TY - JOUR
T1 - Clinical performance of the Xpert (R) Xpress Flu/RSV assay for the detection of influenza A, B, and respiratory syncytial virus on ESwab (TM) medium
AU - Gast, Karin B.
AU - Vrolijk, Angela C.I.M.
AU - Bergmans, Anneke M.C.
AU - Geelen, Tanja H.
AU - Kluytmans, Jan A.J.W.
AU - Pas, Suzan D.
N1 - Publisher Copyright:
© 2022
PY - 2022/2
Y1 - 2022/2
N2 - Background: Prior to the SARS-CoV-2 pandemic, the Xpert® Xpress Flu/RSV assay (GXA) was regularly used, while during the pandemic the Xpert® Xpress SARS-CoV-2/Flu/RSV (plus) assay was developed by Cepheid. In contrast to this new assay, the use of oropharyngeal ESwabs in combination with the Flu/RSV assay is designated as off CE-IVD label use, while these were used frequently in The Netherlands. Aim: To investigate the clinical performance of the GXA using 1,289 ESwab™ oropharyngeal samples for the detection of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV). Methods: The clinical performance of the GXA was prospectively investigated during the influenza seasons of 2017 and 2018 by testing fresh oropharyngeal samples, collected with ESwab™, contemporaneously with both the GXA and a laboratory developed Flu/RSV real time RT-PCR assay (LDA) (reference method). Results: 1,289 Samples from 1,213 patients (46% men, median age 73 (IQR 62–82)) were tested with both tests. Positive percent agreement (95% CI) was 98% (95%-99%) for Influenza A virus, 92% (88%-95%) for influenza B virus, and 88% (73%-96%) for RSV. Negative percent agreement was ≥ 99% for all three viruses. Ct-values of the GXA were on average higher than the LDA. Conclusion: This study showed a good clinical performance of the GXA in oropharyngeal samples for the detection of Influenza A and B virus. The positive percent agreement of the GXA for the detection of RSV in oropharyngeal samples was somewhat lower and in particular for the detection of RSV-A.
AB - Background: Prior to the SARS-CoV-2 pandemic, the Xpert® Xpress Flu/RSV assay (GXA) was regularly used, while during the pandemic the Xpert® Xpress SARS-CoV-2/Flu/RSV (plus) assay was developed by Cepheid. In contrast to this new assay, the use of oropharyngeal ESwabs in combination with the Flu/RSV assay is designated as off CE-IVD label use, while these were used frequently in The Netherlands. Aim: To investigate the clinical performance of the GXA using 1,289 ESwab™ oropharyngeal samples for the detection of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV). Methods: The clinical performance of the GXA was prospectively investigated during the influenza seasons of 2017 and 2018 by testing fresh oropharyngeal samples, collected with ESwab™, contemporaneously with both the GXA and a laboratory developed Flu/RSV real time RT-PCR assay (LDA) (reference method). Results: 1,289 Samples from 1,213 patients (46% men, median age 73 (IQR 62–82)) were tested with both tests. Positive percent agreement (95% CI) was 98% (95%-99%) for Influenza A virus, 92% (88%-95%) for influenza B virus, and 88% (73%-96%) for RSV. Negative percent agreement was ≥ 99% for all three viruses. Ct-values of the GXA were on average higher than the LDA. Conclusion: This study showed a good clinical performance of the GXA in oropharyngeal samples for the detection of Influenza A and B virus. The positive percent agreement of the GXA for the detection of RSV in oropharyngeal samples was somewhat lower and in particular for the detection of RSV-A.
KW - clinical performance
KW - Influenza A virus
KW - Influenza B virus
KW - Rapid molecular testing
KW - RSV
UR - https://www.scopus.com/pages/publications/85126976280
U2 - 10.1016/j.jcvp.2022.100066
DO - 10.1016/j.jcvp.2022.100066
M3 - Article
AN - SCOPUS:85126976280
VL - 2
JO - Journal of clinical virology plus
JF - Journal of clinical virology plus
IS - 1
M1 - 100066
ER -