Detection and quantitation of Epstein-Barr virus (EBV) DNA in EDTA whole blood samples using automated sample preparation and real time PCR

Abstract Background: Detection and quantitation of Epstein-Barr virus (EBV) DNA in EDTA whole blood samples has gained significance in the routine diagnostic laboratory. Methods: In this study, the analytical and clinical performance of the artus ® EBV RG PCR kit in conjunction with automated sample preparation on the QIAsymphony ® SP instrument was evaluated. Results: When the accuracy of the new test system was tested, all results were found to be within ±0.5 log 10 unit of the expected panel results. Determination of linearity showed a quasilinear curve over 4 log units. The lower limit of detection was determined to be 391 EBV DNA copies/mL in EDTA whole blood. The between day imprecision ranged from 18% to 66%, and the within run imprecision ranged from 11% to 50%. When clinical samples were tested and the results compared with those obtained with the routinely used easyMAG™ sample preparation and EBV R-gene™ test system, 60 samples tested positive and 31 samples tested negative by both assays. Nineteen samples were found to be positive using the QIAsymphony ® sample preparation and artus ® EBV RG PCR test system only, and no samples tested positive with the routinely used test system only. Conclusions: The QIAsymphony ® sample preparation and artus ® EBV RG PCR test system is suitable for the detection and quantitation of EBV DNA in EDTA whole blood in the routine diagnostic laboratory. Clin Chem Lab Med 2010;48:413–8.