Test ID: QHCV    
Hepatitis C Virus RNA Quantification by bDNA, Serum

The VERSANT HCV RNA 3.0 Assay (bDNA) is based on a target signal amplification method for the quantification of hepatitis C virus (HCV) RNA in human serum and plasma. In an overnight incubation, HCV RNA is liberated from virions, and its capture to a microwell is mediated by a set of specific, synthetic oligonucleotide capture probes (capture extenders). A set of target probes (label extenders) is also hybridized to the viral RNA during this incubation step. The 2 sets of target probes bind to the conserved 5'-untranslated and core regions of the HCV genome. These target probes have been specifically designed to capture and quantify HCV genotypes 1 through 6 equally. After overnight incubation, the preamplifier and amplifier probes are hybridized to the target probes (label extenders). Multiple copies of an alkaline phosphatase-conjugated probe (label probe) are then hybridized to the immobilized complex. Detection is achieved by incubating the complex with a chemiluminescent substrate and measuring the light emission generated by the bound alkaline phosphatase reacting with the chemiluminescent substrate. Light emission is directly proportional to the amount of HCV RNA present in each specimen. Results are recorded as relative light units by the VERSANT 440 Molecular System. A standard curve is defined by light emission from 5 analytical standards containing known concentrations of recombinant bacteriophage. Concentrations of HCV RNA in clinical specimens are then determined from this standard curve.(Package insert: VERSANT HCV RNA 3.0 Assay [bDNA], Siemens Healthcare Diagnostics Inc., Tarrytown, NY; 03210314 Rev. A, 2007-12)

Varies; 12 p.m.