Open AccessVerification and Validation of SARS-CoV-2 Assay Performance on the Abbott m 2000 and Alinity m Systems
Author(s) -
Julie Hirschhorn,
April Kegl,
Tanisha Dickerson,
W. Bailey Glen,
Gang Xu,
Jay Alden,
Frederick S. Nolte
Publication year - 2021
Publication title -
journal of clinical microbiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.349
H-Index - 255
eISSN - 1070-633X
pISSN - 0095-1137
DOI - 10.1128/jcm.03119-20
Subject(s) - covid-19 , virology , medicine , pathology , infectious disease (medical specialty) , disease , outbreak
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. 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% confidence interval [CI] = 76.2 to 98.14%) and a 100% negative percent agreement (NPA; 95% CI = 97.97 to 100%) between the results of the RealTi m e 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 an NPA of 95.15% (95% CI = 83.47 to 99.4%) between the results of the RealTi m e and TaqPath tests with 77 NP specimens ( P = 0.24). Finally, we tested 203 NP swab specimens for SARS-CoV-2 on the m 2000 on the Alinity m systems. The PPA and NPA were 92.2% (95% CI = 85.3 to 96.59%) and 92% (95% CI = 84.8 to 96.5%), respectively ( P = 0.4). Although cycle number (Cn) values obtained for the concordant positive samples were highly correlated ( R 2 = 0.95), the Cn values were on average 14.14 higher on the Alinity m system due to the unread cycles with the RealTi m e SARS-CoV-2 assay.