ABSTRACT
We verified the analytical performance of the Abbott RealTime SARS-CoV-2 assay on the m2000 system and compared its clinical performance to the CDC 2019-nCoV Real-Time PCR Diagnostic Panel and the ThermoFisher TaqPath RT-PCR COVID-19 kit. We also performed a bridging study comparing the RealTime SARS-CoV-2 assay with the new Abbott Alinity m SARS-CoV-2 assay. A number of standards, reference materials, and commercially available controls were used for the analytical verification to confirm the limit of detection, linearity, and reproducibility. We used nasopharyngeal (NP) swab specimens collected in saline for the clinical verification and bridging studies. Overall, we found 91.2% positive percent agreement (PPA) (95% CI 76.2 to 98.14%) and a 100% negative percent agreement (NPA) (95% CI 97.97 to 100%) between the results of the RealTime SARS-CoV-2 and CDC tests with 217 NP specimens (P=0.13). We found a PPA of 100% (95% CI 90.26 to 100%) and a NPA of 95.15% (95% CI 83.47 to 99.4%) between the results of the RealTime and TaqPath tests with 77 NP specimens (P=0.24). Finally, we tested 203 NP swab specimens for SARS-CoV-2 on the m2000 on the Alinity m systems. The PPA and NPA were 92.2% (95% CI, 85.3 to 96.59%) and 92% (95% PI, 84.8 to 96.5%), respectively (P=0.4). Although cycle number (Cn) values obtained for the concordant positive samples were highly correlated (R2, 0.95), the Cn values were on average 14.14 higher on the Alinity m system due to the unread cycles with the RealTime SARS-CoV-2 assay.
- Copyright © 2021 Hirschhorn et al.
This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.
This article is made available via the PMC Open Access Subset for unrestricted noncommercial re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
