Abstract
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.
| Original language | English (US) |
|---|---|
| Journal | Journal of clinical microbiology |
| Volume | 56 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 1 2018 |
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Keywords
- CLIA-waived
- DNA polymerase
- influenza
- respiratory syncytial virus
ASJC Scopus subject areas
- Microbiology (medical)
Cite this
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 : Comparison to Prodesse ProFlu. / Cohen, Daniel M.; Kline, Jennifer; May, Larissa S.; Harnett, Glenn Eric; Gibson, Jane; Liang, Stephen Y.; Rafique, Zubaid; Rodriguez, Carina A.; McGann, Kevin M.; Gaydos, Charlotte A.; Mayne, Donna; Phillips, David; Cohen, Jason.
In: Journal of clinical microbiology, Vol. 56, No. 2, 01.02.2018.Research output: Contribution to journal › Article
}
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
PY - 2018/2/1
Y1 - 2018/2/1
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
UR - http://www.scopus.com/inward/record.url?scp=85066840935&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85066840935&partnerID=8YFLogxK
U2 - 10.1128/JCM.01237-17
DO - 10.1128/JCM.01237-17
M3 - Article
C2 - 29142048
AN - SCOPUS:85066840935
VL - 56
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
SN - 0095-1137
IS - 2
ER -