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

Bashar S. Shihabuddin; Matthew L. Faron; Ryan F. Relich; Paul Van Heukelom; Donna Mayne; Mary Allen Staat; Rangaraj Selvarangan; Leslie A. Hueschen; Donna M. Wolk; Stacey House; Glenn Harnett; Kevin McGann; Mark T. Steele; Jose R. Romero; Joe Arms; Owen Lander; Michael Loeffelholz; Fiona Strouts; Daniel Cohen

doi:10.1016/j.diagmicrobio.2022.115764

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

Bashar S. Shihabuddin, Matthew L. Faron, Ryan F. Relich, Paul Van Heukelom, Donna Mayne, Mary Allen Staat, Rangaraj Selvarangan, Leslie A. Hueschen, Donna M. Wolk, Stacey House, Glenn Harnett, Kevin McGann, Mark T. Steele, Jose R. Romero, Joe Arms, Owen Lander, Michael Loeffelholz, Fiona Strouts, Daniel Cohen

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

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.

Original language	English
Article number	115764
Journal	Diagnostic Microbiology and Infectious Disease
Volume	104
Issue number	2
DOIs	https://doi.org/10.1016/j.diagmicrobio.2022.115764
State	Published - Oct 2022

Keywords

CLIA-Waved Environment
Influenza
Multiplex real-time PCR test
RSV

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10.1016/j.diagmicrobio.2022.115764

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Shihabuddin, B. S., Faron, M. L., Relich, R. F., Van Heukelom, P., Mayne, D., Staat, M. A., Selvarangan, R., Hueschen, L. A., Wolk, D. M., House, S., Harnett, G., McGann, K., Steele, M. T., Romero, J. R., Arms, J., Lander, O., Loeffelholz, M., Strouts, F., & Cohen, D. (2022). Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment. Diagnostic Microbiology and Infectious Disease, 104(2), Article 115764. https://doi.org/10.1016/j.diagmicrobio.2022.115764

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title = "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{\textquoteright} 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",

author = "Shihabuddin, {Bashar S.} and Faron, {Matthew L.} and Relich, {Ryan F.} and {Van Heukelom}, Paul and Donna Mayne and Staat, {Mary Allen} and Rangaraj Selvarangan and Hueschen, {Leslie A.} and Wolk, {Donna M.} and Stacey House and Glenn Harnett and Kevin McGann and Steele, {Mark T.} and Romero, {Jose R.} and Joe Arms and Owen Lander and Michael Loeffelholz and Fiona Strouts and Daniel Cohen",

note = "Publisher Copyright: {\textcopyright} 2022 Elsevier Inc.",

year = "2022",

month = oct,

doi = "10.1016/j.diagmicrobio.2022.115764",

language = "English",

volume = "104",

journal = "Diagnostic Microbiology and Infectious Disease",

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Shihabuddin, BS, Faron, ML, Relich, RF, Van Heukelom, P, Mayne, D, Staat, MA, Selvarangan, R, Hueschen, LA, Wolk, DM, House, S, Harnett, G, McGann, K, Steele, MT, Romero, JR, Arms, J, Lander, O, Loeffelholz, M, Strouts, F & Cohen, D 2022, 'Cepheid Xpert Xpress Flu/RSV evaluation performed by minimally trained non-laboratory operators in a CLIA-waived environment', Diagnostic Microbiology and Infectious Disease, vol. 104, no. 2, 115764. https://doi.org/10.1016/j.diagmicrobio.2022.115764

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

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

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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 -

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

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Keywords

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