Test DIRECTORY

Explore our comprehensive menu of laboratory tests designed to support accurate, reliable results across every specialty.

APG LAB's test directory provides a comprehensive list of specialty and general laboratory testing services.

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
There are currently 52 names in this directory beginning with the letter H.
Haptoglobin
Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 2 mL Container Red-top tube, gel-barrier tube, green-top (heparin) tube, or lavender-top (EDTA) tube Collection Separate serum or plasma from cells. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation Avoid exercise prior to collection and hemolysis from traumatic venipuncture. Causes for Rejection Excessive lipemia; hemolysis from traumatic venipuncture Test Details Use Decreased to absent levels occur more with intravascular than extravascular hemolysis: haptoglobin binds hemoglobin, and carries it to the reticuloendothelial system. Thus, haptoglobin is useful in work-up for hemolytic states. It is low in the megaloblastic anemias, which have a hemolytic component. It is decreased in infectious mononucleosis. Decreases can occur with hematoma or tissue hemorrhage. Haptoglobin can be low with liver disease. Congenital absence occurs (small fraction of certain ethnic populations have ahaptoglobinemia, absence of detectable haptoglobin). Frequently elevated as an acute phase reactant, in inflammatory disorders (eg, collagen diseases, infections, tissue destruction, and with advanced malignant neoplasms).1 Limitations During inflammation or steroid therapy, normal concentrations do not rule out hemolysis; decreased with oral contraceptives; increased with androgens Methodology Immunologic Reference Interval 34−200 mg/dL Additional Information Haptoglobin is a protein that binds free hemoglobin. Part of α2 on serum protein electrophoresis, serum haptoglobin is a glycoprotein consisting of two pairs of nonidentical chains, α and β, made by the liver. The subunit structure is represented as α2β2. The haptoglobin-bound hemoglobin complex is removed rapidly by the reticuloendothelial system and metabolized to free amino acids and iron in just a few hours. This represents an efficient method for the conservation of iron. Low α2 is commonly due to hemolysis and/or liver disease. Serum protein electrophoretic pattern showing low albumin, polyclonal increase in γ-globulin, and decrease in α2-globulin shown to be due to decreased haptoglobin has been correlated with poor prognosis in severe liver disease.2 Haptoglobin is decreased for two to three days after only 25 mL of blood is lysed.1 Thus, transfusions, which contain red blood cells which do not all survive in the recipient, can lower the level. The decrease in haptoglobin (after hemolysis) precedes any drop in hemopexin levels or the appearance of methemalbumin in serum or urine. Myoglobin, unlike hemoglobin, is not bound by haptoglobin.
HBB Deletion/Duplication Analysis
Special Instructions Full HBB gene sequencing is required (β-Thalassemia: HBB (Full Gene Sequencing) [252823]) before deletion/duplication analysis can be performed. If testing is needed for a known familial large deletion or duplication, please submit a copy of the laboratory report documenting the familial variant in the index family member. Expected Turnaround Time 19 - 28 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. Beta Hemoglobinopathies Genetic Testing Consent for Genetic Testing (Consentimiento para análisis genético) Sample Report Specimen Requirements Specimen Whole blood or amniotic fluid or chorionic villus sample (CVS) Volume 7 mL whole blood or 10 mL amniotic fluid or 10 mg CVS Container Lavender top (EDTA) or yellow-top (ACD) or sterile plastic conical tube or two confluent T-25 flasks for fetal testing Storage Instructions Maintain specimen at room temperature. Causes for Rejection Frozen specimen; hemolysis; quantity not sufficient for analysis; improper container; HBB sequencing not previously performed Test Details Use HBB deletion/duplication analysis is intended for individuals who have a clinical diagnosis of β-thalassemia and have either one or no pathogenic variants detected by HBB full gene sequencing. This test may also be used for carrier screening in individuals at increased risk of being an HBB carrier but have tested negative by HBB full gene sequencing. If testing is needed for a known familial large deletion or duplication, please submit a copy of the laboratory report documenting the familial variant in the index family member. Limitations Multiplex ligation-dependent probe amplification (MLPA) is designed to detect single exon, multi-exon, and full gene deletions or duplications. MLPA may not detect certain genomic rearrangements, such as translocations, inversions, mosaic variants, or some partial exon rearrangements. This assay cannot determine exact breakpoints of deletions or duplications detected. Diagnostic errors may occur due to rare sequence variations. 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 Multiplex ligation-dependent probe amplification (MLPA) Additional Information β-Thalassemia is a typically autosomal-recessive form of severe anemia. Prevalence is estimated at 1:100,000 worldwide and at 1:10,000 in the European Union, reflecting the increased prevalence in Mediterranean populations. Based on disease severity, three types of β-thalassemia are distinguished: β-thalassemia major (also known as Cooley's anemia), β-thalassemia intermedia, and β-thalassemia minor (also known as β-thalassemia trait). β-Thalassemia minor is mostly asymptomatic, but may be accompanied by mild anemia. In contrast, β-thalassemia major is characterized by infancy-onset severe anemia and requires life-long blood transfusions for survival. By definition, the intermediate form requires only intermittent blood transfusions for survival. Bone marrow or cord blood transplantation offers a cure, especially if performed before lasting organ damage has developed. Early diagnosis is, therefore, crucial to allow timely treatment initiation. Distinction between the intermediate and major forms is also important to avoid both unnecessary transfusions and unnecessary delay of required regular transfusions, which can increase the risk that the patient may develop multiple antibodies against donor red blood cells. Genetic testing can help with this diagnosis, since severity of β-thalassemia can partially be predicted from the nature of the causative mutations in HBB, the gene coding for β-globin. In addition, genetic testing can also identify mutations associated with rare cases of dominantly inherited β-thalassemia. Once the mutations causing β-thalassemia in a specific family have been identified, genetic testing for these mutations can also help to diagnose affected siblings of patients prenatally or directly after birth and facilitate genetic counseling in other relatives.
Heart Disease and Stroke Risk Profile
Test Includes C-reactive protein, cardiac; fibrinogen activity; lipoprotein (a); von Willebrand factor antigen Special Instructions State patient's sex on the request form. If the patient's hematocrit exceeds 55%, the volume of citrate in the collection tube must be adjusted. Refer to Coagulation Collection Procedures for directions. Expected Turnaround Time 2 - 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. Procedures for Hemostasis and Thrombosis: A Clinical Test Compendium Specimen Requirements Specimen Serum and plasma, frozen Volume 1 mL serum and 1 mL frozen plasma Container Red-top tube or gel-barrier tube and blue-top (sodium citrate) tube or lavender-top (EDTA) tube Collection Citrated plasma samples should be collected by double centrifugation. Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate.1 Evacuated collection tubes must be filled to completion to ensure a proper blood to anticoagulant ratio.2,3 The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples, except when using a winged blood collection device (ie, "butterfly"), in which case a discard tube should be used.4,5 When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge for 10 minutes and carefully remove 2/3 of the plasma using a plastic transfer pipette, being careful not to disturb the cells. Deliver to a plastic transport tube, cap, and recentrifuge for 10 minutes. Use a second plastic pipette to remove the plasma, staying clear of the platelets at the bottom of the tube. Transfer the plasma into a LabCorp PP transpak frozen purple tube with screw cap (LabCorp No. 49482). Freeze immediately and maintain frozen until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Please print and use the Volume Guide for Coagulation Testing to ensure proper draw volume. Storage Instructions Refrigerate serum. Freeze plasma. Patient Preparation Do not draw from an arm with a heparin lock or heparinized catheter. Test Details Methodology See individual tests.
Heavy Metals Profile I, Whole Blood
Test Includes Arsenic, blood; lead, blood; mercury, blood Expected Turnaround Time 2 - 5 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Arsenic, Whole Blood Lead, Whole Blood (Adult) Mercury, Whole Blood Specimen Requirements Specimen Whole blood Volume 7 mL Minimum Volume 1.1 mL Container Royal blue-top (EDTA) tube; submit original tube. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation Patient should avoid seafood and red wine 72 hours prior to collection. Causes for Rejection Clotted specimen Test Details Use Monitor exposure to arsenic, lead, and mercury Methodology Atomic absorption spectrometry (AAS); inductively-coupled plasma/mass spectrometry (ICP/MS) Reference Interval See individual tests. Additional Information See individual tests.
Heavy Metals Profile II, Urine
Test Includes Arsenic (total), urine; arsenic (inorganic), urine; cadmium, urine; lead, urine; mercury, urine; all ratios; all 24-hour excretions Special Instructions Request form must state 24-hour specimen volume, if applicable. 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 Arsenic Exposure Profile, Urine Cadmium, Urine Lead, Urine Mercury, Urine Urine Specimens Related Documents Sample Report Specimen Requirements Specimen Urine (random or 24-hour) Volume 15 mL Minimum Volume 5.3 mL Container Plastic urine container, no preservative Collection Optional protocol: Instruct the patient to void at 8 AM and discard the specimen. Then collect all urine including the final specimen voided at the end of the 24-hour collection period (ie, 8 AM the next morning). Avoid contact with metal during collection. Screw the lid on securely. See individual tests for collection times for industrial monitoring. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation Patient should avoid seafood and red wine 72 hours prior to collection. Test Details Use Monitor exposure to arsenic, lead, mercury, and cadmium 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 Atomic absorption spectrometry (AAS); inductively-coupled plasma/mass spectrometry (ICP/MS) Reference Interval See individual tests. Additional Information See individual tests.
Helicobacter pylori Antibodies, IgG
Synonyms Anti-H pylori, IgG Anti-Helicobacter pylori Antibodies Test Includes Qualitative result for IgG Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Helicobacter pylori Antibodies, IgM Helicobacter pylori Culture Helicobacter pylori Stool Antigen Related Documents Sample Report Specimen Requirements Specimen Serum Volume 1 mL Minimum Volume 0.5 mL Container Red-top tube, gel-barrier tube, or serum transfer 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 x4 Causes for Rejection Non-serum samples; heat-inativated serum; grossly hemolyzed; icteric or lipemic; samples containing particulate matter or exhibiting obvious microbial contamination Test Details Use The qualitative determination of IgG antibodies to Helicobacter pylori (H. pylori) in human serum from symptomatic adults as an aid in the diagnosis of H. pylori infection. Limitations Assay results should be utilized in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions. Heterophilic antibodies in human serum can react with reagent immunoglobulins or other reagent material, interfering with in vitro immunoassays. This assay has not been evaluated in a pediatric population. This assay should be used only to evaluate patients with clinical signs and symptoms suggestive of gastrointestinal disease and is not intended for use with asymptomatic patients. A positive test result does not allow one to distinguish between active infection and colonization by H. pylori. A positive test only indicates the presence of IgG antibody to H. pylori and does not necessarily indicate that gastrointestinal disease is present. A negative test indicates that IgG antibody to H. pylori is not present or is at a level that cannot be detected by the assay. Methodology Chemiluminescence immunoassay (CLIA) Reference Interval • Negative: 0.89
Helicobacter pylori Urea Breath Test
Synonyms Ubit Urea Breath Test Test Includes Analysis of pre- and postbreath samples to detect 13CO2 Special Instructions This test can be performed on adult patients and pediatric patients between the ages of 3 and 17. Expected Turnaround Time 1 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Helicobacter pylori Culture Helicobacter pylori Stool Antigen Related Documents For more information, please view the literature below. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Breath samples pre- and post-ingestion of fruit-flavored powder solution, containing 13C-urea diagnostic component. Volume One pre- and one post-ingestion breath sample Container One blue sample bag labeled “baseline” and one "postdose" sample bag Collection Blue sample bag (baseline) must be collected as follows: • Remove the blue breath collection bag from the kit. • Remove the pulloff cap from mouthpiece of the breath collection bag. • Instruct the patient to breathe normally, then take a deep breath, pause holding their breath for a full second (counting one, one thousand) then exhale into the mouthpiece of the bag. • Replace the cap in the mouth piece of the bag. Prepare the fruit-flavored powder solution, containing 13C-urea diagnostic component as detailed in the kit instructions Postdose sample bag is collected as follows: • Instruct the patient to drink all the solution without “rinsing” mouth before swallowing. • Have the patient sit quietly for 15 minutes. Set timer for 15 minutes. • After 15 minutes, collect the pink or gray sample bag as outlined for the baseline specimen above. All sample bags must be labeled according to LabCorp specimen labeling policies. Storage Instructions Maintain specimen at room temperature. Patient Preparation The patient should fast for at least one hour prior to testing. The patient should not take antimicrobials, proton pump inhibitors, or bismuth preparations within two weeks prior to testing. Note: Solution contains phenylalanine. Phenylketonurics should be warned. Causes for Rejection Prolonged transport more than seven days; specimens collected from persons younger than 3 years of age Test Details Use The urea breath test can be used to aid in the diagnosis of H pylori infection. The test can also be used to assess therapy when it is administered more than a month after completion of therapy. Methodology IR (infrared) spectroscopy to assess the presence of 13CO2 Reference Interval Negative Additional Information The present standard of care includes testing for and treatment of Helicobacter pylori in patients with documented ulcer disease or recurrent dyspepsia. Although serologic assays have been widely used for the diagnosis of H pylori, the increasing availability of direct tests in the form of stool antigen and urea breath test provide diagnostic alternatives with higher positive predictive values. Use of “direct” tests leads to a reduction in unnecessary treatment, which is important because of the continuing concern regarding antimicrobial treatment and the emergence of antibiotic resistance. These tests each have the added feature of being able to be used as a test of cure when administered a month or more after completion of eradication therapy.
Hematopathology Consultation, Peripheral Smear
Synonyms Consult Smear Pathologist Review Peripheral Smear Special Instructions The test request form must be completed with patient history, including pertinent clinical information and physician's name and telephone number. 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 Whole blood and peripheral blood films made at the time of collection Volume Tube filled to capacity and two freshly prepared blood films Minimum Volume 0.5 mL (500 μL for pediatric microtainer capillary tubes; fill tube to capacity.) Container Lavender-top (EDTA) tube and glass slides Collection Invert tube 8 to 10 times immediately after tube is filled at the time of collection. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 1 day Refrigerated 3 days Frozen Unstable Freeze/thaw cycles Unstable Causes for Rejection Lavender-top tube not submitted; improper labeling; transfer tubes with whole blood; specimen received with plasma removed; clotted specimen; specimen diluted or contaminated with IV fluid; specimen drawn in any anticoagulant other than EDTA; tube not filled with minimum volume; hemolysis; specimen more than 48 hours old; specimen more than 24 hours old without slides prepared at the time of collection or within 24 hours of collection Test Details Use Guidelines for clinician who has prior knowledge of patient history and abnormal labs: • Hemolytic anemia, especially if accompanied by thrombocytopenia • Anemia unresponsive to therapy; unexplained anemia • Leukocyte/bone marrow disorder − pancytopenia, unexplained leukocytosis or leukopenia; leukemia • Congenital disorders Clinician suspects from patient history or previous abnormal labs: • Thrombotic thrombocytopenia purpura (TTP) • Hemolytic uremic syndrome (HUS) or other unspecified hemolytic anemia • Leukocyte/bone marrow disorder − pancytopenia, unexplained leukocytosis or leukopenia; leukemia • Congenital disorders Determine qualitative and quantitative variations in white cell numbers and morphology, morphology of red cells and platelet evaluation; evaluate anemia, leukemia, and other conditions. Methodology Microscopic examination
Hemoglobin (Hb) A1c
Synonyms Glycated Hemoglobin Hgb A1c 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 Whole blood Volume 4 mL Minimum Volume Pediatric EDTA whole blood tubes may be used. Please place original labeled capillary tube in a labeled transport tube for shipment to the laboratory. Container Lavender-top (EDTA) tube, green-top (lithium heparin) tube, or gray-top (sodium fluoride) tube Collection The usual precautions in the collection of venipuncture samples should be observed. The sample must be free of clots. Samples with any hematocrit disorders can lead to erroneous results. Send the entire tube to the laboratory. 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 Clotted specimen; gross hemolysis Test Details Use Hemoglobin A1c values are used to assess glucose control in diabetes, and in 2010 the American Diabetes Associations affirmed the decision of an international expert committee recommendation to use the A1c test to diagnose diabetes with a threshold ≥6.5%. Point-of-care A1c assays are not sufficiently accurate at this time to use for diagnostic purposes. Limitations Any cause of shortened erythrocyte survival will reduce exposure of erythrocytes to glucose with a consequent decrease in Hb A1c (%). Causes of shortened erythrocyte lifetime might be hemolytic anemia or other hemolytic diseases, homozygous sickle cell trait, pregnancy, or recent significant or chronic blood loss. Glycated Hb F (fetal hemoglobin) is not detected as it does not contain the glycated β chain that characterizes Hb A1c. Specimens containing high amounts of Hb F (>10%) may result in lower than expected Hb A1c. Methodology Roche Tina Quant Reference Interval • Hemoglobin (Hb) A1c: 4.8% to 5.6% • Prediabetes: 5.7% to 6.4% • Diabetes: ≥6.5% • Glycemic control for adults with diabetes: <7.0% (DCCT/NGSP) 2010 American Diabetes Association's Summary of Glycemic Recommendations for Adults with Diabetes: Hemoglobin A1c <7.0%. For selected individual patients, providers might reasonably suggest even lower A1c goals than the general goal of <7%, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Such patients might include those with short duration of diabetes, long life expectancy, and no significant CVD. Conversely, less-stringent A1c goals than the general goal of <7% may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, and extensive comorbid conditions and those with longstanding diabetes in whom the general goal is difficult to attain. Additional Information Factors such as duration of diabetes, adherence to therapy, and age of patient should also be considered in assessing the degree of blood glucose control.
Hemoglobin (Hb) Solubility
Synonyms Hb S Hemoglobin S Hgb Solubility Sickle Cell Preparation Sickle Cell Solubility Test Sickle Cell Test Sickle Prep Sickledex™ Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Information Hemoglobin (Hb) Solubility With Reflex to Hemoglobin Fractionation, Blood Related Documents Sample Report Specimen Requirements Specimen Whole blood Volume 1 mL Minimum Volume 0.1 mL Container Lavender-top (EDTA) tube; capillary puncture: three microhematocrit tubes. May also use blue-top (sodium citrate) tube, yellow-top (ACD) tube, or green-top (heparin) tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation No preliminary fluid or food restriction is required. Causes for Rejection Specimen other than whole blood received; clotted specimen Test Details Use Qualitative determination of presence of hemoglobin S; detect sickling hemoglobins; evaluate hemolytic anemia, undiagnosed hereditary anemia with morphologic (sickle-like) abnormalities on peripheral blood smear Limitations False-positive solubility test for sickling may be due to polycythemic blood; interference by some forms of hyperglobulinemia; and a variety of abnormal hemoglobins, including I, Bart, CGeorgetown, Alexandra, CHarlem, Porto Alegre, Memphis/S, CZiguinchor, and STravis.1 Positive tests should be confirmed by hemoglobin fractionation. A positive reaction also occurs in the presence of many Heinz bodies (eg, after splenectomy), and in blood protein disorders due to precipitation of plasma proteins. False-negative solubility test reactions may occur with inadequate quantities of blood from anemic patients (hemoglobin levels <8.0 g/dL); high concentration of Hb F or of phenothiazines may inhibit the sickle reaction;1 quantities of hemoglobin S too small to detect, as at birth or with transfusions of nonhemoglobin S into patients with hemoglobin S. The appearance of hemoglobin S is genetically delayed and is not present in sufficient quantity until after three months of age. Maximum levels are not reached until about six months of age. Solubility tests are unlikely to be reliably positive until after six months of age; therefore, this test should not be used for testing neonates or children younger than six months of age. Methodology Sodium hydrosulfite reduction Reference Interval Negative Additional Information Distinction between Hb S β-thalassemia and sickle cell anemia is not always possible on clinical, hematologic, or electrophoretic grounds. Thalassemia heterozygotes have hypochromia and microcytosis, but overlap values exist. Differentiation can best be made by family or molecular pathology methods. Regional prevalence in the midwest area of Hb S β-thalassemia is estimated to be 1:23,000 of the black population. It is recommended that positive sickle cell patients be further evaluated with Hb fractionation (HPLC), Hb F studies, and family studies. Complete characterization may require sophisticated laboratory studies with DNA amplification.2
Hemoglobinopathy Fractionation Profile
Synonyms Hb Electrophoresis Plus Solubility Test Includes Identification and relative percentages of hemoglobins (A, A2, F, S, C) including variants, if present; hemoglobin solubility; interpretation Special Instructions State patient's age, ethnic background, MCV, transfusion history, and any other known hematological information on the test request form. 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 Whole blood Volume 1 mL Minimum Volume 0.6 mL Container Lavender-top (EDTA) tube Collection To avoid delays in turnaround time, please submit a separate lavender-top tube for each test requiring a lavender-top. Storage Instructions Refrigerate at 2°C to 8°C. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation Fasting or fluid restriction is not necessary. Causes for Rejection Clotted specimen Test Details Use Diagnose thalassemias and hemoglobin variants Methodology Hemoglobin fractionation: high-pressure liquid chromatography (HPLC); hemoglobin solubility: sodium hydrosulfite reduction Reference Interval • Hb A: – <7 months: Not established – 7 months to 1 year: 94.6% to 98.5% – ≥2 years: 96.4% to 98.8% • Hb F: − <7 months: Not established − 7 months to 1 year: 0.1% to 6.8% − ≥2 years : 0.0% to 2.0% • Hb S, D, G: 0% • Hb C, E, O: 0% • Hb A2: – <7 months: Not established – 7 months to 1 year: 1.9% to 2.8% – ≥2 years: 1.8% to 3.2% • Hemoglobin solubility: Negative
Hemophagocytic Lymphohistiocytosis (HLH) Genetic Panel
Special Instructions The following genes associated with hemophagocytic lymphohistiocytosis (HLH) are sequenced using Next Generation Sequencing (NGS): LYST, NLRC4, AP3B1, STX11, PRF1, RAB27A, UNC13D (MUNC13-4), STXBP2, SH2D1A (SAP is protein), and XIAP (BIRC4). Specimen Requirements Specimen Whole blood; acceptable alternate: cheek swab (buccal swab) Volume 3 mL Minimum Volume 1 mL Container Lavender-top (EDTA) tube Collection Invert tube 4 times to ensure adequate mixing. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 1 month Causes for Rejection Sample contamination Test Details Use Hemophagocytic Lymphohistiocytosis (HLH) is a life-threatening disease where an underlying immune defect or triggering event initiates excessive activation of immune cells (macrophages and lymphocytes) leading to multi-organ dysfunction and failure. Median survival without treatment is less than two months. Treatment of HLH may vary depending on the underlying cause, including whether a genetic cause is detected. Limitations This test targets all exons and untranslated regions of the selected genes, 25-bp of intronic DNA flanking the exon-intron boundary, plus several additional known variants of interest elsewhere in the genome for sequencing. This test would not detect a causative mutation within promoter regions or elsewhere in the genome that were not specifically targeted. A rare variant that disrupts primer binding during PCR could potentially lead to a false negative. All our reports are based on the current understanding of the genes and disease. This understanding changes over time as new papers are published. We recommend annual follow-up for more current interpretations. This test will not detect inhibitors to F8, F9 or VWF proteins, which are non-hereditary. This test does not detect pseudo-VWD (also called platelet VWD), caused by mutations in GP1B. Methodology Next Generation Sequencing (NGS)
Hepatic Function Panel (7)
Synonyms Liver Function Panel (LFP) Test Includes Alanine aminotransferase (ALT/SGPT); albumin, serum; alkaline phosphatase, serum; aspartate aminotransferase (AST/SGOT); bilirubin, direct; bilirubin, total; protein, total, serum Expected Turnaround Time Within 1 day Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. AMA-Recognized Organ and Disease Panels Clinical Practice Algorithms for Evaluation of Liver Function Chemistry Tests - Technical Review Sample Report Specimen Requirements Specimen Serum (preferred) or plasma Volume 1 mL Minimum Volume 0.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube, gel-barrier tube, or green-top (heparin) tube Collection Separate serum or plasma from cells within 45 minutes of collection. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 2 days Refrigerated 3 days Frozen 14 days Freeze/thaw cycles Stable x2 Test Details Methodology See individual tests.
Hepatitis A Antibody, IgM
Synonyms Anti-HAV, IgM Antibody to Hepatitis A Virus, IgM HAVAb, IgM 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 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum or plasma Volume 1 mL Minimum Volume 0.4 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube Collection If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Non-EDTA plasma specimen; PST gel-barrier tube Test Details Use Differential diagnosis of hepatitis; the presence of IgM antibody to hepatitis A virus is good evidence for acute hepatitis A. Methodology Immunochemiluminometric assay (ICMA) Reference Interval Negative Additional Information Hepatitis A virus is a picornavirus, and antibody is made to capsid proteins. Fecal excretion of HAV peaks before symptoms develop. If hepatitis A antibody is IgM, the hepatitis A infection is probably acute. IgM antibody develops within a week of symptom onset, peaks in three months, and is usually gone after six months. Hepatitis A antibody of IgG type is indicative of old infection, is found in almost 50% of adults, and is not usually clinically relevant. Many cases of hepatitis A are subclinical, particularly in children. Presence of IgG antibody to HAV does not exclude acute hepatitis B or other forms of hepatitis.
Hepatitis B Surface Antigen (HBsAg) Screen, Qualitative
Synonyms Hepatitis-associated Antigen Test Includes Confirmation of positive results is performed as indicated, by a neutralization assay at no additional charge. • Samples with an index value greater than an established threshold and with positive results for other hepatitis B markers are considered positive for Hepatitis B Surface Antigen without further testing (neutralization testing is not performed). • Samples with an index value greater than an established threshold but with no other positive results for hepatitis B markers, or with an index value less than an established threshold but above the cutoff for positivity, are confirmed by neutralization. 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 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum or plasma Volume 3.5 mL Minimum Volume 1.5 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube Collection If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Non-EDTA plasma specimen; PST gel-barrier tube Test Details Use Test blood donors (HBsAg positive individuals are rejected). Hepatitis B surface antigen is the earliest indicator of the presence of acute infection. Also indicative of chronic infection. Test is useful in the differential diagnosis of hepatitis. Limitations Patients who are negative for HBsAg may still have acute type B viral hepatitis. There is sometimes a “core window” stage when HBsAg has become negative and the patient has not yet developed the antibody (anti-HBs). On such occasions, both tests for anti-HBc are usually positive and anti-HBc, IgM is the only specific marker for the diagnosis of acute infection with hepatitis B. In cases with strong clinical suspicion of viral hepatitis, serologic testing should not be limited to detecting HBsAg, but should include a battery of tests to evaluate different stages of acute and convalescent hepatitis. Methodology Immunochemiluminometric assay (ICMA) Reference Interval Negative Additional Information Hepatitis B virus (HBV) is a DNA virus with a protein coat, the surface antigen (HBsAg) and a nucleic acid core, the core antigen (HBcAg). There are eight different serotypes. Early in infection, HBsAg, HBV DNA, and DNA polymerase can all be detected in serum. HBsAg can be detected one to seven weeks before liver enzyme elevation or the appearance of clinical symptoms. Three weeks after the onset of acute hepatitis, about 50% of patients will still be positive for HBsAg, while at 17 weeks only 10% are positive. The best available markers for infectivity are HBsAg and HBeAg. The presence of anti-HBs is frequently associated with noninfectivity. The chronic carrier state is indicated by the persistence of HBsAg and/or HBeAg over long periods (six months to years) without seroconversion to the corresponding antibodies. Such a condition has the potential to lead to serious liver damage, but may be an isolated asymptomatic serologic phenomenon. Persistence of HBsAg, without anti-HBs, with combinations of positivity of anti-HBc, HBeAg, or anti-HBe indicates infectivity and need for investigation for chronic persistent or chronic aggressive hepatitis. See figure in Hepatitis B Core Antibody, IgM [016881].
Hepatitis B Virus (HBV), Quantitative, DNA (Abbott RealTime)
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 Serum or plasma (EDTA) Volume 3 mL Minimum Volume 1 mL (Note: This volume does not allow for repeat testing.) Collection Freshly drawn specimens (whole blood) may be held at 2° C to 30° C for up to 6 hours prior to centrifugation. Remove serum or plasma, transfer to a screw-cap polypropylene transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate specimens for each test requested. Storage Instructions Freeze. Stable at room temperature for six hours (whole blood) or one day after centrifugation. Stable refrigerated for up to 3 days after centrifugation. Freeze for long term storage. Causes for Rejection Hemolysis; heparinized plasma; nonfrozen specimens; specimen received in "pop-top" or "snap-cap" tube; whole blood Test Details Use Determine the number of international units (IU) of hepatitis B virus DNA per milliliter of serum or plasma in known HBV-positive patients. Limitations Assay range is 10 IU/mL to 1,000,000,000 IU/mL Methodology Abbott m2000 RealTime HBV assay
Hepatitis C Virus (HCV) Antibody
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 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum or plasma Volume 1 mL Container Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube Collection If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Non-EDTA plasma specimen; PST gel-barrier tube Test Details Use Assess exposure to hepatitis C virus infection; test blood safety Limitations Since as many as 90% of commercial intravenous immunoglobulins test positive for hepatitis C antibody, an artifactual positive can result briefly after transfusion. Methodology Enzyme immunoassay (EIA) Additional Information Following the development of sensitive and specific testing for hepatitis B, 90% of post-transfusion hepatitis is now hepatitis C. A gene product (c100) of hepatitis C virus (HCV) was isolated and an assay for anti-HCV developed. The assay detects antibody to a presumptive togavirus or flavivirus which may be an etiologic agent of non-A, non-B hepatitis (which may not be a unitary disease entity). For blood donors, hepatitis C serology correlates with surrogate tests for non-A, non-B hepatitis (ALT and anti-HBc). Since hepatitis C serology identifies a broader group of infected individuals than surrogate testing, it reduces risk of HCV during transfusion. Studies in hemophiliacs indicate that antibody to HCV is a reliable marker of HCV.
Hepatitis C Virus (HCV) NS5B Drug Resistance Assay
Synonyms HCV Drug Resistance NS5B Resistance Analysis Special Instructions Please indicate the patient's HCV genotype (1a or 1b) on the test request form. Submit a separate frozen specimen for each test ordered. Expected Turnaround Time 10 - 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. Related Information Hepatitis C Virus (HCV) GenoSure® NS3/4A Hepatitis C Virus (HCV) NS5A Drug Resistance Assay Related Documents For more information, please view the literature below. LabCorp offers the leading HCV menu for complete care decisions Specimen Requirements Specimen Plasma (preferred) or serum, frozen Volume 2 mL Minimum Volume 1 mL Container Ship in plasma preparation tube (PPT™) or screw-capped polyproplylene frozen transport tubes. Collection Collect specimen in two PPT™ tubes, gel-barrier tubes, or lavender-top (EDTA) tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection, remove serum/plasma, and transfer specimen to polypropylene screw-capped tubes, and freeze. Specimens drawn into PPT™ tubes need to be centrifuged within six hours and frozen. 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. Causes for Rejection PPT™ not centrifuged; insufficient volume; heparinized plasma; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; specimen received in "pop-top" or "snap-cap" tube Test Details Use Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS5B inhibitors. Assay should be used for patients with documented HCV genotype 1. Limitations This procedure may not be successful when the HCV viral load is <1000 IU/mL. This assay requires an HCV genotype of either 1a or 1b. Methodology Polymerase chain reaction (PCR) amplification and DNA next generation sequencing
Hepatitis Panel, Acute
Synonyms Acute Hepatitis Panel Test Includes Hepatitis A antibody, IgM; hepatitis B core antibody, IgM; hepatitis B surface antigen; hepatitis C virus antibody 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 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. AMA-Recognized Organ and Disease Panels Specimen Requirements Specimen Serum or plasma Volume 4 mL Minimum Volume 3 mL Container Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube Collection If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Non-EDTA plasma specimen; PST gel-barrier tube Test Details Use Comprehensive profile for detecting markers for HAV or HBV infections; can be used for all stages of infection Methodology See individual tests.
Hepatitis Profile VII (Hepatitis A and B Profile)
Synonyms HAV/HBV (Profile VII) Test Includes Anti-HAV, IgM; anti-HAV, total; HBeAg; HBsAg; anti-HBc, IgM; anti-HBc, total; anti-HBe; anti-HBs 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 1 - 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. Specimen Requirements Specimen Serum or plasma Volume 4 mL Minimum Volume 3 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube Collection If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Refrigerate Stability Requirements Temperature Period Refrigerated 48 hours Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Non-EDTA plasma specimen; PST gel-barrier tube Test Details Use Comprehensive profile for detecting markers for HAV or HBV infection; can be used for all stages of infection Methodology See individual tests.
Hepatitis Profile X (HBV Prevaccination Profile)
Synonyms HBV Prevaccination (Profile X) Test Includes Hepatitis B core antibody (anti-HBc), IgM; hepatitis B core antibody (anti-HBc), total; hepatitis B surface antibody (anti-HBs); hepatitis B surface antigen (HBsAg) 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 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Specimen Requirements Specimen Serum or plasma Volume 4 mL Minimum Volume 2 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube Collection If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube. Storage Instructions Room temperature Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Non-EDTA plasma specimen; PST gel-barrier tube Test Details Use Determine prior HBV infection (and/or immunity) and define individuals with no immunity as candidates for vaccines Methodology See individual tests.
Hereditary Hemochromatosis, DNA Analysis
Synonyms Cirrhosis Iron Overload Iron Storage Expected Turnaround Time 5 - 7 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Hereditary Hemochromatosis Sample Report Specimen Requirements Specimen Whole blood or LabCorp buccal swab kit (buccal swab collection kit contains instructions for use of a buccal swab) Volume 7 mL whole blood or LabCorp buccal swab kit Minimum Volume 3 mL whole blood or two buccal swabs Container Lavender-top (EDTA) tube, yellow-top (ACD) tube, 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 Follow-up evaluation in individuals with elevated saturated transferrin; detection of affected individuals and carriers of hereditary hemochromatosis Limitations This assay detects only the C282Y, H63D, and S65C mutations in the HFE gene and will help identify those who are at increased risk for hereditary hemochromatosis. Increased risk for hereditary hemochromatosis can be caused by a variety of genetic and nongenetic factors not detected by this 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 Polymerase chain reaction (PCR); restriction enzyme analysis Additional Information Hereditary hemochromatosis (HH) (OMIM 235200) is an autosomal recessive disorder of iron metabolism resulting in the accumulation of excess iron in a variety of organs. Populations of Northern European origin show the highest frequency of HH, with 1 in 300 individuals affected. The HFE gene was identified as being responsible for hemochromatosis. The HFE gene encodes an HLA class I-like protein. In association with β-2 microglobulin, HFE, has an expression pattern that is correlated with the localization of iron absorption. HFE seems to play a role in iron uptake by interacting with the transferrin receptor, which leads to a decreased affinity of the transferrin receptor for transferrin. Eighty-five percent of HH chromosomes have the mutation 845A that results from a G to A mutation at nucleotide 845 of the open reading frame of HFE. This mutation changes a cysteine to a tyrosine at amino acid 282 (C282Y). The second mutation, 187G, results from a C to G mutation at nucleotide 187 of the open reading frame of HFE. It accounts for 40% to 70% of the non-C282Y HH mutations (about 39% of HH). This mutation changes a histidine to an aspartic acid at amino acid 63 (H63D). The third mutation, 193T, results from an A to T mutation at nucleotide 193 of the open reading frame of HFE. This mutation changes a serine to a cysteine at amino acid 65 (S65C). This mutation accounts for 4.7% of the affected HH chromosomes. Of the three mutations, C282Y carries the highest risk for an iron overload pathology, when inherited in the homozygous state. H63D and S65C are mutations of reduced penetrance, and may not cause disease even when detected in the compound heterozygous state with C282Y.
Hereditary Hemorrhagic Telangiectasia (HHT), Prenatal
Test Includes Genes tested: ENG (endoglin), HHT1; ACVRL1 (ALK1), HHT2; or SMAD4 (MADH4) Special Instructions This test is performed at Impact Genetics, Bowmanville, Ontario, Canada. Please direct any questions regarding this test to Impact Genetics at 877-624-9769. Expected Turnaround Time 4 - 8 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Specimen Requirements Specimen Cultured amniocytes, CVS, or cord blood Volume 8.5 mL blood Minimum Volume 2 mL blood (infant); amniocytes in 2 T25 flask of cultured amniotic cells; CVS volume: as much as possible Container Amniocytes in 2 T25 flask of cultured amniotic cells. CVS in sterile tissue/culture medium. Amniocytes must be received at Impact Genetics within five days of collection. CVS must be received at Impact Genetics within 48 hours of collection. Do not freeze. Collection Blood samples and amniocytes must be received at Impact Genetics within five days of collection. CVS must be received at Impact Genetics within 48 hours of collection. Do not freeze. Storage Instructions Room temperature. Stable at room temperature for seven days. Test Details Use Testing for a known HHT genetic mutation in a fetus when the mother or father have a confirmed genetic diagnosis of HHT 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 Sequencing or quantitative multiplex polymerase chain reaction (QM-PCR) to screen for copy number changes as needed for the known mutation type. Maternal cell contamination is also performed.
Hereditary Nonpolyposis Colorectal Cancer (HNPCC): MSH6 (Known Mutation)
Synonyms Lynch Syndrome Special Instructions This option is available when the mutation is known and can be documented by the ordering physician. If the mutation cannot be documented, please order test 511636. Test orders must include an attestation that the provider has the patient's informed consent for genetic testing. See sample physician office consent form: Consent for Genetic Testing. In the case of family tests (ie, known mutations), please submit the result report of the first patient tested in the family (the index case), if not performed at a LabCorp facility. Other family members are subsequently tested for the specific mutation found in the first patient tested. Expected Turnaround Time 23 - 28 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; DNA is accepted (Call 800-345-4363 for DNA collection information.) Volume 2 mL Container Lavender-top (EDTA) tube Collection Samples may be stored for brief periods at 4°C. Ship overnight at room temperature. Storage Instructions Maintain specimen at room temperature. Causes for Rejection Container broken or leaking; container not labeled or label not legible; improper anticoagulant Test Details Use Identify who in a family harbors the familial mutation and is at high risk of the disease and who does not harbor the familial mutation and is not at increased risk of the disease. Family testing for known familial mutations can identify presymptomatic mutation carriers within affected families who are at high risk of developing the familial disease. Limitations Selected regions of the coding sequence of MSH6 are amplified by polymerase chain reaction and each PCR product amplicon) then sequenced bi-directionally, using Sanger sequencing. Nucleotide and codon number are based on the mRNA isoform NM_000179 for the MSH6 gene. 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. This test is not intended to detect somatic variants. Bone marrow transplantation may affect the outcome of these results. Please contact LabCorp to discuss testing options at 1-800-345-GENE. 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 DNA sequencing Additional Information Once a mutation is identified in an index patient, family members can be tested for the presence of that specific mutation (single-amplicon testing). Please note, if additional amplicons are required for family testing, the patient will be charged for each additional amplicon.
HERmark® Breast Cancer Assay
Synonyms HER-2 Total Special Instructions Please attach pathology report. Confirm that all specimens are labeled. Direct any questions regarding this test to Monogram client services at 800-777-0177. 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. Specimen Requirements Specimen Invasive breast carcinoma, FFPE (formalin-fixed paraffin-embedded) tissue specimens (excisional biopsy specimens preferred). Large core biopsies are also acceptable. Volume Four slides: 5-μM sections on glass slides (A total of four unstained slides per patient are required; freshly cut sections should be sent within one week.) or one paraffin-embedded tissue block. If multiple blocks are available, select the tissue block with the highest amount of viable invasive tumor; submit only one block. Minimum Volume 10 mm² of invasive breast cancer per slide. Container Paraffin block transport pouch or slide mailer. Collection Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 48 hours. Storage Instructions Maintain specimen at room temperature. Causes for Rejection Fixative other than neutral-buffered formalin; insufficient tumor specimen; tumor types other than breast (Note: Metastatic biopsies of primary breast origin are acceptable.); only DCIS and LCIS cases Test Details Use Quantitative determination of HER-2 total protein. Limitations Use of fixatives other than 10% neutral-buffered formalin or fixation times less than six hours or more than 48 hours may not yield reliable results. Results of the HERmark® assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, nodal status, patient's age, hormone receptor status, and other known risk factors. Methodology VeraTag® technology. Specimens referred to Monogram Biosciences for testing, reporting, and billing. VeraTag® is a registered trademark of Monogram Biosciences Inc, South San Francisco, Calif.
Heroin Confirmation, Serum, Plasma, or Whole Blood
Synonyms 6-Acetylmorphine Diacetylmorphine Test Includes 6-Acetylmorphine (6-AM); morphine Expected Turnaround Time 10 - 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, plasma, or whole blood Volume 7 mL Minimum Volume 2 mL Container Serum or plasma: red-top tube or green-top (heparin) tube. Gel-barrier tubes are not recommended. Whole blood: Lavender-top (EDTA) tube, gray-top (sodium fluoride) tube, or green-top (heparin) tube 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 Refrigerate; specimen may also be frozen. Causes for Rejection Gel-barrier tubes Test Details Use Detect the presence of heroin metabolites Methodology Gas chromatography/mass spectrometry (GC/MS)
Heroin Metabolite (6-AM), Screen Only, Urine
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. Stability: If arrival at lab will extend beyond seven days then refrigerate. Test Details Use Detect heroin metabolite Methodology Immunoassay (IA)
Herpes Simplex Virus (HSV) Types 1 and 2-Specific Antibodies, IgG With Reflex to Supplemental HSV-2 Testing
Synonyms Herpes 1 and 2; HSV Types 1- and 2- Specific Antibodies, IgG; HSV-1 and HSV-2; HSV Special Instructions For 163034 HSV-2 IgG, Type Specific:If patient result falls between 0.91 (Equivocal) and 5.00 (Low Positive) Index Values, the specimen will reflex to 163006 HSV-6 Supplemental test per CDC guidelines. If reflex test is performed, additional charges/CPT code(s) my apply. Expected Turnaround Time 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Genital Herpes Diagnosis: Technology and Test Options Sample Report Specimen Requirements Specimen Serum Volume 1.5 mL Minimum Volume 1 mL Container Red-top tube, gel-barrier tube, or serum transfer tube Storage Instructions Refrigerate Stability Requirements Temperature Period Room temperature 2 days Refrigerated 7 days Frozen 98 days Freeze/Thaw Cycle Stable x4 Causes for Rejection Hemolysis; lipemia; grossly icteric; visible particulate matter; gross bacterial contamination Test Details Use Detect IgG antibodies specific to HSV types 1 and/or 2 infection; confirm or rule out possible infection with herpes simplex types 1 and/or 2 virus in prenatal patients in whom HSV 2 infection can cause serious prenatal disease. Per CDC guidelines, specimens with equivocal or low positive results for HSV-2 type specific IgG will reflex for supplemental testing by another assay. In a patient with no history of lesion disease, a positive result for this test may be indicative that the primary infection was asymptomatic. Once infected by HSV, it is possible for a patient to shed virus without the development of lesions (asymptomatic shedding). This test does not indicate the site of HSV infection. The magnitude of the Index Value is not indicative of the amount of antibody present in the patient sample. There is a considerable homology between HSV-1 and HSV-2 antigens, so that antibodies formed against either virus are highly cross-reactive. These assays are based on purified recombinant glycoprotein G-1 (HSV-1) or G-2 (HSV-2) antigens. HSV-2 IgG Type Specific HSV-2 IgG Supplemental Interpretation Positive / Equivocal Positive Indicates the presence of detectable IgG antibodies to HSV-2. Positive / Equivocal Negative Unable to confirm the presence of IgG antibodies to HSV-2. Recommend retesting in 2 to 4 weeks. Limitations This test is intended for qualitative determination only. The magnitude of the Index Value is not indicative of the amount of antibody present in the patient sample. Methodology Chemiluminescent immunoassay (CLIA). Reflex of specimens equivocal and low positive for HSV-2 type specific IgG to a membrane based immunoassay. Additional Information Set up Monday thru Friday.
Herpes Simplex Virus (HSV) Types 1/2, Amniotic Fluid, DNA PCR
Synonyms HSV Types 1 and 2 DNA PCR (Real Time) Special Instructions HSV PCR is a single test that both detects the presence of HSV DNA and determines which type is present in the positive samples. There is no mechanism, therefore, for testing for HSV-1 without simultaneously testing for HSV-2. 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 For more information, please view the literature below. Herpes Simplex Virus Specimen Requirements Specimen Amniotic fluid (noncentrifuged) Volume 0.5 mL Minimum Volume 0.2 mL Container Sterile container Collection 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 7 days Refrigerated 7 days Frozen 90 days Causes for Rejection Quantity not sufficient for analysis; gross specimen contamination; specimen too old; leaking or broken tube Test Details Use This test is intended for use as an aid to the diagnosis of herpes simplex virus (HSV) infections; also differentiates HSV-1 from HSV-2. Methodology Real-time polymerase chain reaction (PCR)
Herpes Simplex Virus (HSV) Types 1/2, DNA PCR
Synonyms HSV Types 1 and 2, DNA PCR (Real Time) Special Instructions HSV PCR is a single test that both detects the presence of HSV DNA and determines which type is present in the positive samples. There is no mechanism, therefore, for testing for HSV-1 without simultaneously testing for HSV-2. 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. Herpes Simplex Virus: Genital, Neonatal, Encephalitis, and Other HSV Infections Sample Report Specimen Requirements Specimen Cerebrospinal fluid (CSF), swab, whole blood, serum, plasma, or vitreous fluid Volume 0.5 mL CSF or vitreous fluid; one swab; or 1 mL whole blood, serum, or plasma Minimum Volume 0.2 mL CSF or vitreous fluid; one swab; or 0.5 mL whole blood, serum, or plasma Container Sterile container (CSF or vitreous fluid), universal transport medium (swab), red-top tube, gel-barrier tube, lavender-top (EDTA) tube, or yellow-top (ACD) tube Collection To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Whole blood is stable at room temperature or refrigerated for seven days; do not freeze. Swab samples are stable at room temperature, refrigerated, or frozen for seven days. Serum, plasma, or CSF samples are stable at room temperature or refrigerated for seven days or frozen for 90 days. Vitreous fluid is stable at room temperature or refrigerated for 14 days, frozen for 90 days. Test Details Use This test is intended for use as an aid in the diagnosis of herpes simplex virus (HSV) infections; it also differentiates HSV-1 from HSV-2. PCR testing of blood, serum, or plasma samples is clinically useful only in potential cases of disseminated HSV infection (neonates, immunosuppressed individuals) and not as an aid in the diagnosis of either mucosal or CNS disease. Methodology Real-time polymerase chain reaction (PCR)
Histamine Determination, Whole Blood
Synonyms Whole Blood Histamine Special Instructions This is not the Leukocyte Histamine Release Test (LHRT). 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 Whole blood, frozen Volume 2 mL Minimum Volume 1 mL (Note: This volume does not allow for repeat testing.) Container Green-top (heparin) tube required. (Do not use EDTA.) Collection Transfer the unseparated specimen to a plastic transport tube before freezing. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Freeze. Stability Requirements Temperature Period Room temperature Unstable Frozen 14 days Freeze/thaw cycles Stable x3 Causes for Rejection Specimen not received frozen; improper labeling Test Details Use Measure histamine that was released in vivo prior to collection of the specimen; evaluate possible systemic mastocytosis Limitations Results for this test are for research purposes only by the assay's manufacturer. The performance characteristics of this product have not been established. Results should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. Methodology Enzyme immunoassay (EIA)
Histopathology
CPT: 88300; 88302; 88304; 88305; 88307; 88309; 88311; 88312; 88313; 88314; 88319; 88321; 88323; 88325; 88342 (CPT codes are assigned by the pathologist when the case is complete; the codes listed here [in combination and with the appropriate multipliers] are most commonly used for histopathology.) Include LOINC® in print Synonyms Biopsy Gross and Microscopic Pathology Microscopic Section Pathologic Examination Pathology Skin Lesion(s) Tissue Examination Surgical Pathology Tissue Pathology Test Includes Gross examination only and/or gross and microscopic examination and diagnosis Special Instructions Test request form must state operative diagnosis and source of specimen. LabCorp test number is for tracking purposes only. Additional test numbers may be entered upon receipt of specimen(s) at the test facility. 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 Tissue Volume Entire specimen; paraffin embedded (FFPE) tissue block(s) or slide(s) sectioned from FFPE tissue block(s) at 4-5 microns Container Jars of assorted size containing 10% buffered formalin Collection Small biopsy specimens are to be placed immediately in 10% formalin solution. Use approximately 10 to 20 times as much formalin solution as the bulk of the tissue. Small tissues such as those from bronchoscopic biopsy, bladder biopsy, and endometrium can be compromised in a short time by placing in saline or allowing to dry. The following tissues should always be placed in formalin: small skin tumors and moles; uterine curettings; cervical biopsy; breast biopsy; prostate tissue from transurethral resection (TUR); bladder tumors and calculi; nerves and ganglia; rectal polyps; ear, nose, and throat (ENT) biopsy; lymph nodes (except those to be cultured); bone tumors; intervertebral disc; gallbladder; liver biopsy; bronchoscopic biopsy; fallopian tube segments; and any biopsy from any other site not listed. Organ and larger tissue resections are to be placed in larger containers and covered with adequate amounts of formalin. Specimens such as colons, urinary bladders, and uteri require opening to expose the mucosal surfaces to formalin. Gallbladders undergo rapid degeneration; therefore, they require immediate fixation in 10% formalin solution; an incision made in the gallbladder will aid in more rapid fixation. All specimens should be sent to the pathology department as soon as convenient to expedite the processing that leads to the eventual microscopic diagnosis. Storage Instructions Fix in 10% buffered formalin solution. Causes for Rejection Lack of medical history; improper labeling; unlabeled specimen; no surgical specimen request form Test Details Use Histologic diagnosis Methodology See individual test components.
Homovanillic Acid (HVA), 24-Hour Urine
Synonyms HVA, 24-Hour Urine Special Instructions Record total 24-hour urine volume on the request form. 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 Urine Specimens Related Documents Sample Report Specimen Requirements Specimen Urine Volume 4 mL aliquot Minimum Volume 1 mL aliquot Container Plastic urine container (6N HCl is optional) Collection Instruct the patient to void at 8 AM and discard the specimen. Then collect all urine including the final specimen voided at the end of the 24-hour collection period (ie, 8 AM the next morning). Measure and record total urine volume. Mix well; send aliquot. Label container with patient's name, date and time collection started, and date and time collection finished. Storage Instructions Maintain specimen at room temperature. Stability Requirements Temperature Period Room temperature 14 days Refrigerated 14 days Frozen 14 days Freeze/thaw cycles Stable x3 Patient Preparation Patient should avoid aspirin, disulfiram, reserpine, and pyridoxine, if possible, at least 48 hours prior to collection of the specimen. Levodopa should be avoided for two weeks before collection. Test Details Use Diagnose neuroblastoma, ganglioneuroblastoma, and pheochromocytoma; follow course of tumor treatment 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) Reference Interval 0.0−10.0 mg/24 hours Additional Information HVA is the major terminal metabolite of the dopamine pathway. VMA is the major terminal metabolite of the norepinephrine pathway. HVA is often excreted in excess amounts by neuroblastomas, ganglioneuroblastomas, pheochromocytomas, and in Riley-Day syndrome. Excretion may be intermittent. Plasma HVA is increased in schizotypal personality disorders. Approximately 20% of subjects with neuroblastoma do not have increased VMA.
HRT Female Post Pellet Thyroid Rx
Test Includes Estradiol; Follicle-Stimulating Hormone (FSH), Serum; Testosterone, Total, Serum; Thyroxine (T4); Thyroid-Stimulating Hormone (TSH); Thyroid Peroxidase (TPO) Antibodies; Triiodothyronine (T3), Free 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 1 - 3 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 2 mL Container Gel-barrier tube Test Details Use Results are utilized within a propriety algorithm by certified BioTE providers to insure appropriate (male vs. female) patient medication dosage for individualized therapy. Used to compare against baseline levels for confirmation of optimized pellet hormone replacement therapy in patients who are also prescribed thyroid medication. Methodology See individual test components.
HRT Male Pre Pellet
Test Includes Complete Blood Count (CBC) With Differential; Metabolic Panel (14), Comprehensive; Estradiol; Prostate-specific Antigen (PSA); Testosterone, Free (Direct) with Total Testosterone, LC/MS-MS; Thyroxine (T4); Thyroid-Stimulating Hormone (TSH); Thyroid Peroxidase (TPO) Antibodies; Triiodothyronine (T3), Free; Vitamin B12; Vitamin D, 25-Hydroxy 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 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 Serum, whole blood Volume 7 mL serum, 4 mL whole blood Container Gel-barrier tube, lavender-top (EDTA) tube Test Details Use To diagnose hormone deficiencies due to the aging process or conditions causing hormonal imbalances. To aid in the identification of (male vs female) patients who are candidates for BioTE hormone replacement pellet therapy. To provide baseline levels, used in comparison analysis by physicians, for patients undergoing therapy. Methodology See individual test components.
Human Antimouse Antibodies
Synonyms HAMA Expected Turnaround Time 6 - 10 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Serum Volume 0.4 mL Minimum Volume 0.2 mL (Note: This volume does not allow for repeat testing.) Container Red-top tube or gel-barrier tube Collection If a red-top tube is used, transfer separated serum to a plastic transport tube. Storage Instructions Refrigerate Causes for Rejection Nonserum specimen; gross lipemia Test Details Use This test is intended for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). Limitations The presence of Rheumatoid Factor (RF) and/or heterophilic antibodies in the sample may interfere with the assay and could result in false-positive values. Lipemic serum samples may interfere with the assay and could result in false-positive values. Methodology Enzyme-linked immunosorbent assay (ELISA). The ImmuSTRIP® HAMA ELISA Test System employs a control mouse polyclonal antibody as the capture antibody and a mouse anti-isotypic monoclonal IgG1 to detect HAMA.16,17 The test has been calibrated with baboon anti-mouse IgG serum. Final patient values are reported as nanograms of precipitable antibody present in the sample per mL. Reference Interval 0−74 ng/mL Additional Information The presence of human anti-mouse antibody (HAMA) has been associated with injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.1-13 Circulating levels of HAMA can bind to the injected IgG and reduce the efficacy of the antibody therapy. HAMA also can cause anaphylactic complications to subsequent administration of murine monoclonal IgG. Several studies have shown a correlation between HAMA status and clinical outcomes and prognosis.6-13 HAMA reactivity has been reported to occur in some individuals without known exposure to murine IgG. Such responses may be due to polyclonal rheumatoid factors, heterophilic antibodies, dietary, or other exposure. HAMA has been shown to interfere with some two-site immunometric assays utilizing murine monoclonal antibodies, resulting in both false positive or false-negative results.14,15
Human Herpesvirus 6 (HHV-6) Antibodies, IgG
Synonyms HHV-6, IgG Antibodies 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 1 mL Minimum Volume 0.5 mL Container Red-top tube or gel-barrier tube Collection Specimen should be free of bacterial contamination, hemolysis, and lipemia. 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 Aid in the diagnosis of past infection/exposure to roseola infantum; may be useful in diagnosis of chronic fatigue syndrome Limitations This procedure may be considered by Medicare and other carriers as investigational and, therefore, may not be payable as a covered benefit for patients. Methodology Enzyme immunoassay (EIA) Reference Interval • Negative: 1.10 index Fourfold rises in titer are suggestive of either recent, primary, or reactivated infection. The presence of elevated titers to HHV-6 in the absence of responses to HAV, HBV, CMV, and EMV suggests that titer results are associated with high specificity. Additional Information Human herpesvirus 6 (HHV-6) has recently been identified as the agent associated with both pediatric and adult infections. Most children have been infected by age three. The acute infection in children is characterized clinically by an acute febrile illness, irritability, inflammation of tympanic membranes, and (uncommonly) a rash characteristic of roseola. In adults, HHV-6 has been associated with chronic fatigue and spontaneously resolving fever resembling a mononucleosis-like illness. During the acute episode an elevated IgM HHV-6 is useful. An increase in IgG HHV-6 between acute and convalescent serum sample is consistent with a recent HHV-6 infection.
Human Herpesvirus 6 (HHV-6), DNA PCR
Synonyms HHV-6 DNA PCR HHV6 Human Herpesvirus Type 6 DNA PCR Expected Turnaround Time 3 - 4 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents Sample Report Specimen Requirements Specimen Cerebrospinal fluid (CSF) or whole blood Volume 1 mL Minimum Volume 0.2 mL Container Sterile container (CSF), lavender-top (EDTA) tube or yellow-top (ACD) tube Storage Instructions Whole blood is stable at room temperature or refrigerated for seven days; do not freeze. CSF is stable at room temperature or refrigerated for seven days or frozen for 90 days. Causes for Rejection 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 infection with human herpesvirus 6 (HHV-6). Methodology Real-time polymerase chain reaction (PCR)
Human Immunodeficiency Virus 1 (HIV-1) PhenoSense GT® Plus Integrase (Monogram® Phenotype + Genotype)
Synonyms HIV Resistance PhenoSense GT® Plus Integrase Test Includes This assay is a combined assay in which HIV resistance phenotype and HIV resistance genotype is performed. Special Instructions A separate frozen specimen is required for each frozen test ordered. Expected Turnaround Time 19 - 23 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 Human Immunodeficiency Virus 1 (HIV-1) GenoSure PRIme® Human Immunodeficiency Virus 1 (HIV-1) PhenoSense GT® (Monogram® Phenotype/Genotype) Human Immunodeficiency Virus 1 (HIV-1) PhenoSense Integrase® (Monogram® Integrase Inhibitor Resistance) Related Documents For more information, please view the literature below. HIV Specimen Collection Guide HIV-1 Lifecycle, Drugs, and Susceptibility Assays PhenoSense GT® Plus Integrase Specimen Requirements Specimen Plasma, frozen Volume 5 mL Collection Collect specimen in three lavender-top (EDTA) tubes or three PPT™ tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection. Transfer plasma to one or more polypropylene screw-capped tube(s) (not "pop-top" or "snap-cap") and freeze. Ship specimen 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. Causes for Rejection PPT™ not centrifuged; quantity not sufficient for analysis; heparinized plasma; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; specimen received in "pop-top" or "snap-cap" tube Test Details Use Determines viral phenotype and genotype resistance to four classes of commonly prescribed antiretroviral drugs: nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI), and integrase inhibitors (INI). Limitations This procedure should be used for patients with documented HIV-1 infection and viral loads ≥500 copies/mL. If there is insufficient virus to produce results, HIV-1 RNA quantitation will be performed to confirm viral load, and this procedure will be billed at the account's prevailing fee. Methodology Phenotype: polymerase chain reaction (PCR) amplification and viral culture; Genotype: polymerase chain reaction (PCR) and DNA sequencing. PhenoSense® and PhenoSense GT® are trademarks of Monogram Biosciences®.
Human Immunodeficiency Virus 1 (HIV-1) PhenoSense Integrase® (Monogram® Integrase Inhibitor Resistance)
Synonyms PhenoSense Integrase® Raltegravir Expected Turnaround Time 19 - 23 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 Human Immunodeficiency Virus 1 (HIV-1) PhenoSense GT® (Monogram® Phenotype/Genotype) Related Documents For more information, please view the literature below. HIV Specimen Collection Guide HIV-1 Lifecycle, Drugs, and Susceptibility Assays Supporting Individualized HIV Treatment Decisions Sample Report Specimen Requirements Specimen Plasma, frozen Volume 3 mL Container Lavender-top (EDTA) or plasma preparation tube (PPT™). Collection Collect specimen in two lavender-top (EDTA) tubes or two PPT™ tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection. Transfer plasma to one or more polypropylene screw-capped tube(s) (not "pop-top" or "snap-cap") and freeze. Ship specimen 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 Causes for Rejection PPT™ not centrifuged; insufficient volume; heparinized plasma; nonfrozen specimens Test Details Use The PhenoSense Integrase® assay is a phenotypic resistance test used to determine the susceptibility of a patient's HIV to integrase inhibitors. Integrase inhibitors block HIV replication by preventing the virus from integrating into the host cell's DNA. Raltegravir (Isentress®) is the first approved drug in this class of HIV antiretroviral drugs. Limitations This procedure should be used for patients with documented HIV-1 infection and viral loads ≥500 copies/mL. Methodology Polymerase chain reaction (PCR) amplification and viral culture. PhenoSense Integrase® is a trademark of Monogram Biosciences®.
Human Immunodeficiency Virus 1 (HIV-1) Trofile® DNA (Monogram® Coreceptor Tropism), Whole Blood
Expected Turnaround Time 16 - 22 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. HIV Specimen Collection Guide HIV-1 Lifecycle, Drugs, and Susceptibility Assays Supporting Individualized HIV Treatment Decisions Sample Report Specimen Requirements Specimen Whole blood, frozen Volume 4 mL Container Lavender-top (EDTA) tube Collection Collect specimen in lavender-top (EDTA) tube. Do not centrifuge. 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. Causes for Rejection Insufficient volume; heparinized plasma; nonfrozen specimen Test Details Use Detect HIV-1 coreceptor tropism; determine eligibility for CCR5 antagonist therapy such as Selzentry™ (maraviroc). Limitations This procedure should be used for patients with documented HIV-1 infection and undetectable viral loads. Methodology Polymerase chain reaction (PCR) amplification and viral culture. Trofile™ is a registered trademark of Monogram Biosciences.
Human Immunodeficiency Virus 1 (HIV-1), Qualitative, RNA
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 For more information, please view the literature below. HIV Specimen Collection Guide Sample Report Specimen Requirements Specimen Plasma or serum Volume 1 mL Minimum Volume 0.5 mL Container Lavender-top (EDTA) tube, yellow-top (ACD) tube, red-top tube, or gel-barrier tube Collection Collect specimen in lavender-top (EDTA), yellow-top (ACD), red-top tube, or gel-barrier tube. Whole blood specimens stored at room temperature should be centrifuged within 72 hours of collection. Transfer serum or plasma to a polypropylene screw-cap tube for shipment. Storage Instructions Sample may be stored for 72 hours at room temperature. It is recommended that serum or plasma be refrigerated or frozen for shipment. Stability Requirements Temperature Period Room temperature 3 days Refrigerated 14 days Frozen 6 months Freeze/thaw cycles Stable x5 Causes for Rejection Specimen grossly hemolyzed; received outside of specimen and/or storage requirements Test Details Use This test is intended for use as an aid in the diagnosis of HIV-1 infection, including acute or primary infection. Presence of HIV-1 RNA in the plasma of patients without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection. This assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 antibodies. This assay is not intended for use in donor testing. Methodology Transcription-mediated amplification (TMA)
Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Graphical)
Synonyms HIV-1 Plasma Viremia HIV-1 RNA by Real-time PCR, Quantitative Special Instructions Submit the patient's Social Security number for serial monitoring. To order this test without the serial monitor service, use test 550430. 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. HIV Specimen Collection Guide Human Immunodeficiency Virus 1/O/2 Cascade: Fourth-generation Antigen/Antibody Detection Sample Report Specimen Requirements Specimen Plasma Volume 3.5 mL Minimum Volume 1.1 mL (Note: This volume does not allow for repeat testing.) Container Lavender-top (EDTA) tube or plasma preparation tube (PPT™) Collection Centrifuge sample within 24 hours of collection. Transfer plasma to a screw-cap polypropylene transport tube. Ship frozen (preferred). To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit a separate frozen specimen for each test requested. Storage Instructions Freeze (preferred) or refrigerate. Stable at room temperature for 24 hours or refrigerated for six days. Stable frozen for six weeks. Causes for Rejection Incorrect anticoagulant; PPT™ frozen and/or not centrifuged Test Details Use Detect and quantitate HIV-1 in plasma Limitations Assay range: 20−10,000,000 copies/mL Methodology Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 Test, Version 2.0
Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Graphical) With Reflex to HIV-1 GenoSure® MG
Synonyms HIV-1 RNA by Real-time PCR, Quantitative Reflex to Genotype Viral Load Test Includes Reflex to genotype (at additional charge) if viral load is >500 copies/mL Special Instructions Submit the patient's Social Security number for serial monitoring. To order this test without the serial monitor service, use test 550432. Expected Turnaround Time 9 - 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 Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Nongraphical) With Reflex to HIV-1 GenoSure® MG Related Documents For more information, please view the literature below. HIV Specimen Collection Guide HIV-1 Lifecycle, Drugs, and Susceptibility Assays Human Immunodeficiency Virus 1/O/2 Cascade: Fourth-generation Antigen/Antibody Detection Specimen Requirements Specimen Plasma, frozen Volume 6 mL Minimum Volume 4 mL (Note: This volume does not allow for repeat testing.) Container Ship in a screw-cap polypropylene frozen transport tube. Collection Collect specimen in three lavender-top (EDTA) tubes or three PPT™ tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection. Transfer plasma to one or more screw-cap polypropylene transport tube(s). Snap-cap or pop-top tubes should be avoided and may result in specimen rejection. Immediately freeze specimen at - 20° C. Do not place samples on dry ice until completely frozen. Ship specimens 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. Stable at room temperature for one day or refrigerated for five days. Freeze for long-term storage. Causes for Rejection Hemolysis; green-top (heparin) tube; quantity not sufficient for analysis; frozen PPT™ Test Details Use Detect and quantitate HIV-1 in plasma with reflex to genotype (at additional charge) if viral load is >500 copies/mL. GenoSure® MG test detects mutations in the HIV viral genes that encode the HIV protease and polymerase (reverse transcriptase). Mutations in these genes have been associated with resistance to antiretroviral drugs. Limitations Assay range: 20−10,000,000 copies/mL Methodology Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 Test, Version 2.0
Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antigen/Antibody (Fourth Generation) Preliminary Test With Cascade Reflex to Supplementary Testing
Synonyms HIV-1/O/2, 4th Generation Test Includes Enzyme immunoassay (EIA) for antigen/antibody screen for HIV with reflex to supplementary differentiation assay for HIV-1 or HIV-2. The antigen/antibody assay detects antibodies to HIV-1 and HIV-2 as well as HIV-1 p24 antigen. Specimens positive by the screening assay but negative by the supplementary antibody typing assay will reflex to qualitative nucleic acid amplification (NAA). Special Instructions This test requires a dedicated, unopened, gel-barrier tube or red-top tube sent directly to the testing facility. This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample. Expected Turnaround Time 1 - 2 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary. Related Documents For more information, please view the literature below. Human Immunodeficiency Virus 1/O/2 Cascade: Fourth-generation Antigen/Antibody Detection Sample Report Specimen Requirements Specimen Serum Volume 2 mL Minimum Volume 1 mL (Note: This volume does not allow for repeat testing.) Container Gel-barrier tube with red/gray-mottled top or red-top tube Collection Usual blood collection technique Storage Instructions Refrigerate. Sample may be stored for two days at room temperature. For shipping, it is recommended that serum be refrigerated. Stability: room temperature for 48 hours and refrigerated or frozen for 14 days. Freeze/thaw cycles: x5. Causes for Rejection Specimen aliquot; specimen grossly hemolyzed; specimen in container other than those listed; received outside of specimen and/or storage and/or labeling requirements Test Details Use The fourth-generation HIV antigen-antibody assay is acknowledged to detect acute HIV infection 4 to 12 days earlier than third-generation assays. Coupled with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection. According to the CLSI guideline, anyone testing positive by a fourth-generation screening assay and supplemental tests (either antibody or RNA detection) should initiate care and follow-up tests for clinical staging.1 Limitations Reactive (repeatedly) specimens must be investigated by additional supplemental tests. A negative test for an individual does not preclude exposure to or infection with HIV-1 and/or HIV-2. Negative results can occur if the quantity of the marker present in the sample is too low for detection by the assay or if the marker is not present during the stage of disease in which a sample is collected. Methodology (1) HIV antigen/antibody enzyme immunoassay (EIA) screen for antibodies to HIV-1 and HIV-2 and HIV-1 p24 antigen: Reflex to supplementary differentiation assay; (2) Screen positive with negative antibody typing: Reflex to qualitative nucleic acid amplification (NAA)
Human Papillomavirus (HPV) Genotypes 16 and 18,45
Special Instructions This test can be ordered when a high-risk, HPV-positive test result has been obtained at a non−LabCorp test facility or as an add-on test if the positive high-risk HPV test was performed at LabCorp. 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 For more information, please view the literature below. Aptima® HPV Assay: Helping you provide better patient care Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Cervical cells in liquid-based cytology transport Volume ThinPrep® vial or SurePath™ vial Minimum Volume ThinPrep® vial 2 mL (Note: This volume does not allow for repeat testing.) For SurePath™ specimens that have been processed for a Pap, add 2 mL CytoRich™ fixative to the 0.8 mL cellular concentrate fraction. Container ThinPrep® vial or SurePath™ vial Collection ThinPrep® Vial − Broom or Brush/Spatula: Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to release additional cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial. Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush 1/4 to 1/2 turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial. SurePath™ Vial: When using the SurePath™ vial, the cervical broom must be used for specimen collection. Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial. Storage Instructions Maintain specimen at room temperature. Patient Preparation Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period. Causes for Rejection Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen. For HPV: specimen more than three months old in ThinPrep® vial; specimen more than 21 days old in SurePath™ vial. Test Details Use Detection of HPV type 16 and types 18,45 in cervical specimens where high-risk HPV types have been detected. Limitations A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result. Methodology Nucleic acid amplification (NAA)
Human Papillomavirus (HPV) High-risk DNA Detection
Synonyms HPV DNA Probe, High Risk Hybrid Capture® Test Includes Detection of high-risk type HPV DNA sequences in exfoliated cells or tissue biopsies Special Instructions Specimen must be submitted using HPV collection kit (supplied by LabCorp) or liquid-based cytology preservative. If ThinPrep® vials are QNS for the hybrid capture assay, then a test requiring a lower input volume will be automatically performed if there is sufficient volume to perform that assay. 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 Virology Related Documents For more information, please view the literature below. Microbiology Specimen Collection and Transport Guide Sample Report Specimen Requirements Specimen Cervical brush sample in Digene DNA collection kit or liquid-based cytology preservative; cervical biopsy Volume One brush or tissue biopsy Minimum Volume For cells collected in liquid-based cytology preservative, at least 4 mL of preservative must be submitted for ThinPrep® specimens. For SurePath™ specimens that have been processed for a Pap, add 2 mL CytoRich™ fixative to the 0.8 mL cellular concentrate fraction. Minimum 2 mm biopsy specimen. Container Digene DNA collection kit (contact the LabCorp local branch for collection kits); or liquid-based cytology preservative (ie, ThinPrep® vial with PreservCyt® solution or SurePath™ vial with CytoRich™ fixative) Collection Specimen must be submitted using the Digene DNA collection kit (supplied by LabCorp) or liquid-based cytology fixative. Digene DNA collection kit: Remove excess mucus from the cervical os and surrounding ectocervix using a cotton or polyester swab. Discard this swab. To obtain specimen, insert the Digene cervical sampling brush 1.0 to 1.5 cm into the cervical os until the largest bristles touch the ectocervix. Do not insert the brush completely into the cervical canal. Rotate brush three full turns in a counterclockwise direction and remove from the canal. Insert the brush into the transport tube. Snap off shaft at scored line, leaving brush end inside tube, and recap securely by snapping in place. ThinPrep® Vial − using a cervical broom: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and rotating the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial until the cap passes the torque line on the vial. SurePath™ Vial − using a cervical broom: Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial. Tissue: Submit tissue biopsy (frozen) in an HPV collection tube. Biopsies must be shipped frozen at -20°C. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Maintain liquid-based cytology specimens at room temperature. Digene HPV collection kit can be kept at room temperature for two weeks or refrigerated for three weeks. Freeze biopsy. Cervical specimens collected using the Digene DNA collection kit or SurePath™ vial must be processed for testing within 21 days of collection. Specimens in ThinPrep® vials must be processed for testing within three months of collection. LabCorp may require up to five days for processing. Stability Requirements Temperature Period Room temperature 3 months Refrigerated Unstable Frozen Biopsy only Causes for Rejection Improper collection or inadequate specimen; improper labeling; specimen more than 21 days old in digene DNA collection kit or SurePath™ liquid-based preservative; specimen more than three months old in PreservCyt® solution; specimen leaked in transit; quantity not sufficient for analysis; biopsies less than 2 mm in diameter; name discrepancies; specimens submitted on male patients Test Details Use This assay aids in the diagnosis of sexually-transmitted HPV infection and is used for the triage of patients with an ASC-US Pap test result. The test provides a qualitative molecular detection of 13 different human papillomavirus high-risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 without differentiation of the individual type. Limitations A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may cause a false-negative result. Methodology Nucleic acid amplification (NAA)
Hydrochlorothiazide, Urine
Synonyms Esidrix® Hydrodiuril® Microzide® Oretic® Expected Turnaround Time 10 - 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 Urine (random) Volume 3 mL Minimum Volume 0.6 mL Container Plastic urine container without preservative Storage Instructions Submission/transport (<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen. Causes for Rejection Urine from preservative tube Test Details Use Detect presence of hydrochlorothiazide, a thiazide diuretic Methodology High-pressure liquid chromatography with ultraviolet detection (HPLC/UV)
Hydromorphone, Serum or Plasma
Synonyms Dilaudid® Exalgo® 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 Serum or plasma Volume 5 mL Minimum Volume 2 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) Reference Interval 1−30 ng/mL
Hydroxyzine, Urine
Synonyms Atarax® Hyzine® Vistaril® Vistazine® 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 Urine (random) Volume 10 mL Minimum Volume 1.2 mL Container Plastic urine container without preservative Storage Instructions Submission/transport (<3 days): Room temperature. For storage beyond three days, specimen should be refrigerated or frozen. Causes for Rejection Urine from preservative tube Test Details Use Detect presence of hydroxyzine, a sedating antihistamine Methodology Liquid chromatography/tandem mass spectrometry (LC/MS-MS)
Hyper-IgM Syndrome (HIGM): (CD40 [TNFRSF5] for HIGM3) (Full Gene Sequencing)
Test Includes This test covers all coding nucleotides of gene CD40 (TNFRSF5), plus at least two and typically 20 flanking intronic nucleotides upstream and downstream of each coding exon, covering the conserved donor and acceptor splice sites, as well as typically 20 flanking nucleotides in the 5′ and 3′ UTR. Special Instructions In cases in which a known mutation can be documented, the physician may prefer to order test 252670. Test orders must include an attestation that the provider has the patient's informed consent for genetic testing. See sample physician office consent form: Consent for Genetic Testing. In the case of family tests (ie, known mutations), please submit the result report of the first patient tested in the family (the index case), if not performed at a LabCorp facility. Other family members are subsequently tested for the specific mutation found in the first patient tested. Expected Turnaround Time 28 - 35 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. Consent for Genetic Testing (Consentimiento para análisis genético) Hyper-IgM Syndrome Genetic Testing Specimen Requirements Specimen Whole blood; DNA is accepted (Call 800-345-4363 for DNA collection information.) Volume 2 mL Container Lavender-top (EDTA) tube Collection Samples may be stored for brief periods at 4°C. Ship overnight at room temperature. Storage Instructions Maintain specimen at room temperature. Causes for Rejection Container broken or leaking; container not labeled or label not legible; use of improper anticoagulant Test Details Use Confirm a clinical diagnosis of HIGM; detect carriers; allow early diagnosis in family members, guiding prophylactic measures Limitations This method does not reliably detect mosaic variants; large deletions; large duplications, inversions, or other rearrangements; or deep intronic variants. It may be affected by allele-dropout, it may not allow determination of the exact numbers of T/A or microsatellite repeats, and it does not allow any conclusion as to whether two heterozygous variants are present on the same or on different chromosome copies. Results of this test are for investigational purposes only. The performance characteristics of this assay have been determined by LabCorp. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. Methodology DNA sequencing Reference Interval Normal equals reference sequence or variants that are known or predicted to be benign; abnormal equals all other variants. Additional Information Hyper immunoglobulin M syndrome type 3 (HIM3) is a recessively inherited immune disorder characterized by lack of IgG, IgA, and IgE in the presence of excess IgM, leading to increased susceptibility to bacterial infections. In HIGM3, cellular immunity is also affected, resulting in additional susceptibility to opportunistic pathogens. Mutations in CD40 account for all of HIGM3 and <1% of HIGM overall. Genetic testing can confirm a clinical diagnosis of HIGM3 and detect mutation carriers within affected families.
Hyper-IgM Syndrome (HIGM): Three-gene Profile (AICDA, UNG, CD40) (Full Gene Sequencing)
Test Includes This test covers all coding nucleotides of genes AICDA, UNG, and CD40, plus at least two and typically 20 flanking intronic nucleotides upstream and downstream of each coding exon, covering the conserved donor and acceptor splice sites, as well as typically 20 flanking nucleotides in the 5′ and 3′ UTR. Special Instructions Test orders must include an attestation that the provider has the patient's informed consent for genetic testing. See sample physician office consent form: Consent for Genetic Testing. In the case of family tests (ie, known mutations), please submit the result report of the first patient tested in the family (the index case), if not performed at a LabCorp facility. Other family members are subsequently tested for the specific mutation found in the first patient tested. Expected Turnaround Time 28 - 35 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. Consent for Genetic Testing (Consentimiento para análisis genético) Hyper-IgM Syndrome Genetic Testing Specimen Requirements Specimen Whole blood; DNA is accepted (Call 800-345-4363 for DNA collection information.) Volume 2 mL Container Lavender-top (EDTA) tube Collection Samples may be stored for brief periods at 4°C. Ship overnight at room temperature. Storage Instructions Maintain specimen at room temperature. Causes for Rejection Container broken or leaking; container not labeled or label not legible; use of improper anticoagulant Test Details Use Confirm a clinical diagnosis of HIGM; detect carriers; allow early diagnosis in family members, guiding prophylactic measures Limitations This method does not reliably detect mosaic variants; large deletions; large duplications, inversions, or other rearrangements; or deep intronic variants. It may be affected by allele-dropout, it may not allow determination of the exact numbers of T/A or microsatellite repeats, and it does not allow any conclusion as to whether two heterozygous variants are present on the same or on different chromosome copies. Results of this test are for investigational purposes only. The performance characteristics of this assay have been determined by LabCorp. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. Methodology DNA sequencing Reference Interval Normal equals reference sequence or variants that are known or predicted to be benign; abnormal equals all other variants. Additional Information Hyperimmunoglobulin M syndrome types 2, 3, and 5 (HIGM2, HIGM3, and HIGM5) are autosomally recessive inherited forms of an immune disorder characterized by lack of IgG, IgA, and IgE in the presence of excess IgM, leading to increased susceptibility to bacterial infections. HIGM2 and HIGM5 are also associated with an increased risk of autoimmunity, while HIGM3 impacts cellular in addition to humoral immunity, conferring increased susceptibility to opportunistic pathogens. Mutations in AICDA, CD40, and UNG account for all of HIGM2, HIGM3, and HIGM5, respectively, and about 30% of HIGM overall. Genetic testing can confirm a clinical diagnosis of HIGM2, HIGM3, or HIGM5 and detect mutation carriers within affected families.

Common Lab Tests

Complete Blood Count

LEARN MORE

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

LEARN MORE

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

LEARN MORE

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

Lipid

Panel

LEARN MORE

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

Liver Panel

LEARN MORE

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

Hemoglobin A1C

LEARN MORE

This test is used to diagnose and monitor diabetes.

Urinalysis

LEARN MORE

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

LEARN MORE

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.

APG Labs offers fast & accurate results for a wide range of specialty tests!

LEARN MORE ABOUT OUR SPECIALTY TESTS

APG LABS

Follow Us:

Hours of Operation:

Monday- Friday

9:00 AM - 5:00 PM

Phone Number:

410-599-9977

Email:

Info@APGLabs.com

Quick Links:

© APG Labs 2026. All rights reserved.