Test Details

Mnemonic

HCVSQ

Ordering Code

3010569

CPT-4 Code(s)

87522

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 a screw-capped 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

Heparinized specimens, shared specimens, specimens subjected to repeated freeze/thaw
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Stability

Room temperature: Unacceptable
Refrigerated: 3 days
Frozen: 60 days
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Methodology

This procedure is used to distinguish current active HCV infection. Up to 25% of HCV-infected individuals will clear the infection without antiviral intervention. These individuals will be Reactive in the HCV antibody test and Not Detected in the Qualitative HCV PCR test. This profile will persist for years afer clearing the infection. Patients who have undergone successful antiviral treatment (sustained responders) will have a similar HCV profile. The presence of HCV RNA indicates active HCV replication.
The HCV RNA PCR procedure utilizes a real-time polymerase chain reaction test 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 is 12 IU/mL (1.08 IU/mL).

Specimens reported as "DETECTED" but <12 IU/mL contain detectable levels of Hepatitis C RNA but the viral load is below the limit of quantitation. A "Not detected" result does not rule out infection.
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Reference Range

HCV RNA, Qualitative: Not detected
HCV RNA, Quantitative: <12 IU/mL
Log HCV IU/mL: <1.08 Log IU/mL
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Performing Laboratory

Warde Medical Laboratory
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