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Romero-Ramirez, Alessandra, Somasundaran, Anushri, Kontogianni, Konstantina, Parkes, Jacob, Hussain, Yusra, Gould, Susan, Williams, Christopher T., Wooding, Dominic, Body, Richard, Hardwick, Hayley E., Baillie, J. Kenneth, Dunning, Jake, Semple, Malcolm G., Fletcher, Tom E., Edwards, Thomas, Emperador, Devy and Cubas-Atienzar, Ana I. (2025) 'Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus'. Journal of Infection, Vol 90, Issue 2, p. 106413.
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Abstract
Objectives
Evaluation of diagnostic accuracy of two point-of-care (POC) molecular diagnostic tests for the detection of monkeypox virus (MPXV): Xpert® Mpox (Cepheid, Inc., USA) and STANDARD™ M10 MPX/OPX (SD Biosensor, Inc., Korea).
Methods
Diagnostic accuracy of both POC platforms was evaluated using 53 upper-respiratory swabs (URS) and 32 skin lesions swabs (SS) collected from mpox and COVID-19 patients in the UK against the Sansure (Sansure Biotech Inc.) and CDC reference qPCR tests. The analytical sensitivity of both platforms was assessed using a viral isolate from II, B.1 lineage.
Results
The overall sensitivity and specificity of the Xpert® Mpox was 97.67% [95% CI 87.71–99.94%] and 88.57% [95% CI 73.26–96.80%] and 97.44% [95% CI 86.52–99.94%] and 74.42% [95% CI 58.83–86.48%] comparing the Sansure and CDC qPCR, respectively and for the M10 MPX/OPX was 87.80% [95% CI 73.80–95.92%] and 76.60% [95% CI 61.97–87.70%] and 94.29% [95% CI 80.84–99.30%] and 86.67% [95% CI 73.21–94.95%] with the Sansure and CDC qPCR.
Conclusion
The Xpert® Mpox had good diagnostic accuracy for both sample types while the M10 MPX/OPX clinical accuracy was deficient with URS. Our data supports the use of URS during the first 3 days of symptoms onset for mpox diagnosis.
| Item Type: | Article |
|---|---|
| Subjects: | WB Practice of Medicine > Diagnosis > General Diagnosis > WB 200 Physical diagnosis (General) WC Communicable Diseases > Virus Diseases > Infectious Viral Skin Diseases > WC 570 Infectious viral skin diseases |
| Faculty: Department: | Biological Sciences > Department of Tropical Disease Biology Clinical Sciences & International Health > Clinical Sciences Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1016/j.jinf.2025.106413 |
| Depositing User: | Clare O'Neill |
| Date Deposited: | 17 Feb 2025 10:53 |
| Last Modified: | 17 Feb 2025 10:53 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/26041 |
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