Performance evaluation of the QIAGEN EZ1 DSP Virus Kit with Abbott RealTime HIV-1, HBV and HCV assays

BackgroundAutomated sample preparation systems must meet the demands of routine diagnostics laboratories with regard to performance characteristics and compatibility with downstream assays.ObjectivesIn this study, the performance of QIAGEŃs EZ1 DSP Virus Kit on the BioRobot EZ1 DSP was evaluated in combination with the Abbott RealTime HIV-1, HCV, and HBV assays, followed by thermalcycling and detection on the Abbott m2000rt platform.Study designThe following performance characteristics were evaluated: linear range and precision, sensitivity, cross-contamination, effects of interfering substances and correlation.ResultsLinearity was observed within the tested ranges (for HIV-1: 2.0–6.0 log copies/ml, HCV: 1.3–6.9 log IU/ml, HBV: 1.6–7.6 log copies/ml). Excellent precision was obtained (inter-assay standard deviation for HIV-1: 0.06–0.17 log copies/ml (>2.17 log copies/ml), HCV: 0.05–0.11 log IU/ml (>2.09 log IU/ml), HBV: 0.03–0.07 log copies/ml (>2.55 log copies/ml)), with good sensitivity (95% hit rates for HIV-1: 50 copies/ml, HCV: 12.5 IU/ml, HBV: 10 IU/ml). No cross-contamination was observed, as well as no negative impact of elevated levels of various interfering substances. In addition, HCV and HBV viral load measurements after BioRobot EZ1 DSP extraction correlated well with those obtained after Abbott m2000sp extraction.ConclusionsThis evaluation demonstrates that the QIAGEN EZ1 DSP Virus Kit provides an attractive solution for fully automated, low throughput sample preparation for use with the Abbott RealTime HIV-1, HCV, and HBV assays.