Hepatitis C Virus Antibody Confirmation, Serum
Use
The Hepatitis C Virus Antibody Confirmation test is used to confirm the presence of hepatitis C virus (HCV)-specific IgG antibodies in serum specimens that test reactive on HCV antibody screening tests. This test is crucial for distinguishing between true- and false-reactive results obtained from initial HCV screening assays. While it is critical for users to note that this assay is not meant for the detection of early acute hepatitis C or for differentiating between past resolved and chronic hepatitis C, it serves as part of a confirmatory process, particularly useful for patients with reactive antibody results but undetectable HCV RNA levels.
Special Instructions
For any confirmed HCV screening results without detectable HCV RNA, this test helps to provide additional confirmation. It's not suitable for testing early acute hepatitis or for use on blood or tissue donors.
Limitations
This test has several limitations: It is not intended as an HCV antibody screening test for blood, cells, or tissue donors. The assay is not effective for the detection of early or acute hepatitis C infection, particularly within 2 months of exposure, or in immunocompromised patients who may not develop detectable antibodies for up to 6 months. Also, it cannot differentiate between past (resolved) and chronic HCV infections and is not suited for predicting or monitoring the response to antiviral therapy.
New York Approved
Methodology
Immunoassay (Line Immunoassay)
Biomarkers
LOINC Codes
- 40726-2
- 40726-2
Result Turnaround Time
1-14 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.4 mL
Minimum Volume
0.1 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per collection tube manufacturer's instructions (e.g., centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes). Aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 30 days |