Details

Hepatitis C Virus Antibody (HCV)

HCV Ab, Hep C, Hepatitis C Antibody , Antrim #31310, EPIC: LAB5225, SOFT: HCV

Specimen Collection Criteria

Collect (preferred specimen): One Gold-top SST tube.
Also acceptable: One Lavender-top EDTA tube.

Physician Office/Drawsite Specimen Preparation

  • Let SST specimens clot 30-60 minutes then immediately centrifuge to separate serum from cells. Refrigerate (2-8°C or 36-46°F) the centrifuged SST tube within wo hours of collection. (Min: 2.0 mL)
  • Centrifuge Lavender-top tube immediately to separate plasma from cells. Transfer plasma to a plastic transport tube and refrigerate (2-8°C or 36-46°F) within twelve hours of collection. (Min: 2.0 mL)

Preparation for Courier Transport

Transport: Centrifuged SST tube or plasma aliquot, refrigerated (2-8°C or 36-46°F). (Min: 2.0 mL serum or plasma)

Rejection Criteria

  • Hemolyzed specimens.
  • Severely lipemic specimens.
  • Red-top tubes with serum not separated from cells within two hours of collection.
  • Lavender-top tubes with plasma not separated from cells within twelve hours of collection.

Storage

Centrifuged SST tubes may be transported and stored at ambient temperatures (2o to 30o C; 36o to 86o F) for up to 48 hours. DO NOT FREEZE TUBES CONTAINING BLOOD. For longer storage, the serum should be removed from the gel and refrigerated (2o -8o C) or frozen at -20o C or below.

Red-top tubes and Microtainers® may be stored at ambient temperatures for up to 16 hours and for up to 3 days at refrigerator temperatures (2o - 8o C). DO NOT FREEZE TUBES CONTAINING BLOOD. For longer storage, the serum should be removed from the clot and refrigerated (2o -8o C) or frozen at -20o C or below.

Lavender top tubes can be stored at ambient temperatures (2o to 30o C; 36o to 86o F) for up to 12 hours.

Serum and plasma (pour-overs) may be stored at room temperature (20o to 26o C; 68o to 79o F) for up to 5 days, refrigerator temperature (2o to 8o C; 36o to 47o F) for 2 weeks, and at -20o C (-4o F) for up to 3 months. Specimens stored at -70o C (-94o F) can be stored indefinitely.

Performed

Sunday - Saturday, 24 hours a day.
Results available within 24 hours of receipt in the Laboratory.

Reference Range

Negative/Non-reactive.

Test Methodology

Chemiluminescence Immunoassay.

Interpretation

  • Positive result
    • For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is recommended.
    • For persons who are immunocompromised, testing for HCV RNA can be considered.
    • To differentiate past, resolved HCV infection from biologic false positivity for HCV antibody, testing with another HCV antibody assay can be considered.
    • Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.
    • (Source: CDC. Testing for HCV infection: An update of guidance for clinicians and laboratorians. MMWR 2013;62(18).
  • If a false positive result is a strong possibility (given the patient’s history) the Lab should be contacted to arrange for the sample to be sent out for a different HCV antibody test.
  • Patients with an Equivocal result should be closely monitored by redrawing and retesting at approximately one week intervals as clinically indicated.
  • A negative test result does not exclude the possibility of exposure to or infection with hepatitis C virus (HCV).Negative test results in individuals with prior exposure to HCV may be due to antibody levels below the limit of detection of this assay or lack of antibody reactivity to the HCV antigens used in this assay.
  • A positive antibody assay does not distinguish between an acute infection and a chronic infection. The antibody may persist in the minority of patients who have cleared the infection. (1)

Clinical Utility

The hepatitis C antibody assay can assist in the diagnosis of chronic Hepatitis C infections. The incubation period is approximately 50 days (range, 15-150 days). (1) HCV antibody tests cannot detect acute hepatitis C infection because seroconversion may not occur for 8-16 weeks after exposure. Anti-HCV invariably becomes positive later in the course of the disease. Patients with initially seronegative samples should be retested in 3-6 months. (1)

Reference

  1. Hsu, H., Feinstone, S., Hoofnagle, J. Acute Viral Hepatitis in Mandell, G., Bennett, J., Dolin. R.(eds.), Principles of Infectious Diseases 7th edition New York,N.Y. 2005 Chapter 115,116.

CPT Code

86803.

Test Codes

Antrim #31310, EPIC: LAB5225, SOFT: HCV

Last Updated

7/11/2019