndrome (eg, carcinoma of lung, islet cell tumors, carcinoid tumors, medullary carcinoma of thyroid), Addison disease, hypopituitarism, and ACTH-producing pituitary tumors (eg, Nelson syndrome) Limitations ACTH secretion is pulsatile so multiple specimen collections may be required. Collection in nonsiliconized tubes can result in falsely low results as ACTH adheres to glass. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or who have received them for diagnostic purposes.3 In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur.3 The test contains additives, which minimize these effects. Methodology Electrochemiluminescence immunoassay (ECLIA)

Aerobic Bacterial Culture, General

Synonyms Culture, Bacterial, General, Aerobic Eye Fluids Routine Culture, Abscess Wound Test Includes Isolation and identification (additional CPT codes) of potential aerobic pathogens and drug susceptibility tests (additional charge). Gram stain (additional test) is recommended. CPT coding for microbiology and virology procedures often cannot be determined before the culture is performed. Requests with only a written order and no test number indicated will be processed according to Default Testing for Routine Microbiology. Special Instructions The test request form must state specific site of specimen, age of patient, and time of collection. Inclusion of current antibiotic therapy and clinical diagnosis may aid the laboratory in evaluating the specimen and work-up of the culture. If an unusual organism is suspected, this information must be specifically noted on the test request form (eg, Nocardia) and may result in additional charges. For extended incubation, order Aerobic Culture, Extended Incubation [180803]. Specimens from other sources, such as genital, stool, urine, upper and lower respiratory specimens, cannot be cultured under the aerobic bacterial culture test number. If specimens are incorrectly submitted with an order for aerobic bacterial culture, the laboratory will process the specimen for the test based on the source listed on the test request form. The client will not be telephoned to approve this change, but the change will be indicated on the report. Expected Turnaround Time 3 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Methicillin-resistant Staphylococcus aureus (MRSA) Colonization Screening Culture Methicillin-resistant Staphylococcus aureus (MRSA), NAA Routine Microbiology Related Documents Sample Report Specimen Requirements Specimen Pus or other material properly obtained from a body site (abscesses, eyes, tissue, wounds). Do not send syringe with needle. Volume Swab or 0.5 mL aseptically aspirated pus or tissue Container Sterile screw-cap container or bacterial swab transport; ESwab™ is acceptable Collection Disinfect contiguous areas of skin or mucous membrane containing resident normal flora prior to culture collection. Collect exudates from the interior of productive lesions. Tissue samples must be kept moist. A thin, air-dried smear for Gram stain obtained from the same site as the culture is strongly recommended (additional test). Storage Instructions Maintain specimen at room temperature. Patient Preparation Sterile preparation of the aspiration site is required. Causes for Rejection Improper labeling; specimen received in grossly leaking transport container; specimen received in expired transport media; specimen received after prolonged delay (usually more than 48 hours) Test Details Use Isolate and identify potentially pathogenic aerobic organisms. Susceptibility test is performed at additional charge when organisms isolated meet microbiologic criteria for clinical significance. Limitations Only rapid-growing, nonfastidious aerobic organisms can be recovered and identified by routine methods. Only organisms that predominate will be identified. Unless specifically requested by the physician, fastidious organisms may not be isolated. Anaerobic, fungal, and mycobacterial pathogens should be considered, and appropriate cultures requested if clinically indicated. The procedure will not detect Chlamydia, viruses, fungi, or mycobacteria. Methodology Culture Reference Interval No growth, routine/normal skin flora, routine/normal “body site” flora. Wounds often become colonized by multiple gram-negative rods and mixed culture results are common. A simultaneous Gram stain should always be prepared and performed (additional charge) to facilitate interpretation. Eye: Routine flora of the eye may include Corynebacterium sp (diphtheroids), Staphylococcus epidermidis, saprophytic fungi, Moraxella (Branhamella) catarrhalis, Moraxella sp, Streptococcus sp (nonhemolytic), and gram-negative rods (rare). Abnormal ocular flora include Haemophilus influenzae, Haemophilus aegyptius, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Neisseria gonorrhoeae, and Mycobacterium chelonae. Wound: Routine skin flora may include coagulase-negative staphylococci, Corynebacterium sp (diphtheroids), α-streptococci (Streptococcus viridans, or viridans streptococci). Additional Information Eye: The major modes of transmission of disease to the conjunctiva include the hands, airborne fomites, and spread for adjacent adnexal infections. Eye infections include eyelid infections, blepharitis, dacryocystitis, orbital cellulitis, conjunctivitis, keratitis, endophthalmitis retinitis, and chorioretinitis. Pinkeye is caused by adenovirus. It presents as bilateral conjunctivitis with a sudden onset. Herpes simplex and zoster present as periorbital or corneal infections. Nontuberculous mycobacterial keratitis may occur following trauma or surgery accompanied by the use of local corticosteroids.1 Wound: Susceptibility testing is usually performed. The majority of bacteria infecting surgical wounds are common airborne microörganisms.2 Effective treatment of wound infection usually includes drainage, removal of foreign bodies, infected prosthetic devices, and retained foreign objects such as suture material. Suction irrigation may be helpful in resolving wound infections. Species commonly recovered from wounds include Escherichia coli, Proteus sp, Klebsiella sp, Pseudomonas sp, Enterobacter sp, enterococci, other streptococci, Bacteroides sp, Prevotella sp, Clostridium sp, Staphylococcus aureus, and coagulase-negative Staphylococcus.

Alanine Aminotransferase (ALT/SGPT)

Synonyms Glutamic Pyruvate Transaminase SGPT Transaminases Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Clinical Practice Algorithms for Evaluation of Liver Function Chemistry Tests - Technical Review Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube, gel-barrier tube, green-top (heparin) tube, or lavender-top (EDTA) tube Collection Separate serum or plasma from cells within 45 minutes of collection. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 7 days Refrigerated 14 days Causes for Rejection Gross hemolysis; excessive lipemia; improper labeling Test Details Use A liver function test, ALT is more sensitive for the detection of hepatocyte injury than for biliary obstruction. ALT is more specific for liver injury than AST (SGOT). Useful for hepatic cirrhosis, other liver disease. Increased in Reye syndrome, with AST.1 Test for hepatitis. Acute hepatitis A or B can be confirmed serologically, as can hepatitis C. Negative serological findings in the presence of hepatitis-like chemistry abnormalities may also suggest acute drug-induced hepatitis, an impression supported by resolution after removal of the offending agent.2 The combination of increased AST and ALT with negative hepatitis markers occurs in a number of other entities including infectious mononucleosis. Sensitive to heart failure. Limitations Grossly hemolyzed samples can generate somewhat spurious results. The activity in red cells is six times that of serum. Elevations are reported in trauma to striated muscle, rhabdomyolysis, polymyositis and dermatomyositis, but the CK (CK-MM fraction) is increased in such patients and it is preferable to consider diseases of skeletal muscle. ALT is less sensitive than is AST to alcoholic liver disease. Increased ALT is found with obesity. Methodology Kinetic Additional Information Among entities in which AST and ALT increases occur, are therapeutic applications of bovine or porcine heparin. LD (LDH) abnormality with elevation of hepatic fractions was also reported.3 In children with acute lymphoblastic leukemia, high ALT activity at diagnosis is associated with rapidly progressive ALL.4 A number of drugs, including diphenylhydantoin, heparin therapy and many others, cause ALT increases. Acetaminophen hepatotoxicity may be potentiated in alcoholics, in whom coagulopathy and extremely abnormal aminotransferase levels are described, ALT less than AST.5 The hepatitis C virion has been detected by polymerase chain reaction and reverse transcriptase of HCV-RNA sequences in patients with elevated ALT and positive anti-HCV.6

Albumin

Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube, gel-barrier tube, green-top (heparin) tube, or lavender-top (EDTA) tube Collection Separate serum or plasma from cells within 45 minutes of collection. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Fluoride plasma specimen; gross hemolysis; lipemia; improper labeling Test Details Use Evaluation of nutritional status, blood oncotic pressure; evaluation of renal disease with proteinuria and other chronic diseases. High albumin may indicate dehydration. Look for increase in hemoglobin, hematocrit in such patients. Low albumin is found with use of I.V. fluids, rapid hydration, overhydration; cirrhosis, other liver disease, including chronic alcoholism; in pregnancy and with oral contraceptive use; many chronic diseases including the nephrotic syndromes, neoplasia, protein-losing enteropathies (including Crohn's disease and ulcerative colitis), peptic ulcer, thyroid disease, burns, severe skin disease, prolonged immobilization, heart failure, chronic inflammatory diseases such as the collagen diseases and other chronic catabolic states. Starvation, malabsorption, or malnutrition: In the absence of I.V. fluid therapy and in patients without liver or renal disease, low albumin may be regarded as an indication of inadequate body protein reserves. It is described as the most common nutrition-related abnormality in patients with infection.1 Serum albumin has a half-life of about 18 to 20 days. Its half-life is decreased in patients with catabolic states: infection and with protein loss through the kidneys (eg, nephrosis), gastrointestinal tract, and skin (eg, burns). Its prognostic application is most useful in patients with weight loss, anorexia, stress, surgical therapy, hemorrhage, and infection. Total iron binding capacity <240 μg/dL1 and/or low transferrin levels would support an impression of inadequate protein reserves. Absolute lymphocyte counts <1500/mm3 may also be seen with protein malnutrition.2 In severe malnutrition, albumin has been reported as <2.5 g/dL, total lymphocytes as <800/mm3 and TIBC as <150 μg/dL.2 Albumin levels ≤2.0−2.5 g/dL may be the cause of edema (eg, nephrotic syndrome, protein-losing enteropathies). Albumin, prealbumin, and transferrin are regarded as “negative” acute phase reactants (ie, these proteins decrease with acute inflammatory/infectious processes). Low albumin values are associated with longer hospital stay.1 Methodology Colorimetric Additional Information Twenty-four hour urine collection to measure protein loss is helpful in work-up of some patients with hypoalbuminemia. Other tests useful in assessment of nutritional status include TIBC, transferrin, iron, absolute lymphocyte count, and vitamin B12/folate levels.

Albumin/Creatinine Ratio, Random Urine

Synonyms Albumin:Creatinine Ratio, Random Urine Microalbumin Test Includes Albumin, random urine; creatinine; albumin:creatinine ratio Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Urine Specimens Related Documents Sample Report Specimen Requirements Specimen Urine (random) Volume 10 mL Minimum Volume 2 mL (Note: This volume does not allow for repeat testing.) Container Plastic urine container Collection Collect random urine without preservatives. pH must be 4 to 8. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Bloody specimen Test Details Use Measurement of albumin levels in urine below the detection level of urine dipsticks. This test is useful in the management of patients with relatively early diabetes mellitus to assist in avoiding or delaying the onset of diabetic renal disease. Limitations Because of the inherent day-to-day variability of albumin excretion into the urine, two of three albumin levels measured within a three-month to six-month period should be abnormal before considering a patient to have crossed a diagnostic threshold.1 Physical exercise during the previous 24 hours can cause a transient elevation in albumin. Other variables, including infection, fever, congestive heart failure, marked hyperglycemia, and marked hypertension, can result in increased albumin levels. Methodology Albumin: immunoturbidimetric; Creatinine: kinetic Reference Interval • Normal: 0−30 mg/g creatinine • Albuminuria: 30−300 mg/g creatinine • Clinical albuminuria: >300 mg/g creatinine Additional Information Albumin accounts for approximately 50% of the protein in plasma.2 The kidney works to prevent the loss of albumin into the urine through active resorption, but a small amount of albumin can be measured in urine of individuals with normal renal function. The prognostic value of consistently elevated albumin levels is particularly well established in diabetic patients.1 Renal disease is a common microvascular complication of diabetes. Without specific interventions, 80% of type I diabetics with repeatedly elevated albumin levels will go on to end-stage renal disease. Twenty percent to 40% of type II diabetics with sustained albuminuria will progress to overt nephropathy. The American Diabetes Association (ADA) recommends that routine urinalysis be performed annually on adults with diabetes.1 If the urinalysis is negative for protein, albumin measurement is recommended. The ADA also recommends annual screening of children beginning at puberty or after five years of disease duration. The reference intervals stated above reflect the diagnostic criteria prescribed by the ADA.1

Aldolase

Aldosterone, LC/MS

Special Instructions Instructions for suppression/stimulation tests that involve serum aldosterone measurement can be found in the online Endocrine Appendices: Dexamethasone Suppression and ACTH Stimulation. Also, refer to the online Endocrine Appendix: Multiple-specimen Testing for instructions. Expected Turnaround Time 4 - 7 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Dexamethasone Suppression Screening for Cushing Disease/Syndrome Multiple-specimen Testing Related Documents For more information, please view the literature below. Adrenal Steroid Response to ACTH: Pediatrics Sample Report Specimen Requirements Specimen Serum or plasma Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube Collection If a tube other than gel-barrier is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Refrigerate Stability Requirements Temperature Period Room temperature 3 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation In order to facilitate interpretation of test results, the patient should be taken off medications for at least three weeks prior to sample collection. Dietary sodium levels during the period prior to testing can affect aldosterone levels. Reference intervals are based on the clinician's verification that the patient has been on a normal sodium diet. Since patient posture prior to collection affects aldosterone levels, it is recommended that the patient be ambulatory for at least 30 minutes before blood collection. If inpatients are physically able, they should be asked to ambulate for 30 minutes before blood is drawn for aldosterone. Reference intervals are provided for patients who have ambulated for at least 30 minutes prior to collection (standing patients). Causes for Rejection Gross hemolysis; gross lipemia Test Details Use Evaluate patients with hypertension and possible hyperaldosteronism Limitations Decreased perfusion of the kidneys leads to increased aldosterone and renin. This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration. Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS) Reference Interval • Premature infant: − 26 to 28 weeks, day 4: 5.0−635.0 ng/dL − 31 to 35 weeks, day 4: 19.0−141.0 ng/dL • Full-term infant: − 3 days: 7.0−184.0 ng/dL − 7 days: 5.0−175.0 ng/dL − 1 to 11 months: 5.0−90.0 ng/dL − 1 year: 7.0−54.0 ng/dL − 2 to 9 years: 5.0−80.0 ng/dL − 10 to 14 years: 4.0−48.0 ng/dL − >14 years: 0.0−30.0 ng/dL Additional Information The renin-angiotensin system and potassium ion are the major regulators of aldosterone secretion, whereas ACTH and other POMC peptides, sodium ion, vasopressin, dopamine, ANP, α-adrenergic agents, serotonin, and somatostatin are minor modulators.1,2 Renin cleaves angiotensinogen, which is synthesized by the liver to produce angiotensin I. Angiotensin I is, in turn, rapidly cleaved by angiotensin-converting enzyme (ACE) in the lung and other tissues to form, angiotensin II. Angiotensin II stimulates aldosterone secretion and vasoconstriction. Factors that decrease renal blood flow, such as hemorrhage, dehydration, salt restriction, upright posture, and renal artery narrowing, increase renin levels which, in turn, raise aldosterone levels. In contrast, factors that increase blood pressure, such as high salt intake, peripheral vasoconstrictors, and supine posture, decrease renin and aldosterone levels.3 Aldosterone promotes active sodium transport and excretion of potassium. Hypokalemia increases and hyperkalemia decreases renin release.1 Potassium also directly increases aldosterone secretion by the adrenal cortex and aldosterone then lowers serum potassium by stimulating its excretion by the kidney. High dietary potassium intake increases plasma aldosterone and enhances the aldosterone response to a subsequent potassium or angiotensin II infusion.3 Aldosterone deficiency conditions typically present with electrolyte abnormalities, including a variable degree of hyponatremia, hyperkalemia, and metabolic acidosis.1,2,4 Congenital aldosterone deficiency is characterized by poor growth in childhood and minimal symptoms in adults. Infants typically suffer recurrent dehydration, salt wasting, and failure to thrive. These symptoms are present generally within the first three months of life. A modest uremia with a normal creatinine level reflects dehydration in the presence of intrinsically normal renal function. Plasma renin activity is invariably elevated. Hypoaldosteronism can occur in any condition that causes destruction or dysfunction of the adrenal gland.1,2,4 These conditions include primary adrenal insufficiency, congenital adrenal hypoplasia, isolated mineralocorticoid deficiency, acquired secondary aldosterone deficiency (hyporeninemic hypoaldosteronism), and acquired primary aldosterone deficiency. Hyporeninemic hypoaldosteronism is the most common form of isolated hypoaldosteronism and is caused by impaired renin release from the kidney. Congenital hypoaldosteronism caused by inherited enzymatic defects in aldosterone biosynthesis are rare. Corticosterone methyloxidase I (CMO I) deficiency is associated with elevated serum levels of corticosterone and low levels of 18-hydroxy-corticosterone and aldosterone. Corticosterone methyloxidase II (CMO II) deficiency produces high levels of 18-hydroxy-corticosterone, the immediate precursor of aldosterone. Acquired primary hypoaldosteronism can be caused by the administration of heparin. Also, persistently hypotensive, critically ill patients with sepsis, pneumonia, peritonitis, cholangitis, and liver failure can have inappropriately low plasma aldosterone concentrations in relation to elevated plasma renin activity. Primary hyperaldosteronism, also referred to as Conn syndrome, is caused by the overproduction of aldosterone by one or both of the adrenal glands.1,2 Historically, primary aldosteronism was considered to be an uncommon cause of hypertension; however, recent studies indicate that 10% to 15% of cases are associated with primary hyperaldosteronism.5 Secondary hyperaldosteronism is relatively common and can occur as the result of any condition that decreases blood flow to the kidneys (ie, renal artery stenosis), decreases blood pressure, or lowers plasma sodium levels. Secondary hyperaldosteronism may also be seen with cirrhosis, congestive heart failure. and toxemia of pregnancy. Hyperaldosteronism increases reabsorption of sodium and loss of potassium by the kidneys, resulting in an electrolyte imbalance.1,6 The condition can be asymptomatic, although muscle weakness can occur if potassium levels are very low. Several studies have suggested that high-normal aldosterone levels predict development of high blood pressure in normotensive subjects7 and that increased aldosterone action contributes to hypertension, cardiovascular fibrosis, and cardiac hypertrophy.6-8

Aldosterone:Renin Ratio

Synonyms ARR Test Includes Aldosterone, plasma renin activity (PRA) Expected Turnaround Time 2 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum (refrigerated) and plasma (frozen) Volume 1 mL serum and 1 mL plasma Minimum Volume 0.5 mL serum and 0.8 mL plasma (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube and lavender-top (EDTA) tube Collection Collect blood mid morning, after the patient has been up (sitting, standing, or walking) for at least two hours and seated for 5 to 15 minutes. Refer to descriptions for individual tests Renin Activity, Plasma [002006] and Aldosterone, LC/MS [004374] for more detailed preparation and test collection information. After collection, immediately centrifuge the lavender-top tube at room temperature, transfer plasma to a transport tube, and freeze. Label this tube "Frozen Plasma−Renin." If a red-top tube is used, transfer separated serum to a plastic transport tube. Label the serum tube "Serum−Aldosterone." To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Serum, refrigerated and plasma, frozen Patient Preparation Patients should be instructed to maintain an unrestricted dietary salt intake prior to testing. Washout of all interfering antihypertensive medications may be considered in patients with mild hypertension, but is potentially problematic in others and perhaps unnecessary in that medications with minimal effect on the ARR can be used in their place. The patient should not take drugs that markedly affect the ARR for at least four weeks prior to blood collection. These drugs include: • Spironolactone, eplerenone, amiloride, and triamterene • Potassium-wasting diuretics • Products derived from liquorice root (eg, confectionary licorice, chewing tobacco) More details can be found in the Endocrine Society clinical practice guideline.1 Test Details Use Screening test for primary aldosteronism in higher risk groups of hypertensive patients Limitations A number of factors can affect the aldosterone:renin ratio and thus lead to false-positive or false-negative results.1 These include: Factors producing falsely increased ARR (false negative) • Potassium-wasting diuretics • Potassium-sparing diuretics • Angiotensin-converting enzyme (ACE) inhibitors • Angiotensin II type 1 receptor blockers (ARBs) • Calcium blockers, dihydropyridines (DHPs) • Hypokalemia • Sodium restricted • Pregnancy • Renovascular hypertension • Malignant hypertension Factors producing falsely increased ARR (false positive) • β-adrenergic blockers • Central α2-agonists (eg, clonidine, α-methyldopa) • Nonsteroidal anti-inflammatory drugs (NSAIDs) • Renin inhibitors • Potassium loading • Sodium loaded • Advancing age • Renal impairment • Pseudohypoaldosteronism type 2 The ARR should be regarded as a detection test only, and should be repeated if the initial results are inconclusive or difficult to interpret because of suboptimal sampling conditions (eg, maintenance of some medications listed above). The consensus guideline recommended that patients with a positive ARR should proceed to confirmatory testing by any of four confirmatory tests.1 Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS)

Alkaline Phosphatase

Special Instructions Values obtained with different assay methods should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy. This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring is required, please use the serial monitoring number 480004 to order. Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 2 mL Minimum Volume 0.5 mL Container Red-top tube, gel-barrier tube, or green-top (heparin) tube Collection Separate serum or plasma from cells within 45 minutes of collection. If a red-top tube or green-top tube is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; plasma specimen; specimen collected in EDTA tube; improper labeling Test Details Use Causes of high alkaline phosphatase include bone growth, healing fracture, acromegaly, osteogenic sarcoma, liver or bone metastases, leukemia, myelofibrosis, and rarely myeloma. Alkaline phosphatase is used as a tumor marker.3,4 In rickets and osteomalacia, serum calcium and phosphorus are low to normal, and alkaline phosphatase may be normal or increased. Hypervitaminosis D may cause elevations in alkaline phosphatase. In Paget disease of bone there is often isolated elevation of serum alkaline phosphatase. Some of the highest levels of serum ALP are seen in Paget disease. Hyperthyroidism, by its effects upon bone, may elevate alkaline phosphatase. There is evidence that thyroid hormone (T3) acts to stimulate bone alkaline phosphatase activity through an osteoblast nuclear receptor-mediated process.5 Hyperparathyroidism, in some patients. Pseudohyperparathyroidism. Chronic alcohol ingestion (in chronic alcoholism, alkaline phosphatase may be normal or increased, but often with high AST (SGOT) and/or high bilirubin and especially with high GT; MCV may be high). Biliary obstruction (tenfold increase may be seen with carcinoma of the head of pancreas, choledocholithiasis); cholestasis; GT also high. Cholecystitis with cholangitis. (In most patients with cholecystitis and cholangitis who do not have a common duct stone, alkaline phosphatase is within normal limits or only slightly increased.) Sclerosing cholangitis (eg, with ulcerative colitis), although importantly, 3% of cases of symptomatic sclerosing cholangitis may have normal serum ALP.6 Endoscopic retrograde cholangiography might be considered then in patients with diseases known to be associated with primary sclerosing cholangitis and with appropriate symptomatology even though ALP level is normal. Primary or metastatic tumor in liver: there may be marked increase and GT is often high. Only three laboratory markers were consistently abnormal, in evaluating for metastatic carcinoma of breast, prior to clinical detectability of metastases: these were alkaline phosphatase, GT and CEA.4 Cirrhosis, especially in primary biliary cirrhosis, in which fivefold or more increases are seen. Gilbert syndrome: Increase in intestinal alkaline phosphatase is seen.7 Hepatitis: Moderate increases in alkaline phosphatase occur in viral hepatitis, but greater elevations of the transaminases (AST [SGOT], ALT [SGPT]) are usually found. Fatty metamorphosis of liver (moderate increase occurs in acute fatty liver). Diabetes mellitus, diabetic hepatic lipidosis. Infiltrative liver diseases (eg, sarcoid, TB, amyloidosis, abscess). Sepsis. Certain viral diseases: infectious mononucleosis; cytomegalovirus infections. Postoperative cholestasis. Pancreatitis, carcinoma of pancreas, cystic fibrosis. Pulmonary infarct (one to three weeks after embolism. Healing infarcts in other organs, including kidney, may also cause increased alkaline phosphatase); other situations in which angiofibroplasia occurs, such as healing in a large decubitus ulcer. Tumors, especially hypernephroma; neoplastic ectopic production (Regan, Nagao isoenzymes). Fanconi syndrome. Peptic ulcer, erosion. Intestinal strangulation or obstruction, or ulcerative lesion. Steatorrhea, malabsorption (from bone, secondary to vitamin D deficiency). Ulcerative colitis with pericholangitis, other erosive lesions of colon. Congestive heart failure. Parenteral hyperalimentation of glucose, intravenous albumin administration. Familial hyperphosphatasemia. Idiopathic. Drugs − estrogens (large doses), birth control agents, methyltestosterone, phenothiazines, oral hypoglycemic agents, erythromycin, or any drug producing hypersensitivity or toxic cholestasis. Many commonly and uncommonly used drugs elevate alkaline phosphatase, and tenfold increases may be seen with drug cholestasis. Causes of low alkaline phosphatase are said to include: Hypothyroidism − but most hypothyroid patients have normal alkaline phosphatase. Pernicious anemia − in very few patients. Hypophosphatasia: Very low alkaline phosphatase values are found in the presence of normocalcemia or hypocalcemia. This diagnosis may be confirmed by quantitation of urinary phosphoethanolamine. Malnutrition has been reported to relate to low values, but in practice, diseases causing malnutrition relate often to high alkaline phosphatase results (eg, disseminated neoplasia). Some drugs (clofibrate, azathioprine, estrogens and estrogens in combination with androgens) lower serum ALP activity. Limitations Used alone, alkaline phosphatase may be misleading.

Allergen Profile Plus, IgE (Pediatric)

Synonyms Pediatric Allergy Profile Plus, IgE Test Includes Alternaria alternata; cat dander; Cladosporium herbarum; cockroach, German; codfish; Dermatophagoides farinae; Dermatophagoides pteronyssinus; dog dander; egg white; milk; mouse urine; peanut; shrimp; soybean; walnut; wheat Expected Turnaround Time 3 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 2 mL Minimum Volume 1.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Inadequate labeling; gross hemolysis Test Details Use Detect possible allergic responses to various foods and substances in the environment (see Test Includes) and evaluate for hay fever, asthma, atopic eczema, and respiratory allergy. The quantitative allergen-specific IgE test is indicated (1) to determine whether an individual has elevated allergen-specific IgE antibodies; (2) if specific allergic sensitivity is needed to allow immunotherapy to be initiated; (3) when testing individuals for agents that may potentially cause anaphylaxis; (4) when evaluating individuals who are taking medication (eg, long-acting antihistamines) that may interfere with other testing modalities (eg, skin testing); (5) if immunotherapy or other therapeutic measures based on skin testing results have not led to a satisfactory remission of symptoms; (6) when an individual is unresponsive to medical management where identification of offending allergens may be beneficial. Methodology Thermo Fisher ImmunoCAP®

Allergen Profile With Total IgE, Respiratory−Area 1

Test Includes Area 1: Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont Alternaria alternata; ash, white; Aspergillus fumigatus; Bermuda grass; cat dander; cedar, mountain; Cladosporium herbarum; cockroach, German; common silver birch; cottonwood; Dermatophagoides farinae; Dermatophagoides pteronyssinus; dog dander; elm, American; maple leaf sycamore; maple/box elder; mouse urine; mugwort; oak, white; Penicillium chrysogenum; pigweed, rough; ragweed, short; sheep sorrel; timothy; walnut; white mulberry Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 3.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Inadequate labeling; gross hemolysis Test Details Use Detect possible allergic responses to various substances in the environment (see Test Includes) and evaluate for hay fever, asthma, atopic eczema, and respiratory allergy. The quantitative allergen-specific IgE test is indicated (1) to determine whether an individual has elevated allergen-specific IgE antibodies; (2) if specific allergic sensitivity is needed to allow immunotherapy to be initiated; (3) when testing individuals for agents that may potentially cause anaphylaxis; (4) when evaluating individuals who are taking medication (eg, long-acting antihistamines) that may interfere with other testing modalities (eg, skin testing); (5) if immunotherapy or other therapeutic measures based on skin testing results have not led to a satisfactory remission of symptoms; (6) when an individual is unresponsive to medical management where identification of offending allergens may be beneficial. Methodology Thermo Fisher ImmunoCAP®

Allergen Profile With Total IgE, Respiratory−Area 2

Test Includes Area 2: Delaware, District of Columbia, Maryland, North Carolina, Virginia, Alternaria alternata; Aspergillus fumigatus; Bermuda grass; cat dander; cedar, mountain; Cladosporium herbarum; cockroach, German; common silver birch; cottonwood; Dermatophagoides farinae; Dermatophagoides pteronyssinus; dog dander; elm, American; Johnson grass; maple/box elder; mouse urine; oak, white; pecan, hickory; Penicillium chrysogenum; pigweed, rough; ragweed, short; sheep sorrel; timothy; white mulberry Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 3.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Inadequate labeling; gross hemolysis Test Details Use Detect possible allergic responses to various substances in the environment (see Test Includes) and evaluate for hay fever, asthma, atopic eczema, and respiratory allergy. The quantitative allergen-specific IgE test is indicated (1) to determine whether an individual has elevated allergen-specific IgE antibodies; (2) if specific allergic sensitivity is needed to allow immunotherapy to be initiated; (3) when testing individuals for agents that may potentially cause anaphylaxis; (4) when evaluating individuals who are taking medication (eg, long-acting antihistamines) that may interfere with other testing modalities (eg, skin testing); (5) if immunotherapy or other therapeutic measures based on skin testing results have not led to a satisfactory remission of symptoms; (6) when an individual is unresponsive to medical management where identification of offending allergens may be beneficial. Methodology Thermo Fisher ImmunoCAP®

Allergen Profile, Food

Synonyms Food Allergen Profile Test Includes Clam; codfish; corn; egg white; milk; peanut; scallop; sesame seed; shrimp; soybean; walnut; wheat Expected Turnaround Time 3 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 2 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Inadequate labeling; gross hemolysis Test Details Use Detect possible allergic responses to various foods (see Test Includes) and evaluate for hay fever, asthma, atopic eczema, and respiratory allergy. The quantitative allergen-specific IgE test is indicated (1) to determine whether an individual has elevated allergen-specific IgE antibodies; (2) if specific allergic sensitivity is needed to allow immunotherapy to be initiated; (3) when testing individuals for agents that may potentially cause anaphylaxis; (4) when evaluating individuals who are taking medication (eg, long-acting antihistamines) that may interfere with other testing modalities (eg, skin testing); (5) if immunotherapy or other therapeutic measures based on skin testing results have not led to a satisfactory remission of symptoms; (6) when an individual is unresponsive to medical management where identification of offending allergens may be beneficial. Methodology Thermo Fisher ImmunoCAP®

Allergen Profile, Food−Basic

Test Includes Codfish; cow's milk; egg white; peanut; soybean; wheat Expected Turnaround Time 3 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Allergens, Specific IgE Test Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.8 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Recently administered isotopes; inadequate labeling; gross hemolysis Test Details Methodology Thermo Fisher ImmunoCAP®

Allergen Profile, Food−Meat

Test Includes Beef; chicken; pork Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Allergens, Specific IgE Test Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Recently administered isotopes; inadequate labeling; gross hemolysis Test Details Methodology Thermo Fisher ImmunoCAP®

Allergen Profile, Food−Nuts

Test Includes Almond; Brazil nut; cashew nut; hazelnut/filbert; peanut; pecan nut; walnut Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Allergens, Specific IgE Test Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 1 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Recently administered isotopes; inadequate labeling; gross hemolysis Test Details Methodology Thermo Fisher ImmunoCAP®

Allergen Profile, Food−Shellfish

Test Includes Clam; crab; lobster; oyster; scallop; shrimp Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Allergens, Specific IgE Test Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 1 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Recently administered isotopes; inadequate labeling; gross hemolysis Test Details Methodology Thermo Fisher ImmunoCAP®

Allergen Profile, Mini Profile

Synonyms Mini Allergen Profile Test Includes Alternaria tenuis; Bermuda grass; cat hair (standardized); Dermatophagoides farinae (dust mite); Dermatophagoides pteronyssinus (dust mite); dog epithelia; American elm; English plantain; Kentucky bluegrass (June grass); mouse urine; white oak; ragweed, short/common Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Allergens, Specific IgE Test Related Documents For more information, please view the literature below. Allergy Services: Identify and Manage Patients With Allergic Disease Allergy Test Menu Sample Report Specimen Requirements Specimen Serum Volume 2 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Improper labeling; gross hemolysis Test Details Use Detect possible allergic responses to various substances in the environment (see Test Includes), and evaluate for hay fever, asthma, atopic eczema, and respiratory allergy. The quantitative allergen-specific IgE test is indicated (1) to determine whether an individual has elevated allergen-specific IgE antibodies; (2) if specific allergic sensitivity is needed to allow immunotherapy to be initiated; (3) when testing individuals for agents that may potentially cause anaphylaxis; (4) when evaluating individuals who are taking medication (eg, long-acting antihistamines) that may interfere with other testing modalities (eg, skin testing); (5) if immunotherapy or other therapeutic measures based on skin testing results have not led to a satisfactory remission of symptoms; (6) when an individual is unresponsive to medical management where identification of offending allergens may be beneficial. Methodology Thermo Fisher ImmunoCAP®

Allergen Profile, Peanut, IgE With Component Reflexes

Test Includes Peanut (whole); Reflex criteria: If peanut (whole) IgE ≥0.10 kU/L, Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, and Ara h 9 will be performed. Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Food Component Allergen Testing Services Tree Nut Allergen Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Test Details Use The measurement of specific immunoglobulin E (IgE) to individual components of an allergen, either purified native or recombinant, is referred to as component resolved diagnosis (CRD).1-5 This approach represents an improvement over traditional measurement of IgE to allergen extracts that contain a mixture of proteins. The pattern of specific IgE reactivity to component allergens can predict which patients are at higher risk for systemic allergic reactions versus those who are sensitized but clinically tolerant. CDR can also be used to predict which patients are at risk for more severe reactions and which patients are likely to have milder symptoms. Allergies to plant derived foods can occur as the result of sensitization to relatively stable proteins, such as the seed storage or lipid transfer proteins. Sensitization to this type of protein can be associated with more severe, systemic reactions and a higher risk for anaphylaxis. Alternatively, allergies to plant derived foods may occur in pollen sensitized individuals due to pollen allergens that cross react with food allergens. Examples of pollen associated allergens are the profilins or PR10 proteins that are homologues of the major white birch pollen antigen Bet v 1. Allergy to this family of proteins is associated with symptoms that are generally limited to the oropharyngeal area (commonly referred to as the oral allergy syndrome of pollen food allergy syndrome. Component resolved diagnostics can help to:1-5 • Distinguish between allergy due to cross-reactivity and primary allergy • Improve the risk assessment using allergen components • Improve management of allergic patients Limitations Allergen-specific IgE assays do not demonstrate absolute positive and negative predictive values for allergic disease. Clinical history must be incorporated into the diagnostic determination. Although the use of component resolved IgE testing may enhance the evaluation of potentially allergic individuals over the use of whole extracts alone, it cannot yet replace clinical history and oral food challenge in most cases. Sensitization against thus far unidentified determinants that are not found in the whole extract our in components might cause symptoms in rare cases. Methodology Thermo Fisher ImmunoCAP® Allergen-specific IgE Additional Information Peanut.While sensitization to peanut is common, with somewhere between 8% and 12% of the general public showing sensitivity on either skin prick test or peanut extract allergen specific IgE testing, the majority of these people are not allergic.6-11 Peanut Components Ara h 1 Ara h 2 Ara h 3 • Sensitization to Ara h 1, 2 and 3 is usually acquired in childhood.16 • IgE to Ara h 2 has the best discriminative ability of all diagnostic tests for peanut allergy. It can accurately diagnose peanut allergy in 28% of patients but cannot be used to exclude a peanut allergy in an adult population.6,12-16 • The presence of antibodies to Ara h 1 and/or Ara h 3 increases the risk of severe reactions.8,12,14,13,17-24 • These three major peanut allergens (Ara h 1, Ara h 2 and Ara h 3) contain similar peptide sequences accounting for the high extent of cross-reactivity observed among them.25 • Ara h 1, Ara h 2 and Ara h 3 have been associated with severe symptoms, although anaphylactic reactions have been described in patients negative for these allergens.6 • Reactivity to these dominant allergens at the time of diagnosis in a population of North American infants and toddlers with early-onset peanut allergy was found to be associated with future allergy persistence at age 13 years.26 Ara h 6 • Ara h 6 is a major peanut allergen showing similarity with Ara h 2 in many aspects.37-41 • Because both are storage proteins of the 2S albumin type that are heat stable and resistant to digestion in the gut, they are associated with potentially systemic reactions.38,39 • Up to 4 out of 100 peanut allergic patients are monosensitized** to Ara h 6.40,41 Ara h 8 • IgE antibodies to the Ara h 8 are seldom associated with systemic reactions but more often to local reactions like oral allergy syndrome.16,21,27-31 • Birch-sensitized individuals are frequently co-sensitized to peanut Ara h 8.31 • Sensitization to this birch pollen cross-reactive allergen varies depending on local exposure to birch pollen.21,29,31 • Children that are mono-sensitized to Ara h 8 can usually safely ingest peanut.28 Ara h 9 • Ara h 9 is a minor component of peanuts.34 However, sensitization to this type of allergenic protein, referred to as a Lipid Transfer Protein, is generally associated with severe reactions in addition to OAS.32-35 • Ara h 9 has been correlated with mild to severe symptoms in Mediterranean patients (Vareeda, Ballmer-Weber). General Comments • The heterogeneity in the clinical and immunological phenotype of peanut allergy in distinct geographical areas reflect exposures to different environmental pollen and differences in dietary traditions.16,36 • The most commonly occurring sensitization to peanut proteins in individuals who tolerate peanut is directed to Ara h 8 and Ara h 9.16 • Use of component testing allows for the assessment of sensitization to proteins that may be under-represented in whole peanut extracts.36

Allergens, Specific IgE Test

TEST: (See Individual Allergens in the Allergen Profiles section.) Test number copied CPT: 86003 (each) Include LOINC® in print Related Information Allergen Profile With Total IgE, Respiratory–Area 19 Allergen Profile With Total IgE, Respiratory–Area 20 Allergen Profile With Total IgE, Respiratory–Area 4 Allergen Profile With Total IgE, Respiratory−Area 1 Allergen Profile With Total IgE, Respiratory−Area 10 Allergen Profile With Total IgE, Respiratory−Area 11 Allergen Profile With Total IgE, Respiratory−Area 12 Allergen Profile With Total IgE, Respiratory−Area 13 Allergen Profile With Total IgE, Respiratory−Area 14 Allergen Profile With Total IgE, Respiratory−Area 15 Allergen Profile With Total IgE, Respiratory−Area 16 Allergen Profile With Total IgE, Respiratory−Area 17 Allergen Profile With Total IgE, Respiratory−Area 18 Allergen Profile With Total IgE, Respiratory−Area 2 Allergen Profile With Total IgE, Respiratory−Area 3 Allergen Profile With Total IgE, Respiratory−Area 5 Allergen Profile With Total IgE, Respiratory−Area 6 Allergen Profile With Total IgE, Respiratory−Area 7 Allergen Profile With Total IgE, Respiratory−Area 8 Allergen Profile With Total IgE, Respiratory−Area 9 Allergen Profile, Mini Profile Allergen Profile, Mold Allergen Profile, Pediatric, Birth to Three Years Allergen Profile, Pediatric, Six Years Plus Allergen Profile, Pediatric, Three to Six Years Allergen Profile, Perennial Allergen Allergen Profile, Seasonal Allergen, Fall−Weed Allergen Profile, Seasonal Allergen, Spring−Tree Allergen Profile, Seasonal Allergen, Summer−Grass Specimen Requirements Specimen Serum Volume 0.1 mL per allergen Minimum Volume 0.07 mL per allergen Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Causes for Rejection Improper labeling; gross hemolysis Test Details Use Detect possible allergic responses to various substances in the environment and evaluate for hay fever, asthma, atopic eczema, and respiratory allergy. The quantitative allergen-specific IgE test is indicated (1) to determine whether an individual has elevated allergen-specific IgE antibodies; (2) if specific allergic sensitivity is needed to allow immunotherapy to be initiated; (3) when testing individuals for agents that may potentially cause anaphylaxis; (4) when evaluating individuals who are taking medication (eg, long-acting antihistamines) that may interfere with other testing modalities (eg, skin testing); (5) if immunotherapy or other therapeutic measures based on skin testing results have not led to a satisfactory remission of symptoms; (6) when an individual is unresponsive to medical management where identification of offending allergens may be beneficial. Limitations Quantitative allergen-specific IgE test results should be interpreted in the context of all available clinical and laboratory findings. High levels of total IgE (>3000 IU/mL as may be seen due to parasitic infestation or other conditions) may result in nonspecific binding. Testing in these patients should be re-evaluated once the medical condition has been eliminated. Methodology Thermo Fisher ImmunoCAP® Additional Information Identification of allergen or allergens in patients with atopic disease may be approached clinically by history, physical findings, skin and/or quantitative allergen-specific IgE testing. Numerous reports comparing skin testing and quantitative allergen-specific IgE have accumulated in the literature, generally to assess which method has the better sensitivity/specificity.

Alternaria alternata

Synonyms Alternaria tenuis Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Individual Allergens Related Documents Sample Report Specimen Requirements Specimen Serum Volume 0.2 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 3 months Freeze/thaw cycles Stable x3 Test Details Methodology Thermo Fisher ImmunoCAP®

Amino Acid Profile, Quantitative, Plasma

Expected Turnaround Time 3 - 6 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Amino Acid Test Options Related Documents Sample Report Specimen Requirements Specimen Plasma, frozen Volume 0.5 mL Minimum Volume 0.25 mL Container Preferred: Frozen plasma from green-top (sodium heparin) tube. Acceptable: Frozen plasma from green-top (lithium heparin) tube, frozen plasma from lavender-top (EDTA) tube or frozen plasma from PPT™. Frozen serum from serum separator tube (SST) or frozen serum from red-top tube will not be rejected. Note: Plasma reference ranges will be applied to all specimen types. Collection Separate plasma from cells. Transfer specimen to plastic transport tube before freezing. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Centrifuge, remove plasma from cells, and freeze immediately. Stability Requirements Temperature Period Room temperature Unstable Refrigerated Unstable Frozen 14 days Causes for Rejection Gross hemolysis; room temperature or thawed specimen; specimens collected in yellow-top (ACD) tubes Test Details Use Diagnosis and monitoring of inherited aminoacidurias, organic acidurias, and urea cycle defects. May be used as a follow-up confirmatory test to some abnormal newborn screen results. Limitations False-negative results can occur, especially when a patient is affected with a mild or intermittent variant of a disorder or when clinical condition or dietary treatment causes secondary changes to the profile. Results of amino acid profiling should be interpreted in the context of clinical presentation, as well as other laboratory tests. Frozen serum may be diagnostic, however, certain amino acids may be falsely elevated or low. This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration. Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS)

Ammonia, Plasma

Special Instructions Date and time specimen was drawn must be written on tube of blood and request form. Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Plasma, frozen Volume 1 mL Minimum Volume 0.5 mL Container Lavender-top (EDTA) tube; EDTA is the only acceptable anticoagulant. Collection Tube must be filled completely and kept tightly stoppered at all times. Mix well. Specimen must be placed on ice immediately. Separate plasma from cells within 15 minutes of collection. Patient should not clench fist. Transfer specimen to a plastic transport tube before freezing. Avoid contamination of samples by ammonia from smoking or traffic in the laboratory or patient's room, glassware, or water. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Freeze. Ammonia is stable for several days at -20°C. Caution: Blood ammonia increases rapidly at room temperature. Stability Requirements Temperature Period Room temperature Unstable Refrigerated Unstable Frozen 14 days Freeze/thaw cycles Unstable Patient Preparation Patient should be fasting 12 to 14 hours to avoid lipemia, which interferes with the test. Causes for Rejection Hemolysis which increases plasma ammonia; specimen not received frozen; anticoagulants such as citrate, oxalate, ammonium heparin, or sodium fluoride (may cause spuriously high results); lithium heparin may cause spuriously low results; serum specimen (ammonia values in serum are significantly but variably higher than their corresponding plasma values, as ammonia may be generated during clotting); lipemia Test Details Use Ammonia is elevated in the following conditions: liver disease, urinary tract infection with distention and stasis, Reye syndrome, inborn errors of metabolism including deficiency of enzymes in the urea cycle, HHH syndrome (hyperammonemia-homocitrullinuria, hyperornithinemia), some normal neonates (usually returning to normal in 48 hours), total parenteral nutrition, ureterosigmoidostomy, and sodium valproate therapy. Ammonia determination is indicated in neonates with neurological deterioration, subjects with lethargy and/or emesis not explained, and in patients with possible encephalopathy. Ammonia measurements are mainly of use in the diagnosis of urea cycle deficiencies (any neonate with unexplained nausea, vomiting, or neurological deterioration appearing after first feeding), and they play an important part in the detection of Reye syndrome. In Reye syndrome threefold increases in AST, ALT and plasma ammonia are required for diagnosis with/or the diagnostic liver biopsy findings. Ammonia levels increase characteristically early; plasma ammonia ≥100 μg/dL reflects severe hepatic changes. Prothrombin time is increased in essentially all patients, prototypically three seconds longer than the control. Bilirubin is usually normal. Glucose should be monitored; hypoglycemia may develop. Hyperosmolality and acid-base imbalance may develop, lactate may increase, CK may increase and CK-MB may be elevated. Uric acid may increase.1,2 Increased ammonia and prolonged prothrombin time provide indicators of disease progression.3 Limitations The correlation between blood ammonia levels and hepatic coma is poor. Ammonia determinations are not reliable predictors of impending hepatic coma. Ammonia levels are not always high in all patients with urea cycle disorders. High protein diet may cause increased levels.4 Ammonia levels may also be elevated with gastrointestinal hemorrhage. If portal hypertension develops with cirrhosis, hepatic blood flow is altered, leading to elevated blood ammonia levels. Methodology Enzymatic

Amphetamines, Screen and Confirmation, Urine

Synonyms Adderall® Benzedrine® Dexedrine® Methamphetamine Test Includes Amphetamine; methamphetamine; automatic confirmation by mass spectrometry (MS) performed on positive samples (additional charge) Special Instructions Chain-of-custody documentation is required for samples submitted for preëmployment, random employee testing, and forensic purposes. For other applications, use the standard test request form. Please mark chain-of-custody test number on the test request form. Expected Turnaround Time 1 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Specimen Requirements Specimen Urine Volume 20 mL Container Use plastic urine drug bottle and evidence tape or tamper-evident container for forensic specimen. Collection kits are available by request from the laboratory. Collection Urine temperature monitoring is recommended for samples to be tested for medicolegal purposes. Storage Instructions Maintain specimen at room temperature. If arrival extends beyond seven days, then refrigerate. Causes for Rejection Quantity not sufficient for analysis; improper specimen (serum, plasma, blood); incomplete chain-of-custody documentation; incomplete specimen identification; improper or missing tamper-evident seals Test Details Methodology Initial testing by immunoassay (IA); confirmation of positives by mass spectrometry (MS)

Amylase

Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Amylase, Urine Lipase Related Documents Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube, gel-barrier tube, or green-top (heparin) tube Collection Separate serum or plasma from cells within 45 minutes of collection. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Improper labeling Test Details Use Work-up for abdominal pain, epigastric tenderness, nausea, and vomiting. Such findings characterize acute pancreatitis as well as acute surgical emergencies such as gastrointestinal perforation (eg, peptic ulcer with perforation) or bowel infarct. Amylase is used in the differential diagnosis of acute or chronic pancreatitis, which may or may not in an individual be related to alcoholism. Hypercalcemia related to pancreatitis is described with hyperparathyroidism and other entities. About 80% of subjects with acute pancreatitis have increased serum amylase within 24 hours.1 Limitations Poor specificity. Oxalate or citrate depress results. Lipemic sera (hypertriglyceridemia) may contain inhibitors which falsely depress results. About 20% of patients with acute pancreatitis have abnormal lipids. Normal serum amylase may occur in pancreatitis, especially relapsing and chronic pancreatitis. (Subjects in whom pseudocysts complicate chronic pancreatitis often do have elevations of the pancreatic enzymes.) The entire pancreas can be destroyed in pancreatitis; in such cases serum amylase will derive from other structures (eg, the salivary glands). Urine amylase increases often persist longer than do those of serum. High levels in alcoholics, in pregnancy and in diabetic ketoacidosis are of salivary rather than pancreatic origin. Salivary type amylase makes up about 60% of the enzyme, while it is the pancreatic fraction that is of clinical interest.2 The expression “salivary amylase” includes other nonpancreatic sources of the enzyme. Serum amylase is cleared by renal excretion. Serum amylase may increase one to two times upper limit of normal in renal failure without diagnostic significance. In such cases, urine amylase is normal or low. Methodology Enzymatic

Anabolic Steroids, Screen and Confirmation, Urine

Synonyms Steroids Test Includes Bolasterone; boldenone; 4-chlorotestosterone; clenbuterol; danazol; drostanolone; epitestosterone; fluoxymesterone; mesterolone; methandienone; methandriol; methenolone; methyltestosterone; nandrolone; norethandrolone; oxandrolone; oxymesterone; oxymetholone; probenecid; stanozolol; testosterone; testosterone:epitestosterone ratio; trenbolone; specific gravity Expected Turnaround Time 7 - 10 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Urine (random) Volume 30 mL Minimum Volume 10 mL Container Plastic urine container without preservative Storage Instructions Refrigerate; specimen may also be frozen. Stability Requirements Temperature Period Refrigerated 2 weeks Frozen 2 months Causes for Rejection Urine from a preservative tube Test Details Use Detect presence of anabolic steroids Methodology Initial presumptive testing by gas chromatography/mass spectrometry (GC/MS); presumptive positives are confirmed by definitive chromatography with mass spectrometry (GC/MS or LC/MS-MS)

Anaerobic and Aerobic Culture

Synonyms Anaerobic Culture, Abscess Anaerobic Culture, Body Fluid Anaerobic Culture, Wound Culture, Anaerobic Wound Anaerobic Culture Test Includes Isolation and identification (additional CPT coding of 87076, 87077, 87143, or other code depending on methods required) of potential anaerobic and aerobic pathogens; susceptibility testing if culture results warrant at an additional charge. CPT coding for microbiology and virology procedures often cannot be determined before the culture is performed. Special Instructions Gram Stain [008540] is recommended with all anaerobic cultures (additional charge). The test request form must state specific site of specimen, age of patient, current antibiotic therapy, clinical diagnosis, and time of collection. If an unusual organism is suspected, such as Actinomyces, this information must be specifically noted on the test request form. For extended incubation use Aerobic Culture, Extended Incubation [180803] or Anaerobic Culture, Extended Incubation [008900]. Aspirates are preferable to swabs. A thin smear for Gram stain obtained from the same site is strongly recommended and must be ordered separately. Culture samples must be collected to avoid contamination with indigenous anaerobic flora from skin and mucous membranes. Because of resident anaerobic flora, the following sites are inappropriate for anaerobic cultures and will be rejected: throat and nasopharynx, sputum, bronchoscopy specimens, gastrointestinal contents, voided or catheterized urine, urogenital swabs (eg, vaginal and/or cervical), and specimens from superficial wounds. Expected Turnaround Time 4 - 7 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Routine Microbiology Related Documents For more information, please view the literature below. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Pus, tissue, or other material properly obtained from an abscess, biopsy, aspirate, drainage, exudate, lesion, or wound. To ensure proper growth of organisms, place swabs/specimen in anaerobic transporter. Do not refrigerate. Volume Swab in anaerobic transporter or ESwab™ transport, 0.5 mL pus, or other fluid or tissue from aspirated site in anaerobic transporter Container Anaerobic transport or aerobic/anaerobic bacterial swab transport containing gel medium; ESwab™ transport Collection Some anaerobes will be killed by contact with molecular oxygen for only a few seconds. Overlying and adjacent areas must be carefully disinfected to eliminate contamination with indigenous flora. Ideally, pus or other fluid obtained by needle aspiration through intact skin or mucosal surface that has been cleaned with antiseptic should be collected. Sampling of open lesions is enhanced by deep aspiration using a sterile plastic catheter. Curettings of the base of an open lesion are optimal. If irrigation is necessary, nonbacteriostatic sterile normal saline may be used. Lower respiratory samples must be obtained by transtracheal percutaneous needle aspiration, transbronchial biopsy, transthoracic needle biopsy, or open lung biopsy by physicians trained in these procedures. If swabs must be used, collect two, use one for Gram stain and one for culture. Anaerobic transports must be used for swabs and for aspirates. Specimens are to be collected from a prepared site using sterile technique. Contamination with normal flora from skin, rectum, vaginal tract, or other body surfaces must be avoided. Storage Instructions Specimens for anaerobic culture should be maintained at room temperature. Under these conditions, aerobes and anaerobes will survive 24 to 72 hours when properly collected in the anaerobic transport tube. Storage of specimens in the ESwab™ transport at room temperature for greater than 48 hours may result in diminished recovery of certain anaerobic species. Patient Preparation Sterile preparation of the aspiration site is imperative. Causes for Rejection Unlabeled specimen or name discrepancy between specimen and test request label; specimen not received in appropriate anaerobic transport tube; swab not in gel transport medium or ESwab™ transport; swab not stored in oxygen-free atmosphere; specimen refrigerated; specimen received after prolonged delay in transport (usually more than 48 hours). Note: Refrigeration inhibits viability of certain anaerobic organisms. Specimens from sites that have anaerobic bacteria as indigenous flora will not be cultured anaerobically (eg, throat, feces, colostomy stoma, rectal swabs, bronchial washes, cervical-vaginal mucosal swabs, sputa, skin and superficial wounds, voided or catheterized urine, ulcer surfaces, drainages onto contaminated surfaces). Test Details Use Isolate and identify anaerobic pathogenic organisms; determine susceptibility of isolates (extra charge). When actinomycetes are suspected, a specific request must be made. Anaerobic cultures are indicated particularly when suspected infections are related to gastrointestinal tract, pelvic organs, associated with malignancy, related to use of aminoglycosides, or occur in a setting in which the diagnosis of gas gangrene or actinomycosis is considered. Anaerobic culture is especially indicated when an exudate has a foul odor or if the exudate has a grayish discoloration and is hemorrhagic. Frequently, more than one organism is recovered from an anaerobic infection. Limitations The only sources for specimens with established validity for meaningful anaerobic culture in patients with pleuropulmonary infections are blood, pleural fluid, transtracheal aspirates, transthoracic pulmonary aspirates, and specimens obtained at thoracotomy. Pleural fluid is preferred for patients with empyema.1 Blood cultures yield positive results in <5% of cases of anaerobic pulmonary infection. Specimens received in anaerobic transport containers are not optimal for aerobic fungus cultures. Mycobacterium sp or Nocardia sp, which may cause abscesses, will not be recovered even if present, since extended incubation periods, aerobic incubation, and special media are necessary for their isolation. Cultures for these organisms should be specifically requested. IUDs will be cultured for Actinomyces sp only. Methodology Anaerobic and aerobic culture Contraindications Bronchoscopically obtained specimens are not ideal as the instrument becomes contaminated by organisms normally contaminating the oropharynx during insertion. Culture of specimens from sites harboring endogenous anaerobic organisms or contaminated by endogenous organisms may be misleading with regard to etiology and selection of appropriate therapy. Additional Information In open wounds, anaerobic organisms may play an etiologic role, whereas aerobes may represent superficial contamination. Serious anaerobic infections are often due to mixed flora that are pathologic synergists. Anaerobes frequently recovered from closed postoperative wound infections include Bacteroides fragilis, ∼50%; Prevotella melaninogenica, ∼25%; Peptostreptococcus prevotii, ∼15%; and Fusobacterium sp, ∼25%. Anaerobes are seldom recovered in pure culture (10% to 15% of cultures). Aerobes and facultative bacteria when present are frequently found in lesser numbers than the anaerobes. Anaerobic infection is most commonly associated with operations involving opening or manipulating the bowel or a hollow viscus (eg, appendectomy, cholecystectomy, colectomy, gastrectomy, bile duct exploration, etc). The ratio of anaerobes to facultative species is normally about 10:1 in the mouth, vagina, and sebaceous glands and at least 1000:1 in the colon. Biopsy culture is particularly useful in establishing the diagnosis of anaerobic osteomyelitis,2 clostridial myonecrosis, intracranial actinomycosis, and pleuropulmonary infections. Anaerobic infections of soft tissue include anaerobic cellulitis, necrotizing fasciitis, clostridial myonecrosis (gas gangrene), anaerobic streptococcal myositis or myonecrosis, synergistic nonclostridial anaerobic myonecrosis, and infected vascular gangrene. These infections, particularly clostridial myonecrosis, necrotizing fasciitis, and nonclostridial anaerobic myonecrosis, may be fulminant and are frequently characterized by the presence of gas and foul-smelling necrotic tissue.3 Empiric therapy based on likely pathogens should be instituted as soon as appropriate cultures are collected. Clinical symptoms suggestive of anaerobic infection include: • Foul-smelling discharge • Location of infection in proximity to a mucosal surface • Necrotic tissue, gangrene, pseudomembrane formation • Gas in tissues or discharges • Endocarditis with negative routine blood cultures • Infection associated with malignancy or other process producing tissue destruction • Septic thrombophlebitis • Bacteremic picture with jaundice • Infection resulting from human or other bites • Black discoloration of blood-containing exudates (may fluoresce red under ultraviolet light in P melaninogenica infections) • Presence of “sulfur granules” in discharges (actinomycosis) • Classical clinical features of gas gangrene • Clinical setting suggestive for anaerobic infection (septic abortion, infection after gastrointestinal surgery, genitourinary surgery, etc)

Anaerobic and Aerobic Culture and Gram Stain

Synonyms Anaerobic Culture, Abscess Anaerobic Culture, Body Fluid Anaerobic Culture, Wound Culture, Anaerobic Wound Anaerobic Culture Test Includes Gram stain, isolation, and identification of potential anaerobic and aerobic pathogens (additional charges/CPT code[s] may apply); susceptibility testing if culture results warrant (at an additional charge). CPT coding for microbiology and virology procedures often cannot be determined before the culture is performed. Special Instructions The test request form must state specific site of specimen, age of patient, current antibiotic therapy, clinical diagnosis, and time of collection. If an unusual organism is suspected, such as Actinomyces, this information must be specifically noted on the test request form. For extended incubation use Aerobic Culture, Extended Incubation [180803] or Anaerobic Culture, Extended Incubation [008900]. Aspirations are preferable to swabs. A thin smear for Gram stain prepared at the time of specimen collection may better represent the flora present than one prepared in the laboratory several hours after specimen collection. Culture samples must be collected to avoid contamination with indigenous anaerobic flora from skin and mucous membranes. Because of resident anaerobic flora, the following sites are inappropriate for anaerobic cultures and will be rejected: throat and nasopharynx, sputum, bronchoscopy specimens, gastrointestinal contents, voided or catheterized urine, urogenital swabs (eg, vaginal and/or cervical), and specimens from superficial wounds. Expected Turnaround Time 4 - 7 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Pus, tissue, or other material properly obtained from an abscess, biopsy, aspirate, drainage, exudate, lesion, or wound. To ensure proper growth of organisms place swabs/specimen in anaerobic transporter. Do not refrigerate. Volume Swab(s) in aerobic/anaerobic swab transport or ESwab™ transport; or 0.5 mL pus, other fluid, or tissue from aspirated site in anaerobic transporter and one thin smear Container Aerobic/anaerobic bacterial swab transport containing gel medium or anaerobic transporter and one prepared smear in slide carrier; ESwab™ transport Collection Some anaerobes will be killed by contact with molecular oxygen for only a few seconds. Overlying and adjacent areas must be carefully disinfected to eliminate contamination with indigenous flora. Ideally, pus or other fluid obtained by needle aspiration through intact skin or mucosal surface that has been cleaned with antiseptic should be collected. Sampling of open lesions is enhanced by deep aspiration using a sterile plastic catheter. Curettings of the base of an open lesion are optimal. If irrigation is necessary, nonbacteriostatic sterile normal saline may be used. Lower respiratory samples must be obtained by transtracheal percutaneous needle aspiration, transbronchial biopsy, transthoracic needle biopsy, or open lung biopsy by physicians trained in these procedures. If swabs must be used, collect two, use one for Gram stain and one for culture. Anaerobic transports must be used for swabs and for aspirates. Specimens are to be collected from a prepared site using sterile technique. Contamination with normal flora from skin, rectum, vaginal tract, or other body surfaces must be avoided. Storage Instructions Specimens for anaerobic culture should be maintained at room temperature. Under these conditions, aerobes and anaerobes will survive 24 to 72 hours when properly collected in the anaerobic transport tube. Storage of specimens in the ESwab™ transport at room temperature for greater than 48 hours may result in diminished recovery of certain anaerobic species. Patient Preparation Sterile preparation of the aspiration site is imperative. Causes for Rejection Unlabeled specimen or name discrepancy between specimen and test request label; specimen not received in appropriate anaerobic transport tube; swab not in gel transport medium or ESwab™ transport; swab not stored in oxygen-free atmosphere; specimen refrigerated; specimen received after prolonged delay in transport (usually more than 72 hours). Note: Refrigeration inhibits viability of certain anaerobic organisms. Specimens from sites that have anaerobic bacteria as indigenous flora will not be cultured anaerobically (eg, throat, feces, colostomy stoma, rectal swabs, bronchial washes, cervical-vaginal mucosal swabs, sputa, skin and superficial wounds, voided or catheterized urine, ulcer surfaces, drainages onto contaminated surfaces). Test Details Use Isolate and identify anaerobic pathogenic organisms; determine susceptibility of isolates (extra charge). When actinomycetes are suspected a specific request must be made. Anaerobic cultures are indicated particularly when suspected infections are related to gastrointestinal tract, pelvic organs, associated with malignancy, related to use of aminoglycosides; or occur in a setting in which the diagnosis of gas gangrene or actinomycosis is considered. Anaerobic culture is especially indicated when an exudate has a foul odor or if the exudate has a grayish discoloration and is hemorrhagic. Frequently, more than one organism is recovered from an anaerobic infection. Limitations The only sources for specimens with established validity for meaningful anaerobic culture in patients with pleuropulmonary infections are blood, pleural fluid, transtracheal aspirates, transthoracic pulmonary aspirates, and specimens obtained at thoracotomy. Pleural fluid is preferred for patients with empyema.1 Blood cultures yield positive results in <5% of cases of anaerobic pulmonary infection. Specimens received in anaerobic transport containers are not optimal for aerobic fungus cultures. Mycobacterium sp or Nocardia sp, which may cause abscesses, will not be recovered even if present, since extended incubation periods, aerobic incubation, and special media are necessary for their isolation. Cultures for these organisms should be specifically requested. IUDs will be cultured for Actinomyces sp only. Methodology Anaerobic and aerobic culture and Gram stain smear Contraindications Bronchoscopically obtained specimens are not ideal as the instrument becomes contaminated by organisms normally contaminating the oropharynx during insertion. Culture of specimens from sites harboring endogenous anaerobic organisms or contaminated by endogenous organisms may be misleading with regard to etiology and selection of appropriate therapy. Additional Information In open wounds, anaerobic organisms may play an etiologic role, whereas aerobes may represent superficial contamination. Serious anaerobic infections are often due to mixed flora that are pathologic synergists. Anaerobes frequently recovered from closed postoperative wound infections include Bacteroides fragilis, approximately 50%; Prevotella melaninogenica, approximately 25%; Peptostreptococcus prevotii, approximately 15%; and Fusobacterium sp, approximately 25%. Anaerobes are seldom recovered in pure culture (10% to 15% of cultures). Aerobes and facultative bacteria when present are frequently found in lesser numbers than the anaerobes. Anaerobic infection is most commonly associated with operations involving opening or manipulating the bowel or a hollow viscus (eg, appendectomy, cholecystectomy, colectomy, gastrectomy, bile duct exploration, etc). The ratio of anaerobes to facultative species is normally about 10:1 in the mouth, vagina, and sebaceous glands and at least 1000:1 in the colon. Biopsy culture is particularly useful in establishing the diagnosis of anaerobic osteomyelitis,2 clostridial myonecrosis, intracranial actinomycosis, and pleuropulmonary infections. Anaerobic infections of soft tissue include anaerobic cellulitis, necrotizing fasciitis, clostridial myonecrosis (gas gangrene), anaerobic streptococcal myositis or myonecrosis, synergistic nonclostridial anaerobic myonecrosis, and infected vascular gangrene. These infections, particularly clostridial myonecrosis, necrotizing fasciitis, and nonclostridial anaerobic myonecrosis, may be fulminant and are frequently characterized by the presence of gas and foul-smelling necrotic tissue.3 Empiric therapy based on likely pathogens should be instituted as soon as appropriate cultures are collected. Clinical symptoms suggestive of anaerobic infection include: • Foul-smelling discharge • Location of infection in proximity to a mucosal surface • Necrotic tissue, gangrene, pseudomembrane formation • Gas in tissues or discharges • Endocarditis with negative routine blood cultures • Infection associated with malignancy or other process producing tissue destruction • Septic thrombophlebitis • Bacteremic picture with jaundice • Infection resulting from human or other bites • Black discoloration of blood-containing exudates (may fluoresce red under ultraviolet light in P melaninogenica infections) • Presence of “sulfur granules” in discharges (actinomycosis) • Classical clinical features of gas gangrene • Clinical setting suggestive for anaerobic infection (septic abortion, infection after gastrointestinal surgery, genitourinary surgery, etc) See table. Principle Types of Anaerobic Infections Location Type of Infection Adapted from Styrt B, Gorbach SL. Recent developments in the understanding of the pathogenesis and treatment of anaerobic infections. N Engl J Med. 1989 Jul 24; 321(4):240-246. Head and neck Brain abscess Gingivitis Chronic sinusitis Chronic otitis Odontogenic and oropharyngeal space infections Respiratory tract Aspiration pneumonia Necrotizing pneumonia Lung abscess Empyema (adults) Gastrointestinal tract Peritonitis Intra-abdominal abscess Liver abscess Female genital tract Tubo-ovarian abscess Salpingitis (30% to 50% of cases) Septic abortion and endometritis Bartholin gland abscess Bacterial vaginosis Skin and soft tissue Crepitant cellulitis Necrotizing fasciitis Myonecrosis (gas gangrene) Decubitus ulcer Diabetic foot ulcer Bite wounds

Anaplasma phagocytophilum, DNA PCR

Synonyms Human Granulocytic Anaplasmosis (HGA) by PCR Human Granulocytic Ehrlichiosis (HGE) by PCR Expected Turnaround Time 3 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Whole blood Volume 1 mL Minimum Volume 0.2 mL Container Lavender-top (EDTA) tube or yellow-top (ACD) tube Storage Instructions Refrigerate Stability Requirements Temperature Period Room temperature 7 days Refrigerated 7 days Frozen Unstable Freeze/thaw cycles Unstable Test Details Use This test is intended to be used as an aid to the diagnosis of human granulocytic anaplasmosis (HGA), a condition formerly known as human granulocytic ehrlichiosis (HGE) caused by Anaplasma phagocytophilum. Methodology Polymerase chain reaction (PCR)

Androstenedione, LC/MS

Synonyms 4-Androstenedione δ4-Androstene,3,17-dione Expected Turnaround Time 4 - 6 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Dehydroepiandrosterone (DHEA) Dehydroepiandrosterone (DHEA) Sulfate Testosterone, Total Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube. Do not use a gel-barrier tube. The use of gel-barrier tubes is not recommended due to slow absorption of the steroid by the gel. Depending on the specimen volume and storage time, the decrease in androstenedione level due to absorption may be clinically significant. Collection Transfer separated serum to a plastic transport tube. Storage Instructions Refrigerate. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x2 Causes for Rejection Gross hemolysis; lipemia; gel-barrier tube Test Details Limitations This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS) Reference Interval See table. Age Male (ng/dL) Female (ng/dL) 0 to 30 d Not established Not established 1 to 6 m 0−50 0−81 7 m to 1 y 0−41 0−48 2 to 5 y 0−22 0−67 6 to 8 y 10−78 0−67 9 to 14 y 10−78 28−288 15 to 60 y 27−152 41−262 61 to 80 y 22−96 17−99 >80 y Not established Not established Additional Information Androstenedione (also known as 4-androstenedione and δ4-androstenedione) is a 19-carbon steroid hormone produced in the adrenal glands and the gonads that is the common precursor in the biochemical pathway that produces the androgen testosterone and the estrogens estrone and estradiol.1-7 Androstenedione has approximately one tenth of the androgenic potency of testosterone.1 Androstenedione is synthesized by means of two biochemical pathways. The predominant pathway involves conversion of 17-hydroxypregnenolone to dehydroepiandrosterone (DHEA) catalyzed by the enzyme 17,20-lyase, with subsequent conversion of DHEA to androstenedione catalyzed by the enzyme 3-β-hydroxysteroid dehydrogenase. A secondary pathway for androstenedione production involves conversion of 17-hydroxyprogesterone to androstenedione directly by 17,20-lyase. 17,20-lyase is required for both pathways of androstenedione synthesis. The production of adrenal androstenedione is controlled by ACTH, whereas production of gonadal androstenedione is governed by the gonadotropins, luteinizing hormone (LH), and follicle stimulating hormone (FSH). Androstenedione produced in the adrenal gland of both men and women is further converted to testosterone by the enzyme 17-β-hydroxysteroid dehydrogenase.1 In women, androstenedione produced by theca cells of the ovary is converted to estrogen by the enzyme aromatase in the granulosa cells of the ovary.5 Androstenedione secreted into the plasma by either the adrenal or ovary can be converted to testosterone and estrogens by the same enzymes in peripheral tissues. Androstenedione, largely of ovarian origin, is the only circulating androgen that is higher in premenopausal women than in men.1 After menopause, androstenedione production is about halved, primarily due to the reduction of the steroid secreted by the ovary. Nevertheless, androstenedione is the principal steroid produced by the postmenopausal ovary. Congenital adrenal hyperplasia (CAH) is a family of disorders caused by defects in one of the enzymes of the adrenal steroidogenic pathway.1,3,6 The most common form of CAH results from mutations in the gene that codes for the 21-hydroxylase enzyme.1,3,6 Patients with CAH develop varying degrees of glucocorticoid and mineralocorticoid deficiency due to the inability to produce cortisol and aldosterone, respectively.1,3,6 Diminished cortisol levels cause an increase in pituitary adrenocorticotrophic hormone (ACTH) secretion due to a lack of negative feedback. The resultant high levels of ACTH lead to adrenal hyperplasia and dramatically increased production of adrenal steroids proximal to the enzyme block.1,3,6 These steroids (progesterone and 17-hydroxyprogesterone) are shunted into the adrenal androgen pathway that leads to increased concentrations of dehydroepiandrosterone and androstenedione.1,3,6 These weakly androgenic steroids are then peripherally converted to testosterone that produces the androgenic symptoms frequently associated with CAH.1,3,6 The diagnosis and therapeutic monitoring of CAH is based on clinical parameters and the measurement of the concentrations of adrenal steroid products and their metabolites.1,3,6 Recent clinical guidelines have recommended the use of 17-hydroxyprogesterone (17OHP) as the primary marker for diagnosis and monitoring of CAH.6 Other steroid products--including androstenedione and testosterone--can provide additional clinical information in some circumstances.3,6,8-11 There is generally a good correlation between 17OHP, androstenedione, and testosterone concentrations in a single blood sample, suggesting these hormone concentrations are all under similar influences.9 Random serum steroid levels in CAH patients tend to fluctuate with time of day and timing relative to glucocorticoid administration.3 For this reason, samples for a given patient should be collected at a consistent time before the administration of the morning glucocorticoid dose.3 Polycystic ovary syndrome (PCOS) is a syndrome of ovarian dysfunction characterized by hyperandrogenism, menstrual irregularities, and polycystic ovaries.9,12 PCOS is associated with an increased risk of diabetes and cardiovascular disease.1 The measurement of circulating androstenedione levels has been applied to the diagnosis of PCOS in several studies.6,12-14

Anemia Profile A

Test Includes CBC with differential and platelet count; iron; iron binding capacity; reticulocyte count Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Specimen Requirements Specimen Serum and whole blood Volume 4 mL serum and 5 mL whole blood Container Gel-barrier tube and lavender-top (EDTA) tube Collection Separate serum from cells within 45 minutes of collection. Storage Instructions Maintain serum and EDTA whole blood at room temperature. Causes for Rejection Hemolysis; improper labeling Test Details Methodology See individual tests.

Anemia Profile B

Test Includes CBC with differential and platelet count; ferritin; folates (folic acid); iron; iron binding capacity; reticulocyte count; vitamin B12 Special Instructions This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample. Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Specimen Requirements Specimen Serum and whole blood Volume 4 mL serum and 7 mL whole blood Container Gel-barrier tube or transport tube and lavender-top (EDTA) tube Storage Instructions Maintain serum and EDTA whole blood at room temperature. Causes for Rejection Hemolysis; improper labeling Test Details Methodology See individual tests.

Angiotensin-converting Enzyme (ACE)

Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 0.5 mL Minimum Volume 0.2 mL Container Red-top tube or gel-barrier tube Collection Separate serum from cells at the time of collection. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 7 days Frozen 3 days Freeze/thaw cycles Stable x3 Patient Preparation Stop administration of captopril, enalapril, or lisinopril for 12 hours prior to venipuncture (reduces ACE activity). Causes for Rejection Captopril, enalapril, or lisinopril administration; hemolyzed or icteric specimen; whole blood, cerebrospinal fluid (CSF), or EDTA plasma specimen received Test Details Use High in sarcoidosis, more often when the disease is active. Of value in assessing the response of sarcoidosis to corticosteroid therapy. Changes in serum ACE correlate with clinical status and results of gallium scans (which reflect presence and activity of inflammatory granulomatous lesions). Falling ACE level is a favorable prognostic sign. Rising levels may reflect activity uncontrolled by therapy. Limitations Elevations have been reported in about 35% to 80% of cases of sarcoidosis. ACE levels are less likely to be increased with chronic sarcoidosis. Different admixtures of acute and chronic cases may explain some of the apparent variation in reported incidence of elevation in sarcoidosis. Elevations have been found in patients with diabetes mellitus, Gaucher disease, and leprosy. Twenty-five percent of 86 patients with acute histoplasmosis had elevated levels.3 Increased in some patients with primary biliary cirrhosis, amyloidosis, myeloma, some alpha1-antitrypsin variants, Melkersson-Rosenthal syndrome, and hyperthyroidism. It has been found increased in some cases of hyperparathyroidism and in some instances of oncogenic hypercalcemia. Thus, it is not a specific marker for the diagnosis of sarcoidosis.4 Positives are also reported in patients with extrinsic allergic alveolitis, coccidioidomycosis, beryllium disease, asbestosis, silicosis, and alcoholic liver disease.5 ACE activity is decreased during starvation, independent of the level of thyroid activity (as monitored by T3 levels).6 Methodology Kinetic Reference Interval Pediatric1,2 and adults: • 0 to 2 years: 18−95 units/L • 3 to 14 years: 22−108 units/L • 15 years or older: 14−82 units/L Additional Information Other abnormalities found in some sarcoidosis patients include elevations of serum alkaline phosphatase, calcium, gamma globulin with polyclonal gammopathy, and hypercalciuria. Serum angiotensin converting enzyme is elevated in 50% of cases of sarcoidosis but not in cases of active tuberculosis or Hodgkin disease. Increases are less frequent when sarcoidosis is inactive.6 Some 80% to 90% of patients with demonstrably active sarcoidosis have elevated serum ACE. Angiotensin converting enzyme activity is also increased in sarcoid lymph node homogenate. The diagnosis of sarcoidosis is an histopathologic/clinical complex. Noncaseating granulomas must be proven not to be caused by tuberculosis, histoplasmosis, or other microbiologic entities. Berylliosis is a very rare cause of such granulomas. ACE is a dipeptidyl carboxypeptidase. It functions to split dipeptides from the free carboxy end of a variety of polypeptides including angiotensin I and bradykinin. It is especially known for its generation of the octapeptide angiotensin II by releasing the dipeptide histidyl-leucine from angiotensin I. The major site of ACE production is the pulmonary bed of endothelial cells. Thyroid hormone may modulate ACE activity. Both patients with low T3 levels (and clinical hypothyroidism) and patients with anorexia nervosa with associated findings of hypothyroidism may have low serum ACE activity.7,8 Monitoring of ACE levels may have application in assessing risk of pulmonary damage due to use of some antineoplastic agents, in particular bleomycin.9 Serum ACE is decreased in some patients with bronchogenic carcinoma. With response to chemotherapy/radiation therapy the ACE level has been noted to normalize.10 Cerebrospinal fluid ACE is useful in patients with neurosarcoidosis. Elevated serum ACE levels in a case of the uncommon entity, Melkersson-Rosenthal syndrome, probably relate to the sarcoid-like noncaseating granulomas that are found in this condition. ACE levels normalized after successful (clinical management) therapy with methotrexate.11 Serum ACE abnormality has been reported in 20% to 30% of alpha1-antitrypsin variants (MZ, ZZ, and MS Pi types) but in only about 1% of individuals with normal MM Pi type.12 There is evidence that paraquat poisoning (because of its effect on pulmonary capillary endothelium) is associated with elevated serum ACE.13

Anti-DNase B (Streptococcal) Antibodies

Synonyms ADB Anti-DNase B Antibodies DNase-B DNase-B Antibodies Streptococcal Antibodies Streptodornase Expected Turnaround Time 2 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 9 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Gross lipemia that cannot be clarified by ultracentrifugation; heat-inactivated samples; severe hemolysis Test Details Use Provides evidence of an existing or past streptococcal infection Methodology Immunonephelometry Reference Interval • <1 year: not established • 1 to 6 years: <78 U/mL • 7 to 17 years: ≤170 U/mL • 18 years and older: ≤120 U/mL Additional Information ADNase B antibodies react against the exoenzyme desoxyribonuclease B produced by streptococci. The detection of these antibodies provides evidence of an existing or past streptococcal infection (rheumatic fever, scarlet fever, tonsillitis, glomerulonephritis, and others). The antibody reaction against streptococcal DNase B starts later than the antibody production against streptolysin O, but it can then be detected on a greater percentage of patients.1 An increase in the antistreptolysin concentration rarely occurs with skin infections, while a rise in the ADNase B titer can be observed.1-3

Anti-Jo-1

Synonyms Polymyositis t-RNA Synthetase Test Includes Semiquantitative result of IgG class antibodies Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 0.6 mL Minimum Volume 0.3 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; icterus; lipemia; bacterial contamination Test Details Use Evaluate patients suspected of having polymyositis, dermatomyositis, or polymyositis-scleroderma overlap syndrome Methodology Multiplex flow immunoassay Reference Interval 0.0−0.9 AI Additional Information Anti-Jo-1 antibodies are present in approximately 20% to 30% of patients with adult-onset polymyositis syndromes. They are present in >65% of patients with both myositis and interstitial lung disease. In such patients, the presence of anti-Jo-1 antibodies may be predictive of a response to steroid treatment. Testing for ANAs is not adequate for the detection of anti-Jo-1 antibodies.

Anti-Müllerian Hormone (AMH) (Endocrine Sciences)

Synonyms Müllerian-inhibiting Substance Expected Turnaround Time 4 - 10 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Anti-Müllerian Hormone Assay Sample Report Specimen Requirements Specimen Serum, frozen Volume 1 mL Minimum Volume 0.2 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Collection Transfer specimen to a plastic transport tube before freezing. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Freeze. Stability Requirements Temperature Period Room temperature 1 day Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x6 Causes for Rejection Gross hemolysis; gross lipemia; specimen at room temperature Test Details Methodology Electrochemiluminescence (ECL)

Antibody Screen

Antibody Screen TEST: 006015 Test number copied CPT: 86850 Include LOINC® in print Synonyms Indirect Antiglobulin Test Indirect Coombs' Test Includes Red cell antibody screening. Note: Identification of antibody(ies) and titer of clinically significant antibody(ies) will be automatically performed at an additional charge if the antibody screen is positive. Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Whole blood (Note: This should not be a shared specimen. If antibody identification is necessary, the entire volume of this lavender-top tube will be required.) Volume 4 mL Minimum Volume 1 mL (Note: This minimum amount will not allow for antibody identification if the antibody screen is positive.) Container Lavender-top (EDTA) tube Storage Instructions Specimens should be tested as soon as possible or within 72 hours of collection. Samples that cannot be tested immediately should be stored at 2°C to 8°C. Do not freeze red cells. Causes for Rejection Gross hemolysis; bacterial or other contamination Test Details Use Detect atypical IgG antibodies prior to transfusion or during pregnancy. The technique is designed specifically to detect IgG antibodies, though on occasion, some IgM antibodies may also be detected. Antibodies detected by the antibody screen will be subsequently identified, and a titer performed if the antibody identified is considered to be clinically significant during pregnancy. Limitations No antibody screening test will detect all antibodies. This method may not detect IgM antibodies or antibodies to low frequency antigens. Extremely low-titered antibodies may be detected but may be too weak to identify. Methodology Antiglobulin test Contraindications Specimens known to test positive for red cell antibody screening should not be submitted for antibody screen testing. In order to facilitate proper routing and testing, Antibody Identification (006213) should be ordered. This test should not be ordered for the husband or partner of a prenatal patient since antibodies detected in the serum or plasma of these individuals are irrelevant during pregnancy. Reference Interval Negative

Anticardiolipin Antibodies (ACA), IgA, IgG, IgM, Quantitative

Synonyms Antiphospholipids Cardiolipin Antibodies Test Includes Anticardiolipin antibodies, IgA, quantitative; anticardiolipin antibodies, IgG, quantitative; anticardiolipin antibodies, IgM, quantitative Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anticardiolipin Antibodies Antiphosphatidylserine, IgA, IgG, IgM β2-Glycoprotein 1 Antibodies, IgA, IgG, IgM Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 14 days Frozen 14 days Test Details Use Anticardiolipin antibodies are often present in individuals with the antiphospholipid antibody syndrome.1,2 Limitations ACA can often be observed during the convalescent phase of acute bacterial and viral infections and in individuals with syphilis. These infection-induced antibodies are usually transient and are not associated with an increased risk of clinical complications. In general, all patients who test positive for ACA should be retested after six to eight weeks to rule out transient antibodies that are usually of no clinical significance. Methodology Enzyme-linked immunosorbent assay (ELISA) detecting isotype-specific ACA binding to a microtiter plate coated with purified cardiolipin antigen

Anticardiolipin Antibodies (ACA), IgA, Quantitative

Synonyms Antiphospholipids Cardiolipin Antibodies Test Includes IgA anticardiolipin antibodies, quantitative Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anticardiolipin Antibodies Antiphosphatidylserine, IgA, IgG, IgM β2-Glycoprotein 1 Antibodies, IgA, IgG, IgM Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 14 days Frozen 14 days Causes for Rejection Hemolysis; lipemia; icteric specimen Test Details Use Anticardiolipin antibodies are often present in individuals with the antiphospholipid antibody syndrome.1,2 Limitations ACA can often be observed during the convalescent phase of acute bacterial and viral infections and in individuals with syphilis. These infection-induced antibodies are usually transient and are not associated with an increased risk of clinical complications. In general, all patients who test positive for ACA should be retested after six to eight weeks to rule out transient antibodies that are usually of no clinical significance. Methodology Enzyme-linked immunosorbent assay (ELISA) detecting isotype-specific ACA binding to a microtiter plate coated with purified cardiolipin antigen Reference Interval • Negative: 20−80 APL units/mL • Positive: >80 APL units/mL 1 APL unit = cardiolipin-binding activity of purified IgA anticardiolipin (at 1 U/mL) from an international reference standard. Additional Information Individuals with the antiphospholipid antibody syndrome (APS) have an increased risk for stroke, myocardial infarction, venous thrombosis, thromboembolism, thrombocytopenia, and/or recurrent miscarriages. In 1999, an international consensus conference found that one criterion for the serologic diagnosis of “definite antiphospholipid syndrome” is the presence of anticardiolipin antibody of IgG and/or IgM isotype, at medium or high titer, on two or more occasions, at least six weeks apart.3 The presence of ACA of moderate to high titer for IgG is strongly associated with both arterial and venous thrombosis and recurrent pregnancy loss.4-6 The IgM isotype of ACA has also been shown to be associated with venous thrombosis.4 Other studies found that ACA of the IgA isotype at moderate to high titer can also be associated with increased risk of APS.2,6 ACA antibodies are quite common in the general population and are not always associated with APS. Studies indicate that there is a higher prevalence of IgM positives than IgG in the general population with these isotypes occurring in 9.4% and 6.5% of the population, respectively.7 The incidence of these ACA is even higher in normal pregnancy with detection rates of 17% for IgM and 10.6% for IgG.8 Many of these antibodies are transient and not associated with APS. The diagnosis of APS should not be made on the basis of a single ACA result but rather on repeated positive results obtained at least six weeks apart.1 The Venereal Disease Research Laboratory (VDRL) agglutination test that has been used for decades in the diagnosis of syphilis is based on the detection of antibodies to cardiolipin.9 The first solid-phase immunoassays for ACA were developed in the early 1980s.9 These solid-phase assays are at least 100-fold more sensitive than the classical VDRL assay and produce many more positive results. In general, ACA are considered to be more sensitive than lupus anticoagulants (LA) for the detection of APS.4 The ACA test is positive in 80% to 90% of patients with APS,10 and ACA are implicated in approximately five times more cases of APS than are LA;2 however, LA are considered to be more specific for APS than ACA.2,10 Due to the heterogeneity of antibodies associated with APS, both LA and ACA testing is recommend when APS is suspected.4,11 ACA are frequently observed in patients with other autoimmune disorders and malignancies. Individuals with ACA secondary to these other conditions are at increased risk of developing APS. A variety of therapeutic drugs can induce the production of ACA. These drug-induced antibodies may be clinically significant if they persist.2,12

Anticardiolipin Antibodies (ACA), IgG, IgM, Quantitative

Synonyms Antiphospholipids Cardiolipin Antibodies Test Includes Anticardiolipin antibodies, IgG, quantitative; anticardiolipin antibodies, IgM, quantitative Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anticardiolipin Antibodies Antiphosphatidylserine, IgA, IgG, IgM β2-Glycoprotein 1 Antibodies, IgA, IgG, IgM Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Causes for Rejection Hemolysis; lipemia; icteric specimen Test Details Use Anticardiolipin antibodies are often present in individuals with the antiphospholipid antibody syndrome.1,2 Limitations ACA can often be observed during the convalescent phase of acute bacterial and viral infections and in individuals with syphilis. These infection-induced antibodies are usually transient and are not associated with an increased risk of clinical complications. In general, all patients who test positive ACA should be retested after six to eight weeks to rule out transient antibodies that are usually of no clinical significance. Methodology Enzyme-linked immunosorbent assay (ELISA) detecting isotype-specific ACA binding to a microtiter plate coated with purified cardiolipin antigen Reference Interval • IgG: − Negative: 20−80 GPL − Positive: >80 GPL • IgM: − Negative: 20−80 MPL − Positive: >80 MPL Additional Information Individuals with the antiphospholipid antibody syndrome (APS) have an increased risk for stroke, myocardial infarction, venous thrombosis, thromboembolism, thrombocytopenia, and/or recurrent miscarriages. In 1999, an international consensus conference found that one criterion for the serologic diagnosis of “definite antiphospholipid syndrome” is the presence of anticardiolipin antibody of IgG and/or IgM isotype, at medium or high titer, on two or more occasions, at least 6 weeks apart.3 The presence of ACA of moderate to high titer for IgG is strongly associated with both arterial and venous thrombosis and recurrent pregnancy loss.2,4,5 The IgM isotype of ACA has also been shown to be associated with venous thrombosis.4 Other studies found that ACA of the IgA isotype at moderate to high titer can also be associated with increased risk of APS.2,6 ACA antibodies are quite common in the general population and are not always associated with APS. Studies indicate that there is a higher prevalence of IgM positives than IgG in the general population with these isotypes occurring in 9.4% and 6.5% of the population, respectively.7 The incidence of these ACA is even higher in normal pregnancy with detection rates of 17% for IgM and 10.6% for IgG.8 Many of these antibodies are transient and not associated with APS. The diagnosis of APS should not be made on the basis of a single ACA result but rather on repeated positive results obtained at least six weeks apart.1 The Venereal Disease Research Laboratory (VDRL) agglutination test that has been used for decades in the diagnosis of syphilis is based on the detection of antibodies to cardiolipin.9 The first solid-phase immunoassays for ACA were developed in the early 1980s.9 These solid-phase assays are at least 100-fold more sensitive than the classical VDRL assay and produce many more positive results. In general, ACA are considered to be more sensitive than lupus anticoagulants (LA) for the detection of APS.4 The ACA test is positive in 80% to 90% of patients with APS,10 and ACA are implicated in approximately five times more cases of APS than are LA;2 however, LA are considered to be more specific for APS than ACA.2,10 Due to the heterogeneity of antibodies associated with APS, both LA and ACA testing is recommend when APS is suspected.4,11 ACA are frequently observed in patients with other autoimmune disorders and malignancies. Individuals with ACA secondary to these other conditions are at increased risk of developing APS. A variety of therapeutic drugs can induce the production of ACA. These drug-induced antibodies may be clinically significant if they persist.2,12

Anticardiolipin Antibodies (ACA), IgG, Quantitative

Synonyms Antiphospholipids Cardiolipin Antibodies Test Includes IgG anticardiolipin antibodies, quantitative Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anticardiolipin Antibodies Antiphosphatidylserine, IgA, IgG, IgM β2-Glycoprotein 1 Antibodies, IgA, IgG, IgM Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Causes for Rejection Hemolysis; lipemia; icteric specimen Test Details Use Anticardiolipin antibodies are often present in individuals with the antiphospholipid antibody syndrome.1,2 Limitations ACA can often be observed during the convalescent phase of acute bacterial and viral infections and in individuals with syphilis. These infection-induced antibodies are usually transient and are not associated with an increased risk of clinical complications. In general, all patients who test positive for ACA should be retested after six to eight weeks to rule out transient antibodies that are usually of no clinical significance. Methodology Enzyme-linked immunosorbent assay (ELISA) detecting isotype-specific ACA binding to a microtiter plate coated with purified cardiolipin antigen Reference Interval • Negative: 20−80 GPL • Positive: >80 GPL 1 GPL unit = cardiolipin-binding activity of purified IgA anticardiolipin (at 1 U/mL) form an international reference standard. Additional Information Individuals with the antiphospholipid antibody syndrome (APS) have an increased risk for stroke, myocardial infarction, venous thrombosis, thromboembolism, thrombocytopenia, and/or recurrent miscarriages. In 1999, an international consensus conference found that one criterion for the serologic diagnosis of “definite antiphospholipid syndrome” is the presence of anticardiolipin antibody of IgG and/or IgM isotype, at medium or high titer, on two or more occasions, at least six weeks apart.3 The presence of ACA of moderate to high titer for IgG is strongly associated with both arterial and venous thrombosis and recurrent pregnancy loss.2,4,5 The IgM isotype of ACA has also been shown to be associated with venous thrombosis.4 Other studies found that ACA of the IgA isotype at moderate to high titer can also be associated with increased risk of APS.2,6 ACA antibodies are quite common in the general population and are not always associated with APS. Studies indicate that there is a higher prevalence of IgM positives than IgG in the general population with these isotypes occurring in 9.4% and 6.5% of the population, respectively.7 The incidence of these ACA is even higher in normal pregnancy with detection rates of 17% for IgM and 10.6% for IgG.8 Many of these antibodies are transient and not associated with APS. The diagnosis of APS should not be made on the basis of a single ACA result but rather on repeated positive results obtained at least six weeks apart.1 The Venereal Disease Research Laboratory (VDRL) agglutination test that has been used for decades in the diagnosis of syphilis is based on the detection of antibodies to cardiolipin.9 The first solid-phase immunoassays for ACA were developed in the early 1980s.9 These solid-phase assays are at least 100-fold more sensitive than the classical VDRL assay and produce many more positive results. In general, ACA are considered to be more sensitive than lupus anticoagulants (LA) for the detection of APS.4 The ACA test is positive in 80% to 90% of patients with APS,10 and ACA are implicated in approximately five times more cases of APS than are LA;2 however, LA are considered to be more specific for APS than ACA.2,10 Due to the heterogeneity of antibodies associated with APS, both LA and ACA testing is recommend when APS is suspected.4,11 ACA are frequently observed in patients with other autoimmune disorders and malignancies. Individuals with ACA secondary to these other conditions are at increased risk of developing APS. A variety of therapeutic drugs can induce the production of ACA. These drug-induced antibodies may be clinically significant if they persist.2,12

Anticardiolipin Antibodies (ACA), IgM, Quantitative

Synonyms Antiphospholipids Cardiolipin Antibodies Test Includes Anticardiolipin antibodies, IgM, quantitative Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anticardiolipin Antibodies Antiphosphatidylserine, IgA, IgG, IgM β2-Glycoprotein 1 Antibodies, IgA, IgG, IgM Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Causes for Rejection Hemolysis; lipemia; icteric specimen Test Details Use Anticardiolipin antibodies are often present in individuals with the antiphospholipid antibody syndrome.1,2 Limitations ACA can often be observed during the convalescent phase of acute bacterial and viral infections and in individuals with syphilis. These infection-induced antibodies are usually transient and are not associated with an increased risk of clinical complications. In general, all patients who test positive for ACA should be retested after six to eight weeks to rule out transient antibodies that are usually of no clinical significance. Methodology Enzyme-linked immunosorbent assay (ELISA) detecting isotype-specific ACA binding to a microtiter plate coated with purified cardiolipin antigen Reference Interval • Negative: 20−80 MPL • Positive: >80 MPL 1 MPL unit = cardiolipin-binding activity of purified IgM anticardiolipin (at 1 U/mL) from an international reference standard. Additional Information Individuals with the antiphospholipid antibody syndrome (APS) have an increased risk for stroke, myocardial infarction, venous thrombosis, thromboembolism, thrombocytopenia, and/or recurrent miscarriages. In 1999, an international consensus conference found that one criterion for the serologic diagnosis of “definite antiphospholipid syndrome” is the presence of anticardiolipin antibody of IgG and/or IgM isotype, at medium or high titer, on two or more occasions, at least six weeks apart.3 The presence of ACA of moderate to high titer for IgG is strongly associated with both arterial and venous thrombosis and recurrent pregnancy loss.2,4,5 The IgM isotype of ACA has also been shown to be associated with venous thrombosis.4 Other studies found that ACA of the IgA isotype at moderate to high titer can also be associated with increased risk of APS.2,6 ACA antibodies are quite common in the general population and are not always associated with APS. Studies indicate that there is a higher prevalence of IgM positives than IgG in the general population with these isotypes occurring in 9.4% and 6.5% of the population, respectively.7 The incidence of these ACA is even higher in normal pregnancy with detection rates of 17% for IgM and 10.6% for IgG.8 Many of these antibodies are transient and not associated with APS. The diagnosis of APS should not be made on the basis of a single ACA result but rather on repeated positive results obtained at least six weeks apart.1 The Venereal Disease Research Laboratory (VDRL) agglutination test that has been used for decades in the diagnosis of syphilis is based on the detection of antibodies to cardiolipin.9 The first solid-phase immunoassays for ACA were developed in the early 1980s.9 These solid-phase assays are at least 100-fold more sensitive than the classical VDRL assay and produce many more positive results. In general, ACA are considered to be more sensitive than lupus anticoagulants (LA) for the detection of APS.4 The ACA test is positive in 80% to 90% of patients with APS,10 and ACA are implicated in approximately five times more cases of APS than are LA;2 however, LA are considered to be more specific for APS than ACA.2,10 Due to the heterogeneity of antibodies associated with APS, both LA and ACA testing is recommend when APS is suspected.4,11 ACA are frequently observed in patients with other autoimmune disorders and malignancies. Individuals with ACA secondary to these other conditions are at increased risk of developing APS. A variety of therapeutic drugs can induce the production of ACA. These drug-induced antibodies may be clinically significant if they persist.2,12

Antidiuretic Hormone (ADH) Profile

Synonyms ADH Arginine Vasopressin AVP Vasopressin Test Includes ADH; osmolality Expected Turnaround Time 7 - 10 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum, refrigerated and plasma, frozen Volume 1 mL serum and 2 mL plasma Minimum Volume 0.5 mL serum and 1 mL plasma (Note: This volume does not allow for repeat testing.) Container Gel-barrier tube and lavender-top (EDTA) tube Collection Draw serum and plasma samples and separate from cells using a refrigerated centrifuge. Transfer separated samples into clearly labeled “plasma” and “serum” plastic transport tubes. Freeze plasma immediately and refrigerate serum. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Freeze plasma immediately. Refrigerate serum. Patient Preparation No isotopes administered 24 hours prior to venipuncture Causes for Rejection Recently administered isotopes; serum specimen not received; plasma specimen not received frozen Test Details Use Aid in the diagnosis of urine concentration disorders, especially diabetes insipidus, syndrome of inappropriate ADH (SIADH), psychogenic water intoxication, and syndromes of ectopic ADH production Limitations Results for this test are for research purposes only by the assay's manufacturer. The performance characteristics of this product have not been established. Results should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. Methodology ADH: radioimmunoassay (RIA); osmolality: freezing point depression Reference Interval • ADH: 0.0−4.7 pg/mL • Osmolality: − Neonates: May be as low as 266 mOsmol/kg − 0 to 60 years: 275−295 mOsmol/kg − >60 years: 280−301 mOsmol/kg Additional Information ADH, produced in the supraoptic and paraventricular locations of the hypothalamus, acts on the collecting tubules of the kidney to cause increase in permeability to water and urea. ADH release is triggered by a number of both osmotic and nonosmotic stimuli. Measurement of ADH is useful in separating central diabetes insipidus, which is marked by polydipsia and polyuria and is caused by inadequate ADH production from nephrogenic diabetes insipidus caused by the inability of renal tubules to respond to ADH. In SIADH, release of ADH is disproportionate to a low serum osmolality. SIADH results due to a number of conditions such as pulmonary disease, head trauma, and cancer.

Antiextractable Nuclear Antigens

Synonyms Anti-ENA Anti-RNP Anti-Sm Test Includes Semiquantitative result of IgG class antibodies Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; icterus; lipemia; bacterial contamination Test Details Use Detect antibodies associated with SLE and mixed connective tissue disease. Anti-Sm is highly specific for SLE. Anti-RNP is found with a variety of rheumatoid diseases with high titers associated mainly with MCTD. Methodology Multiplex flow immunoassay Reference Interval 0.0−0.9 AI Additional Information Antibodies that produce a speckled ANA pattern are usually directed against extractable nucleoprotein complexes found in the nucleus and/or cytoplasm of substrate cells. Included in this group of antigens are RNP, Sm, SS-A, SS-B, Scl-70, and Jo-1.

Antiglomerular Basement Membrane Antibodies

Synonyms Anti-GBM Goodpasture Syndrome Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Microbially contaminated, heat-treated specimens, or specimens containing visible particulate; grossly hemolyzed or lipemic specimens Test Details Use Detect the presence of circulating glomerular basement membrane-specific antibodies in Goodpasture syndrome; quantitation may be useful in monitoring treatment. This test is often used in conjunction with the antineutrophil cytoplasmic antibody (ANCA) test for Wegener granulomatosis and vasculitis. Methodology Enzyme immunoassay (EIA) Reference Interval 0−20 units/mL

Antihistone Antibodies

Synonyms DIL Drug-induced Lupus Antibodies H2a/H2b and H3 and H4 Antibodies Histone Antibodies Test Includes Semiquantitative result of IgG class antibodies Expected Turnaround Time 2 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Causes for Rejection Hemolysis; icterus; lipemia; bacterial contamination Test Details Use Histones are lysine-rich and arginine-rich basic proteins of eukaryotic cells which are predominantly found as complexes with DNA. Antibodies to histones are detected in approximately 30% to 60% of patients with systemic lupus erythematosus (SLE), but their presence in about 95% of patients with drug-induced lupus is more important diagnostically. Drug-induced lupus (primarily caused by procainamide and hydralazine) is clinically similar to SLE, except that the former patients do not have kidney or central nervous system involvement and they do not demonstrate the multiple types of antinuclear antibodies (ANAs) often found in SLE patients. In addition, drug-induced antihistone antibodies react strongly with H2a/H2b fragments (in procainamide-induced SLE) as well as H3 and H4 (in hydralazine-induced SLE). In patients with drug-induced lupus, antihistone antibodies are usually the only ANAs, although antibodies to denaturated DNA have been detected in a small percentage of patients. Antihistone antibodies also occur in approximately 20% of patients with rheumatoid arthritis. Limitations The expected value in the normal population is negative; however, apparently healthy individuals may contain ANA in their sera. This percentage increases with aging, particularly in the seventh decade of life. Certain therapeutic drug regimens and viral syndromes may also cause ANAs. Methodology Enzyme-linked immunosorbent assay (ELISA)

Antineutrophil Cytoplasmic Antibodies (ANCA)

Test Includes Antineutrophil cytoplasmic autoantibodies exhibiting pANCA or cANCA patterns are detected using indirect immunofluorescent antibody (IFA) techniques with a substrate of ethanol-fixed human neutrophils. Positive patient sera with perinuclear or nuclear patterns are repeated using a formalin-fixed substrate in order to differentiate the presence of true pANCA antibodies from possible interference with antinuclear antibodies (ANA). Expected Turnaround Time 2 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Antimyeloperoxidase (MPO) Antibodies Antiproteinase 3 (PR3) Antibodies Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Gross hemolysis; lipemia; bacterial contamination Test Details Use Antineutrophil cytoplasmic autoantibodies (ANCA) are a serological marker associated with vasculitis and glomerulonephritis. Specifically, ANCA have been found (at frequencies ranging from 70% to 90%) in patients with active Wegener granulomatosis, microscopic polyarteritis nodosa, and idiopathic crescentic glomerulonephritis (with manifestations ranging from kidney-limited disease to extrarenal systemic disease, including pulmonary-renal syndromes). Glomerular lesions in patients with ANCA-associated systemic vasculitis or renal-limited disease are virtually identical. Normal controls are negative for ANCA and <10% of patients with other renal diseases are positive. ANCA may be directly involved in the pathogenesis of the vascular injury that causes the clinical manifestations in ANCA-associated disease. Methodology Indirect fluorescent antibody (IFA)

Antinuclear Antibodies (ANA) by IFA, Reflex to 9-biomarker profile, dsDNA, RNP, Sm, SS-A, SS-B, Scl-70, Chromatin, Jo-1, Centromere B by Multiplex Immunoassay

Synonyms ANA IFA Reflex Test Includes Detect antibodies to nuclear antigens by IFA with patterns and titers with reflex if positive to centromere B; chromatin; dsDNA; Jo-1; RNP; scl-70; Sjögren's A; Sjögren's B; Smith (Sm). If reflex testing is performed, additional charges/CPT code(s) may apply. Expected Turnaround Time 1 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Antinuclear Antibodies (ANA), Qualitative, by Multiplex Immunoassay Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 7 days Frozen 7 days Freeze/thaw cycles Stable x2 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Assay for screening for ANAs in patients suspected of having connective tissue disease. Limitations Males and females older than 80 years of age have a 50% incidence of low titer ANA. Various medications can induce a "lupoid" condition and elevated ANA titers. Usually the titer decreases following removal of the drug. Low antibody levels may be found in diseases other than connective tissue disease.

Antinuclear Antibodies (ANA) Profile, 11 biomarkers, by Multiplex Immunoassay, dsDNA, RNP, Sm, SS-A, SS-B, Scl-70, Chromatin, Jo-1, Centromere B, Sm/RNP, Ribosomal P

Synonyms ANA Comprehensive Plus Profile Test Includes Centromere B; chromatin; dsDNA; Jo-1; ribosomal P; RNP; scl-70; Sjögren's A; Sjögren's B; Sm/RNP; Smith (Sm) Special Instructions Test is intended to be used as a follow-up to Antinuclear Antibodies (ANA) Direct [164855]. Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination; icterus Test Details Use Detect antibodies associated with SLE and mixed connective tissue disease. Sm antibodies are highly specific for SLE. RNP antibodies are found with a variety of rheumatoid diseases. RNP, Sm, SS-A, SS-B, Scl-70, and Jo-1 are extractable nucleoprotein complexes found in the nucleus and/or cytoplasm of substrate cells. Autoantibodies to the ribosomal P protein represent a highly specific marker for the diagnosis of SLE, where they have been associated with certain clinical manifestations. The native protein SmRNP contains two different regions: Sm and RNP that are different regions of the same macromolecule. SmRNP is the best antigen for detection of antibodies to either Sm or RNP but cannot discriminate between the antibody specificities. Inclusion of SmRNP increases sensitivity while inclusion of Sm and RNP increases specificity. Methodology Multiplex flow immunoassay

Antinuclear Antibodies (ANA), by IFA

Synonyms ANA, IFA ANA-Hep2 Expected Turnaround Time 1 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Complement C3 Complement C4 Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 7 days Frozen 7 days Freeze/thaw cycles Stable x2 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Detect antibodies to nuclear antigens Limitations Males and females older than 80 years of age have a 50% incidence of low titer ANA. Various medications can induce a "lupoid" condition and elevated ANA titers. Usually, the titer decreases following removal of the drug. Methodology Indirect fluorescent antibody (IFA) Reference Interval • Negative: 1:80 Additional Information The indirect immunofluorescent test has three elements to consider in the result: 1. Positive or negative fluorescence. A negative test is strong evidence against a diagnosis of SLE but not conclusive. See Anti-DNA (Single-stranded) Antibodies, Quantitative, IgG [161422]. 2. The titer (dilution) to which fluorescence remains positive (provides a reflection of the concentration or avidity of the antibody). Many individuals, particularly the elderly, may have low titer ANA without significant disease substantiated after work-up. 3. The pattern of nuclear fluorescence (reflecting specificity for various diseases). Homogenous and/or nuclear rim (peripheral) pattern correlates with antibody to native DNA and deoxynucleoprotein and bears correlation with SLE, SLE activity, and lupus nephritis. Homogenous (diffuse) pattern suggests SLE or other connective tissue diseases. Speckled pattern correlates with antibody to nuclear antigens extractable by saline; it is found in many disease states, including SLE and scleroderma. When antibodies to DNA and deoxyribonucleoprotein are present (rim and homogenous pattern), there may be interference with the detection of speckled pattern. Nucleolar pattern is seen in sera of patients with progressive systemic sclerosis and Sjögren's syndrome. Centromere pattern is seen in CREST syndrome. Antinuclear Antibody ANA Pattern Identification

Antinuclear Antibodies (ANA), by IFA, Reflex to 11-biomarker profile, dsDNA, RNP, Sm, SS-A, SS-B, Scl-70, Chromatin, Centromere B, Sm/RNP, Ribosomal P by Multiplex Immunoassay

Synonyms ANA by IFA Reflex Special Instructions If reflex test is performed, additional charges/CPT code(s) may apply. Expected Turnaround Time 1 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anti-DNA (Single-stranded) Antibodies, Quantitative, IgG Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 7 days Refrigerated 7 days Frozen 7 days Freeze/thaw cycles Stable x2 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Assay for screening for ANAs in patients suspected of having connective tissue disease. The indirect immunofluorescent test has three elements to consider in the result: 1. Positive or negative fluorescence. A negative test is strong evidence against a diagnosis of SLE but not conclusive. See Anti-DNA (Single-stranded) Antibodies, Quantitative, IgG [161422]. 2. The titer (dilution) to which fluorescence remains positive (provides a reflection of the concentration or avidity of the antibody). Many individuals, particularly the elderly, may have low titer ANA without significant disease substantiated after work-up. 3. The pattern of nuclear fluorescence (reflecting specificity for various diseases). Cytoplasmic (non-nuclear) staining patterns may also be noted with the IFA methodology. Multiplex ANA detects up to 11 specific antibodies of the 100+ antibodies that may be found in the ANA IFA. Limitations Males and females older than 80 years of age have a 50% incidence of low titer ANA. Various medications can induce a "lupoid" condition and elevated ANA titers. Usually the titer decreases following removal of the drug. Low antibody levels may be found in diseases other than connective tissue disease. Methodology Indirect Immunofluorescence Assay (IFA) and Multiplex Flow Immunoassa

Antinuclear Antibodies (ANA), by Multiplex Immunoassay, Reflex to 5-biomarker profile (ENA), dsDNA, RNP, Sm, SS-A, SS-B

Synonyms ANA With Reflex ANA-specific Antibodies Extractable Nuclear Antibodies Test Includes Antinuclear antibodies (ANA) will reflex if positive to dsDNA; RNP; Sjögren's A; Sjögren's B; Smith (Sm). If reflex testing is performed, additional charges/CPT code(s) may apply. Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination; icterus Test Details Methodology Multiplex flow immunoassay

Antinuclear Antibodies (ANA), by Multiplex Immunoassay, Reflex to 9-biomarker profile, dsDNA, RNP, Sm, SS-A, SS-B, Scl-70, Chromatin, Jo-1, Centromere B

Synonyms ANA With Reflex if Positive Test Includes Antinuclear antibodies (ANA) will reflex if positive to centromere B; chromatin; dsDNA; Jo-1; RNP; scl-70; Sjögren's A; Sjögren's B; Smith (Sm). If reflex testing is performed, additional charges/CPT code(s) may apply. Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination; icterus Test Details Use Assay for screening for ANAs in patients suspected of having SLE Limitations Low antibody levels may be found in diseases other than connective tissue disease. Methodology Multiplex flow immunoassay

Antinuclear Antibodies (ANA), Qualitative, by Multiplex Immunoassay

Synonyms ANA Direct Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination; icterus Test Details Use Detect antibodies to nuclear antigens Limitations Males and females older than 80 years of age have a 50% incidence of low titer ANA. Various medications can induce a “lupoid” condition. Methodology Multiplex flow immunoassay Reference Interval Negative

Antipancreatic Islet Cells

Expected Turnaround Time 2 - 7 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Glutamic Acid Decarboxylase (GAD) Autoantibody IA2 Autoantibodies (Endocrine Sciences) Insulin Autoantibodies (IAA) (Endocrine Sciences) Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Storage Instructions Refrigerate Test Details Use Differential diagnosis of insulin-dependent diabetes from noninsulin-dependent diabetes Methodology Indirect fluorescent antibody (IFA)

Antiparietal Cell Antibody (APCA)

Synonyms Gastric Parietal Cell Antibodies Test Includes Titer Expected Turnaround Time 1 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Vitamin B12 Deficiency Cascade Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.3 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination; heat-treated specimen; specimen with preservative added Test Details Use Detection of gastric parietal cell antibodies of the IgG class in human sera. Autoantibodies to gastric parietal cells are found in approximately 90% of patients with pernicious anemia and in about 30% of first degree relatives of patients with pernicious anemia. Increased levels of gastric parietal cells have been found in patients with thyroid disease, iron deficiency anemia, alopecia areata, and vitiligo. Limitations The presence of immune complexes in a patient's sample may cause an elevated level of nonspecific binding and produce false-positive results. Assay performance has not been established for pediatric patients. Methodology Enzyme-linked immunosorbent assay (ELISA)

Antiphosphatidylserine, IgA, IgG, IgM

Expected Turnaround Time 2 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anticardiolipin Antibodies Anticardiolipin Antibodies (ACA), IgA, IgG, IgM, Quantitative Anticardiolipin Antibodies (ACA), IgA, Quantitative Anticardiolipin Antibodies (ACA), IgM, Quantitative β2-Glycoprotein 1 Antibodies, IgA, IgG, IgM Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Collection Separate serum from cells by centrifugation after clot formation. Storage Instructions Refrigerate Causes for Rejection Gross hemolysis; bacterial contamination; lipemia Test Details Use An adjunct to β2-glycoprotein and anticardiolipins in diagnosing aPS (antiphospholipid syndrome) for assessing thrombotic risk and other obstetric complications such as miscarriage or fetal growth restriction Methodology Enzyme-linked immunosorbent assay (ELISA) Additional Information Antiphospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of antiphospholipid antibodies are frequently detected in patients with autoimmune (ie, SLE) and nonautoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia, and fetal loss. These manifestations are the main features of the antiphospholipid syndrome. Antiphospholipid antibodies are detected either by ELISAs using cardiolipin or other negatively-charged phospholipids as the antigen (anticardiolipin antibodies) or coagulation assays (lupus anticoagulants). Unlike cardiolipin, phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets and its role in the coagulation cascade. The detection of antiphosphatidylserine (aPS) antibodies by ELISA has been recommended for the serological diagnosis of antiphospholipid syndrome. Patients with positive reactions to both cardiolipin and phosphatidylserine are more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of antiphosphatidylserine antibodies have been reported in autoimmune patients. In addition, antiphosphatidylserine antibodies in SLE patients correlated with clinical manifestations of antiphospholipid syndrome and their pathogenic role has been demonstrated in a murine model.

Antiphosphatidylserine/Prothrombin Complex, IgM

Synonyms Antiphosphatidylserine/Prothrombin Antibody Expected Turnaround Time 4 - 8 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Anticardiolipin Antibodies (ACA), IgA, IgG, IgM, Quantitative Antiphosphatidylserine, IgA, IgG, IgM Prothrombin Antibodies, IgG β2-Glycoprotein 1 Antibodies, IgA, IgG, IgM Related Documents Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Collection Separate serum or plasma from cells by centrifugation. Storage Instructions Freeze Stability Requirements Temperature Period Room temperature 6 hours Refrigerated 6 hours Frozen 12 months Freeze/thaw cycles Stable x5 Causes for Rejection Gross hemolysis; gross lipemia Test Details Use As an aid in the diagnosis of certain autoimmune thrombotic disorders, such as antiphospholipid syndrome (aPS). Antibodies to PS/PT correlate with the presence of lupus anticoagulants (LA) and this test may be useful in cases with difficult LA test interpretation. This assay may also assist in the determination of risk for thrombosis as well as obstetric complications in patients with antiphospholipid antibodies. Limitations The clinical significance of aPS/PT antibodies in diseases other than aPS or SLE is under investigation. Diagnosis cannot be made on the basis of aPS/PT antibody results alone and results must be interpreted with the patient's clinical condition. Treatment must not be initiated on the basis of aPS/PT antibody results alone and should also rely on supportive clinical indications. Patients with aPS and be a PS/PT positive yet lupus anticoagulant, anticardiolipin or anti-B2Gp1 negative. Methodology Enzyme-linked immunosorbent assay (ELISA) Additional Information Antiphospholipid antibodies (aPL) are a family of immunoglobulins of considerable clinical significance due to their association with arterial and/or venous thrombosis, recurrent pregnancy loss, neurological disorders, pulmonary hypertension and thrombocytopenia. These antibodies are directed against phospholipid binding proteins or their complex with phospholipid. The best-studied phospholipid-binding proteins include B2 glycoprotein 1 and prothrombin. Current laboratory assays recommended in the diagnosis of antiphospholipid syndrome (aPS), based on an international consensus guidelines, include anticardiolipin antibodies (aCL), B2 glycoprotein 1 antibodies (aB2Gp1) and detection of a lupus anticoagulant (LA) using clot-based assays. In regard to correlation with clinical manifestations of aPS, lupus anticoagulants are the most important laboratory finding followed by B2Gp1 IgG, then B2Gp1 IgM with isolated aCL, antiprothrombin and antiphosphatidylserine antibodies demonstrating significantly less correlation with aPS clinical manifestations. It has more recently been demonstrated that the antibodies most closely associated with aPS and LA are actually directed to a complex of anionic phospholipids such as phosphatidylserine/prothrombin (PS/PT) rather than to prothrombin alone. Also, thrombosis and pregnancy-related complications are more common in those with positivity in all three assays (LA, aCL and B2GpI of the same isotype) when the ELISA assays at positive at significant titer and this constellation is called triple positivity. A very high degree of concordance has been demonstrated between the concentration of aPS/PT and lupus anticoagulant (LA) activity, and thus aPS/PT may play a useful role in confirming LA activity in those patients on anticoagulant therapy where LA testing may be spuriously positive due to the anticoagulant interference or when there is difficult LA test interpretation.1 Furthermore, in APS patients, aPS/PT antibodies have been found to be highly associated with venous thrombosis and obstetric abnormalities.1 aPS/PT testing may help identify APS in patients with thrombosis or pregnancy loss in whom APS is strongly suspected but conventional antiphospholipid testing is repeatedly negative. In a cohort of patients with SLE, triple positivity for LA, antiB2GP1 and aPS/PT was more strongly associated with thrombosis and/or pregnancy loss (OR 23.2) than any other combination of LA and antiphospholipid antibodies, including triple positivity for LA, anticardiolipin and antiB2Gp1 (OR 14.9).2 Inclusion of aPT/PS testing into the standard aPL battery of assays may allow better quantitation of thrombotic risk and risk for pregnancy loss. Antiprothrombin IgG, IgM and antiphosphatidylserine IgG, IgM and IgA assays demonstrate little specificity for the clinical manifestations of aPS.3

Antiphospholipid Syndrome (APS) Profile

Test Includes (1) If the dilute Russell viper venom time (dRVVT) screen is high, a confirmation test will be performed. ( 2) If thrombin time is greater than 30.0 seconds, thrombin neutralization will be performed. (3) If activated partial thromboplastin time (aPTT) is 3 or more seconds above the upper limit of the reference range, activated partial thromboplastin time 1:1 normal plasma will be performed. Expected Turnaround Time 3 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Antiphospholipid Syndrome Lupus Anticoagulants Thrombin Time Related Documents Sample Report Specimen Requirements Specimen Plasma, frozen; and serum, room temperature Volume Three 2-mL citrated plasma tubes and 2 mL serum Container Blue-top (sodium citrate) platelet-free plasma tubes and red-top tube or gel-barrier tube Collection Citrated plasma samples should be collected by double centrifugation. Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood to anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples, except when using a winged blood collection device (ie, "butterfly"), in which case a discard tube should be used.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge for 10 minutes and carefully remove 2/3 of the plasma using a plastic transfer pipette, being careful not to disturb the cells. Deliver to a plastic transport tube, cap, and recentifuge for 10 minutes. Use a second plastic pipette to remove plasma, staying clear of the platelets at the bottom of the tube. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N° 49482). Freeze immediately and maintain frozen until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume. Storage Instructions Plasma, frozen; serum, room temperature. Stable at room temperature, refrigerated, or frozen for 14 days. Patient Preparation Ideally, the patient should not be on anticoagulant therapy. Avoid warfarin (Coumadin®) therapy for two weeks prior to the test and heparin, direct Xa, and thrombin inhibitor therapies for about three days prior to testing. Causes for Rejection Severe hemolysis; improper labeling; clotted specimen; specimen diluted with IV fluids; samples thawed in transit; improper sample type; sample out of stability Test Details Use Qualitative detection of lupus anticoagulants (LA) in plasma;6 semiquantitative detection of anticardiolipin and β2-glycoprotein 1 (β2GP1) antibodies in serum Limitations Anticoagulant therapies may result in false-positive LA results but will not interfere with aCL and β2GP1 testing. Methodology Clot; enzyme-linked immunosorbent assay (ELISA). A written assessment of the APS profile results is also provided as an aid in interpretation. Additional Information Antiphospholipid antibodies are a heterogeneous population of immunoglobulins directed against phospholipid-binding proteins that fall into one or two groups: lupus anticoagulants (which are identified using plasma-based clotting assays) and solid phase antibodies (which are identified using enzyme immunoassays and include anticardiolipin antibodies, antibodies to β2-glycoprotein 1 (β2GP1), antibodies to prothrombin, and others). Antiphospholipid antibodies, if present persistently during at least a 12-week period, may be associated with venous thrombosis, pulmonary embolism, arterial thrombosis, and pregnancy morbidity including recurrent fetal loss.7,8 In order to determine the presence of APS, both lupus anticoagulants (LA) and immunoassays for anticardiolipin and β2GP1 antibodies should be performed. Lupus anticoagulants are nonspecific inhibitors that extend the clotting time of phospholipid-dependent clotting assays, such as the activated partial thromboplastin time (aPTT).6,7 Unlike specific factor inhibitors, LA are not associated with an increased bleeding risk, unless the patient also suffers from thrombocytopenia or hypoprothrombinemia as a manifestation of the antibody. LA do not specifically inhibit individual coagulation factors; rather they neutralize anionic phospholipid-protein complexes that are involved in the coagulation process. Prolongation of clot-based assays is highly dependent on the sensitivity of the reagent employed to the presence of LA. Reagents with reduced amounts of phospholipid, such as the hexagonal phospholipid neutralization assay (aPTT LA) and dilute Russell viper venom time (dRVVT), have enhanced sensitivity for LA.6 Due to the heterogeneity of LA antibodies, no single assay will identify all cases.8 The International Society of Thrombosis and Haemostasis (ISTH) has established criteria for the diagnosis of lupus anticoagulants; there is also an international consensus statement describing criteria for antiphospholipid syndrome diagnosis.6-8 The laboratory criteria for definitive APS include one or more of the following; positive anticardiolipin IgG or IgM antibody at significant titer (>40 GPL or MPL units), positive β2GP1 IgG or IgM antibody, positive LA, and at least one result must demonstrate persistence of positivity at an interval of at least 12 weeks. Testing for lupus anticoagulant, anticardiolipin and β2GP1, and the antiphospholipid syndrome that is associated with these antibodies is described in more detail in the online coagulation appendices: Lupus Anticoagulants and Antiphospholipid Syndrome.

Antiproteinase 3 (PR3) Antibodies

Synonyms cANCA-specific Antibody Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Antineutrophil Cytoplasmic Antibodies (ANCA) Related Documents Sample Report Specimen Requirements Specimen Serum Volume 0.6 mL Minimum Volume 0.3 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x1 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use For diagnosis and monitoring inflammatory activity in primary systemic small vessel vasculitides. Antineutrophil antibodies are best demonstrated in these diseases by using a combination of IFA and EIAs that detect ANCA specific for PR3-ANCA or MPO-ANCA. Presence of anti-MPO antibodies are highly specific for idiopathic and vasculitis associated crescentic glomerulonephritis, classic polyarteritis nodosa, Churg-Strauss syndrome, and polyangiitis overlap syndrome without renal involvement. Presence of anti-PR3 antibodies are highly specific for Wegener granulomatous (WG) disease, for which the sensitivity is reported to be 98%. Some patients with WG have pANCA with MPO specificity. About 60% of patients with microscopic polyangiitis or pauci-immune segmental necrotizing glomerulonephritis have pANCA with MPO specificity but 30% have cANCA with PR3 specificity. Levels of anti-PR3 or anti-MPO are elevated during active phases of disease and lower during remission and can be monitored for management of disease. Limitations Results of this assay are not diagnostic proof of the presence or absence of disease and should be used in conjunction with clinical findings and other serological tests. Methodology Enzyme immunoassay (EIA)

Antiscleroderma − 70 Antibodies

Synonyms Anti-Scl 70 Test Includes Semiquantitative result of IgG class antibodies Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Hemolysis; icterus; lipemia; gross bacterial contamination Test Details Use Differential diagnosis of scleroderma (progressive systemic sclerosis) Methodology Multiplex flow immunoassay Reference Interval 0.0−0.9 AI Additional Information Scl-70 antibody is seen in 20% of patients with scleroderma, and in some patients with CREST syndrome (calcinosis, Raynaud, esophageal dysfunction, sclerodactyly, telangiectasia). These syndromes are also associated with a high frequency of speckled pattern immunofluorescent antinuclear antibody tests. Scl-70 may identify a subset of scleroderma patients with severe skin, joint, and lung disease. In addition, the presence of Scl-70 in Raynaud phenomenon may indicate a poor prognosis.

Antistreptolysin O (ASO) Antibodies

Synonyms ASO Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 2 mL Container Red-top tube or gel-barrier tube Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Gross hemolysis; lipemia Test Details Use Document exposure to streptococcal streptolysin O. A marked rise in titer or a persistently elevated titer indicates that a Streptococcus infection or poststreptococcal sequelae are present. Limitations False-positive ASO titers can be caused by increased levels of serum β-lipoprotein produced in liver disease and by contamination of the serum with Bacillus cereus and Pseudomonas sp ASO titers are elevated in 85% of patients with rheumatic fever but may not be elevated in cases involving skin or renal sequelae. For patients suffering from skin or renal involvement, anti-DNase B test (096289) may be a better choice. Methodology Latex immunoturbidimetry Reference Interval 0.0−200.0 IU/mL Additional Information Streptolysin is a hemolysin produced by group A streptococci. In an infected individual streptolysin O acts as a protein antigen, and the patient mounts an antibody response. A rise in antibody level begins about one week after infection and peaks two to three weeks later. In the absence of complications or reinfection, the ASO titer will usually fall to preinfection levels within 6 to 12 months. Both clinical and laboratory findings should be correlated in reaching a diagnosis.

Antithrombin (AT) Activity

Antithrombin (AT) Activity TEST: 015040 Test number copied CPT: 85300 Include LOINC® in print Synonyms Antithrombin III Activity Antithrombin III, Functional AT3 Activity Factor Xa Inhibitor Heparin Cofactor Activity Serine Protease Inhibitor Special Instructions If the patient's hematocrit exceeds 55%, the volume of citrate in the collection tube must be adjusted. Refer to Coagulation Collection Procedures for directions. Expected Turnaround Time 2 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Antithrombin (AT) Antigen (Immunologic) Antithrombin (AT) Deficiency Profile Genetic Thrombophilia Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Plasma, frozen Volume 1 mL Container Blue-top (sodium citrate) tube Collection Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood-to-anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples unless the sample is collected using a winged (butterfly) collection system. With a winged blood collection set a discard tube should be drawn first to account for the dead space of the tubing and prevent under-filling of the evacuated tube.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternative anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume. Storage Instructions Freeze. Patient Preparation Do not draw from an arm with a heparin lock or heparinized catheter. Patients ideally should not be on unfractionated heparin or direct Xa inhibitor anticoagulant therapy. Causes for Rejection Severe hemolysis; improper labeling; clotted specimen; specimen diluted with IV fluids; samples thawed in transit; improper sample type; sample out of stability Test Details Use Confirmation and characterization of acquired or congenital AT deficiency Limitations AT testing should not be performed on patients on unfractionated heparin therapy because heparin decreases plasma AT levels.6,7 AT results for individuals on warfarin therapy should be interpreted with caution because warfarin can increase levels of AT of patients with heterozygous deficiency into the normal range.7 Thrombin inhibitors, such as dabigatran, hirudin, and argatroban, will not interfere with the assay unless it is based on inhibition of thrombin. Direct Xa inhibitor anticoagulants will interfere with the AT activity assay when it is Xa based, falsely elevating the result, possibly masking a deficiency.6 Methodology The patient plasma is mixed with heparin and thrombin. The extent of thrombin inhibition is proportional to the AT concentration of the patient sample. Residual thrombin activity is measured as the rate of conversion of a chromogenic substrate and is used to calculate AT concentration.

Apixaban Anti-Xa

Expected Turnaround Time 2 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Apixaban Related Documents Sample Report Specimen Requirements Specimen Plasma, frozen Volume 1 mL Minimum Volume 0.5 mL (Note:This volume does not allow for repeat testing.) Container Blue-top (3.2% or 3.8% sodium citrate) tube Collection Separate plasma from cells by centrifugation. Transfer plasma to a plastic transport tube before freezing. Storage Instructions Freeze. Stable at room temperature for six hours. Freeze/thaw cycles: stable x6 Causes for Rejection Gross hemolysis; gross lipemia Test Details Use To measure plasma apixaban concentration in ng/mL. Although routine monitoring is not needed, there are a number of clinical circumstances in which clinicians want or need to know a patient's apixaban level. Levels can be accurately and precisely measured using either a chromogenic anti-Xa assay or LC/MS-MS. Limitations The assay is not specific for apixaban and will measure any direct or indirect factor Xa anticoagulant. This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Chromogenic anti-Xa. Apixaban inhibition of factor Xa (present in excess). Residual Xa is measured using a chromogen and is inversely proportional to the apixaban present. Additional Information Clinical Information Apixaban is an oral anticoagulant that prevents thrombin generation by inhibiting factor Xa produced as the result of both the intrinsic and extrinsic coagulation pathways.1,2 This drug inhibits free and prothrombinase-associated factor Xa in a concentration-dependent manner.3,4 Apixaban has a rapid onset reaching a maximal plasma concentration within one to three hours after oral administration.5,6 Steady-state concentrations are reached within three days with a half-life of 9 to 14 hours in healthy adults.5-7 Oral bioavailability of apixaban is not affected by food intake.4,5 Apixaban is almost insoluble in water and exhibits high plasma protein binding (87%) in humans.6 Approximately one-fourth of apixaban is excreted by the kidneys about one-half by the fecal route.5,6 Significant renal impairment results in decreased clearance and increases overall exposure to the drug.6 The P-glycoprotein (P-gp) multidrug transporter protein facilitates the transport of apixaban across cell membranes and influences the absorption and disposition of the drug in vivo.8,9 Apixaban is metabolized by the mixed function oxidase, cytochrome P450 3A4/5 (CYP3A4/5).5 Drugs that affect the activity of CYP3A4/5 and P-glycoprotein can potentially affect the pharmacokinetic profile of apixaban, Apixaban is transported across the intestinal wall by P-glycoprotein, and drugs that induce or inhibit P-glycoprotein activity may decrease or increase the levels of apixaban, respectively. Routine therapeutic monitoring of apixaban level is not required because of the drug's relatively wide therapeutic index. Despite the use of fixed doses of apixaban, determination of the amount of drug present in a given individual may be valuable in several clinical situations, such as patients who experience bleeding or treatment failure.10,11 Determination of drug concentration may also be needed in patients who require thrombolytic therapy, surgery, or in those who have suffered trauma. It may also be of value in patients with renal insufficiency, advanced age, and low body weight.10,11 Measurement of levels can inform clinicians with concerns regarding patient compliance and adherence to therapy as well as in situations of suspected or known overdose. Apixaban can be measured using a validated liquid chromatography/mass spectrometry (HPLC/MS-MS) method as well as a validated chromogenic anti-Xa method. Use of liquid LC/MS-MS provides highly accurate measurement of apixaban concentrations without the variable interferences associated with traditional clot-based and chromogenic assays.12 In fact, studies performed using the LabCorp LC/MS-MS method indicate that the assayed drug recovery was unaffected by the presence of lupus anticoagulants or heparin administration. Factor VIII deficiency and multiple factor deficiency associated with coumadin treatment had no effect on the recovery of drug. A chromogenic anti-Xa assay calibrated with an apixaban standard can accurately determine apixaban concentration in plasma, although this assay is not specific for apixaban and will detect any anti-Xa anticoagulant, both direct and indirect.11 Therapeutic Range In the Aristotle trial in nonvalvular atrial fibrillation patients receiving a 5 mg bid dose yielded a median Cmax apixaban value of 171 ng/mL with a 91-321 ng/mL range for the 5th to 95th percentile. A 2.5 mg bid dose yielded a median Cmax value of 123 ng/mL with a 68.5−221 ng/mL range for the 5th to 95th percentile.13 In the AMPLIFY trial in venous thromboembolism treatment, patients receiving a 5 mg bid dose yielded a median Cmax value of 132 ng/mL with a 58.6−302.2 ng/mL range for the 5th to 95th percentile. A 2.5 mg bid dose yielded a median Cmax value of 67 ng/mL with a 29.7−153.2 ng/mL range for the 5th to 95th percentile.12

APOE Alzheimer's Risk

Expected Turnaround Time 5 - 7 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Whole blood Volume 5 mL whole blood or 4 buccal swabs Minimum Volume 0.5 mL or two buccal swabs (Note: This volume does not allow for repeat testing.) Container Lavender-top (EDTA) tube (preferred), yellow-top (ACD) tube, or buccal swab kit provided by LabCorp. Storage Instructions Maintain specimen refrigerated or at room temperature. Stable at room temperature or refrigerated for seven days. Specimen is unstable frozen. Causes for Rejection Frozen whole blood samples; quantity not sufficient for analysis; improper container; one buccal swab Test Details Use This test is to detect the presence of the APOE4 variant, which is associated with increased risk of late-onset (age >60-65) Alzheimer's disease (AD). Testing may be considered for patients with dementia to supplement information from clinical and other evaluations. This test is not appropriate for children. APOE genotype results are E2/E2, E2/E3, E2/E4, E3/E3, E3,E4, or E4/E4. APOE genotyping supplies supplementary information for the clinical diagnosis of Alzheimer's disease. Alzheimer's disease (AD) is the most common form of dementia in the elderly and currently affects more that 5 million Americans. It is a progressive neurodegenerative disorder with brain findings of amyloid plaques containing β-amyloid and neurofibrillary tangles. AD is a complex and heterogeneous disease, influenced by many genetic and environmental factors. An early-onset variety in 1% to 5% of AD cases is autosomal-dominant and caused by rare mutations in known genes, including PSEN1, PSEN2, and APP. The predominant form of AD is late-onset (age >60-65), which can be familial (15% to 20%) or sporadic. The APOE4 (E4) variant of apolipoprotein E is strongly associated with risk of late-onset AD. Apolipoprotein E (apoE) has multiple roles, including lipid transport in the blood and the brain. The APOE4 variant increases the risk for late-onset Alzheimer's disease and may contribute to the pathology of the disease through influence on β-amyloid, inflammation, or other processes. The risk for development of late-onset AD is increased approximately two- to threefold for individuals with one copy of the APOE4 variant and by approximately 10- to 15-fold for individuals with two copies of the variant (E4/E4 genotype). The APOE2 variant has some protective effect against development of late-onset AD. The lifetime risk for late-onset Alzheimer's disease is approximately 10% to 12% in the general population, though it is higher in women than men and doubles when there is a first-degree relative with this disorder. The lifetime risk is approximately 9% for individuals negative for APOE4, and for individuals with E4/E4 may be as high as 25% for males and 45% for females. Among patients with late-onset AD, the presence of APOE4 may lead to earlier development of symptoms. However, APOE4 is neither necessary nor sufficient for the development of Alzheimer's disease. Approximately 30% to 50% of patients with late-onset Alzheimer's disease do not have an APOE4 allele. APOE4 is common, with 25% of the general population having one copy and 1% having two copies of this variant. Among patients with late-onset AD, 50% to 70% are positive for APOE4. The development of late-onset Alzheimer's disease is influenced by many factors other than APOE4, including age, gender, family history, level of education, and history of head trauma. Midlife cardiovascular risk factors in individuals with APOE4 also increase risk for cognitive decline. A number of genetic influences on Alzheimer's development in addition to APOE4 have also been reported and are under investigation. APOE4 is also associated with poor outcome to brain trauma, and it can influence therapeutic response to drugs for AD. Limitations This is not a diagnostic test. APOE4 increases risk of late-onset Alzheimer's disease, but many patients with APOE4 do not develop AD and—of patients with late-onset AD—30% to 50% are negative for APOE4. This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Polymerase chain reaction (PCR) with restriction enzyme digestion and polyacrylamide gel electrophoresis

Apolipoprotein B

Synonyms Beta Apolipoprotein Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Spanning the Continuum of Cardiovascular Care Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 2 mL Container Red-top tube, gel-barrier tube, green-top (heparin) tube, or lavender-top (EDTA) tube Collection Separate serum or plasma from cells. Transfer specimen to a plastic transport tube. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation Patient must be fasting 12 to 14 hours. Causes for Rejection Specimen from nonfasting patient Test Details Use LDL and its major protein, apolipoprotein B, play an essential role in lipid transport and metabolism. Apo B may regulate cholesterol synthesis through its interaction with specific cell membrane receptors and by inhibition of HMG Co A reductase. This enzyme has been identified as the rate controlling enzyme in cholesterol biosynthesis. Apo B may be important in the genesis of atherosclerosis and its quantitation useful in the evaluation of patients at risk for or having coronary atherosclerosis (CAD). High levels indicate increased risk for CAD. Methodology Immunologic Reference Interval Apolipoprotein B (mg/dL) Desirable Borderline High High Very High 130 ASCVD Risk Category Therapeutic Target APO B (mg/dL) Very High Risk <80 (if extreme risk <70) High Risk <90 Moderate Risk <90

aPTT Mixing Studies

Test Includes Activated partial thromboplastin time (aPTT); aPTT 1:1 mix normal plasma (NP); aPTT 1:1 mix saline; aPTT 1:1 mix incubated; aPTT 1:1 mix NP, incubated control Expected Turnaround Time 2 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Partial Thromboplastin Time (PTT), Activated Related Documents For more information, please view the literature below. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Sample Report Specimen Requirements Specimen Plasma, frozen Volume 2 mL Container Blue-top (sodium citrate) tube Collection Citrated plasma samples should be collected by double centrifugation. Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood to anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples, except when using a winged blood collection device (ie, "butterfly"), in which case a discard tube should be used.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge and carefully remove the plasma using a plastic transfer pipette, being careful not to disturb the cells. Deliver to a plastic pipette to remove the plasma, staying clear of the platelets at the bottom of the tube. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp No. 49482). Freeze immediately and maintain frozen until tested. Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume. Storage Instructions Freeze. Patient Preparation Ideally, the patient should not be on anticoagulant therapy. Avoid warfarin (Coumadin®) therapy for two weeks prior to the test and heparin, direct Xa, and thrombin inhibitor therapies for about three days prior to testing. Do not draw from an arm with a heparin lock or heparinized catheter. Causes for Rejection Severe hemolysis; improper labeling; clotted specimen; specimen diluted with IV fluids; samples thawed in transit; improper sample type; sample out of stability Test Details Use Distinguish specific (ie, factor VIII) and nonspecific (lupus anticoagulant) inhibitors; determine heparin presence; detect single or multiple factor deficiencies Limitations Lupus anticoagulant sensitive reagents are more responsive to the presence of lupus anticoagulants and are used in this panel. aPTT mixing studies will not be performed unless the aPTT is prolonged to 5 seconds or more above the upper end of the reference interval as they cannot be accurately interpreted when the aPTT is only slightly prolonged. The aPTT may not be extended in individual factor deficiencies unless the levels drop to 25% to 45% depending on the factor.6 Less significant individual factor deficiencies in combination (multiple factor deficiency) can extend the aPTT.6 The aPTT is more sensitive to intrinsic pathway factor deficiencies than common pathway factor deficiencies.6 Factor VIII elevations, as can occur due to acute phase reactions, can normalize a mildly extended aPTT result.6 Methodology To perform mixing studies, the patient specimen is mixed 1:1 with normal platelet-free plasma and with veronal buffered saline. aPTTs are performed on these mixtures. An aliquot of the normal plasma/patient plasma mixture is also incubated at 37°C for one to two hours and then an aPTT is performed to further clarify the cause of the prolongation. Normal platelet-free plasma and patient plasma are also incubated separately and then mixed after incubation as a control for possible factor degradation during incubation. Additional Information An isolated prolonged aPTT result with a normal prothrombin time implies either the presence of heparin and inhibitor (either specific factor or lupus anticoagulant) or a factor deficiency of the intrinsic system.7 Unless the cause for the prolonged aPTT is known, as in the case of heparin therapy, mixing studies may be necessary to determine the etiology of the prolonged result. If the result obtained with the immediate normal plasma mixture corrects to within the reference range and the saline mixture result increases dramatically, a factor deficiency or specific factor inhibitor is suspected.7 With factor deficiency, heparin, or a specific factor inhibitor, the 1:1 saline mix shows significant prolongation of the aPTT result. If the result obtained with the immediate normal plasma mixture shows only partial or no correction and the result obtained with the saline mixture shows near correction to the reference range or only mild prolongation, then a nonspecific inhibitor, such as lupus anticoagulant (LA), is suspected. After incubation at 37°C, an aPTT result equivalent to that of the original mixture is indicative of a factor deficiency or heparin. If the result of the aPTT on the incubated mixture demonstrates further prolongation (with the control remaining equivalent to the original result), a specific factor inhibitor is indicated. A specific factor VIII inhibitor may show initial correction of the original mixture, but will demonstrate prolongation upon incubation. If mixing studies indicate the possibility of single or multiple factor deficiencies, a PT may be performed to differentiate between common pathway and intrinsic pathway deficiencies. Factor assays should then be performed to determine specific factors involved. If a factor inhibitor is suspected, specific factor assays and inhibitor titers may be necessary. If heparin is suspected without clinical confirmation, a thrombin time with addition of heparin neutralizer should be performed on the original specimen. Plasma suspected of containing a lupus anticoagulant (LA) should be further tested with low phospholipid tests and associated confirmatory tests. A patient with an initial positive antiphospholipid antibody or lupus anticoagulant test should be tested after 12 or more weeks to determine if the antibody is persistent.

Aspartate Aminotransferase (AST/SGOT)

Synonyms Serum Glutamic Oxaloacetic Transaminase SGOT Transaminases Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Hereditary Hemochromatosis Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube, gel-barrier tube, green-top (heparin) tube, or lavender-top (EDTA) tube Collection Separate serum or plasma from cells within 45 minutes of collection. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 7 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Gross hemolysis; improper labeling Test Details Use A wide range of disease entities alters AST (SGOT), with origin from many organs. When an increased AST is from the liver, it is more likely to relate to disease of the hepatocyte. Other enzymes, including alkaline phosphatase and GT, are more sensitive indicators of biliary obstruction. Causes of low AST: uremia, vitamin B6 deficiency (this can be corrected), metronidazole, trifluoperazine. Causes of high AST: chronic alcohol ingestion, not limited to overt chronic alcoholism; cirrhosis. In alcoholic hepatitis, AST values usually are 3, and very high AST peaking at 500−3000 units/L in acute viral hepatitis (ie, in clinical acute viral hepatitis the transaminases may be increased 10 times or more above their upper limits of normal). AST increases are found in other types of liver disease, including earlier stages of hemochromatosis; chemical injury (eg, necrosis related to toxins such as carbon tetrachloride). Some instances of cholecystitis cause increased AST. AST and ALT (SGPT) are increased in Reye syndrome.1,2 In infectious mononucleosis, LD (LDH) is commonly considerably higher than AST. Trauma (including head trauma and including surgery) and other striated muscle diseases, including dystrophy, dermatomyositis, trichinosis, polymyositis, and gangrene cause AST increases. Both AST and ALT elevations are found with Duchenne muscular dystrophy. Look for high CK in myositis, high LD5 (or isomorphic pattern in some instances of polymyositis) on LD isoenzymes. In myocardial infarction AST peaks about 24 hours after infarct and returns to normal three to seven days later. In acute MI without shock or heart failure, ALT is not apt to increase significantly. AST increases in congestive failure with centrilobular liver congestion, in which high LD5 on LD isoenzymes is found, and in pericarditis, myocarditis, pancreatitis, and other inflammatory states including Legionnaires' disease. In renal infarction LD is usually high, out of proportion to AST.3 Lung infarction and other disease entities leading to necrosis including large, necrotic tumors cause increased AST; LD is commonly also increased in such instances. Shock (LD also usually increased); hypothyroidism (LD and/or CK not infrequently increased in myxedema); hemolytic anemias (LD high with increased LD1) and certain CNS diseases may increase AST. Very high AST levels usually are caused by liver disease and/or by shock. Drugs: A large number of commonly used drugs have been reported to elevate AST: isoniazid, phenothiazines, erythromycin, progesterone, anabolic-androgenic steroids, halothane, methyldopa, opiates, indomethacin, salicylates in children, and other drugs. Hepatotoxicity from drugs may cause high aminotransferase activity with elevation of AST:ALT ratio.4 Acetaminophen hepatotoxicity deserves special mention. In alcoholics, apparently moderate doses of the analgesic have caused severe hepatotoxicity. Doses of 2.6−16.5 g/24 hours are reported with total bilirubin 1.3−23.9 mg/dL, AST 1960−29,700 units/L, and ALT 12,000−12,550 units/L. The characteristic pattern included mild to severe coagulopathy and AST greater than ALT by a considerable margin.5 Macroenzyme causing unexplained increase of AST is described with normal levels of CK and ALT.6 Methodology Kinetic Additional Information AST has origin from heart, liver, skeletal muscle, kidney, pancreas, spleen, and lung. Very high values, >500 units/L, usually suggest hepatitis or other kinds of hepatocellular necrosis but can also be found with large necrotic tumors, other types of necrosis or extensive hypoxia, congestive failure, and shock. Unexplained AST elevations should first be investigated with ALT and GT. Mitochondrial AST (m-AST) may be useful in the diagnosis of alcoholic liver disease; it is reviewed by Rej.4

Aspergillus Galactomannan Antigen Detection, Bronchoalveolar Lavage or Serum

Special Instructions Avoid opening the specimen after collection. Do not aliquot (Package insert (PI) specifies transport in sealed tubes). The client must submit the patient's Social Security number for serial monitoring. Expected Turnaround Time 1 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum or bronchoalveolar lavage (BAL) Volume 2 mL Minimum Volume 0.35 mL (Note: This volume does not allow for repeat testing.) Container Serum: Red-top tube or gel-barrier tube; BAL: sterile screw-cap, leakproof container Collection Collect specimen using aseptic technique. Avoid opening the specimen after collection. Do not aliquot (Package insert (PI) specifies transport in sealed tubes). Storage Instructions Storage: Refrigerate unopened at 2°C to 8°C for five days. After opening, store at 2°C to 8°C for 48 hours. Freeze at: -70°C after five days. Stability: Not stable at room temperature. Stable refrigerated when unopened for five days. Stable opened for 48 hours. Stable frozen for 14 days. Patient Preparation Usual aseptic technique Causes for Rejection Unlabeled specimen or name discrepancy between specimen and test request form; blood collected in collection tubes other than those specified; grossly hemolyzed, lipemic, or icteric blood specimens; respiratory specimens other than BAL; inadequate specimen volume; specimen received after the specified time or improperly stored/transported; specimen source other than BAL or serum. (For CSF, see test 183858. CSF received for test 183805 will default to the correct test number without informing the client.) Test Details Use Patients diagnosed with chronic granulomatous disease and/or Job's syndrome may yield a reduced detection of galactomannan.1 Reduced assay sensitivity may occur in patients receiving concomitant antifungal therapy.2 Penicillium species, Alternaria species, Paecilomyces species, Geotrichum species, and Histoplasma species have demonstrated reactivity with the monoclonal antibodies used in the assay and may, therefore, yield a positive test result. Positive results in patients with no clinical signs of disease have been reported, especially in young children.3 Most of these are considered to be false positives. Young children may have a positive assay result due to the presence of galactofuranaase contained in various foods (cereals) and milk. Patients receiving piperacillin/tazobactam or semisynthetic beta-lactamase therapy may have false-positive results.4,5 False-positive results may also occur with use of PLASMA-LYTE™ for either intravenous hydration or BAL specimen collection.6 Limitations A negative result does not exclude the possibility of invasive aspergillosis. Patients at risk for invasive aspergillosis should be tested twice weekly. Results close to the cutoff (ie, index of 0.5) should be interpreted with caution and supported by clinical, radiological, or laboratory culture results. BAL samples with an index value between 0.5 and 1.0 have a lower predictive value than those with a value >1.0. Methodology Enzyme immunoassay (EIA)

Autoimmune Profile

Test Includes Anti-DNA (double-stranded) antibodies; antinuclear antibodies; complement C3 Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Specimen Requirements Specimen Serum Volume 3 mL Minimum Volume 1.5 mL Container Red-top tube or gel-barrier tube Collection Transfer specimen to a plastic transport tube. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 2 days Refrigerated 3 days Frozen 7 days Freeze/thaw cycles Stable x3

Common Lab Tests

Complete Blood Count

This test, also known as a CBC, is the most common blood test performed. It measures the types and numbers of cells in the blood, including red and white blood cells and platelets. This test is used to determine general health status, screen for disorders and evaluate nutritional status. It can help evaluate symptoms such as weakness, fatigue and bruising, and can help diagnose conditions such as anemia, leukemia, malaria and infection.

Prothrombin Time

Also known as PT and Pro Time, this test measures how long it takes blood to clot. This coagulation test measures the presence and activity of five different blood clotting factors. This test can screen for bleeding abnormalities, and may also be used to monitor medication treatments that prevent the formation of blood clots.

Basic Metabolic Panel

This test measures glucose, sodium, potassium, calcium, chloride, carbon dioxide, blood urea nitrogen and creatinine which can help determine blood sugar level, electrolyte and fluid balance as well as kidney function. The Basic Metabolic Panel can help your doctor monitor the effects of medications you are taking, such as high blood pressure medicines, can help diagnose certain conditions, or can be part of a routine health screening. You may need to fast for up to 12 hours before this test.

Lipid

Panel

The lipid panel is a group of tests used to evaluate cardiac risk. It includes cholesterol and triglyceride levels.

Liver Panel

The liver panel is a combination of tests used to assess liver function and establish the possible presence of liver tumors.

Hemoglobin A1C

This test is used to diagnose and monitor diabetes.

Urinalysis

Often the first lab test performed, this is a general screening test used to check for early signs of disease. It may also be used to monitor diabetes or kidney disease.

Cultures

Cultures are used to test for diagnosis and treatment of infections. Illnesses such as urinary tract infections, pneumonia, strep throat, MRSA and meningitis can be detected and tested for appropriate antibiotic treatment.

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