Diagnostic microbiology and infectious disease · 2022
Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment.
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Shihabuddin Bashar S, Faron Matthew L, Relich Ryan F, Van Heukelom Paul, Mayne Donna, Staat Mary Allen, Selvarangan Rangaraj, Hueschen Leslie A, Wolk Donna M, House Stacey, Harnett Glenn, McGann Kevin, Steele Mark T, Romero Jose R, Arms Joe, Lander Owen, Loeffelholz Michael, Strouts Fiona, Cohen Daniel
Аннотация
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.