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

Diagn Microbiol Infect Dis. 2022 Oct;104(2):115764. doi: 10.1016/j.diagmicrobio.2022.115764. Epub 2022 Jul 10.


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.

MeSH terms

  • COVID-19* / diagnosis
  • Humans
  • Influenza A virus* / genetics
  • Influenza B virus / genetics
  • Influenza, Human* / diagnosis
  • Molecular Diagnostic Techniques / methods
  • Nasopharynx
  • Pandemics
  • Real-Time Polymerase Chain Reaction / methods
  • Respiratory Syncytial Virus Infections* / diagnosis
  • Respiratory Syncytial Virus, Human* / genetics
  • Sensitivity and Specificity