Test Details
Mnemonic
HCVSQ
Ordering Code
3010569
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 vial. Dedicated specimens are required. Specimens used in other assays will not be tested.
Alternate Specimen
Serum: Red top
Minimum Volume
2.5 mL
Transport Temperature
Frozen
Rejection Criteria
Heparinized specimens, shared specimens, specimens subjected to repeated freeze/thaw
Stability
Room temperature: Unacceptable
Refrigerated: 3 days
Frozen: 60 days
Refrigerated: 3 days
Frozen: 60 days
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.
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.
Reference Range
HCV RNA, Qualitative: Not detected
HCV RNA, Quantitative: <12 IU/mL
Log HCV IU/mL: <1.08 Log IU/mL
HCV 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