Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment

Abstract

The COVID-19 pandemic highlighted the significance of readily available and easily performed viral testing for surveillance during future infectious pandemics. The objectives of this study were: to assess the performance of the Xpert Xpress Flu and/or RSV test, a multiplex PCR assay for detecting influenza A and B virus and respiratory syncytial virus nucleic acids in respiratory tract specimens, relative to the Quidel Lyra Influenza A+B assay and the Prodesse ProFlu+ assay, and the system's ease of use by minimally trained operators. Overall, the Xpert Xpress Flu/RSV test demonstrated a high positive and negative percent agreement with the comparator assays, and was easy to use and interpret results, based on the operators' feedback. We concluded that the Xpert Xpress Flu/RSV test is sensitive, specific, and easy to use for the diagnosis of influenza and RSV by minimally trained operators and can be a valuable tool in future infectious clusters or pandemics.

Keywords: CLIA-Waved Environment; Influenza; Multiplex real-time PCR test; RSV.

Fig. 1

Distribution of cycle threshold values by specimen types, for FLUAV (A), FLUBV (B), and RSV (C). NP: nasopharyngeal swab; NS: nasal swab. NP swabs resulted in significantly lower Ct values for FLUAV and FLUBV, but not RSV. *P < 0.05; **P < 0.01; ***P < 0.001.