An "Undetected" result indicates the absence of detectable hepatitis C virus (HCV) RNA in the specimen.
An "Indeterminate" result may be due to 1 or more of the following causes: 1) low HCV RNA level (ie,<500 IU/mL), 2) HCV genotype 6, 3) probe reactivity with multiple HCV genotypes, or 4) variation in patient's HCV target sequences with mismatches to PCR primers and/or probes. Specimens generating indeterminate results with this assay will be automatically evaluated with the subsequent test HCVGR / Hepatitis C Virus Genotype Resolution, Serum.
An HCV genotype result of "1" without a subtype result may be due to 1 or more of the following causes: 1) low HCV RNA level (ie, <500 IU/mL), 2) probe reactivity with multiple genotype 1 subtypes, 3) variation in HCV genotype 1 target sequence, or 4) misclassification of some true genotype 6 strains. This assay is able to differentiate between HCV subtypes 1a and 1b. However, subtypes are not reported for HCV genotypes 2 to 5 due to limitations of the current genotyping assay in accurately differentiating the various subtypes of these genotypes.
Results with multiple or mixed HCV genotypes (eg, 1, 5; 1a, 2; or 3, 5) may be due to mixed genotype infection or assay probe cross-reactivity. Only those specimens with multiple or mixed genotype results containing genotype 1 but no subtype will be automatically evaluated with the subsequent test HCVGR / Hepatitis C Virus Genotype Resolution, Serum.