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Test Code HCVL Hepatitis C Virus Antibody Confirmation, Serum

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.

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

Reporting Name

HCV Ab Confirmation, S

Specimen Type

Serum


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 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 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

Method Name

Line Immunoassay (LIA)

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)