title: Performance evaluation of the QIAGEN EZ1 DSP Virus Kit with Abbott RealTime HIV-1, HBV and HCV assays.
abstract: BACKGROUND
  Automated sample preparation systems must meet the demands of routine diagnostics laboratories with regard to performance characteristics and compatibility with downstream assays.
  
  
  OBJECTIVE
  In this study, the performance of QIAGEN 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.
  
  
  METHODS
  The following performance characteristics were evaluated: linear range and precision, sensitivity, cross-contamination, effects of interfering substances and correlation.
  
  
  RESULTS
  Linearity 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.
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: Abbott Molecular Inc, Des Plaines, IL 60018-3315, USA.
authors.forename: George J
authors.initials: GJ
authors.lastname: Schneider
authors.forename: Kevin G
authors.initials: KG
authors.lastname: Kuper
authors.forename: Klara
authors.initials: K
authors.lastname: Abravaya
authors.forename: Carolyn R
authors.initials: CR
authors.lastname: Mullen
authors.forename: Marion
authors.initials: M
authors.lastname: Schmidt
authors.forename: Astrid
authors.initials: A
authors.lastname: Bunse-Grassmann
authors.forename: Markus
authors.initials: M
authors.lastname: Sprenger-Haussels
mesh_terms: D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000302:isolation & purification; D016174:Hepacivirus / Q000302:isolation & purification; D006509:Hepatitis B / Q000175:diagnosis*; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D017918:Orthohepadnavirus / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D014773:Virology / Q000379:methods*
chemical_list: D011933:Reagent Kits, Diagnostic