tetano
Editor, Senior Moderator
J Clin Virol
. 2021 May 14;140:104869.
doi: 10.1016/j.jcv.2021.104869. Online ahead of print.
Performance characteristics of the Abbott Alinity m SARS-CoV-2 assay
Garrett A Perchetti[SUP] 1 [/SUP], Gregory Pepper[SUP] 1 [/SUP], Lasata Shrestha[SUP] 1 [/SUP], Katrina LaTurner[SUP] 1 [/SUP], Da Yae Kim[SUP] 1 [/SUP], Meei-Li Huang[SUP] 1 [/SUP], Keith R Jerome[SUP] 2 [/SUP], Alexander L Greninger[SUP] 3 [/SUP]
Affiliations
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 (C[SUB]T[/SUB] 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 (C[SUB]T[/SUB] 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 <2% CV. These data illst u illustrate the Abbott Alinity m system's high concordance with reference assays and analyti high analytical for SARS-CoV-2 molecular detection.
Keywords: Abbott; Alinity m; COVID-19; Coronavirus; Limit of Detection; SARS-CoV-2.
. 2021 May 14;140:104869.
doi: 10.1016/j.jcv.2021.104869. Online ahead of print.
Performance characteristics of the Abbott Alinity m SARS-CoV-2 assay
Garrett A Perchetti[SUP] 1 [/SUP], Gregory Pepper[SUP] 1 [/SUP], Lasata Shrestha[SUP] 1 [/SUP], Katrina LaTurner[SUP] 1 [/SUP], Da Yae Kim[SUP] 1 [/SUP], Meei-Li Huang[SUP] 1 [/SUP], Keith R Jerome[SUP] 2 [/SUP], Alexander L Greninger[SUP] 3 [/SUP]
Affiliations
- PMID: 34023572
- DOI: 10.1016/j.jcv.2021.104869
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 (C[SUB]T[/SUB] 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 (C[SUB]T[/SUB] 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 <2% CV. These data illst u illustrate the Abbott Alinity m system's high concordance with reference assays and analyti high analytical for SARS-CoV-2 molecular detection.
Keywords: Abbott; Alinity m; COVID-19; Coronavirus; Limit of Detection; SARS-CoV-2.