Hepatitis C – Genotyping/Subtyping
- Hepatitis C virus (HCV) genotyping is tested in conjunction with a detected HCV RNA viral load.
- All specimens submitted for HCV RNA viral load without a previous HCV genotype that meets HCV genotype testing requirements will be automatically tested for HCV genotype.
- HCV genotyping will be automatically repeated for patients with suspected HCV reinfection (as indicated on the test requisition) , as long as the HCV viral load meets the testing requirements.
|Test Requested||Required Requisition(s)||Specimen Type||Minimum Volume||Collection Kit|
Blood clotted- vacutainer tubes (SST)
Submission and Collection Notes
Freshly drawn whole blood specimens collected in serum separator tubes (SST) may be stored and/or transported at 2°C to 25°C for up to 24 hours before centrifugation. Following centrifugation, remove serum from cells immediately. Serum specimens may be stored and/or transported at 2°C to 8°C for up to 72 hours or at ≤-18°C for up to 6 weeks. If more extended storage of serum specimens is required, it must be frozen at ≤-60°C.
Grossly haemolysed, icteric, lipemic or microbially contaminated serum is not recommended for testing.
Complete the Hepatitis PCR Requisition: Hepatitis C RNA and/or Hepatitis B DNA viral load. To avoid cancellation and facilitate timely testing, complete all fields on the requisition. Date and time of collection must be recorded on the test requisition.
Test Frequency and Turnaround Time (TAT)
HCV genotyping testing is performed 3 times a week Monday to Friday.
Turnaround time is up to 10 days from receipt by PHO’s laboratory.
Results are reported to the ordering physician or health care provider as indicated on the requisition.
Specimens for HCV genotyping/subtyping are tested using the Roche cobas® HCV GT assay, which is a real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for the qualitative detection of HCV genotypes 1 (including subtypes a and b), 2, 3, 4, 5, 6.
The LOD of the cobas® HCV GT is 50 IU/mL for genotype 2, 125 IU/mL for genotypes 1a, 1b, 3, 4, and 6 and 500 IU/mL for genotype 5.
HCV specimens must have a detectable viral load of at least 125 IU/mL for HCV genotyping to be performed. The first pre-treatment (baseline) specimen submitted for HCV RNA viral load testing will be automatically tested for HCV genotype if it meets the minimum viral load requirement.
Note: HCV genotype 5 is relatively uncommon in Canada, however, it may be missed in specimens with a viral load <500 IU/ml.
The detected genotype/subtype is reported. If a genotype cannot be determined, the result is reported as “Indeterminate”. If warranted, Indeterminate specimens will be sent to the National Microbiology Laboratory for further testing.