Hepatitis C Virus Genotype, Serum
Use
Determining hepatitis C virus (HCV) genotype (1 to 5) is crucial for guiding antiviral therapy in patients with chronic hepatitis C. Differentiating between HCV subtypes 1a and 1b can optimize treatment strategies. Infections with genotypes 2 and 3 typically have better therapeutic response rates to combination therapy (ribavirin and pegylated interferon alpha-2) compared to genotypes 1 and 4. Accurate genotyping aids in selecting appropriate direct acting antivirals, which significantly improve therapeutic outcomes for genotype 1 infections.
Special Instructions
This test should not be used as a screening tool for HCV infection. It is necessary to perform this assay only on specimens confirmed to have an HCV RNA level of 500 IU/mL or higher. A minimum viral load of 500 IU/mL is required for accurate results. Specimens should be handled appropriately to avoid issues such as gross hemolysis, which can cause rejection.
Limitations
This assay cannot be used to determine HCV infection status. Probe cross-reactivity can limit genotype identification and may result in indeterminate or mixed genotype results. Subtypes for genotypes 2-5 are not reported due to current assay limitations in subtype differentiation. Resolution testing is automatically performed in cases of indeterminate results or mixed genotypes involving genotype 1 without a subtype.
FDA ApprovedNew York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
LOINC Codes
- 32286-7
- 32286-7
Result Turnaround Time
1-6 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
5 mL
Minimum Volume
1.5 mL
Container
Plastic vial
Collection Instructions
Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.
Storage Instructions
Ship specimen frozen on dry ice. If shipment is delayed for more than 3 days, freeze serum at -20°C or colder for up to 42 days before shipping.
Causes for Rejection
Gross hemolysis
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 72 hours |
| Frozen | 42 days |