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|40740:HEPATITIS C VIRUS (HCV) GENOTYPING|
|Alias Names:||HCV Genotype / HEP C Genotype / HEP C Geno|
|Methodology:||Line Blot Hybridization|
|Specimen Collection Details|
|Collection:||Two 7.5 mL serum separator tubes (SST). Also acceptable: Two 5 mL red top tubes, or two 4 mL lavender top tubes (EDTA), or two 6 mL yellow top tubes (ACD). For pediatric draw, collect lavender top tube (EDTA). Note: HCV RNA PCR and HCV Genotype require separate tubes. Do not combine with other tests.|
|Handling:||Allow to clot, centrifuge and separate plasma or serum from cell within 6 hours. Freeze in a screw-top plastic vial ≤ -20° C. May be stored refrigerated at 2-8° C for 72 hours.|
|Standard Volume:||2 mL plasma or serum.|
|Minimum Volume:||1.5 mL plasma or serum.|
|Transport:||Frozen on dry ice if not transported within 72 hours.|
|Comments:||This assay uses a commercial kit designated “Research use only, not for use in diagnostic procedures”.|
|Rejection Criteria:||Heparinized specimen; specimen left ambient more than 6 hours.|
Interpretive Data: Isolates of HCV are grouped into six major genotypes differing in nucleic acid sequence. These genotypes are subtyped according to sequence characteristics and are designated as 1a, 1b, 1c, 2a, 2b, 2c, 3a, 3b, 3c, 4a-h, 5a, and 6a.
Current surveys indicate that genotypes 1, 1a, 1b, 2, 2a, 2b, and 3, 3a account for almost all HCV patients in the United States.
Reports suggest that patient prognosis and disease course may be genotype dependent. Clinical outcomes are genotype dependent and differ with regard to disease severity and responses to interferon (IFN)/Ribavirin combination therapy. A better long-term response to IFN/Ribavirin combination therapy has been observed with genotypes 2, 2a, 2b, 3, 3a, and 3b than with types 1, 1a and 1b.
|PeaceHealth Laboratories is certified under the Clinical Laboratory Improvement Amendment of 1988 (CLIA-88) to perform high complexity laboratory testing. These results have been generated using a test that has not been approved by FDA. The performance characteristics of this test have been established by PeaceHealth Laboratories.|