Test Details

Mnemonic

HCVGG

Ordering Code

3016130

CPT-4 Code(s)

87522, plus 87902 for HCV Genotype if performed, at additional cost

Specimen Information

Collect

Lavender EDTA
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Specimen Preparation

Centrifuge and separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma frozen in screw-capped plastic vial. Dedicated specimens are required. Specimens used in other assays will not be tested.
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Alternate Specimen

Serum: Red-top
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Minimum Volume

2.5 mL
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Transport Temperature

Frozen
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Rejection Criteria

Any gel-based plasma separation media, shared specimens, specimens subjected to repeated freeze-thaw cycles. specimens that do not meet the storage/handling criteria above
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Stability

Room temperature: Unacceptable
Refrigerated: 3 days
Frozen (-20°C): 60 days
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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.
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Reference Range

Hepatitis C RNA: Negative
Hepatitis C RNA, Quantitative: <12 IU/mL
Log HCV IU/mL: <1.08 Log IU/mL
HCV Genotype: See report
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Performing Laboratory

Warde Medical Laboratory
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