Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Blazek, L.
Comparison of automated systems for detection of viruses relevant for immunosuppressed patients
Humanmedizin; [ Diplomarbeit ] Medical University of Graz; 2015. pp. 66
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- Autor*innen der Med Uni Graz:
- Betreuer*innen:
- Kessler Harald
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- Abstract:
- Background: Today, real-time PCR-based techniques are the method of choice for detection of viruses relevant for immunosuppressed patients. Recently, novel platforms have been introduced including automated PCR setup. Objectives: To evaluate the accuracy, clinical performance, and workflow of the new Sentosa™ SA assays for detection of human cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varizella-zoster virus (VZV). To compare the clinical performance and the times-to-results to the corresponding R-gene® kits employed in the routine diagnostic laboratory. Materials and methods: The accuracy of the Sentosa™ SA CMV and EBV assays was determined using proficiency panels provided by an international external quality assessment/proficiency testing organization (QCMD). For evaluation of the clinical performance, 106 EDTA whole blood specimens that remained following routine clinical testing were tested and results compared. Results: When the accuracy of the Sentosa™ SA CMV and EBV assays was determined, the difference between results was found to be 0.1 log10 or less in the majority of the panel members. When the clinical performance was compared, concordant results were observed in 76% for CMV, 63% for EBV, 91% for HSV-1, 97% for HSV-2, and 97% for VZV. The mean difference in values obtained with the Sentosa™ SA CMV PCR Test compared to those obtained with the CMV R-gene® kit was 0.31 log10 unit. The corresponding value for EBV assays was 0.62 log10 unit. Times-to-results for 16 samples were 270 min for the Sentosa™ SA assays and 230 min for the R-gene® kits. Conclusions: The Sentosa™ SA assay showed excellent accuracy. Comparison of the clinical performance revealed concordant results in the majority of samples. However, the variability in viral load results is remarkably high. It is thus still mandatory to monitor a single patient with the identical assay.