HEPATITIS C VIRUS GENOTYPING PANEL

Components
The HCV Genotype includes the quantitative HCV Viral Load test. Specimens with viral loads <625 IU/mL will not be genotyped.

Specimen Required
Draw blood in 2 lavender EDTA tubes. Centrifuge and separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma (2.5 mL minimum) frozen in screw-capped plastic vial.
Dedicated specimens are required. Specimens used in other assays will not be tested.

Alternate Specimen
Serum: Red-top

Rejection Criteria
The following specimens will not be tested:
Any gel-based plasma separation media
Shared specimens
Specimens subjectted to repeated freeze-thaw cycles
Specimens that do not meet the storage/handling criteria above

Methodology
The quantitative Hepatitis C viral load procedure uses a real-time Polymerase Chain Reaction (PCR) from Abbott Molecular. The amplification target is a conserved region of the HCV genome. The lower limit of quantitation is 12 IU/mL (1.08 Log IU/mL) and the upper limit of quantitation is 100 million IU/mL (8.00 Log IU/mL). The qualitative limit of detection for this assay is 12 IU/mL (1.08 Log IU/mL). Specimens reported as POSITIVE but <12 IU/mL contain detectable levels of Hepatitis C RNA but the viral load is below the limit of quantitation. A negative result does not rule out infection.The Hepatitis C genotype assay includes multiplex polymerase chain reaction (PCR) amplification of two segments of the HCV genome - the 5' non-translated region and the 3' core region. Amplicon detection and genotyping are done using the eSensor HCVg Direct Test from Genmark. This procedure can detect and distinguish HCV genotypes 1a,1b, 2 a/c, 2 b, 3, 4, 5, and 6.

Stability
Room Temperature: Unacceptable; Refrigerated: 3 days; Frozen (-20°C): 60 days

Reference Range
Viral load:
Hepatitis C RNA: Negative
Hepatitis C RNA, Quantitative: <12 IU/mL
Log HCV IU/mL: <1.08 Log IU/mL
HCV Genotype: By report

Performed
RNA Isolation: Sunday, Tuesday, Thursday
Reporting: Monday, Wednesday, Friday

Turnaround Time5 days
Test CodeHCVGG
CPT-4 Code (s)
87522 HCV RNA, Quant,
plus 87902 HCV Genotype, if performed, at an additional charge
LOINC Codes
HCV Genotype: 32286-7
Hepatitis C RNA, Qualitative   11259-9  
Hepatitis C RNA, Quantitative   49376-7  
Log HCV IU/mL   38180-6  

Warde
Medical
Laboratory