20.500.12556/RUL-138709 Real-life head-to-head comparison of performance of two high-throughput automated assays for the detection of SARS-CoV-2 RNA in nasopharyngeal swabs the Alinity m and cobas 6800 SARS-CoV-2 assays The Alinity m (Abbott Molecular, Des Plaines, IL) automated molecular analyzer allows continuous loading of samples and sample-to-result molecular detection of several microorganisms. The detection of SARS-CoV-2 by the Alinity m was compared with that of the cobas 6800 (Roche Molecular Systems, Branchburg, NJ; standard comparator) in a manufacturer-independent clinical evaluation on 2157 consecutive nasopharyngeal swab samples. Valid initial results on Alinity m and cobas 6800 were obtained from 2129 (98.7%) and 2157 (100%) samples, respectively. The overall percent agreement (95% CI) was 98.3% (2092/2129 [97.6%–98.7%]); positive percent agreement, 100% (961/961 [99.6%–100%]); negative percent agreement, 96.8% (1131/1168 [95.7%–97.7%]); and high κ value, 0.965 (0.954–0.976). There were 37 discordant results on Alinity m and, based on discordant analyses, including previous and/or follow-up PCR results, 22 could be considered analytically true positive with high probability. Due to a lack of additional information and an inability to perform repeated/further testing, the status of the remaining 15 discordant results remained unresolved. The throughput of the two analyzers was compared using testing on 564 samples in parallel across two 8-hour shifts in clinical practice. The turnaround times were compared using processing of 94 routine samples in parallel on each working day for 5 consecutive days. The two analyzers showed similar performance, with certain differences that have potential importance in some laboratory settings. SARS-CoV2 molecular analyzer Abbott's Alinity m SARS-CoV2 molekularni analizator Abbott Alinity m true false true Angleški jezik Slovenski jezik Članek v reviji 2022-08-10 09:59:42 2022-08-10 09:59:46 2022-09-15 04:17:05 0000-00-00 00:00:00 2021 0 0 Str. 920-928 no. 8 Vol. 23 2021 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.9 1525-1578 10.1016/j.jmoldx.2021.05.003 67502851 1-s2.0-S1525157821001252-main.pdf 1-s2.0-S1525157821001252-main.pdf 1 CD9821C51DDA5D168974CEBBD1A64CD4 5c14b2d88a657049be0feacb26c02fd8ef3cc484cd4536780ab4651c4569d80e 9587405b-1882-11ed-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=159122 https://www.sciencedirect.com/science/article/pii/S1525157821001252 0 1cda1057-1882-11ed-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=159121 Medicinska fakulteta 0 0 0