Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum
Use
This test is useful for the diagnosis of recent or chronic hepatitis C virus (HCV) infection in symptomatic patients. It involves an initial HCV antibody screening, and if reactive, a reflex to HCV RNA by reverse transcription polymerase chain reaction (PCR) is performed to confirm the infection. This approach allows for direct detection of the virus in symptomatic patients, thus differentiating between past (resolved) infections and active HCV infections.
Special Instructions
This test is not intended for screening asymptomatic individuals or for use in blood or tissue donor screenings. It is specifically indicated for symptomatic patients with potential hepatitis C exposure. It should be noted that the reflex testing incurs additional charges if conducted. Clinicians should ensure specimens are collected in accordance with the provided guidelines and avoid multivitamin or biotin supplements in the 24 hours leading up to collection. NY State approval ensures it is available for order by NY State clients.
Limitations
This test cannot be used as a confirmatory or screening test for hepatitis C in blood or human cells/tissue donors. It is also not useful for detecting acute hepatitis C infections (less than 2 months post-exposure), as antibodies may not be detectable within this timeframe. False negatives can occur in immunocompromised patients, and false positives may arise from non-specific reactivity. Biotin interference and high antibody titer can also affect test results. Proper specimen handling and patient preparation are crucial to ensure accuracy.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 40726-2
- 40726-2
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.3 mL
Minimum Volume
0.9 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube as per the manufacturer's instructions and aliquot within 2 hours of collection. Aliquot serum into a plastic vial.
Patient Preparation
Avoid multivitamins or dietary supplements containing biotin (vitamin B7) 24 hours before specimen collection.
Storage Instructions
If shipment is delayed for more than 24 hours, freeze serum at -70°C and ship on dry ice.
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 84 days |