Multicenter clinical evaluation of the revogene strep a molecular assay for detection of streptococcus pyogenes from throat swab specimens

D. Banerjee, J. Michael, B. Schmitt, H. Salimnia, N. Mhaissen, D. M. Goldfarb, P. Lachance, M. L. Faron, T. Aufderheide, N. Ledeboer, A. Weissfeld, R. Selvarangan

Research output: Contribution to journalArticle

Abstract

Group A streptococcus (GAS) species cause bacterial pharyngitis in both adults and children. Early and accurate diagnosis of GAS is important for appropriate antibiotic therapy to prevent GAS sequalae. The Revogene Strep A molecular assay (Meridian Bioscience Canada Inc, Quebec City, QC, Canada) is an automated real-time PCR assay for GAS detection from throat swab specimens within approximately 70 min. This multicenter prospective study evaluated the performance of the Revogene Strep A molecular assay compared to that of bacterial culture. Dual throat swab specimens in either liquid Amies or Stuart medium were collected from eligible subjects (pediatric population and adults) enrolled across 7 sites (USA and Canada). Revogene Strep A and reference testing was performed within 7 days and 48 h of sample collection, respectively. Of the 604 evaluable specimens, GAS was detected in 154 (25.5%) samples by the reference method and in 175 (29%) samples by the Revogene Strep A assay. Revogene Strep A assay sensitivity and specificity were reported to be 98.1% (95% confidence interval [CI], 94.4 to 99.3) and 94.7% (95% CI, 92.2 to 96.4), respectively. The positive predictive value was 86.3% (95% CI, 80.4 to 90.6), negative predictive value was 99.3% (95% CI, 98.0 to 99.8) with a 1.0% invalid rate. Discrepant analysis with alternative PCR/bidirectional sequencing was performed for 24 false-positive (FP) and 3 false-negative (FN) specimens. Concordant results were reported for 17 (FP only) of 27 discordant specimens. The Revogene Strep A assay had high sensitivity and specificity for GAS detection and provides a faster alternative for GAS diagnosis.

Original languageEnglish (US)
Article numbere01775-19
JournalJournal of clinical microbiology
Volume58
Issue number7
DOIs
StatePublished - Jul 2020

Keywords

  • Clinical trial
  • Group A streptococcus
  • Molecular assay
  • Multicenter

ASJC Scopus subject areas

  • Microbiology (medical)

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    Banerjee, D., Michael, J., Schmitt, B., Salimnia, H., Mhaissen, N., Goldfarb, D. M., Lachance, P., Faron, M. L., Aufderheide, T., Ledeboer, N., Weissfeld, A., & Selvarangan, R. (2020). Multicenter clinical evaluation of the revogene strep a molecular assay for detection of streptococcus pyogenes from throat swab specimens. Journal of clinical microbiology, 58(7), [e01775-19]. https://doi.org/10.1128/JCM.01775-19