Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Evaluation of Standard M10 Assay for Rapid Molecular Diagnosis of SARS-CoV-2, Influenza A/B virus and Respiratory Syncytial Virus (RSV)

Azwani Abdullah
* ORCID logo ,
I-Ching Sam
,
Yin Jie Ong
,
Chun Hao Theo
,
Muhammad Harith Pukhari
,
Yoke Fun Chan
* ORCID logo
Version 1 : Received: 14 September 2023 / Approved: 14 September 2023 / Online: 15 September 2023 (05:38:13 CEST)

A peer-reviewed article of this Preprint also exists.

Abdullah, A.; Sam, I.-C.; Ong, Y.J.; Theo, C.H.; Pukhari, M.H.; Chan, Y.F. Comparative Evaluation of a Standard M10 Assay with Xpert Xpress for the Rapid Molecular Diagnosis of SARS-CoV-2, Influenza A/B Virus, and Respiratory Syncytial Virus. Diagnostics 2023, 13, 3507. Abdullah, A.; Sam, I.-C.; Ong, Y.J.; Theo, C.H.; Pukhari, M.H.; Chan, Y.F. Comparative Evaluation of a Standard M10 Assay with Xpert Xpress for the Rapid Molecular Diagnosis of SARS-CoV-2, Influenza A/B Virus, and Respiratory Syncytial Virus. Diagnostics 2023, 13, 3507.

Abstract

SARS-CoV-2, influenza A/B virus (IAV/IBV) and respiratory syncytial virus (RSV) are among the common viruses causing acute respiratory infections. Clinical diagnosis to differentiate these viruses is challenging due to similar clinical presentations, thus laboratory-based real-time RT PCR is the gold standard for diagnosis. The study aimed to evaluate the diagnostic performance of STANDARD M10 Flu/RSV/SARS-CoV-2 (SD Biosensor Inc, Seoul, Korea). This retrospective study was conducted with archived respiratory samples positive and negative for SARS-CoV-2, IAV, IBV or RSV. The evaluation study involved a total of 322 respiratory samples comprising 215 positive samples (49 SARS-CoV-2, 48 IAV, 53 IBV, 65 RSV) and 107 negative samples. All samples were tested with both STANDARD M10 and either Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV (Cepheid, USA). The sensitivity, specificity, positive predictive value and negative predictive value rates of STANDARD M10 were very similar to Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV ranges for each virus (98-100%). The overall agreement was 99.4% with 99.1% agreement for positive samples and 100% agreement for negative samples. In conclusion, the STANDARD M10 point-of-care test is suitable for rapid simultaneous detection of SARS-CoV-2, IAV, IBV and RSV.

Keywords

respiratory syncytial virus; influenza A virus; influenza B virus; SARS-CoV-2; rapid RT-PCR; diagnostic accuracy; point-of-care testing

Subject

Medicine and Pharmacology, Clinical Medicine

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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