1. Performance characteristics of the Abbott Alinity m SARS-CoV-2 assay
- Author
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Alexander L. Greninger, Da Yae Kim, Keith R. Jerome, Katrina LaTurner, Meei-Li Huang, Lasata Shrestha, Garrett A. Perchetti, and Gregory Pepper
- Subjects
0301 basic medicine ,Detection limit ,2019-20 coronavirus outbreak ,Molecular Diagnostic Testing ,Coronavirus disease 2019 (COVID-19) ,Clinical Laboratory Techniques ,SARS-CoV-2 ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,030106 microbiology ,COVID-19 ,Sensitivity and Specificity ,Virology ,03 medical and health sciences ,COVID-19 Testing ,0302 clinical medicine ,Infectious Diseases ,Limit of Detection ,Humans ,RNA, Viral ,Medicine ,030212 general & internal medicine ,business ,Pandemics - Abstract
Mass molecular diagnostic testing for the SARS-CoV-2 pandemic has drawn on laboratory developed tests, commercial assays, and fully-automated platforms to accommodate widespread demand. The Alinity m instrument by Abbott is capable of detecting several clinically relevant pathogens and has recently received FDA emergency use authorization for SARS-CoV-2 molecular testing. The Alinity m performs automatic sample preparation, RT-PCR assembly, amplification, detection, and result calculation in under two hours. Here, we validate the performance characteristics of the Alinity m SARS-CoV-2 assay in comparison with the Roche cobas 6800 and Hologic Panther Fusion platforms. Across 178 positive and 195 negative nasopharyngeal swab specimens (CT range 14.30-38.84), the Alinity m detected one additional positive specimen that was found to be negative on the Roche cobas 6800 (PPA 100%, NPA 99.5%). Across a separate set of 30 positive and 174 negative nasopharyngeal swab specimens (CT range 14.1-38.5), the Alinity m had 100% positive and negative agreement with the Hologic Panther Fusion. Using SeraCare SARS-CoV-2 RNA standards, the assay limit of detection was verified to be two-fold more sensitive than the parameters stated by the SARS-CoV-2 AMP kit package insert, at 50 virus copies/mL. Assay specificity was 100% over 20 specimens positive for other respiratory viruses and intraday precision was 100% concordant with
- Published
- 2021
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