Abstract

Quantification of EBV DNA is important in transplantation settings for the diagnosis of post-transplantation.We evaluated the performance of the AltoStar® EBV PCR Kit 1.5 on whole blood specimens: limit of detection, linearity, accuracy, and precision were determined using the WHO NIBSC 09/260 international standard. Results of 69 clinical samples were compared between the AltoStar® EBV PCR Kit 1.5 (altona Diagnostics) and the RealTime EBV assay (Abbott).The LoD of the AltoStar® Kit was 148 IU/mL and linearity was between 375 and 500000. A high concordance was found between nominal value of the NIBSC dilutions and the AltoStar EBV result. The total variation ranged from 2.2% to 9.6%.Out of 69 clinical samples tested, there was a high concordance between the 22 paired results within the overlapping linear ranges of both tests.The AltoStar® EBV assay is reliable and accurate for EBV viral load determination on whole blood samples.

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