Hepatitis C Virus (HCV) RNA Quantification with Reflex to HCV Genotype, Serum
Use
This test is used for the detection of acute hepatitis C virus (HCV) infection before antibodies appear in serum, detection and confirmation of chronic HCV infection, and determining HCV genotype to guide antiviral therapy. It's essential for quantifying HCV RNA in serum before initiating treatment and for detecting relapse after the therapy is completed. Its accurate quantification helps in managing treatment decisions and evaluating the efficacy of antiviral therapy in chronic hepatitis C patients.
Special Instructions
This test is reflexive and primarily intended for patients with reactive HCV antibody screens. It's suitable for high-risk or immunosuppressed individuals who may test negative for HCV antibodies. The test result assists in establishing an HCV viral load and genotype baseline prior to therapy. Follow the specimen collection and shipping instructions to ensure reliable results, especially concerning maintaining specimens frozen and shipped on dry ice.
Limitations
The assay has a quantification range from 15 IU/mL to 100,000,000 IU/mL for HCV RNA. Results above or below this range cannot be accurately quantified. Inconclusive results due to inhibitory substances require a new specimen. False-reactive HCV antibody screens require further investigation. This test should not be used as the sole basis for diagnosing chronic HCV, and repeat RNA testing is necessary for transient low viremia cases.
FDA ApprovedNew York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 11011-4
- 11011-4
Result Turnaround Time
1-8 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
3.5 mL
Minimum Volume
1.6 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 specimen frozen on dry ice. If delayed, freeze serum at -20 to -80 degrees C until shipment.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 72 hours |
| Frozen | 42 days |