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Hübner, M; Bozic, M; Konrad, PM; Grohs, K; Santner, BI; Kessler, HH.
Analytical and clinical performance of a new molecular assay for Epstein-Barr virus DNA quantitation.
J Virol Methods. 2015; 212(6):39-43 Doi: 10.1016/j.jviromet.2014.11.002
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Leading authors Med Uni Graz
Hübner Margit
Kessler Harald
Co-authors Med Uni Graz
Bozic Michael
Santner Brigitte
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Abstract:
Quantitation of EBV DNA has been shown to be a useful tool to identify and monitor patients with immunosuppression and high risk for EBV-associated disease. In this study, the analytical and clinical performance of the new Realquality RS-EBV Kit (AB Analitica, Padova, Italy) was investigated. The clinical performance was compared to that of the EBV R-gene (bioMerieux, Varilhes, France) assay. When the accuracy of the new assay was tested, all results except of one were found to be within ±0.5log10 unit of the expected panel results. Determination of linearity showed a quasilinear curve, the between day imprecision ranged from 18% to 88% and the within run imprecision from 16% to 53%. When 96 clinical EDTA whole blood samples were tested, 77 concordant and 19 discordant results were obtained. When the results for the 69 samples quantifiable with both assays were compared, the new assay revealed a mean 0.31log10 unit higher measurement. The new assay proved to be suitable for the detection and quantitation of EBV DNA in EDTA whole blood in the routine diagnostic laboratory. The variation between quantitative results obtained by the assays used in this study reinforces the use of calibrators traceable to the existing international WHO standard making different assays better comparable. Copyright © 2014 Elsevier B.V. All rights reserved.
Find related publications in this database (using NLM MeSH Indexing)
DNA, Viral - genetics
DNA, Viral - isolation & purification
Epstein-Barr Virus Infections - diagnosis
Epstein-Barr Virus Infections - virology
Herpesvirus 4, Human - genetics
Herpesvirus 4, Human - isolation & purification
Humans -
Molecular Diagnostic Techniques - methods
Reproducibility of Results -
Viral Load - methods

Find related publications in this database (Keywords)
Epstein-Barr virus
Molecular diagnostics
Quantitation
Real-time PCR
Standardization
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