TY - JOUR
T1 - Accurate pcr detection of influenza a/b and respiratory syncytial viruses by use of cepheid xpert flu+rsv xpress assay in point-of-care settings
T2 - Comparison to prodesse proflu+
AU - Cohen, Daniel M.
AU - Kline, Jennifer
AU - May, Larissa S.
AU - Harnett, Glenn Eric
AU - Gibson, Jane
AU - Liang, Stephen Y.
AU - Rafique, Zubaid
AU - Rodriguez, Carina A.
AU - McGann, Kevin M.
AU - Gaydos, Charlotte A.
AU - Mayne, Donna
AU - Phillips, David
AU - Cohen, Jason
N1 - Publisher Copyright:
© 2018 American Society for Microbiology.
PY - 2018/2
Y1 - 2018/2
N2 - The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A and B viruses and respiratory syncytial virus (RSV) performed on the Cepheid GeneXpert Xpress System. The objective of this study was to establish performance characteristics of the Xpert Flu+RSV Xpress Assay compared to those of the Prodesse ProFlu+ real-time reverse transcription- PCR (RT-PCR) assay (ProFlu+) for the detection of influenza A and B viruses as well as RSV in a Clinical Laboratory Improvement Amendments (CLIA)-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with results of the ProFlu_ assay in the combined CW and non-CW settings with positive percent agreements (PPA) (100%, 100%, and 97.1%) and negative percent agreements (NPA) (95.2%, 99.5%, and 99.6%) for influenza A and B viruses and RSV, respectively. In conclusion, this multicenter study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for influenza A and B viruses and RSV in ∼60 min for use at the point-of-care in the CW setting.
AB - The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A and B viruses and respiratory syncytial virus (RSV) performed on the Cepheid GeneXpert Xpress System. The objective of this study was to establish performance characteristics of the Xpert Flu+RSV Xpress Assay compared to those of the Prodesse ProFlu+ real-time reverse transcription- PCR (RT-PCR) assay (ProFlu+) for the detection of influenza A and B viruses as well as RSV in a Clinical Laboratory Improvement Amendments (CLIA)-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with results of the ProFlu_ assay in the combined CW and non-CW settings with positive percent agreements (PPA) (100%, 100%, and 97.1%) and negative percent agreements (NPA) (95.2%, 99.5%, and 99.6%) for influenza A and B viruses and RSV, respectively. In conclusion, this multicenter study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for influenza A and B viruses and RSV in ∼60 min for use at the point-of-care in the CW setting.
KW - CLIA-waived
KW - DNA polymerase
KW - Influenza
KW - Respiratory syncytial virus
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U2 - 10.1128/JCM.01237-17
DO - 10.1128/JCM.01237-17
M3 - Article
C2 - 29142048
AN - SCOPUS:85066840935
SN - 0095-1137
VL - 56
JO - Journal of clinical microbiology
JF - Journal of clinical microbiology
IS - 2
M1 - e01237-17
ER -