Abdullah, Azwani and Sam, I-Ching and Ong, Yin Jie and Theo, Chun Hao and Pukhari, Muhammad Harith and Chan, Yoke Fun (2023) 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, 13 (23). ISSN 2075-4418, DOI https://doi.org/10.3390/diagnostics13233507.
Full text not available from this repository.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. This retrospective study aimed to evaluate the diagnostic performance of STANDARD M10 Flu/RSV/SARS-CoV-2 (SD Biosensor Inc., Seoul, Korea) using archived positive and negative respiratory samples for SARS-CoV-2, IAV, IBV, and RSV. A total of 322 respiratory samples were tested, 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 compared to either Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV (Cepheid, Sunnyvale, CA, 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 duration of testing and workflows were similar. The overall agreement was 99.4%, including 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.
| Item Type: | Article |
|---|---|
| Funders: | SD BioSensor, Inc. [Grant no. IF073-2022], Universiti Malaya [Grant no. MG016-2023] |
| Uncontrolled Keywords: | Respiratory syncytial virus; Influenza A virus; Influenza B virus; SARS-CoV-2; Rapid RT-PCR; Diagnostic accuracy; Point-of-care testing; Malaysia |
| Subjects: | Q Science > QR Microbiology R Medicine |
| Divisions: | Faculty of Medicine > Medical Microbiology Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 03 Nov 2025 06:49 |
| Last Modified: | 03 Nov 2025 06:51 |
| URI: | http://eprints.um.edu.my/id/eprint/48574 |
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