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Stelzl, E; Kessler, HH; Parulekar, AD; Bier, C; Norz, D; Schneider, T; Kumar, S; Simon, CO; Luetgehetmann, M.
Comparison of four commercial EBV DNA quantitative tests to a new test at an early stage of development
J CLIN VIROL. 2023; 161: 105400 Doi: 10.1016/j.jcv.2023.105400
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Leading authors Med Uni Graz
Kessler Harald
Stelzl Evelyn
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Abstract:
Background: Regular screening for Epstein-Barr virus (EBV) DNA using quantitative RT-PCR is recommended for early intervention in at-risk patients. Harmonization of quantitative RT-PCR assays is critical to avoid misin-terpretation of results. Here, we compare quantitative results of the cobas (R) EBV assay to four commercial RT-qPCR assays.Methods: The cobas EBV, EBV R-Gene, artus EBV RG PCR, RealStar EBV PCR kit 2.0 and Abbott EBV RealTime assays were compared for analytic performance using a 10-fold dilution series of EBV reference material, normalized to the WHO standard. For clinical performance, their quantitative results were compared using anonymized, leftover EBV-DNA-positive EDTA plasma samples.Results: For analytic accuracy, the cobas EBV deviated-0.0097 log10 from target values. The other tests showed deviations between 0.0037 and-0.12 log10. For clinical performance, accuracy and linearity of cobas EBV data from both study sites were excellent. Bland-Altman bias and Deming regression analyses showed statistical correlation for cobas EBV to both EBV R-Gene and Abbott RealTime assays but an offset of cobas EBV to artus EBV RG PCR and RealStar EBV PCR kit 2.0.Conclusion: The cobas EBV showed the closest correlation to the reference material, followed closely by EBV R-Gene and Abbott EBV RealTime. Values obtained are stated in IU/mL, facilitating comparison across testing sites and potentially improving utilization of guidelines for diagnosis, monitoring, and treatment of patients.

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Epstein -Barr virus
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