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Hepatitis C Virus Antibody Diagnostic

HCV Ab, Hep C, Hepatitis C Antibody

Test Codes

EPIC: LAB3543, Beaker: HCV, Antrim: 31310

Department

Chemistry

Specimen Collection Criteria

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

Physician Office/Draw 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. (Minimum: 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. (Minimum: 2.0 mL)

Preparation for Courier Transport

Transport: Centrifuged SST tube or plasma aliquot refrigerated (2-8°C or 36-46°F). (Minimum: 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.

In-Lab Processing

Let SST specimens clot 30-60 minutes. Centrifuge SST, Lavender-top tubes, or Microtainers^® to separate serum or plasma from cells. Deliver immediately to the appropriate testing station.

Storage

Specimen Stability for Testing:

Centrifuged SST Tubes and Microtainers^® with Separator Gel
Room Temperature (20-26°C or 68-78.8°F): 2-4 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): Unacceptable

Red-top Tubes and Microtainers^® without Separator Gel
Room Temperature (20-25°C or 68-77°F): 2-4 hours
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Serum Specimens (Pour-Overs)
Room Temperature (20-26°C or 68-78.8°F): 2-4 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 7 days

Plasma Specimens (Aliquots)
Room Temperature (20-26°C or 68-78.8°F): 12 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 7 days

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Dearborn Chemistry Laboratory
Royal Oak Automated Chemistry Laboratory 

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)

Disease Reporting

This is a reportable infection and positive results will be reported to the Oakland County Health Department. For more information on reportable diseases, contact the Epidemiology Department at (248) 551-4040.

Incubation Period

The incubation period is approximately 50 days (range, 15-150 days). (1)

Transmission

Hepatitis C virus (HCV) causes 70-95% of post-transfusion hepatitis infections making it the most common cause of post- transfusion hepatitis. However, with improved universal donor testing HCV infections are rare after blood transfusions. Parenteral exposure due to illicit drug use and needle sharing constitutes the major means of transmission in the U.S. HCV has also been implicated to be the cause of 65-90% of cases of sporadic acute viral hepatitis. Thus, another means of transmission may be identified in the future. (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 Codes

86803

Contacts

Last Updated

10/30/2024