Shihabuddin, Bashar S.Faron, Matthew L.Relich, Ryan F.Van Heukelom, PaulMayne, DonnaStaat, Mary AllenSelvarangan, RangarajHueschen, Leslie A.Wolk, Donna M.House, StaceyHarnett, GlennMcGann, KevinSteele, Mark T.Romero, Jose R.Arms, JoeLander, OwenLoeffelholz, MichaelStrouts, FionaCohen, Daniel2023-08-012023-08-012022Shihabuddin BS, Faron ML, Relich RF, et al. Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment. Diagn Microbiol Infect Dis. 2022;104(2):115764. doi:10.1016/j.diagmicrobio.2022.115764https://hdl.handle.net/1805/34639The 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.en-USPublisher PolicyMultiplex real-time PCR testCLIA-waved environmentRSVInfluenzaArticle