Determining hepatitis C virus (HCV) genotype (1 to 5) to guide antiviral therapy in patients with chronic hepatitis C
Differentiating between HCV subtypes 1a and 1b
This assay should not be used as a screening test for HCV infection. It should be performed only on specimens obtained from patients confirmed to have HCV RNA levels in serum of 500 IU/mL or higher.
Serum Gel (SST)
Additional Processing Details
Centrifuge blood collection tube within 2 hours of collection
Transfer serum into aliquot tube.
Ship specimen frozen on dry ice only
If shipment will be delayed for more than 3 days, freeze serum at ≤ -20 ^C (up to 42 days) until shipment on dry ice
Frozen (preferred): 42 days
Refrigerated: 72 hours
Specimens should contain a recommended minimum HCV viral load of 500 IU/mL
Serum specimens previously submitted to other laboratories for non-microbiology tests are NOT acceptable for add-on test requests, due to possible sample-to-sample carryover from automation used for those tests
An "Undetected" or "Indeterminate" hepatitis C virus (HCV) genotype result does not rule-out active HCV infection. Test results should be correlated with routine serologic and molecular-based testing, as well as clinical presentation. Specimens with indeterminate results will be automatically evaluated with the subsequent test HCVGR / Hepatitis C Virus Genotype Resolution, Serum
Known cross-reactivity between the assay probes and various HCV genotypes limits the ability of this assay to identify multiple HCV genotypes present in a given specimen. Such cross-reactivity or the actual presence of multiple HCV genotypes in the same specimen may result in an "Indeterminate" or multiple/mixed genotype result.
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) followed by Hybridization with Sequence-Specific, Fluorescent-Labeled Oligonucleotide Probes