The COBAS AmpliPrep/COBAS TaqMan HCV Test, version 2.0 is an FDA-approved in vitro nucleic acid amplification test for the quantification of HCV RNA in human serum using the COBAS AmpliPrep instrument for automated viral nucleic acid extraction (generic silica-based capture technique) and the COBAS TaqMan analyzer for automated amplification and detection of the viral nucleic acid target. This assay targets the highly conserved 5' noncoding region of the HCV genome and generates amplification products that are detected real-time by a sequence-specific TaqMan probe during amplification. The probe contains a reporter fluorophore and a quencher dye that absorbs light emitted by the reporter. Cleavage of the probe physically separates the quencher from the reporter, enabling light emitted by the latter to be detected by a photomultiplier tube. Because amplification and detection are performed simultaneously, amplification products are measured during the exponential phase of DNA amplification regardless of the initial target concentration.(Package insert: COBAS AmpliPrep/COBAS TaqMan HCV Test; Roche Molecular Systems, Inc., Branchburg, NJ, 04/2015)
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