Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Achathaler, A.
Evaluation of a new EBV DNA quantitative prototype test
Humanmedizin; [ Diplomarbeit ] Medizinische Universität Graz; 2021. pp. 37
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- Autor*innen der Med Uni Graz:
- Betreuer*innen:
- Kessler Harald
- Stelzl Evelyn
- Altmetrics:
- Abstract:
- Background: After infection, the Epstein-Bar virus (EBV) maintains lifelong but the healthy immune system keeps it in check. In immunocompromised patients, EBV may reactivate and lead to chronic disease such as post-transplant lymphoproliferative disorder (PTLD). Detection and accurate quantitation of EBV DNA is of paramount importance to recognize reactivation as early as possible in order to initiate a preemptive strategy. Objectives: The aim of this study was to compare results obtained by a prototype test for detection and quantitation of EBV DNA on the cobas® 6800/8800 systems. Materials and Methods: The performance of the cobas® EBV prototype test was evaluated at the Medical University of Graz, Austria. The cobas® EBV prototype test was compared to a CE-IVD labeled EBV test (bioMerieux R-GENE®) after extraction with either the eMAG® or the MagNA Pure 24 platform. For determination of analytical performance, an EBV EDTA plasma panel based on the 1st WHO International Standard for EBV was used. EBV DNA concentrations ranged from 1.0E+05 to 1.0E+02 International Units IU/mL. For determination of clinical performance, 30 plasma samples positive for EBV DNA were diluted in EBV negative human plasma and dilutions were tested. Results: When the analytical performance of the cobas® EBV prototype test was studied with dilutions of the WHO panel, concentrations obtained with the cobas® EBV prototype test were found to be very close to those expected (-0.04 to 0.06 log10 IU/mL). When clinical samples were tested, the mean difference observed with the cobas® EBV prototype test was found to be 0.07 log10 IU/mL. The mean difference between the cobas® EBV prototype test and R-GENE® was -0.23 log10IU/mL, respectively. Conclusions: The cobas® EBV prototype test showed high agreement when tested with the 1st WHO International Standard for EBV. When clinical samples were tested with the cobas® EBV prototype test and compared to alternative test systems, an excellent correlation was observed.