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Pseudonyms: HCV, jaundice, sexually transmitted disease, STD, bloodborne disease
TURNAROUND TIME: 10 days
TESTING METHODOLOGY:
RealTime cDNA reaction combined with a polymerase chain reaction (PCR) that generates cDNA from the viral RNA and amplifies the resulting DNA. The PCR phase of the assay combines multiple primer sets targeted at the viral sequence that is specific for genotypes 1a, 1b, 2, 3, 4, 5 and 6 as well as one targeted at a highly conserved region of the viral RNA that provides for the detection of all common HCV genotypes. The testing is best performed in conjunction with or as a reflex from the HCV quantitation assay.
SPECIMEN REQUIREMENTS:
- Collect: Prefer 5ml whole blood in an EDTA tube which will then be processed to obtain serum or plasma.
- Min. Collection: 1.0 ml whole blood.
- Transport: Separated serum or plasma is sent at room temperature to the main laboratory. The serum should be stored frozen within 24 hours of collection.
- Stability: Ambient: up to 24 hours.
- Unacceptable Conditions: Frozen or severely hemolyzed blood. Clotted blood.
Contact the Molecular Laboratory at 918-502-1721 to obtain further information.
INTERPRETATIVE DATA:
Purpose: 1 in 50 individuals in the United States have an active or chronic HCV infection. Different HCV subtypes may respond differently to anti-viral therapy. Identification of a genotype may help predict the likelihood of response and probable therapeutic duration.
Limitation: The test may not detect a genotype if the viral load is less than 500 IU/cc.
Related Tests: HCV quantitation by PCR, HBV quantitation by PCR
Clinical Sensitivity: 99%
Analytical Sensitivity: 99%
Indications for Testing
- Confirmed HCV infection with a viral load of greater than 500 IU/cc.
- Patients being considered for a specific anti-viral therapy.
ADDITIONAL RESOURCES: