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HelpTest Code HCVL Hepatitis C Virus Antibody Confirmation, Serum
Reporting Name
HCV Ab Confirmation, SPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Confirming the presence of hepatitis C virus (HCV)-specific IgG antibodies in serum specimens that are reactive by HCV antibody screening tests
Distinguishing between true- and false-reactive HCV antibody screening test results
This test is not intended for use as an HCV antibody screening test for blood or human cells/tissue donors.
This assay is not useful for detection of early or acute hepatitis C (<2 months from exposure) as immunocompromised patients may not develop detectable HCV antibodies in blood until 6 months after infection.
This assay is not useful for differentiating between past (resolved) and chronic hepatitis C.
Method Name
Line Immunoassay (LIA)
Ordering Guidance
This test does not differentiate between past (resolved) and chronic hepatitis C. To distinguish between past (resolved) and chronic hepatitis C, order HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum.
For screening of asymptomatic individuals for HCV, order HCSRN / Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum.
For detection of HCV in symptomatic at-risk individuals, order HCVDX / Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum.
Necessary Information
Date of collection is required.
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.4 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Specimen Type
SerumSpecimen Minimum Volume
0.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 30 days | |
| Refrigerated | 7 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Reference Values
Negative
Interpretation
A positive result indicates the presence of hepatitis C virus (HCV)-specific IgG antibodies due to past (resolved) or chronic hepatitis C. Past (resolved) HCV infection (accounting for about 25% of all HCV-infected patients) can be distinguished from chronic HCV infection (about 75% of all cases) only by direct detection of HCV RNA using molecular test methods; eg, HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum. HCV RNA is present in acute or chronic hepatitis C but not in past (resolved) HCV infection.
A negative result indicates the absence of HCV-specific IgG antibodies. A reactive HCV antibody screening test result with a negative HCV antibody confirmatory result indicates a probable false-reactive screening test result.
An indeterminate result indicates that HCV-specific IgG antibodies may or may not be present. Indeterminate results should be interpreted along with patient's risk factors for HCV infection and clinical findings. Individuals at risk for HCV infection with indeterminate results should be retested with an HCV antibody confirmatory test in 1 to 2 months to determine the definitive HCV antibody status. Molecular tests to detect HCV RNA may be necessary to determine HCV infection status in those at-risk immunocompromised patients with indeterminate HCV antibody confirmatory test results due to delayed appearance of fully complement of HCV-specific antibodies.
An unreadable result indicates nonspecific cross reactivity was present and HCV-specific antibody bands could not be visualized reliably. Repeat confirmatory serologic testing in 1 to 2 months or HCV RNA (HCVQN / Hepatitis C Virus [HCV] RNA Detection and Quantification by Real-Time Reverse Transcription-PCR [RT-PCR], Serum) is recommended for at-risk patients.
Day(s) Performed
Tuesday
Report Available
1 to 14 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
86804
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HCVL | HCV Ab Confirmation, S | 40726-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 63063 | HCV Ab Confirmation, S | 40726-2 |
Forms
If not ordering electronically, complete, print, and send 1 of the following:
Testing Algorithm
This test is available as a confirmatory test for reactive Hepatitis C virus (HCV) antibody screening test results.
For more information see Hepatitis C: Testing Algorithm for Screening and Diagnosis