Evaluation of a new extraction platform in combination with molecular assays useful for monitoring immunosuppressed patients

Abstract

BackgroundIn the immunosuppressed, detection of viral reactivation at the earliest convenience and molecular monitoring are of paramount importance. Nucleic acid extraction has a major impact on the reliability of results obtained from molecular assays. ObjectivesThe aim of this study was to investigate the accuracy of the new EMAG® nucleic acid extraction platform and to compare the performance of the new platform to that of the standard NucliSENS® easyMAG® instrument in the routine clinical laboratory. Study designFor accuracy testing, reference material and for comparison studies, clinical specimens were used. In addition, a lab-flow analysis including estimation of hands-on time and that for automated extraction was performed. ResultsWhen accuracy was tested, all 89 results obtained were found to be concordant with the results expected. When 648 clinical results were compared, 85.7% were found to be within ±0.5 log10 unit, 9.5% between ±0.5 and ±1.0 log10 unit, and 4.8% more than ±1.0 log10 unit. The overall time required for nucleic acid extraction of 8 samples in parallel was 94 min for the fully automated extraction mode and 82 min for the partly automated mode with the new platform, and 73 min with the standard instrument. Hands-on time was found to be shorter with the new platform. ConclusionsThe extraction performance of both platforms was found to be similar for EDTA whole blood, BAL, and urine specimens. The total turn-around time for nucleic acid extraction was found to be longer with the EMAG® platform, whereas hands-on time was reduced.