4.3 Article

Evaluation of two automated real-time PCR-based quantification methods for whole blood Epstein-Barr viral load

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ELSEVIER SCIENCE INC
DOI: 10.1016/j.diagmicrobio.2023.116101

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AltoStar (R); Epstein-Barr Virus; m2000; Viral load; Whole blood

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Quantification of EBV DNA is crucial in transplantation settings for post-transplantation diagnosis. This study evaluated the performance of the AltoStar (R) EBV PCR Kit 1.5 on whole blood samples and found it to be reliable and accurate, with good sensitivity and linear range for EBV viral load determination.
Quantification of EBV DNA is important in transplantation settings for the diagnosis of post-transplantation. We evaluated the performance of the AltoStar (R) 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 (R) EBV PCR Kit 1.5 (altona Diagnostics) and the RealTime EBV assay (Abbott).The LoD of the AltoStar (R) 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 (R) EBV assay is reliable and accurate for EBV viral load determination on whole blood samples.

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