Verification and Validation of SARS-CoV-2 Assay Performance on the Abbott <i>m</i> 2000 and Alinity <i>m</i> Systems
Julie Hirschhorn, April Kegl, Tanisha Dickerson, W. Bailey Glen, Gang Xu, Jay Alden, Frederick S. Nolte
Abstract
We verified the analytical performance of the Abbott RealTi m e SARS-CoV-2 assay on the m 2000 system and compared its clinical performance to the CDC 2019-nCoV real-time PCR diagnostic panel and the Thermo Fisher TaqPath RT-PCR COVID-19 kit. We also performed a bridging study comparing the RealTi m e SARS-CoV-2 assay with the new Abbott Alinity m SARS-CoV-2 assay.
Topics & Concepts
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Coronavirus disease 2019 (COVID-19)2019-20 coronavirus outbreakVirologyMedicinePathologyInfectious disease (medical specialty)DiseaseOutbreakSARS-CoV-2 detection and testingSARS-CoV-2 and COVID-19 ResearchRespiratory viral infections research