Lab Med Qual Assur.  2022 Sep;44(3):165-169. 10.15263/jlmqa.2022.44.3.165.

Performance Evaluation of the ELITe InGenius System for Detecting Cytomegalovirus, EpsteinBarr Virus, and BK Virus Infections

• Woo KS
• Han JY

• KMID: 2534080
• DOI: http://doi.org/10.15263/jlmqa.2022.44.3.165

Abstract

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.

Keyword

Cytomegalovirus; Epstein-Barr virus; BK virus