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Daniel A. Ortiz, PhD, D(ABMM)
Article
Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System.
Journal of Clinical Microbiology (2021)
  • Karen Yanson, Becton Dickinson
  • William Laviers, Becton Dickinson
  • Lori Neely, Becton Dickinson
  • Elizabeth Lockamy, Becton Dickinson
  • Luis Carlos Castillo-Hernandez, CTMD Research
  • Christopher Oldfied, Fellows Research Alliance
  • Ronald Ackerman, Comprehensive Clinical Research
  • Jamie Ackerman, Comprehensive Clinical Research
  • Daniel A Ortiz, Beaumont
  • Sixto Pacheco, BioCollections Worldwide
  • Patricia J Simner, Johns Hopkins University School of Medicine
  • Stephen Young, Tricore Reference Laboratory
  • Erin McElvania, NorthShore University HealthSystem
  • Charles K Cooper, Becton Dickinson
Link
Abstract
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 SARS-CoV-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.
Keywords
  • BD MAX,
  • COVID-19,
  • Hologic Aptima,
  • RT-qPCR,
  • SARS-COV-2,
  • agreement,
  • nucleic acid amplification test
Disciplines
Publication Date
November 18, 2021
DOI
10.1128/JCM.01019-21
Citation Information
Yanson K, Laviers W, Neely L, Lockamy E, Castillo-Hernandez LC, Oldfied C, Ackerman R, Ackerman J, Ortiz DA, Pacheco S, Simner PJ, Young S, McElvania E, Cooper CK. Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System. J Clin Microbiol. 2021 Nov 18;59(12):e0101921. doi: 10.1128/JCM.01019-21. Epub 2021 Sep 29. PMID: 34586894; PMCID: PMC8601249.