Name: Hepatitis C Genotyping
Test Name: Hepatitis C Genotyping
Health Link Test Code: XHCVG
LIS Test Code: HCVGEN
CPT Code(s): 87902
Methodology: Real-Time PCR followed by Direct Sequencing
Days Performed: Once a week.
In-Lab Turnaround Time: 10 days.
Stat In-Lab Turnaround Time: Not available stat.
Collection Container: Lavender top
Collection Volume: 6 mL
Pediatric Collection Volume: 2 mL
Whole blood - 6 hours
Plasma - 3 days
|Whole Blood||Not acceptable|
|Plasma||6 weeks at -70°C|
Sample Analyzed: Plasma
Testing Volume: 3 mL
Pediatric Testing Volume: 1.2 mL
Separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube within 6 hours of collection. Freeze plasma at -60°C to -80°C (preferred). Prior to freezing, EDTA plasma may also be stored at either 2-8°C for up to 72 hours or frozen at -20°C for up to 7 days.
Outreach Specimen Processing:
For clinic locations, transport plasma on dry ice to Laboratory.
Transport specimen to Laboratory immediately.
Whole blood specimens greater than 6 hours old when received by laboratory are not acceptable.
Patient prognosis and disease course is Hepatitis C virus (HCV) genotype dependent. HCV genotypes 1 and 4 are generally associated with more severe disease and are less responsive to therapy. HCV isolates are grouped into at least seven major genotypes (designated 1-7) based on nucleic acid sequence. Genotypes are subtyped further according to sequence characteristics and designated: 1a-m; 2a-r; 3a-i, 3k, 3l; 4a-h, 4k-t; 5a, 6a-u; or 7a.
This is a reverse-transcription real-time PCR assay. This assay is not a screening, confirmatory or test procedure for the diagnosis of HCV infection.
HCV Genotyping can be ordered as an "add-on" to Hepatitis C RNA RT- PCR (Blood) within 3 weeks of collection of the specimen. HCVPCR should be requested at the same time to verify the presence of HCV virus. If HCVPCR is negative (no virus found) or below the assay sensitivity of approximately 22,000 IU/mL, HCV Genotyping will be canceled.
The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.