Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum
Use
This test is crucial for detecting acute hepatitis C virus (HCV) infection before the appearance of HCV antibodies in serum and for confirming chronic HCV infections. It provides quantification of HCV RNA levels, essential for monitoring disease progression in chronic HCV infection and assessing response to antiviral therapy. The test also helps determine cure and detect relapse after completion of therapy. It acts as a baseline for HCV viral load before starting antiviral treatment, making it integral for therapeutic monitoring and determining sustained virologic response.
Special Instructions
Not provided.
Limitations
The test can't accurately quantify HCV RNA levels below 15 IU/mL due to the lower detection limit of the assay. False-negative results may occur in cases of transient viremia or in the presence of inhibitory substances in the submitted specimen. Subsequent testing with new specimen collection may be required if the result is inconclusive.
FDA ApprovedNew York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
Hepatitis C Virus
Microorganism
LOINC Codes
- 11011-4 - HCV RNA SerPl NAA+probe-aCnc
- 11011-4 - HCV RNA SerPl NAA+probe-aCnc
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.5 mL
Minimum Volume
0.8 mL
Container
Plastic vial
Collection Instructions
Centrifuge and aliquot serum into plastic vial within 2 hours of collection.
Storage Instructions
Freeze serum immediately and ship on dry ice. If shipment is delayed for more than 24 hours, freeze at -20 to -80 degrees C until shipment.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 84 days |