TY - JOUR
T1 - Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment
AU - Shihabuddin, Bashar S.
AU - Faron, Matthew L.
AU - Relich, Ryan F.
AU - Van Heukelom, Paul
AU - Mayne, Donna
AU - Staat, Mary Allen
AU - Selvarangan, Rangaraj
AU - Hueschen, Leslie A.
AU - Wolk, Donna M.
AU - House, Stacey
AU - Harnett, Glenn
AU - McGann, Kevin
AU - Steele, Mark T.
AU - Romero, Jose R.
AU - Arms, Joe
AU - Lander, Owen
AU - Loeffelholz, Michael
AU - Strouts, Fiona
AU - Cohen, Daniel
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
KW - CLIA-Waved Environment
KW - Influenza
KW - Multiplex real-time PCR test
KW - RSV
UR - https://www.scopus.com/pages/publications/85135545220
U2 - 10.1016/j.diagmicrobio.2022.115764
DO - 10.1016/j.diagmicrobio.2022.115764
M3 - Article
C2 - 35917666
AN - SCOPUS:85135545220
SN - 0732-8893
VL - 104
JO - Diagnostic Microbiology and Infectious Disease
JF - Diagnostic Microbiology and Infectious Disease
IS - 2
M1 - 115764
ER -