Test Details
Mnemonic
HCVQN
Ordering Code
3041400
CPT-4 Code(s)
87522
Specimen Information
Collect
Lavender EDTA
Specimen Preparation
Centrifuge and separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma in a screw capped plastic vial. Dedicated specimens are required. Specimens used in other assays will not be tested.
Alternate Specimen
HCV PCR: Serum: red top. *PCR and antibody testing cannot be done on shared specimens.
Separate tubes must be clearly labeled for antibody and PCR specimens.
Separate tubes must be clearly labeled for antibody and PCR specimens.
Minimum Volume
2.5 mL
Transport Temperature
Frozen
Rejection Criteria
HCV PCR: gross hemolysis, gross lipemia, heparin plasma, gel-based plasma separation tubes,
specimens subjected to repeat freeze thaw cycles, shared specimens.
specimens subjected to repeat freeze thaw cycles, shared specimens.
Stability
Room temperature: Unacceptable
Refrigerated: 3 days
Frozen (-20°C): 60 days
Frozen (-70°C): 60 days
Refrigerated: 3 days
Frozen (-20°C): 60 days
Frozen (-70°C): 60 days
Methodology
This procedure utilizes a real-time Polymerase Chain Reaction (PCR) 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 Log 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.
The qualitative limit of detection is 12 IU/mL (1.08 Log 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.
Reference Range
Hepatitis C RNA: Not detected
Hepatitis C RNA, Quantitative: <12 IU/mL
LOG HCV IU/mL: <1.08 Log IU/mL
Hepatitis C RNA, Quantitative: <12 IU/mL
LOG HCV IU/mL: <1.08 Log IU/mL
Performing Laboratory
Warde Medical Laboratory
New York DOH Approval Status
Yes