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There are currently 61 names in this directory beginning with the letter B.

B-Cell, IgH Gene Rearrangements

Special Instructions Please direct any questions regarding this test to customer service at 800-345-4363. 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 Information B-Cell Gene Rearrangements Profile, IgH and IgK B-Cell, IgK Gene Rearrangements T-Cell Receptor Gene Rearrangements Profile, γ and β T-Cell Receptor β-Chain Gene Rearrangements T-Cell Receptor γ-Chain Gene Rearrangements Specimen Requirements Specimen Whole blood, bone marrow, formalin-fixed, paraffin-embedded (FFPE) tissue block or slides, fresh or frozen tissue Volume 3 to 5 mL whole blood, 1 mL bone marrow, five unstained slides at 10 uM or formalin-fixed, paraffin-embedded tissue block, tissue in RPMI or frozen Minimum Volume 0.5 mL whole blood, 0.5 mL bone marrow, two unstained slides at 10uM Container Lavender-top (EDTA) tube, yellow-top (ACD) tube, green-top (heparin) tube, FFPE tissue block or slides, tissue in RPMI or frozen Collection Fresh tissue should be placed in RPMI medium or shipped frozen on dry ice. Small samples (eg, punch biopsies, fine-needle aspirates) will also be accepted. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate specimens for each test requested. Storage Instructions Maintain whole blood/bone marrow or tissue in RPMI at 2°C to 8°C; FFPE specimens at room temperature; frozen tissue at -80°C. Causes for Rejection Frozen whole blood/bone marrow; quantity not sufficient for analysis; tumor block containing no tumor tissue; broken or stained slides Test Details Use This assay can be used to detect clonal immunoglobulin receptor heavy chain gene rearrangements in blood, bone marrow, and tissue specimens. The presence of a monoclonal gene rearrangement usually, but not always, reflects the presence of a B-lymphocytic neoplasm, while polyclonal gene rearrangement patterns are found in benign reactive condition. Thus, the results of these studies can assist in the diagnosis of lymphoproliferative disorders. Limitations This PCR assay is able to detect a clonal DNA population at the sensitivity of 5% in a background of polyclonal DNA. 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)

B-Type Natriuretic Peptide (BNP)

Synonyms BNP Brain Natriuretic Peptide 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. Related Documents Sample Report Specimen Requirements Specimen Plasma, frozen Volume 0.8 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Lavender-top (EDTA) tube Collection Do not collect in glass. Collect in a plastic lavender-top (EDTA) tube. Centrifuge and transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N° 49482). Freeze within 24 hours 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. Storage Instructions Freeze. Unstable at room temperature. Stable refrigerated up to 24 hours or frozen up to 9 months. Causes for Rejection Non-EDTA plasma specimen; EDTA plasma collected in glass Test Details Use Support a diagnosis of congestive heart failure (CHF) Methodology Immunochemiluminometric assay (ICMA) Reference Interval 0−100 pg/mL Additional Information B-type natriuretic peptide (BNP), also referred to as brain natriuretic peptide, is a member of a family of structurally similar peptide hormones that includes atrial natriuretic peptide.1 BNP is a 32-amino-acid peptide that contains a 17-amino-acid ring structure that is formed as the result of an internal disulfide bond. BNP is predominantly secreted by the ventricles of the heart in response to increased pressure. BNP acts as a vasodilator and has diuretic and natriuretic properties. BNP suppresses both sympathetic tone and the renin-angiotensin system. These physiologic effects serve to reduce intraventricular pressure and improve the symptoms of congestive heart failure (CHF). BNP levels increase with age and can be transiently increased by vigorous exercise.1,2 BNP levels correlate with end-diastolic pressure and tend to be increased in patients with diminished left ventricular ejection fraction.1,3 BNP levels have been shown to be useful in the diagnosis of patients with symptoms that are consistent with CHF. Maisel and coworkers4 found that a BNP cutoff of 75 pg/mL could be used to predict systolic and/or diastolic abnormalities accurately in symptomatic patients referred to echocardiology for left ventricular function studies. They found that this cutoff identified patients with abnormal function from a population of 200 patients with a sensitivity of 95.9%, specificity of 86%, positive predictive value of 98%, and a negative predictive value of 89%. The overall accuracy of the diagnosis with a cutoff of 75 pg/mL was 93%. These results were similar to those found by Dao and coworkers.5 They found that BNP levels could be used to accurately identify patients with CHF from a population of patients presenting at the emergency room with shortness of breath (dyspnea). They found that a BNP value >80 pg/mL could be used to identify patients with CHF from this population with a sensitivity of 97%, specificity of 98%, positive predictive value of 92%, and a negative predictive value of 98%.6

Babesia microti Antibodies, IgG and IgM

Synonyms Babesia Antibody Babesia IgM, IgG Test Includes Babesia IgG; Babesia, 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 Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.2 mL Container Red-top tube or gel-barrier tube Storage Instructions Refrigerate Causes for Rejection Extensive hemolysis; lipemia; clotted specimen; quantity not sufficient for analysis; leaking or broken tube Test Details Use Screening assay for Babesia microti infection or exposure Methodology Immunofluorescence assay (IFA)

Babesia microti, Real-time DNA PCR

Synonyms Babesia, DNA Babesia, PCR Test Includes Babesia microti 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. Specimen Requirements Specimen Whole blood Volume 0.5 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 Causes for Rejection Extensive hemolysis; lipemia; clotted specimen; quantity not sufficient for analysis; gross specimen contamination; specimen too old; leaking or broken tube Test Details Use This test is intended to be used as an aid in the diagnosis of Babesia microti infection. Limitations This test is intended to detect Babesia microti, the primary etiologic agent of human babesiosis in the United States. Cross-reactivity may occur with other human pathogenic species, such as Babesia duncani (WA-1), Babesia divergens, and Babesia MO-1. Alternate approaches, such as organism-specific serologic testing, should be considered if a definitive identification is required. Methodology Real-time polymerase chain reaction (PCR)

Bacterial Vaginosis (Sialidase) and Vaginal Yeast Culture

Synonyms BV (Sialidase) and Vaginal Yeast (Culture) 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 Documents For more information, please view the literature below. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Vaginal fluid Volume Swab Container Copan double swab in Amies liquid medium Collection Using transport swabs provided, collect vaginal fluid sample by contacting the lower one-third of the vaginal wall, rotating for 10 to 20 seconds to absorb fluid. Immediately place the swabs into the transport tubes. Storage Instructions Maintain specimen at room temperature for up to 48 hours. Causes for Rejection Specimen collected or transport other than previously described Test Details Use BV (sialidase) activity: Enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacteria associated with bacterial vaginitis, including Bacteroides spp, Prevotella spp, and Mobiluncus spp, and some G vaginalis. In a recent study, Bradshaw et al demonstrated the test to be 88% sensitive and 95% specific. Vaginal yeast culture: Detect yeast in vaginal fluid. Limitations BV (sialidase) activity: Collecting specimens from the cervix should be avoided because (a) it might increase the risk to OB patients, and (b) cervical sialidase activity is usually higher than vaginal sialidase activity. Do not collect specimens from patients who have (a) used a vaginal cream or ointment product, (b) douched, or (c) used spermicides, vaginal lubricants, or feminine sprays within 72 hours of testing. If insufficient sample is collected or collected from a patient undergoing antimicrobial therapy, the test may give a false-negative result. Methodology BV (sialidase) activity: chromogenic enzyme activity test; vaginal yeast culture: culture

Bacterial Vaginosis and Candida, NAA, NuSwab®

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 Vaginitis (VG), NuSwab® Vaginitis Plus (VG+), NuSwab® Related Documents Sample Report Specimen Requirements Specimen Vaginal swab Volume One swab Minimum Volume One swab Container Aptima® vaginal or unisex swab Collection Vaginal swab: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Storage Instructions Maintain specimen at room temperature or refrigerate (2°C to 30°C). Stable at room temperature or refrigerated for 30 days. Causes for Rejection Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay (usually >72 hours); specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non−Gen-Probe® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs Test Details Use This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test utilizes semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 are positive for BV, and samples with a score of 2 are indeterminate for BV. Used to detect the presence of Candida albicans and Candida glabrata DNA in vaginal samples as an aid to the diagnosis of vulvovaginal candidiasis in symptomatic women. 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). The FDA has determined that such clearance or approval is not necessary. Methodology Nucleic acid amplification (NAA)

Bacterial Vaginosis, NAA

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 Vaginitis (VG), NuSwab® Vaginitis Plus (VG+), NuSwab® Related Documents For more information, please view the literature below. LABupdate: Candida Species Identification by NAA Microbiology Specimen Collection and Transport Guide NuSwab℠: Smart Testing Has Arrived Protect Your Patients From the Consequences of Untreated Chlamydia, Gonorrhea, and Trichomonas: Easily Detected and Easily Treated The Most Accurate Results Come From the Best Specimens Trichomonas vaginalis: Detect More Infections With Nucleic Acid Amplification Sample Report Specimen Requirements Specimen Vaginal swab Volume One swab Minimum Volume One swab Container Aptima® vaginal or unisex swab Collection Vaginal swab: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Storage Instructions Maintain specimen at room temperature or refrigerate (2°C to 30°C). Stability Requirements Temperature Period Room temperature 30 days Refrigerated 30 days Causes for Rejection Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay (usually >72 hours); specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non−Gen-Probe® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs Test Details Use This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test utilizes semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 are positive for BV, and samples with a score of 2 are indeterminate for BV. 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). The FDA has determined that such clearance or approval is not necessary. Methodology Nucleic acid amplification (NAA)

Barbiturate Confirmation, Urine

Test Includes Amobarbital; butalbital; pentobarbital (Nembutal®); phenobarbital (Luminal®); secobarbital 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 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. Specimen Requirements Specimen Urine Volume 20 mL Minimum Volume 7 mL Container Use plastic urine drug bottle and tamper-evident seal 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 Use Confirm the presence of barbiturates Methodology Mass spectrometry (MS) Reference Interval Detectability: 200 ng/mL

Barbiturate Confirmation, Whole Blood

Test Includes Amobarbital; butabarbital; butalbital; mephobarbital (as phenobarbital); pentobarbital; phenobarbital; secobarbital; thiopental (as pentobarbital) 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. Specimen Requirements Specimen Whole blood Volume 7 mL Minimum Volume 3 mL Container Lavender-top (EDTA) tube, gray-top (sodium fluoride) tube, or green-top (heparin) tube Storage Instructions Refrigerate; specimen may also be frozen. Test Details Use Detect presence of barbiturate class drugs Methodology Gas chromatography/mass spectrometry (GC/MS)

Barbiturates, Screen and Confirmation, Urine

Test Includes Identification and confirmation of barbiturates in urine, including amobarbital, butalbital, pentobarbital (Nembutal®), phenobarbital (Luminal®), and secobarbital. Confirmation by mass spectrometry (MS) is automatically performed on positives at an 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 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 tamper-evident seal 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 Use Confirm the presence of barbiturates Limitations Short- and intermediate-acting barbiturates can be detected in urine for at least 24 to 72 hours following ingestion, longer-acting drugs for at least seven days. Methodology Initial testing by immunoassay (IA); confirmation of positives by mass spectrometry (MS) Additional Information The presence of barbiturates in urine is presumptively positive at a level >300 ng/mL using secobarbital as a standard and can indicate prescribed or abused intake of this class of drugs.

Bartonella Antibody Profile

Synonyms Rochalimaea Bacillary Angiomatosis (BA) Cat Scratch Disease Antibody Test Includes Bartonella henselae, IgG; Bartonella henselae, IgM; Bartonella quintana, IgG; Bartonella quintana, IgM 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 Volume 2 mL Minimum Volume 1 mL Container Red-top tube or gel-barrier tube Storage Instructions Refrigerate. Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Bartonella (formerly Rochalimaea) henselae has become firmly established as the primary etiologic agent for cat scratch disease (CSD). Bartonella quintana, known for some time as a cause of trench fever, is also associated with CSD and bacillary angiomatosis (BA). Both diseases frequently affect immunocompromised patients, particularly those infected with HIV-1. Although CSD is generally a self-limiting disease, it can be life-threatening. Limitations There is some cross-reactivity between the IgG classes of B henselae and B quintana. 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). The FDA has determined that such clearance or approval is not necessary. Methodology Indirect fluorescent antibody (IFA)

BCR-ABL1 Oncology, FISH

Synonyms ALL FISH CML FISH Special Instructions Pertinent clinical diagnosis, previous cytogenetic studies, and probe of interest should be included with the specimen. Please provide targeted FISH probe and diagnosis. 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 BCR-ABL1 Transcript Detection for Chronic Myelogenous Leukemia (CML) and Acute Lymphocytic Leukemia (ALL), Quantitative Fluorescence in situ Hybridization (FISH), Paraffin Block Oncology Fluorescence in situ Hybridization (FISH) Related Documents Sample Report Specimen Requirements Specimen Fixed-cell pellet from a cytogenetic analysis, slides with metaphases and/or interphase nuclei or bone marrow touch prep slides. Blood, bone marrow, cerebrospinal fluid (CSF). Volume Fixed-cell pellet, three slides, 10 mL blood (adult), 5 mL blood (pediatric), or 3 mL bone marrow Minimum Volume Fixed-cell pellet from a cytogenetic analysis, two slides, 5 mL blood (adult), 1 mL blood (pediatric), or 1 mL bone marrow Container Green-top (heparin) tube, pediatric Vacutainer® (optimal), or lavender-top (EDTA) tube Collection Transport to the testing lab at room temperature; LabCorp transport kit. Do not allow sample to overheat or freeze. Storage Instructions Maintain specimen at room temperature. Causes for Rejection Broken or dirty slides; excessive cellular debris or stained slides/paraffin blocks; decalcified bone cores; frozen specimen Test Details Use Confirmation/identification of leukemia/lymphoma-related alterations; leukemia/lymphoma monitoring of residual disease. Methodology Fluorescence in situ hybridization (FISH)

BCR-ABL1 Transcript Detection for Chronic Myelogenous Leukemia (CML) and Acute Lymphocytic Leukemia (ALL), Quantitative

Synonyms Acute Lymphocytic Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative Chronic Myelogenous Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative Quantitative BCR-ABL1 Translocation Detection by RT-PCR for CML and ALL Special Instructions Please direct any questions regarding this test to oncology customer service at 800-345-4363. 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 Information Fluorescence in situ Hybridization (FISH), Oncology Oncology Fluorescence in situ Hybridization (FISH) Specimen Requirements Specimen Whole blood, bone marrow, or cell pellet Volume 3 to 5 mL whole blood or 1 to 2 mL bone marrow Minimum Volume 1 mL whole blood or bone marrow Container Lavender-top (EDTA) tube, green-top (sodium heparin) tube, or yellow-top (ACD-A) tube Collection Submit at room temperature. Specimens should arrive in the laboratory within 48 hours of collection. Indicate date and time of collection on test request form. Storage Instructions Submit at room temperature. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C. Causes for Rejection Specimen does not meet collection criteria; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed; otherwise visibly degraded; contamination by another specimen; containing suspicious foreign material Test Details Use This assay can detect three different types of BCR-ABL1 fusion transcripts associated with CML, ALL, and AML:e13a2 (previously b2a2) and e14a2 (previously b3a2) (major breakpoint, p210), as well as e1a2 (minor breakpoint, p190). The e13a2 and e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular response (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. Results should be correlated with appropriate clinical and laboratory information as indicated. Limitations In vitro studies have indicated that this assay has an analytical detection sensitivity of 4.5 log below the standard baseline. A negative result does not rule out the presence of low levels of BCR-ABL1 transcript below the level of detection of this assay, or the presence of rare BCR-ABL1 transcripts not detected by the assay. 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 Total RNA is isolated from the sample and subject to a real-time, reverse transcriptase polymerase chain reaction (RT-PCR). The PCR primers and probes are specific for BCR-ABL1 e13a2, e14a2 and e1a2 fusion transcripts. The ABL1 transcript is amplified as the control for cDNA quantity and quality. Serial dilutions of a validated positive control RNA with known t(9;22) BCR-ABL1 are used as reference for quantification of BCR-ABL1 relative to ABL1. The numeric BCR-ABL1 level is reported as % BCR-ABL1/ABL1 and the detection sensitivity is 4.5 log below the standard baseline.

Benzodiazepine and Metabolite Confirmation (LabCorp MedWatch®)

Test Includes Alprazolam; clonazepam; flurazepam; lorazepam; midazolam; nordiazepam; oxazepam; temazepam; triazolam Special Instructions This profile is intended for pain management. It is not intended for workplace testing and does not comply with state regulatory workplace testing programs. Expected Turnaround Time 4 - 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 Urine (random) Volume 20 mL Container Plastic urine container Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Causes for Rejection Quantity not sufficient for analysis; incorrect specimen Test Details Use Drug analysis/clinical drug monitoring Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS)

Benzodiazepine Confirmation, Urine

Synonyms Diazepam Librium® Valium® Test Includes α-OH-alprazolam; nordiazepam; oxazepam 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. Specimen Requirements Specimen Urine Volume 20 mL Minimum Volume 7 mL Container Plastic urine drug bottle and tamper-evident seal 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 Use Evaluate the presence of benzodiazepines Methodology Mass spectrometry (MS)

Benzodiazepines Screen With Reflex Confirmation, Whole Blood

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 Sample Report Specimen Requirements Specimen Whole blood Volume 7 mL Minimum Volume 3 mL Container Gray-top (sodium fluoride/potassium oxalate) tube, green-top (heparin) tube, or lavender-top (EDTA) tube Storage Instructions Submission/transport (<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen. 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 Initial presumptive testing by immunoassay at a testing threshold of 20 ng/mL; presumptive positives confirmed to limit of quantitation by definitive chromatography mass spectrometry (GC/MS or LC/MS-MS).

Benzodiazepines, Screen and Confirmation, Urine

Synonyms Diazepam Librium® Valium® Test Includes α-hydroxy-alprazolam; diazepam; nordiazepam; oxazepam. Confirmation is performed at an 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 request form. Please mark chain-of-custody test number on the 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. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Test Details Use Detect the presence of benzodiazepines Methodology Initial testing by immunoassay (IA); confirmation of positives by mass spectrometry (MS) Additional Information The benzodiazepines are a class of chemically related central nervous depressants used as sedative-hypnotics to treat sleep disorders, anxiety, alcohol withdrawal, and seizure disorders. The drug class in low doses can cause sedation, drowsiness, blurred vision, fatigue, mental depression, and loss of coördination. In higher doses, or used chronically, they can cause confusion, slurred speech, hypotension, and diminished reflexes. Chronic use may produce a physical dependence and a withdrawal syndrome which can last for weeks. Urine should be tested for benzodiazepines in suspected overdose cases, or as part of an abused drug program. These drugs have a relatively low potential for abuse.1 They are, however, frequently found with other drugs in emergency room drug tests. Immunoassay procedures detect a broad range of drugs and their metabolites in this class using either oxazepam or nordiazepam as positive controls. Positive results (usually >300 ng/mL of urine metabolites) should be confirmed by an alternate technique.

Benzodiazepines, Screen and Confirmation, Urine (Pain Management)

Synonyms Diazepam Librium® Valium® Test Includes Expanded benzodiazepine confirmation on reflex of positive screen includes α-hydroxy-alprazolam, α-hydroxy- midazolam, α-hydroxy-triazolam, 7-aminoclonazepam, hydroxyl-ethyl-flurazepam, lorazepam, nordiazepam, oxazepam, and temazepam. Special Instructions This assay is designed for pain management. It is not intended for workplace testing and does not comply with state regulatory workplace testing programs. 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. Specimen Requirements Specimen Urine Volume 20 mL Container Plastic urine container Storage Instructions Maintain specimen at room temperature. If arrival at lab will extend beyond seven days, refrigerate. Test Details Use Detect and confirm the presence of benzodiazepines Methodology Initial testing by Immunoassay (IA); confirmation of positives by mass spectrometry (MS)

Benzodiazepines, Screen Only, Urine

Synonyms Diazepam Librium® Valium® Special Instructions This assay is designed for pain management. It is not intended for workplace testing and does not comply with state regulatory workplace testing programs. 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 Plastic urine container Storage Instructions Maintain specimen at room temperature. If arrival at lab will extend beyond seven days, refrigerate. Test Details Use Detect the presence of benzodiazepines Methodology Immunoassay (IA)

Benzodiazepines, Screen Only, Whole Blood

Synonyms Diazepam Librium® Valium® 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. Specimen Requirements Specimen Whole blood Volume 7 mL Minimum Volume 3 mL Container Lavender-top (EDTA) tube, gray-top (sodium fluoride) tube, or green-top (heparin) tube Storage Instructions Submission/transport (<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen. Test Details Use Detect presumptive presence of benzodiazepine class drugs Methodology Presumptive testing by immunoassay (IA) at a testing threshold of 20 ng/mL. Presumptive positives are not confirmed by a definitive method.

Bermuda Grass

Beryllium, Serum or 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. Specimen Requirements Specimen Serum or plasma Volume 2 mL Minimum Volume 0.5 mL Container Royal blue-top (EDTA) metal-free tube Collection Serum or plasma should be separated from cells within two hours of venipuncture. Transfer separated serum or plasma to a metal-free transport tube. Storage Instructions Submission/transport (<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen. Causes for Rejection Use of non−metal-free collection tubes Test Details Use Evaluate exposure to beryllium Methodology Inductively coupled plasma/mass spectrometry (ICP/MS) Reference Interval <1.0 ng/mL

Bile Acids

Synonyms Glyco and Taurochenodeoxycholic Acid 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 Documents Sample Report Specimen Requirements Specimen Serum, frozen Volume 1 mL Minimum Volume 0.2 mL Container Red-top tube or gel-barrier tube Collection Transfer serum 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 3 days Frozen 7 days Freeze/thaw cycles Stable x3 Patient Preparation Patient should be fasting; however, a two-hour postprandial level has been used by various physicians in order to evaluate hepatic function after the gallbladder has been completely emptied (ie, challenge the liver with a high level of bile acids in the portal circulation). Causes for Rejection Specimen not transported and received refrigerated; plasma sample Test Details Use Evaluate the enterohepatic cycle consisting of the biliary system, intestine, portal circulation, and hepatocytes Methodology Enzymatic Reference Interval 0.0 – 10.0 µmol/L Additional Information The concentration of bile acids in serum is elevated in patients with many structural liver diseases, due to the inability of the liver to extract bile acids efficiently from portal blood. Metabolic liver diseases such as Gilbert disease, Crigler-Najjar syndrome, or Dubin-Johnson syndrome do not appear to cause elevated bile acid concentrations. Bile acid levels may be altered even when other liver function tests are normal and may serve as a sensitive and specific indicator of liver disease. Intrahepatic cholestasis of pregnancy (ICP) is a temporary condition caused by maternal liver dysfunction during pregnancy. It is characterized by intense generalized pruritus (itchiness) which usually begins in the third trimester. ICP is also known as cholestatic jaundice of pregnancy, cholestatic hepatosis, icterus gravidarum, and obstetric cholestasis. There are several laboratory tests which can be done to confirm a diagnosis of cholestasis of pregnancy, including bile acids. Maternal blood levels of bile salts are often at least three times the normal level in ICP; however, the levels may be 10 to 100 times normal. Blood tests can also reveal increased levels of other liver enzymes that indicate general liver dysfunction, such as ALT, AST, and alkaline phosphatase. While ALT/AST levels may be normal or slightly elevated, alkaline phosphatase levels are almost always higher than normal (though this may be due, in part, to the alkaline phosphatase added to the mother's blood from the placenta). However, if the liver enzymes are extremely elevated, other causes, such as viral hepatitis, should be considered. In the absence of bile acid tests, elevated ALT, AST and/or alkaline phosphatase levels in the setting of intense pruritus are generally adequate to diagnose cholestasis of pregnancy. Though it may cause extreme discomfort, cholestasis of pregnancy is regarded as benign to the mother; however, it has been widely established that ICP poses a significant increased risk to the fetus and is associated with an increased incidence of stillbirth. Fetal death in ICP is a real risk and the primary objective of treatment is to make certain that the baby is born before stillbirth occurs. While the fetal death rate for untreated patients is around 10%, studies in which patients are induced before term have found fetal mortality rate to be 0% to 2%. The danger from ICP is eliminated when the child is safely delivered and labor is induced when the fetus' lungs are mature, regardless of any other test results. After delivery, the symptoms in the mother usually decrease within 48 hours of delivery and disappear completely within four weeks postpartum. Cholestasis of pregnancy does not cause permanent liver impairment to the mother and the liver returns to normal function, once the baby is delivered.

Bile Acids, Fractionated and Total, LC/MS-MS

Expected Turnaround Time 5 - 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 (preferred) or plasma, frozen Volume 1 mL Minimum Volume 0.3 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube, gel-barrier tube, lavender-top (EDTA) tube, or green-top (sodium heparin) tube Collection Serum/plasma must be separated from cells within two hours of venipuncture. Transfer serum/plasma to a plastic transport tube before freezing. Storage Instructions Refrigerate or freeze. Stability Requirements Temperature Period Room temperature 1 day Refrigerated 3 days Frozen 14 days Freeze/thaw cycles Stable x6 Patient Preparation Patient should be fasting. Causes for Rejection Whole blood Test Details Use This assay uses LC/MS-MS to quantify the free acid, glycine-conjugate and taurine-conjugate forms of cholic acid, chenodeoxycholic acid, deoxycholic acid, and ursodeoxycholic acid. Bile acids may be measured to investigate obstructive cholestasis in pregnancy.1 In addition, bile acids are required for cholesterol absorption, fat-soluble vitamin absorption, and to provide resistance to overgrowth of intestinal bacteria.1 Bile acid levels may be reduced or elevated due to various genetic defects. Methodology High-pressure liquid chromatography/tandem mass spectrometry (HPLC/MS-MS) Additional Information Bile acids are formed in the liver from cholesterol, stored and concentrated in the gallbladder, and excreted into the intestines in response to food. The liver synthesizes cholesterol into two primary bile acids, cholic acid and chenodeoxycholic acid. The primary bile acids are converted by intestinal bacteria to the secondary bile acids, deoxycholic acid and lithocholic acid. A fraction of chenodeoxycholic acid is also transformed into the tertiary bile acid, ursodeoxycholic acid.

Bilirubin, Direct

Bilirubin, Total

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, or green-top (lithium heparin) tube Collection Separate serum or plasma from cells within 45 minutes of collection. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 3 days Refrigerated 3 days Frozen 14 days Freeze/thaw cycles Stable x2 Causes for Rejection Gross hemolysis; improper labeling; gross lipemia Test Details Use Causes of high bilirubin: Liver disease: hepatitis, cholangitis, cirrhosis, other types of liver disease (including primary or secondary neoplasia); alcoholism (usually with high AST (SGOT), GGT, MCV, or some combination of these findings); biliary obstruction (intrahepatic or extrahepatic); infectious mononucleosis (look also for increased LD (LDH), lymphocytosis); Dubin-Johnson syndrome; Gilbert disease1 (familial hyperbilirubinemia) is encountered as a moderate elevation with otherwise unremarkable chemistries. Anorexia or prolonged fasting: 36 hours or more may cause moderate rise. Pernicious anemia, hemolytic anemias, erythroblastosis fetalis, other neonatal jaundice, hematoma, and following a blood transfusion, especially if several units are given in a short time. Pulmonary embolism and/or infarct, congestive heart failure. Drugs: A large number of drugs can cause jaundice by in vivo action or by chemistry methodology. Drugs causing cholestasis and/or hepatocellular damage include diphenylhydantoin, azathioprine, phenothiazines, erythromycin, penicillin, sulfonamides, oral contraceptives, anabolic-androgenic steroids, halothane, aminosalicylic acid, isoniazid, methyldopa, indomethacin, pyrazinamide, and others. Methodology Colorimetric Reference Interval See table. Age Range (mg/dL) Newborns, term, and near term 24 hours 0.0−8.0 48 hours 0.0−13.2 72 hours 0.0−15.6 96 hours to 1 month 0.0−16.6 Children ≥1 month and adults 0.0−1.2 Additional Information Interpretation of increased bilirubin is greatly enhanced by other chemistry results. In acute viral hepatitis with jaundice, for instance, the transaminases ALT (SGPT) and AST (SGOT) are consistently increased, while an isolated elevation of bilirubin is seen in Gilbert disease.1 Obstruction causes increases in bilirubin and alkaline phosphatase greater than and out of proportion to the transaminases.2 Amylase and lipase are useful in differential diagnosis of obstructive jaundice. In intrahepatic cholestasis, the transaminases are not as increased, relative to bilirubin, as they are in hepatitis.3 Work-up of jaundice has been outlined.4,5 Nicotinic acid increases the formation of bilirubin in the spleen, leading to a rise in unconjugated bilirubin. This can be used as a test for Gilbert disease1 in which there is a decreased hepatic clearance of unconjugated bilirubin. Although the indirect bilirubin level is increased in normal controls when nicotinic acid is given, the increase is much greater in patients with Gilbert disease. In the Crigler-Najjar syndrome type I, the unconjugated bilirubin is >20 μg/dL. In type II, the level is <20 μg/dL.

Bilirubin, Total and Direct

Synonyms Bilirubin, Total, Conjugated, and Unconjugated Test Includes Bilirubin, conjugated (direct); bilirubin, indirect; bilirubin, total 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 3 mL Minimum Volume 1 mL Container Red-top tube, gel-barrier tube, or green-top (lithium heparin) tube Collection Separate serum or plasma from cells within 45 minutes of collection. Storage Instructions Refrigerate Stability Requirements Temperature Period Room temperature 2 days Refrigerated 3 days Frozen 14 days Freeze/thaw cycles Stable x2 Causes for Rejection Severe hemolysis; improper labeling; severe lipemia Test Details Use Liver and biliary tests are useful in the differential diagnosis of jaundice from bilirubin overproduction (hemolysis), decreased uptake (Gilbert disease), decreased conjugation (hepatocellular disease, familial, drug-induced, pregnancy; obstructive bile duct disease). Methodology Colorimetric

Bilirubin, Total, Neonatal

Special Instructions This test is intended for newborn infants only. 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 Volume 0.2 mL Container Red-top tube or gel-barrier tube Collection Protect from light. Storage Instructions Refrigerate. Test Details Use Evaluation for liver and biliary disease Methodology Kinetic

Bipolaris

Synonyms Curvularia spicifera 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®

Bismuth, Whole Blood

BK Virus Quantitation, Real-time DNA PCR

Synonyms Polyomavirus BK Quantitation Quantitation of BK Virus, DNA, Using Real-time PCR 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 Plasma or serum Volume 1 mL Minimum Volume 0.5 mL Container Ship in a screw-cap polypropylene frozen transport tube. Collection Collect specimen in lavender-top (EDTA) tube, yellow-top (ACD) tube, plasma preparation tube (PPT™), red-top tube, or gel-barrier tube. Centrifuge specimen within 24 hours of collection, remove serum or plasma, transfer specimen to polypropylene screw-capped tube, and freeze. Ship frozen. 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 (preferred) or refrigerate. Stability Requirements Temperature Period Room temperature Unstable Refrigerated 7 days Frozen 90 days Causes for Rejection Quantity not sufficient for analysis; leaking or broken tube; inadequate storage or transport; whole blood Test Details Use Detection and quantitation of BK virus plasma or serum specimens as an aid in the diagnosis and management of BK virus infections Limitations Quantitative range is 200−10,000,000 copies/mL. Cross-reactivity with the related Simian virus SV40 may occur; SV40 is not a human pathogen. Methodology Real-time polymerase chain reaction (PCR)

Black Pepper

Synonyms Black Pepper 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 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®

Bladder Cancer FISH, Pathologist Review

Synonyms Urothelial Carcinoma, FISH UroVysion®, FISH Special Instructions Specimens should be received at the laboratory within 72 hours postcollection for optimal testing. Specimens older than 72 hours will not be rejected; however, results not guaranteed. In these instances, clients should consider recollection if possible. Expected Turnaround Time 4 - 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 Oncology Fluorescence in situ Hybridization (FISH) Specimen Requirements Specimen Urine Volume 50 mL urine mixed with preservative in TCC Monitoring kit Minimum Volume 33 mL urine mixed with preservative in TCC Monitoring kit Container TCC Monitoring kit (PeopleSoft item N° 44921). Other containers that are accepted, but not recommended: PreservCyt® vial, Cytology Special Studies Kit (PeopleSoft item N° 3203), or sterile urine container with Carbowax® fixative (two parts urine; one part fixative). Collection Step 1: Use the large, open cup in the kit to collect the urine specimen. First void of the day is preferred. Ensure that the urine specimen reaches the minimum fill line of 33 mL. Step 2: Slowly pour urine into the smaller container to the maximum fill line of 90 mL. Step 3: Tighten the lid until you hear a click in order to prevent leakage. Storage Instructions Specimen should be refrigerated at 2°C to 8°C and shipped on cool packs. Do not freeze. Causes for Rejection Incorrect fixative; significant contamination with blood obscuring bacterial overgrowth; inadequate specimen cellularity Test Details Use The assay is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from subjects with transitional cell carcinoma of the bladder. This assay does not detect other chromosomal or genetic alterations. Results are intended for use as a noninvasive method of monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The clinical interpretation of test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results. Limitations Positive FISH results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract-related cancers (eg, ureter, urethra, renal, and/or prostate in males), and further patient follow-up may be helpful. Negative FISH results in the presence of other signs and symptoms of bladder cancer recurrence may need to be regarded as suspicious false-negative results; repeat testing may be indicated. Although the assay was designed to detect chromosome changes associated with most bladder cancers, there are some bladder cancers whose genetic changes are not targeted by this test. Methodology Fluorescence in situ hybridization (including diagnostic interpretation by MD pathologist)

Blastomyces Antibodies, Quantitative, DID

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 1.0 mL Container Red-top tube or gel-barrier tube Storage Instructions Refrigerate Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Establish the diagnosis of infection due to Blastomyces dermatitidis Methodology Double immunodiffusion (DID) Reference Interval Negative: ≤1:1

Bleeding With Normal aPTT/PT

Expected Turnaround Time 4 - 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 Abnormal Screening Results Plasminogen Activity Related Documents Sample Report Specimen Requirements Specimen Plasma (3.2% citrated), frozen Volume 6 mL frozen citrated plasma (2 mL into each of three tubes) Minimum Volume 3 mL frozen citrated plasma (1 mL into each of three tubes) 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 tubes. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge for 10 minutes and (using a plastic transfer pipette) carefully remove two-thirds of the plasma without disturbing the cells. Deliver to a plastic transfer 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). The specimen should be frozen immediately and maintained frozen until tested. Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume. Storage Instructions Freeze plasma, refrigerate serum, and maintain whole blood and buccal swab kit at room temperature or refrigerate. Patient Preparation Do not draw from an arm with a heparin lock or heparinized catheter. Test Details Use Assist in the determination of a cause of bleeding in a patient with a normal aPTT and PT. Methodology See individual tests.

Blood Culture, Routine

Synonyms Culture, Blood, Routine Test Includes Culture; isolation, identification, and susceptibility testing (additional charges/CPT code[s] may apply). 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 Mycology, Mycobacteriology, and Other Reference Microbiology Testing.. Special Instructions The test request form must state clinical diagnosis and time of collection. List current antibiotic therapy, clinical diagnosis, and any special organisms suspected or to rule out. Must indicate if culture is for Brucella or Francisella. Do not use expired blood culture media. Expected Turnaround Time 5 - 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 Routine Microbiology Related Documents For more information, please view the literature below. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Whole blood Volume Adult: 16 to 20 mL total; 8 to 10 mL per aerobic and anaerobic bottle. Pediatric: up to 4 mL in one pediatric bottle; as age increases so should the volume of blood collected. Do not add more than 10 mL of blood to either the aerobic or anaerobic bottles, or more than 4 mL of blood to a pediatric bottle. The aerobic bottle has no minimum volume requirement. Container One aerobic and one anaerobic blood culture bottle for adults or one pediatric bottle. Do not vent. Collection Use adult or pediatric blood culture collection kits provided by LabCorp. See the Procedural Chart for Blood Culture Collection provided in each collection kit for detailed information regarding bottle preparation, venipuncture, and bottle inoculation. Blood cultures should be drawn prior to initiation of antimicrobial therapy. The time of collection must be indicated. Strict aseptic technique is essential. If more than one culture is ordered, the specimens should be drawn separately at no less than 30 minutes apart to rule out the possibility of transient bacteremia due to self-manipulation by the patient of mucous membranes in the mouth caused by brushing teeth, etc, or by local irritations caused by scratching of the skin. • Suspected sepsis, meningitis, osteomyelitis, arthritis, listeriosis, or acute untreated bacterial pneumonia: Obtain two blood cultures from two different sites, such as the left and right arms. • Fever of unknown origin such as that caused by an occult abscess: Obtain two blood cultures initially. If those are negative, obtain two more 24 to 36 hours later. The yield beyond three or four cultures is virtually nil in this condition. • Suspected early typhoid fever and brucellosis: Obtain four blood cultures during 24 to 36 hours due to low-grade bacteremia involved in these rarely seen diseases. • Endocarditis (acute infective endocarditis): Obtain three blood cultures from three separate venipuncture sites during the first one to two hours and begin therapy. • Subacute infective endocarditis: Obtain three blood cultures within the first 24 hours, ideally within no less than hourly intervals. If all are negative at 24 hours, obtain two more. The yield beyond five blood cultures in subacute and endocarditis is virtually nil. Storage Instructions Maintain specimen at room temperature. Do not refrigerate. Patient Preparation The major difficulty in interpretation of blood cultures is potential contamination by skin flora. This difficulty can be markedly reduced by careful attention to the details of skin preparation and antisepsis prior to collection of the specimen. Skin preparation: First cleanse the venipuncture site with isopropanol. Then use an antiseptic swabstick to disinfect the site, using progressively larger concentric circles. This prepping agent should remain in contact with the skin for 30 seconds and be allowed to dry to ensure adequate disinfection. The venipuncture site must not be palpated after preparation. Blood is then safely drawn. Causes for Rejection Unlabeled specimen or name discrepancy between specimen and request label; bottles received broken; blood culture bottles received after a prolonged delay (usually more than 72 hours); blood not received in blood culture bottles; expired blood culture bottle Test Details Use Isolate and identify potentially pathogenic organisms causing bacteremia; establish the diagnosis of endocarditis Limitations Three negative sets of blood cultures in the absence of antimicrobial therapy are usually sufficient to exclude the presence of bacteremia. One set is seldom ever sufficient.1 Prior antibiotic therapy may cause negative blood cultures or delayed growth. Blood cultures from patients suspected of having Brucella must be requested as special cultures. Consultation with the laboratory for special culture procedures for the recovery of these organisms prior to collecting the specimen is recommended. Yeast often are isolated from routine blood cultures; however, if yeast or other fungi are specifically suspected, a separate fungal blood culture should be drawn along with each of the routine blood culture specimens. See separate list for proper collection of Fungus (Mycology) Culture [008482]. Mycobacterium avium complex (MAC) is frequently recovered from blood of immunocompromised patients, particularly those with acquired immunodeficiency syndrome (AIDS). Special procedures are required for the recovery of these organisms; use Acid-fast (Mycobacteria) Smear and Culture With Reflex to Identification [183753]. Methodology Culture Additional Information Sequential blood cultures in nonendocarditis patients using a 20 mL sample resulted in an 80% positive yield after the first set, a 90% yield after the second set, and a 99% yield after the third set. Volume of blood cultured seems to be more important than the specific culture technique being employed by the laboratory. The isolation of coagulase-negative Staphylococcus poses a critical and difficult clinical dilemma. Although coagulase-negative Staphylococcus is the most commonly isolated organism from blood cultures, only a few (6.3%) of the isolates represent “true” clinically significant bacteremia.2 Conversely, coagulase-negative Staphylococcus is well recognized as a cause of infections involving prosthetic devices, cardiac valves, CSF shunts, dialysis catheters, and indwelling vascular catheters.3 Ultimately, the physician is responsible for determining whether an organism is a contaminant or a pathogen. The decision is based on both laboratory and clinical data. Frequently this determination includes patient data (ie, patient history), physical examination, body temperatures, clinical course, and laboratory data (ie, culture results, white blood cell count, and differential). The number of positive cultures as defined by a venipuncture is the most relevant criterion to use in determining whether an isolate is a contaminant. Clinical experience and judgment may play a significant role in resolving this clinical dilemma.4 In patients who have received antimicrobial drugs, four to six blood cultures may be necessary. Any organism isolated from the blood is usually tested for susceptibility. It is not recommended to culture blood while antimicrobials are present unless verification of an agent's efficacy is needed. This is confirmed with a single culture. The diagnosis of bacterial meningitis is accomplished by blood culture, as well as culture and examination of the cerebrospinal fluid.5 Most children with bacterial meningitis are initially bacteremic.6 See tables. Blood Culture Collection Clinical Disease Suspected Culture Recommendation Rational Sepsis, meningitis osteomyelitis, septic arthritis, bacterial pneumonia Two sets of cultures—one from each of two prepared sites, the second drawn after a brief time interval, then begin therapy. Assure sufficient sampling in cases of intermittent or low level bacteremia. Minimize the confusion caused by a positive culture resulting from transient bacteremia or skin contamination. Fever of unknown origin (eg, occult abscess, empyema, typhoid fever, etc) Two sets of cultures—one from each of two prepared sites, the second drawn after a brief time interval (30 minutes). If cultures are negative after 24 to 48 hours obtain two more sets, preferably prior to an anticipated temperature rise. The yield after four sets of cultures is minimal. A maximum of three sets per patient per day for three consecutive days is recommended. Endocarditis Acute Obtain three blood culture sets within two hours, then begin therapy. 95% to 99% of acute endocarditis patients (untreated) will yield a positive in one of the first three cultures. Subacute Obtain three blood culture sets on day one, repeat if negative after 24 hours. If still negative or if the patient had prior antibiotic therapy, repeat again. Adequate sample volume despite low level bacteremia or previous therapy should result in a positive yield. Immunocompromised Host (eg, AIDS) Septicemia, fungemia mycobacteremia Obtain two sets of cultures from each of two prepared sites; consider lysis concentration technique to enhance recovery for fungi and broth systems for recovery of mycobacteria. Low levels of fungemia and mycobacteremia frequently encountered. Previous Antimicrobial Therapy Septicemia, bacteremia; monitor effect of antimicrobial therapy Obtain two sets of cultures from each of two prepared sites; increased volume >10 mL/set. Recovery of organisms is enhanced by dilution and increased sample volume. Interpretation of Positive Blood Cultures* *Adapted from Flournoy DJ, Adkins L. Understanding the blood culture report. Am J Infect Control. 1986 Feb; 14(1):41-46.

Bloom Syndrome, DNA Analysis

Synonyms 2281del6ins7 Mutation Jewish Heritage Test Sister Chromatid Exchange Special Instructions If cultured cells are needed, an additional 7-12 days may be required. Additional culture fee may be included. Expected Turnaround Time 8 - 15 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 Whole blood, amniotic fluid, chorionic villus sample (CVS) (submission of maternal blood is required for fetal testing), or LabCorp buccal swab kit (buccal swab collection kit contains instructions for use of a buccal swab) Volume 7 mL whole blood, 10 mL amniotic fluid, 20 mg CVS, or LabCorp buccal swab kit Minimum Volume 3 mL whole blood, 5 mL amniotic fluid, 10 mg CVS, or two buccal swabs Container Lavender-top (EDTA) tube, yellow-top (ACD) tube, sterile plastic conical tube or two confluent T25 flasks for fetal testing, or LabCorp buccal swab kit Storage Instructions Maintain specimen at room temperature or refrigerate. Causes for Rejection Frozen specimen; hemolysis; quantity not sufficient for analysis; improper container; one buccal swab; wet buccal swab Test Details Use Identification of carrier and affected individuals for the 2281del6ins7 mutation associated with Bloom syndrome in the Ashkenazi Jewish population. Prenatal testing is available. Limitations This test only detects the 2281del6ins7 mutation that is responsible for Bloom syndrome in the Ashkenazi Jewish population.1 This test is not appropriate for non-Ashkenazi Jewish individuals. Methodology Polymerase chain reaction (PCR); primer extension; flow-sorted bead array analysis Additional Information Bloom syndrome (OMIM 210900) is a rare autosomal recessive disorder that is characterized by small stature, photosensitivity, chromosomal instability, immunodeficiency, and a predisposition to develop multiple cancers.1,2 In the Ashkenazi Jewish population, the carrier frequency is approximately 1 in 104 individuals.2

Body Fluid Culture, Sterile, Routine

Synonyms Culture, Body Fluid, Sterile, Routine Sterile Body Fluid Culture Test Includes Culture; isolation and identification of potential aerobic pathogens ( additional charges/CPT code[s] may apply). Susceptibility testing if culture results warrant (at an additional charge). Gram stain [008540] is recommended with all body fluid cultures (additional charge). 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 Indicate the specific source and pertinent clinical history on the request form. Do not use expired transport device. Expected Turnaround Time 4 - 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 Routine Microbiology Related Documents For more information, please view the literature below. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Aseptically aspirated body fluid (eg, cerebrospinal fluid (CSF), synovial, peritoneal fluid). Do not submit syringes with needles attached. Swabs without visible fluid are not acceptable for Body Fluid Culture. Minimum Volume 2 mL Container Sterile tube or other sterile leakproof container, blood culture bottle, Vacutainer™ Plus no Additive tube, sodium heparin tube, and swabs with visible fluid; do not use red-top Vacutainer™ tubes. Collection Contamination with normal flora from skin, rectum, vaginal tract, or other body surfaces should be avoided. If anaerobes are suspected, order Anaerobic Culture (see Anaerobic Culture [008904]). Storage Instructions Maintain specimen at room temperature. Patient Preparation Swab skin over the site of puncture with 2% tincture of iodine in concentric circles. Note: Iodine should remain in contact with skin for at least one minute prior to puncture to ensure complete antisepsis. Following puncture, 70% alcohol is used to remove iodine from skin. Causes for Rejection Improper labeling; red-top Vacutainer™ tubes; swabs without visible fluid Test Details Use Isolate and identify pathogenic organisms from normally sterile body fluids Methodology Culture

Bone Marrow Aspiration and Biopsy

Synonyms Bone Marrow Aspirate Iron Stain, Bone Marrow Test Includes H and E stain; iron stain; Wright stain Special Instructions Must include clinical/laboratory information, clinical hematological diagnosis, and a recent CBC or peripheral blood in EDTA. 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. Specimen Requirements Specimen Bone marrow aspirate clot and/or biopsy, bone marrow aspirate smears, and peripheral blood smears Volume 2 to 5 mL, at least 1 cm core of bone marrow (complete specimen), bilateral if for staging of lymphoma Collection Smeared slides are prepared and labeled at the bedside by a laboratory technologist. Biopsy and clot are placed in fixative by technologist. Bone marrow smears for enzyme histochemistry must be fixed immediately in 10% neutral buffered formalin, absolute methyl alcohol, or 40% formalin vapor. Fixative container must be labeled with patient's full name, room number, date, and time and the fixative employed. Causes for Rejection No marrow obtained Test Details Use Evaluate bone marrow morphology, erythropoiesis, myelopoiesis, myeloid:erythroid ratio, megakaryocytes, cellularity, and marrow iron stores; evaluate etiology of abnormalities of production of RBC, WBC, or platelets; establish the presence of various primary or secondary malignancies: myeloma, carcinoma, lymphoproliferative diseases, or myeloproliferative diseases; evaluate respiratory therapy of hematologic disorders Additional Information Marrow culture can make valuable contribution to study of fever of undetermined origin and

Bone-specific Alkaline Phosphatase (BAP)

Synonyms BAP Ostase® Skeletal Alkaline Phosphatase (SALP) 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 Gel-barrier tube or transport tube Collection Separate serum from cells within 45 minutes of collection. If a red-top tube is used, transfer separated serum 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 Causes for Rejection Gross hemolysis; quantity not sufficient for analysis Test Details Use Quantitative measurement of skeletal alkaline phosphatase to be used as an aid in the management of patients with Paget disease and osteoporosis Limitations Serum specimens with significant elevations of liver alkaline phosphatase may cause aberrantly elevated results with the Ostase® assay. Methodology Immunochemiluminometric assay (ICMA) Contraindications Patients who have undergone therapy that includes infusion with mouse monoclonal antibody may produce erroneous results. Reference Interval Reference interval change (November 2015)1-3 Age Male (μg/L) Female (μg/L) 0 to 5 m Not established Not established 6 to 11 m 48.2−170.2 50.4−154.0 1 y 41.9−229.6 44.2−178.3 2 y 41.7−139.4 34.9−195.4 3 to 4 y 37.2−127.7 37.4−96.8 5 to 6 y 42.0−104.2 31.4−100.8 7 to 8 y 59.0−101.3 44.0−135.8 9 to 10 y 50.4−133.0 47.9−150.8 11 to 12 y 53.3−156.8 24.2−133.3 13 to 14 y 77.5−169.8 19.8−92.7 15 to 16 y 26.8−173.4 11.2−30.2 17 to 18 y 15.4−69.8 8.8−29.0 19 to 20 y 12.2−36.6 7.7−16.8 21 to 29 y 7.4−27.7 See below 30 to 34 y 7.0−27.4 See below 35 to 39 y 4.0−27.0 See below 40 to 44 y 7.4−26.7 See below 45 to 49 y 7.5−26.4 See below 50 to 54 y 7.5−26.1 See below 55 to 59 y 7.5−25.7 See below 60 to 64 y 7.5−25.4 See below 65 to 69 y 7.6−25.1 See below 70 to 74 y 7.6−24.8 See below 75 to 100 y 7.6−24.4 See below Female Premenopausal: 6.0−22.7 μg/L Postmenopausal: 8.1−31.6 μg/L

Bordetella pertussis and Bordetella parapertussis, Real-time DNA PCR

Synonyms B pertussis and B parapertussis, DNA PCR (Real-time) Whooping Cough 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. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Nasopharyngeal (NP) swab, throat swab (dacron or rayon), or nasopharyngeal aspirate/wash Volume One NP/throat swab or 0.5 mL nasal aspirate/wash Container • Option 1 (preferred): Flocked NP swab submitted dry in plastic transport sleeve (PeopleSoft N° 93307) • Option 2 (alternate): NP swab submitted in charcoal-containing transport media • Option 3 (alternate): NP/throat swab submitted in universal transport media (UTM) • Option 4 (alternate): NP wash/aspirate submitted in sterile container Storage Instructions Maintain specimen at room temperature or refrigerate. Do not freeze charcoal transport swabs or dry swabs. Swabs in UTM and NP aspirates/washes may be frozen for seven days. Stability Requirements Temperature Period Room temperature 5 days Refrigerated 7 days Causes for Rejection Calcium alginate swabs; swabs in noncharcoal-containing transport media; swabs in Regan-Lowe culture media Test Details Use This assay is intended to be used as an aid to the diagnosis of Bordetella pertussis (whooping cough) and Bordetella parapertussis (whooping cough-like syndrome). Limitations The target for the B pertussis PCR reaction, a region of IS481, is also found in Bordetella holmesii. A false-positive result for B pertussis DNA may occur if B holmesii is present in the sample tested. Methodology Real-time polymerase chain reaction (PCR)

Bordetella pertussis Antibodies, IgA, IgG, IgM

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 Volume 2 mL Minimum Volume 1 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 x4 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Establish evidence of infection/exposure to Bordetella pertussis, the causative agent of whooping cough Methodology Enzyme-linked immunosorbent assay (ELISA) Additional Information Patients with acute infection develop IgG, IgM, and IgA antibodies to fimbrial agglutinogens, and IgM and IgA antibodies are probably diagnostic. Following vaccination, IgG and IgM antibodies can be demonstrated, except in infants. IgA antibodies do not develop.

Bordetella pertussis Antibodies, IgG

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 Documents Sample Report Specimen Requirements Specimen Serum Volume 0.4 mL Minimum 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 14 days Freeze/thaw cycles Stable x4 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Establish evidence of infection/exposure to Bordetella pertussis, the causative agent of whooping cough Methodology Enzyme-linked immunosorbent assay (ELISA) Reference Interval • Negative: 1.04 index Additional Information Patients with acute infection develop IgG, IgM, and IgA antibodies to fimbrial agglutinogens, and IgM and IgA antibodies are probably diagnostic. Following vaccination, IgG and IgM antibodies can be demonstrated. IgG antibodies can only be used to diagnose acute infection when paired sera are available and a rise in antibody level can be demonstrated.

Bordetella pertussis Antibodies, IgM

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 Volume 0.4 mL Minimum 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 14 days Freeze/thaw cycles Stable x4 Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Establish evidence of early/acute infection with Bordetella pertussis, the causative agent of whooping cough Methodology Enzyme-linked immunosorbent assay (ELISA) Reference Interval Negative: <1.0 index Additional Information Patients with acute infection develop IgG, IgM, and IgA antibodies to fimbrial agglutinogens, and IgM and IgA antibodies are probably diagnostic. Following vaccination, IgG and IgM antibodies can be demonstrated. The presence of specific IgM in a single sample may indicate an acute infection and should be considered suggestive of recent infection or a presumptive diagnosis of a supporting clinical presentation.

Bordetella pertussis, Nasopharyngeal Culture

Synonyms Bordetella pertussis Culture Culture, Bordetella pertussis, Nasopharyngeal Pertussis Culture Whooping Cough Culture Test Includes Culture; isolation and identification by fluorescent antibody staining (additional charges/CPT code[s] may apply). 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 request form must state evaluate for Bordetella pertussis. Expected Turnaround Time 13 - 16 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 Nasopharyngeal (NP) swab Volume One swab Container Flexible swab and special charcoal-containing Bordetella transport media (available from laboratory). Collection Guide the flexible swab into the contour of the nares and into the nasopharynx. Pass the swab gently through the nose. Leave swab in place near septum and floor of nose for 15 to 30 seconds. Rotate and remove. Place into special transport media available from the laboratory. Storage Instructions If possible, preincubate at 37°C; then use refrigerated temperature (2°C to 8°C) for transport. Patient Preparation Patient must not be on antimicrobial therapy. Causes for Rejection Unlabeled specimen or name discrepancy between specimen and request label; prolonged delay in transport (usually more than 72 hours); inappropriate specimen transport device (eg, noncharcoal-containing transport medium) Test Details Use Isolate and identify B pertussis and B parapertussis; establish diagnosis of whooping cough Methodology Culture Additional Information Nucleic Acid Amplification (NAA/PCR) procedures provide more rapid results and have been increasingly used in the diagnosis of B pertussis infection. Studies have shown that the best yield is obtained when PCR and culture are used to diagnose this infection.

Bowel Disorders Evaluation Rule-out Cascade

Synonyms Celiac Disease Gluten Sensitivity Inflammatory Bowel Disease (IBD) Irritable Bowel Syndrome (IBS) Test Includes Celiac disease screen (simultaneous detection of IgG and IgA for both tissue transglutaminase [tTG] and deamidated gliadin peptide [DGP]); atypical perinuclear antineutrophil cytoplasmic antibody (pANCA); anti-Saccharomyces cerevisiae antibodies (ASCA) IgG; antigliadin antibodies IgG 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 For more information, please view the literature below. Bowel Disorders Evaluation Rule-out Cascade: Applying Exclusionary Criteria to Assist Diagnosis Celiac Disease Testing Services 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; heat-treated specimen; gross bacterial contamination Test Details Use Aid in diagnosis of celiac disease, IBD, differential diagnosis of Crohn's disease (CD) and ulcerative colitis (UC), nonceliac gluten sensitivity, and IBS Limitations Results of this profile should be used in conjunction with clinical findings and other laboratory tests. Methodology Enzyme-linked immunosorbent assay (ELISA): celiac screen (tTG/DGP IgG/IgA), ASCA IgG, antigliadin IgG; Indirect fluorescent antibody (IFA): atypical pANCA Additional Information Disorders of the lower gastrointestinal tract in adults and children are among the most common conditions and may pose a difficult diagnostic problem. They account for 1 in 20 of all general practitioner consultations and their symptoms are frequently ill-defined.1 Those disorders include a wide range of pathologic conditions, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) that includes Crohn's disease (CD), ulcerative colitis (UC), and indeterminate colitis; microscopic colitis, infectious colitis, small intestinal bacterial overgrowth, celiac disease, and colon neoplasia (including colon cancer).2 The most prevalent condition is IBS. Its prevalence in Europe and North America is estimated to be 10% to 15%.3 Prevalence of celiac disease increased at least four times during the last 50 years and approaches 0.9%.4 The incidence rate of Crohn’s disease increased from 0.1 (three decades ago) to 4.6 (in 2003) per 100,000 children and the incidence of UC from 0.5 to 3.2 per 100,000 children.5 The prevalence of IBD in the adult population is approaching 0.3%.6 Recently another condition termed “gluten sensitivity” emerged as an important and often underdiagnosed and undertreated disease.7-11 It is reported that as many as 12% of the healthy population may have serological evidence of gluten sensitivity.9 Difficulties in differential diagnosis of those conditions often prompt clinicians to use an exclusion approach by performing tests to rule out the alternative etiologies.2 Interestingly, one study shows that most of the celiac disease serological test requests are now from general practitioners rather than gastroenterologists.12 Another study reports that 72% of general practitioners endorsed IBS as a diagnosis of exclusion.2 Endoscopy with biopsies for histological examination remains the gold standard for the diagnosis of many of these conditions.13 In recent years, however, introduction of a number of new and improved serological tests may allow for reduction in the number of intestinal biopsies.14 The cascade includes three testing steps: Step 1: Celiac Disease Screen: The cascade begins with a celiac screen that includes simultaneous detection of IgA and IgG antibodies to both deamidated gliadin peptide (DGP) and human tissue transglutaminase (tTG). The screen performance is reported to achieve a clinical sensitivity of 98.6% and specificity of 97.0% for the patients with celiac disease or controls.14 When the result is positive, the testing stops and the interpretive comment on the report would read: “Suggestive of celiac disease or other gluten-sensitive enteropathies. Subsequent testing for Endomysial Antibody, IgA [164996] and/or genetic testing for Celiac Disease HLA DQ Association [167082] may be indicated for further patient evaluation.” When the result is negative, the testing reflexes to the second step. Step 2: Inflammatory Bowel Disease Screen: Inflammatory bowel disease screen includes testing for IgG antibodies to anti-Saccharomyces cerevisiae (ASCA), and atypical perinuclear antineutrophil cytoplasmic antibodies (pANCA). This profile of tests aids in the serological identification of patients with IBD and in differentiation among its three clinical forms: CD, UC, and indeterminate colitis. When the marker for CD (ASCA IgG) is positive, the clinical sensitivity for CD is reported to be as high as 74.4% and specificity for IBD as high as 94.4%.15 When atypical pANCA (a marker of UC) is positive, the clinical sensitivity for UC is reported to be as high as 70% and specificity as high as 80%.16 It must be emphasized that neither of the markers negatively rules out IBD. Similarly, the presence of these antibodies does not strictly confirm the diagnosis of IBD.17 Testing for step two is described below and (depending on the combination of results) the interpretive comment on the report would be one of the following: When ASCA IgG is positive and atypical pANCA is negative, testing stops and the comment would read: “Suggestive of Crohn's disease. Subsequent testing with the Crohn's Disease Prognostic Profile [162020] that includes antiglycan antibodies AMCA, ALCA, ACCA, and gASCA may aid in the differentiation of clinical forms of CD and prognosis of disease progression.” When ASCA IgG is negative or equivocal and atypical pANCA is positive testing stops and the comment would read: “Suggestive of ulcerative colitis.” When both ASCA IgG and atypical pANCA are positive testing stops and the comment would read: “Suggestive of IBD. Subsequent testing with the Crohn's Disease Prognostic Profile [162020] that includes antiglycan antibodies AMCA, ALCA, ACCA, and gASCA may aid in the differentiation of clinical forms of IBD and prognosis of disease progression.” When all results are negative then the testing reflexes to the third step. Step 3: Nonceliac Gluten Sensitivity Screen: The nonceliac gluten sensitivity screen includes testing for IgG antibodies to gliadin with reported clinical sensitivity as high as 87% (for untreated clinically defined celiac disease patients) and specificity as high as 91%.18 Recent reports show that there is a significant subset of patients who have normal histology for celiac disease, negative for antibodies to DGP and tTG, positive for antigliadin antibodies and clinically indistinguishable from those with celiac disease. Those patients constitute the so-called “nonceliac gluten sensitivity” group, and many of them will benefit from a gluten-free diet. This group of patients is also reported to have increased mortality.7,8-10,14 When the result is positive, the testing stops and the interpretive comment on the report would read: “Suggestive of nonceliac gluten sensitivity. The patient may benefit from a gluten-free diet.” When all results are negative, the testing stops and the interpretive comment on the report would read: “Suggestive of irritable bowel syndrome (IBS). Careful evaluation of the patient's history, physical examination, and application of Rome III diagnostic criteria may help to rule in or rule out the diagnosis of IBS. Subsequent testing for Calprotectin, Fecal [123255] may be recommended. If IBD is strongly suspected, subsequent testing with the Crohn's Disease Prognostic Profile [162020] that includes antiglycan antibodies AMCA, ALCA, ACCA, and gASCA may aid in differential diagnosis.”

BRAF Gene Mutation Analysis

Special Instructions Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363. BRAF testing will be delayed if the pathology report is not received. 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 Information KRAS Gene Mutation Analysis, Extended NRAS Gene Mutation Analysis, Extended Specimen Requirements Specimen Solid tumor: Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides; thyroid fine needle aspirate (FNA). Leukemia: whole blood or bone marrow Volume FFPE tissue block or four unstained slides and one matching H&E-stained slide at 5 μM; 5 to 10 mL FNA in CytoLyt container; 3 to 5 mL whole blood, 1 to 2 mL bone marrow Minimum Volume Two unstained slides and one matching H&E-stained slide at 5 μM. Samples with >4mm² and ≥50% tumor content are preferred; FNA (with sufficient cells for DNA extraction); 3 mL blood, 1 mL bone marrow Container FFPE tissue block or slides, lavender-top (EDTA) tube, green-top (sodium heparin) tube, yellow-top (ACD-A) tube, FNA in CytoLyt container Storage Instructions Maintain specimen at room temperature. If specimen is to be stored prior to shipment, store at 2°C to 8°C. Store FFPE block or slides, FNA in CytoLyt container at room temperature. Causes for Rejection Tumor block containing no tumor; broken or stained slides; specimen does not meet collection criteria; frozen whole blood, marrow, or cell pellet; leaking tube; clotted blood or marrow; grossly hemolyzed specimen or otherwise visibly degraded; contamination by another specimen; specimens containing suspicious foreign material Test Details Use BRAF is an important member of the mitogen-activated protein kinase (MAPK) pathway that influences cell proliferation. This test will detect all V600 mutations of the BRAF oncogene frequently found in human cancers, such as melanoma, colorectal cancer, lung cancer, ovarian cancer, thyroid cancer, and hairy cell leukemia, allowing the determination of drug response, aiding the diagnosis and providing prognosis information. More than 90% of mutations are the V600E (c1799T>A) mutation, but other V600 mutations have been reported. This test can detect the following BRAF V600 mutations: V600E, V600E2, V600K, V600D, V600R, V600A, V600G, V600M, V600L. Limitations This assay is able to detect 5% mutation in a background of wild-type DNA. This assay does not distinguish between the V600E, V600D and V600E2 mutations. 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 SNaPshot Multiplex PCR (primer extension-based method)

BRAF Gene Mutation Analysis, Melanoma

Updated on 10/21/2019 Include LOINC® in print Special Instructions Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363. BRAF testing will be delayed if the pathology report is not received. 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. Specimen Requirements Specimen Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides Volume Formalin-fixed, paraffin-embedded tissue block or eight unstained slides and one matching H&E-stained slide at 5 μM. Minimum Volume Four unstained slides at 5 μM and one matching H&E-stained slide. The minimum total tumor surface area needed for this assay is 40 mm² for 5-μm sections and >80% tumor cells. Container Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides Storage Instructions Ship at room temperature. Store FFPE block or slides at room temperature. Causes for Rejection Tumor block containing insufficient tumor tissue; tumor is not melanoma primary; broken or stained slides Test Details Use The THxID™-BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAFV600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanomatissue. The THxID™-BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib (Tafinlar®) and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib (Mekinist™). Limitations This assay is able to detect 5% mutation in a background of wild-type DNA. Methodology Amplification refraction mutation-specific system (ARMS) polymerase chain reaction (PCR)

BRCA1/2 Comprehensive Analysis (BRCAssure®)

Special Instructions A Hereditary Cancer Clinical Questionnaire should be submitted with specimens. Contact CMBP genetics services at 800-345-4363 to coordinate testing. Expected Turnaround Time 14 - 24 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. BRCAssure℠: BRCA1 and 2 Analysis Hereditary Breast and Ovarian Cancer Testing and Genetic Counseling Services BRCA 1/2 Next Generation Sequencing Assay Summary Specimen Requirements Specimen Whole blood, saliva collected in an Oragene Dx collection kit Volume 7 mL whole blood, 2 mL saliva Minimum Volume 3 mL whole blood, 0.5 mL saliva Container Lavender-top (EDTA) tube or yellow-top (ACD) tube or Oragene Dx 500 saliva collection kit Storage Instructions Maintain specimen at room temperature. Causes for Rejection Frozen whole blood, serum, or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed specimen; incorrect anticoagulant; saliva collection in an incorrect container. Do not eat, drink, smoke, or chew gum 30 minutes prior to saliva sample collection. See Oragene Dx 500 saliva kit for detailed instructions. Test Details Use According to the National Comprehensive Cancer Network,1 testing is indicated if one of the features mentioned below is present in the family: Early-age-onset (age <50 years) breast cancer, including both invasive and ductal carcinoma in situ (DCIS) breast cancers; two breast primaries or breast and ovarian/fallopian tube/primary peritoneal cancer in a single individual or two or more breast primaries or breast and ovarian/fallopian tube/primary peritoneal cancers in close (first-, second-, and third-degree) relatives(s) from the same side of the family; populations at risk (eg, Ashkenazi Jewish); member of a family with a known BRCA1 or BRCA2 mutation; any male breast cancer; ovarian/fallopian tube/primary peritoneal cancer at any age. Limitations Sequencing cannot detect variants in regions not covered by this analysis, including noncoding or deep intronic variants and may not reliably detect changes in repetitive elements, such as microsatellite repeats. Sequencing may not detect mosaic variants, inversions, or other genomic rearrangements such as transposable element insertions. Sequence analysis may also be affected by allele drop-out due to the presence of a rare variant under a primer site or homopolymeric regions. The method does not allow any conclusion as to whether two heterozygous variants are present on the same or on different chromosome copies. Copy number variations are assessed by multiple-ligation-probe amplification assay (MLPA) to detect gross deletions and duplications. Copy number analyses are designed to detect single exon, multi-exon, and full gene deletions or duplications. These analyses may not detect certain genomic rearrangements, such as mosaic variants, translocations (balanced or unbalanced), inversions, or some partial exon rearrangements. This assay cannot determine exact breakpoints of deletions or duplications detected. This test is not intended to detect somatic variants. Bone marrow transplantation may affect the outcome of these results. Please contact LabCorp at 1-800-345-GENE to discuss testing options. 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 Next generation sequencing and multiplex ligation-dependent probe amplification (MLPA) platform

Breast Discharge Cytology

Synonyms Breast Smear Nipple Discharge Special Instructions Include patient's name, date of birth, sex, Social Security number, previous malignancy, drug therapy, radiation therapy, mammogram, and all other pertinent clinical information on the request form. 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 Nipple discharge Volume Pea-size drop Container Cardboard or plastic slide holder(s), Coplin jar(s) Collection Gently grip subareolar area and nipple with thumb and forefinger. When secretion occurs, allow pea-sized drop to accumulate on apex of nipple. Touch a clean slide to the nipple and withdraw quickly. Immediately spray slide with fixative or place slides in 95% ethyl alcohol. Repeat procedure until all secretions from nipple are collected on two or more slides. Using a graphite pencil, label the frosted end of the slide with the patient's name. Storage Instructions Maintain specimen at room temperature. Causes for Rejection Improper labeling; improper fixative; air-drying artifact Test Details Use Diagnose primary or metastatic malignant neoplasms; differential diagnosis of benign versus malignant processes; aid in the diagnosis of infectious and inflammatory disease Limitations Drying of smear(s) before fixation will render specimen unsatisfactory for evaluation. Methodology Pap stained: microscopic examination

Brucella Antibody, IgM, EIA

Expected Turnaround Time 2 - 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 Documents Sample Report Specimen Requirements Specimen Serum Volume 0.4 mL Minimum Volume 0.2 mL Container Red-top tube or gel-barrier tube Collection Specimen should be free of bacterial contamination, hemolysis, and lipemia. Storage Instructions Maintain specimen at room temperature. Causes for Rejection Hemolysis; lipemia; gross bacterial contamination Test Details Use Detection of IgM antibodies to Brucella abortus in human sera Methodology Enzyme immunoassay (EIA)

Budgerigar Feather

Synonyms Parakeet Feather Parrot Feather 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 Individual Allergens Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Container One 8.5 mL red-top tube or one 8.5 mL 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® Additional Information See Thermo Scientific.

Buprenorphine and Metabolite

Synonyms Buprenex® Free Buprenorphine Subutex® 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 Documents Sample Report Specimen Requirements Specimen Serum, plasma, or whole blood Volume 0.25 mL Minimum Volume 0.1 mL Container Red-top tube, lavender-top (EDTA) tube, gray-top (sodium fluoride) tube, or green-top (heparin) tube. Do not use a gel-barrier tube. The use of gel-barrier tubes is not recommended due to slow absorption of the drug by the gel. Depending on the specimen volume and storage time, the decrease in drug level due to absorption may be clinically significant. Collection Separate serum or plasma within two hours of collection and transfer to a plastic transport tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Causes for Rejection Gel-barrier tube Test Details Use Buprenorphine is used in the management of moderate to severe chronic pain. Half-life elimination: IV: 2.2 to 3 hours, Sublingual tablet: approximately 37 hours, Transdermal patch: approximately 26 hours Time to peak plasma: Sublingual: 30 minutes to 1 hour Limitations 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)

Buprenorphine Confirmation, Urine

Synonyms Suboxone® 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 the chain-of-custody test number on the test request form. Expected Turnaround Time 4 - 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. Specimen Requirements Specimen Urine Volume 20 mL Minimum Volume 10 mL Container Use plastic urine container and evidence tape or a tamper-evident container for forensic specimens. Collection kits are available on request from the laboratory. Storage Instructions Maintain specimen at room temperature. If arrival at lab will extend beyond seven days, refrigerate. Test Details Use Monitor use of prescribed medication or detection of illicit use. Methodology Mass spectrometry (MS)

Buprenorphine Medication Assisted Treatment Monitoring 1, Urine

Synonyms Opioid Use Disorder Suboxone™ MAT Special Instructions This profile is designed for Suboxone™/buprenorphine medication assisted treatment. It is not intended for workplace testing and does not comply with state regulatory workplace testing programs. 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 Documents Sample Report Specimen Requirements Specimen Urine (random) Volume 30 mL Minimum Volume 15 mL Container Urine container Collection Random urine Storage Instructions Submission /Transport(<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen. Stability Requirements Room temperature: 5 days Causes for Rejection Insufficient volume; no ID on container; urine from preservative tube Test Details Use Detect and confirm presence of prescribed and illicit drugs for monitoring Suboxone™/buprenorphine medication assisted treatment (MAT). Please note this testing is designed specifically for monitoring patients who are on Suboxone™/buprenorphine only. This testing should not be used for monitoring chronic pain patients (medical drug monitoring) or methadone medication assisted treatment. Limitations Some components of this panel were developed and performance characteristics determined by LabCorp (EtG and Tapentadol). They have not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Initial presumptive testing by immunoassay for buprenorphine at a testing threshold of 5 ng/mL; buprenorphine, norbuprenorphine, naloxone presumptive positives confirmed by definitive chromatography mass spectrometry (LC/MS-MS). Initial presumptive testing by immunoassay at the following thresholds: alcohol biomarkers (EtG, EtS), 500 ng/mL; amphetamines, 500 ng/mL; barbiturates, 200 ng/mL; benzodiazepines, 200 ng/mL; cocaine metabolite, 150 ng/mL; phencyclidine, 25 ng/mL; cannabinoids (THC), 20 ng/mL; heroin metabolite (6-AM), 10 ng/mL; opiates, 300 ng/mL; oxycodones, 100 ng/mL; tapentadol, 200 ng/mL; methadone, 300 ng/mL; propoxyphene, 300 ng/mL; tramadol, 200 ng/mL. Definitive confirmation testing is not performed; contact laboratory if additional definitive testing is desired.

Buprenorphine Medication Assisted Treatment Monitoring 2, Urine

Synonyms MAT Drug Screen 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 Sample Report Specimen Requirements Specimen Urine Volume 30 mL Minimum Volume 15 mL Collection Random urine Storage Instructions Ambient Stability Requirements Room Temperature: 5 days Causes for Rejection Insufficient volume; no ID on container; urine from preservative tube Test Details Use Detect and confirm presence of prescribed and illicit drugs for monitoring Suboxone™/buprenorphine medication assisted treatment (MAT). Please note: This testing is designed specifically for monitoring patients who are on Suboxone™/buprenorphine only. This testing should not be used for monitoring chronic pain patients (medical drug monitoring) or methadone medication assisted treatment. Limitations Some components of this panel were developed, and performance characteristics determined, by LabCorp (EtG, Carisoprodol, Fentanyl, Tapentadol, and Gabapentin). They have not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Initial presumptive testing by immunoassay at the following testing thresholds: buprenorphine, 5 ng/mL; alcohol biomarkers (EtG, EtS), 500 ng/mL; amphetamines, 500 ng/mL; barbiturates, 200 ng/mL; benzodiazepines, 200 ng/mL; cocaine metabolite, 150 ng/mL; phencyclidine, 25 ng/mL; cannabinoids (THC), 20 ng/mL; heroin metabolite (6-AM), 10 ng/mL; opiates, 300 ng/mL; oxycodones, 100 ng/mL; tapentadol, 200 ng/mL; fentanyl, 2.0 ng/mL; methadone, 300 ng/mL; propoxyphene, 300 ng/mL; tramadol, 200 ng/mL; carisoprodol, 100 ng/mL; gabapentin, 1.5 μg/ml. Presumptive positives are confirmed by definitive mass spectrometry (LC/MS-MS or GC/MS).

Buprenorphine, Screen and Confirmation, Urine

Synonyms Suboxone® 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 (random) Volume 20 mL Container Plastic urine container Storage Instructions Maintain specimen at room temperature. If arrival at lab will extend beyond seven days, refrigerate. Stability Requirements Temperature Period Room temperature 34 days Causes for Rejection Insufficient volume; no identification Test Details Use Monitor use of prescribed medication and detection of illicit use Methodology Initial testing by immunoassay (IA); confirmation of positives by mass spectrometry (MS)

Buprenorphine, Screen Only, Urine

Synonyms Suboxone® Special Instructions This assay is designed for pain management. It is not intended for workplace testing and does not comply with state regulatory workplace testing programs. 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 Plastic urine container Storage Instructions Maintain specimen at room temperature. If arrival at lab will extend beyond seven days, refrigerate. Test Details Use Detect the presence of buprenorphine Methodology Immunoassay (IA)

Buprenorphine, Whole Blood

Synonyms Buprenex® Suboxone® Subutex® Expected Turnaround Time 7 - 14 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 Whole blood Volume 3 mL Minimum Volume 300 μL Container Gray-top (sodium fluoride) tube (preferred), lavender-top (EDTA) tube, or green-top (heparin) tube Storage Instructions Room temperature is acceptable for shipping and/or short-term storage (three days). Test Details Use Detect and measure buprenorphine and metabolite Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS)

Bupropion and Hydroxybupropion, Serum or Plasma

Synonyms Wellbutrin® Zyban® 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. Specimen Requirements Specimen Serum or plasma, frozen Volume 3 mL Minimum Volume 0.6 mL Container Red-top (no additive) tube or green-top (heparin) tube. Gel-barrier tubes are not recommended. Storage/Transport: Custom "Transfer for Bupropion Analysis" tube containing Sodium Citrate Monobasic (PeopleSoft N° 116538) Collection Centrifuge within 30 minutes of collection. Transfer separated serum or plasma to the "Transfer for Bupropion Analysis" tube containing sodium citrate monobasic (white powder). Mix well. Freeze. Storage Instructions Freeze immediately; ship frozen on dry ice. Patient Preparation Trough levels are most reproducible. Causes for Rejection Gel-barrier tubes; specimen received not frozen; specimen not received in Bupropion Analysis Tube containing Sodium Citrate Monobasic Test Details Use Therapeutic drug management Methodology Liquid chromatography with tandem mass spectrometry (LC/MS-MS) Reference Interval Bupropion: 50−100 ng/mL; hydroxybupropion: 600−2000 ng/mL

Buspirone, Serum or Plasma

Synonyms Buspar® Vanspar® Expected Turnaround Time 7 - 14 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 or plasma Volume 3 mL Minimum Volume 0.6 mL Container Red-top tube or green-top (heparin) tube. Gel-barrier tubes are not recommended. Collection Serum or plasma should be separated from cells within two hours of venipuncture. Submit serum or plasma in a plastic transport tube. Storage Instructions Submission/transport (<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen. Patient Preparation Trough levels are most reproducible. Causes for Rejection Gel-barrier tubes Test Details Use Therapeutic drug management Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS)

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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.

Comprehensive Metabolic Panel
This test combines the Basic Metabolic Panel with six more tests for a more comprehensive evaluation of metabolic functions, with a focus on organ systems.

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.

Thyroid Stimulating Hormone
This test screens and monitors the function of the thyroid.

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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