Lab Med Qual Assur 2022; 44(3): 165-169
Published online September 30, 2022
Copyright © Korean Association of External Quality Assessment Service.
Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea
Correspondence to:Jin-Yeong Han
Department of Laboratory Medicine, Dong-A University Hospital, Dong-A University College of Medicine, 26 Daesingongwon-ro, Seo-gu, Busan 49201, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: The ELITe-MGB Kit (ELITech Group, Italy) is a qualitative and quantitative nucleic acid amplification assay used for the detection and quantification of various viruses, especially in the clinical management of post-transplant infections. In this study, we evaluated the performance of a fully automated cassette-based real-time polymerase chain reaction (PCR) method for cytomegalovirus (CMV), Epstein-Barr virus (EBV), and BK virus (BKV) in comparison with the routine PCR method.
Methods: The precision and linearity of each assay using the ELITe InGenius system were evaluated. Comparative studies of the ELITe MGB kit and commercially available real-time PCR assay were performed using clinical patient specimens for each virus.
Results: The assay variability of the cycle threshold measurements was ≤1% for all concentrations. The analytical sensitivity of the assay was evaluated using purified control genomic DNA at known concentrations, and the coefficient of correlation was 0.999.
Conclusions: The assay showed a good correlation between CMV DNA levels detected by routine PCR assay and excellent validation results. Therefore, the use of the ELITe MGB assay in combination with the ELITe InGenius system allows for rapid, sensitive, and reliable detection and quantification of viral DNA, making early evidence-based intervention possible. However, the clinical value of this assay needs further investigation.
Keywords: Cytomegalovirus, Epstein-Barr virus, BK virus