TY - JOUR
T1 - Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System
AU - Yanson, Karen
AU - Laviers, William
AU - Neely, Lori
AU - Lockamy, Elizabeth
AU - Castillo-Hernandez, Luis Carlos
AU - Oldfied, Christopher
AU - Ackerman, Ronald
AU - Ackerman, Jamie
AU - Ortiz, Daniel A.
AU - Pacheco, Sixto
AU - Simner, Patricia J.
AU - Young, Stephen
AU - McElvania, Erin
AU - Cooper, Charles K.
N1 - Funding Information:
This study was funded by Becton, Dickinson and Company, BD Life Sciences–Integrated Diagnostic Solutions. Non-BD employee authors received research funds to support their work for this study.
Funding Information:
All authors contributed to the interpretation of the data, critically revised the manuscript for important intellectual content, approved the final version to be published, and agree to be accountable for all aspects of the work. K.Y., W.L., L.N., E.L., and C.K.C. are current and previous employees of Becton, Dickinson and Company. All authors declare no conflicts of interest. This work was supported by Becton, Dickinson and Company, BD Life Sciences–Integrated Diagnostic Solutions (Sparks, MD, USA).
Publisher Copyright:
Copyright © 2021 Yanson et al.
PY - 2021/12
Y1 - 2021/12
N2 - Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two emergency use authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. The limits of detection (LOD) for the BD SARS-CoV-2 reagents for the BD MAX system (MAX SARS-CoV-2 assay), the bioMérieux BioFire respiratory panel 2.1 (BioFire SARSCoV-2 assay), the Roche cobas SARS-CoV-2 assay (cobas SARS-CoV-2 assay), and the Hologic Aptima SARS-CoV-2 assay Panther (Aptima SARS-CoV-2 assay) NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with 7 target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a postmarket clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using the cobas and BioFire SARS-CoV-2 NAATs. In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/ml; 95% confidence interval [CI], 186 to 427) was comparable to the cobas SARS-CoV-2 assay (298 copies/ml; 95% CI, 225 to 509) and the BioFire SARS-CoV-2 assay (302 copies/ml; 95% CI, 219 to 565); the Aptima SARS-CoV-2 assay had an LOD of 612 copies/ml (95% CI, 474 to 918). The MAX SARS-CoV-2 assay had a PPA of 100% (95% CI, 97.3% to 100.0%) and an NPA of 96.7% (95% CI, 94.9% to 97.9%) compared to the Aptima SARS-CoV-2 assay. The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.
AB - Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two emergency use authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. The limits of detection (LOD) for the BD SARS-CoV-2 reagents for the BD MAX system (MAX SARS-CoV-2 assay), the bioMérieux BioFire respiratory panel 2.1 (BioFire SARSCoV-2 assay), the Roche cobas SARS-CoV-2 assay (cobas SARS-CoV-2 assay), and the Hologic Aptima SARS-CoV-2 assay Panther (Aptima SARS-CoV-2 assay) NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with 7 target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a postmarket clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using the cobas and BioFire SARS-CoV-2 NAATs. In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/ml; 95% confidence interval [CI], 186 to 427) was comparable to the cobas SARS-CoV-2 assay (298 copies/ml; 95% CI, 225 to 509) and the BioFire SARS-CoV-2 assay (302 copies/ml; 95% CI, 219 to 565); the Aptima SARS-CoV-2 assay had an LOD of 612 copies/ml (95% CI, 474 to 918). The MAX SARS-CoV-2 assay had a PPA of 100% (95% CI, 97.3% to 100.0%) and an NPA of 96.7% (95% CI, 94.9% to 97.9%) compared to the Aptima SARS-CoV-2 assay. The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.
KW - BD MAX
KW - COVID-19
KW - Hologic Aptima
KW - RT-qPCR
KW - SARS-CoV-2
KW - agreement
KW - nucleic acid amplification test
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U2 - 10.1128/JCM.01019-21
DO - 10.1128/JCM.01019-21
M3 - Article
C2 - 34586894
AN - SCOPUS:85122046756
SN - 0095-1137
VL - 59
JO - Journal of clinical microbiology
JF - Journal of clinical microbiology
IS - 12
M1 - e01019-21
ER -