Evaluation of the Alliance HCV Quantitative Analyte Specific Reagent (ASR) Assay and Comparison to the COBAS HCV TaqMan ASR Assay.

To evaluate the Abbott/Celera Alliance HCV Quantitative ASR (Alliance) assay using the Qiagen BioRobot 9604 and QiaAmp Virus Kit for viral RNA isolation. And compare Alliance HCV TaqMan ASR to the Roche COBAS HCV TaqMan ASR (CTM) assay calibrated using Armored RNA solutions and WHO 2nd international standard Metods: To evaluate linearity, dilutions of an Armored RNA solution and high titer patient specimens assayed in the Alliance assay using the Qiagen 9604 BioRobot and QIAamp Virus BioRobot 9604 Kit for RNA extraction. A split sample study was conducted using one hundred forty clilnical samples previously assayed by CTM assay (calibrated directly to the 2nd WHO international standard, with results from 200 to 100.000,000 IU/mL) and tested in the Alliance assay. The results were analyzed using Deming regression. Ninety-two clinical samples previously tested in the CTM assay with result <200 IU/mL were randomly selected and tested in the Alliance assay to determine the number of samples were measurable HCV RNA status. Within-run linearity was evaluated using replicated date from the linerity studies and between-run precisoion was estimated from control material replicated.