HEPATITIS C VIRUS GENOTYPING PANEL

The quantitative Hepatitis C viral load procedure uses a real-time Polymerase Chain Reaction (PCR) 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 for this assay is 12 IU/mL (1.08 Log IU/mL). Specimens reported as POSITIVE but <12 IU/mL contain detectable levels of Hepatitis C RNA but the viral load is below the limit of quantitation. A negative result does not rule out infection.The Hepatitis C genotype assay includes multiplex polymerase chain reaction (PCR) amplification of two segments of the HCV genome - the 5' non-translated region and the 3' core region. Amplicon detection and genotyping are done using the eSensor HCVg Direct Test from Genmark. This procedure can detect and distinguish HCV genotypes 1a,1b, 2 a/c, 2 b, 3, 4, 5, and 6.