Performance of an automated platform for CMV, EBV and BKPyV DNA detection and quantification

Quantification of cytomegalovirus (CMV), Epstein-Barr virus (EBV), and BK polyomavirus (BKPyV) DNA is crucial for diagnosing related infections. The analytical performance of the Altostar® CMV, EBV and BKPyV DNA assays used in the AltoStar® AM16 instrument was assessed. The Limit of detection was 215 international units/ml (IU/ml) for the CMV assay, 330 IU/ml for the EBV assay and 133 IU/ml for the BKPyV assay. A good concordance was found between the nominal value of the NIBSC standards and the AltoStar® results. Linearity was verified up to 5.7 log 10 IU/ml. Intra-assay and inter-assay reproducibility showed low disparity with a standard deviation < 0.27 log 10 IU/ml. The concordance with our previous DNA assays on clinical samples for CMV detection was 95.5% ( n = 22), 90.6% for EBV ( n = 32) and 92% for BKV ( n = 25). The quantitative results were highly correlated. The Altostar® platform provides accurate quantification for clinical monitoring of CMV, EBV and BKPyV DNA.