Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System

Karen Yanson, William Laviers, Lori Neely, Elizabeth Lockamy, Luis Carlos Castillo-Hernandez, Christopher Oldfied, Ronald Ackerman, Jamie Ackerman, Daniel A. Ortiz, Sixto Pacheco, Patricia J. Simner, Stephen Young, Erin McElvania, Charles K. Cooper

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)e0101921
JournalJournal of clinical microbiology
Volume59
Issue number12
DOIs
StatePublished - Nov 18 2021
Externally publishedYes

Keywords

  • BD MAX
  • COVID-19
  • Hologic Aptima
  • RT-qPCR
  • SARS-CoV-2
  • agreement
  • nucleic acid amplification test

ASJC Scopus subject areas

  • Microbiology (medical)

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