Molecular Diagnostics | Hepatitis C Genotyping with HCVRNA Quantitative Viral Load

UWHC Lab Test Details
Test NameHepatitis C Genotyping with HCVRNA Quantitative Viral Load
Test Code(s)HCVGWRNA
CPT Code(s)87902, 87522
MethodologyReal-Time PCR followed by Direct Sequencing
Testing SiteUniversity Hospital
Days PerformedOnce a week.
In-Lab Turnaround Time10 days.
Stat In-Lab Turnaround TimeNot available stat.
Collection Requirements
SpecimenBlood
Collection Container
Collection ContainerLavender top
Collection Instructions

Collect two lavender tops, one for genotyping (XHCVG) and one for viral load (HCVRNA)

Collection Volume6 mL
Pediatric Collection Volume2 mL
Specimen Processing Requirements
Stability
Stability Ambient

Whole blood - 6 hours       Plasma - 24 hours

 

Stability Refrigerated

Plasma - 5 days

Stability Frozen
Whole Blood Not acceptable
Plasma 60 days at -20°C
Sample AnalyzedPlasma
Testing Volume3 mL
Pediatric Testing Volume1.5 mL
Specimen Processing

Separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube within 6 hours of collection. Freeze plasma at -20°C (preferred) for up to 60 days. Prior to freezing at -20°C, EDTA plasma may also be stored at 2°C to 8°C for up to 5 days.

Outreach Specimen Processing

For clinic locations, transport plasma on dry ice to Laboratory.

Specimen Transport

Transport specimen to Laboratory immediately.

Freeze plasma if not delivered immediately.

Unacceptable Criteria

Whole blood specimens greater than 6 hours old when received by laboratory are not acceptable.

Interpretation

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.

Test Limitations

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.

Additional Information

HCV Genotyping (XHCVG) can be ordered as an "add-on" to Hepatitis C RNA viral load (HCVRNA) within 3 weeks of collection of the specimen.

HCVPCR is 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 3,500 IU/mL (log 3.54), 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.