Evaluation of analytical performance of the STANDARD
            <sup>TM</sup>
            M10 MPX/OPX assay for the simultaneous DNA detection and clade attribution of
            <i>Monkeypox virus</i>

Mancon, Alessandro; Raccagni, Angelo Roberto; Gagliardi, Gloria; Moschese, Davide; Rizzo, Alberto; Giacomelli, Andrea; Cutrera, Miriam; Salari, Federica; Bracchitta, Fiorenza; Antinori, Spinello; Gori, Andrea; Rizzardini, Giuliano; Castagna, Antonella; Gismondo, Maria Rita; Nozza, Silvia; Mileto, Davide

doi:10.1080/22221751.2024.2337666

Cited by 2 publications

References 30 publications

(22 reference statements)

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Evaluation of the diagnostic accuracy and analytical sensitivity of the novel Xpert® Mpox (Cepheid®) and STANDARD™ M10 MPX/OPX (SD Biosensor) molecular point-of-care assays for the detection of Mpox virus in skin lesion swabs and upper-respiratory swab samples

Romero-Ramirez,

Somasundaran,

Kontogianni

et al. 2024

Preprint

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ObjectivesEvaluation 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).MethodsDiagnostic accuracy of both 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 the CDC reference qPCR tests. The analytical sensitivity of both platforms was assessed using a viral isolate from the lineage II, B.1.ResultsThe limit of detection was 1×101pfu/ml for both tests. 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.ConclusionThe 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.HighlightsThe Xpert® Mpox detected Monkeypox virus (MPXV) DNA in more samples than the M10 MPX/OPX, CDC qPCR and Sansure qPCR suggesting higher sensitivity at lower viral loads.Xpert® Mpox fulfilled the performance requirements recommended in the World Health Organisation (WHO) target product profile (TPP) using upper-respiratory swabs (URS) and skin lesion swabs (SS) but M10 MPX/OPX performance was only met when using SS.MPXV DNA was reliably detectable in SS up to 5 days after onset of symptoms. with all PCR testsThe use of URS for mpox diagnosis is not recommended for use more than 3 days after onset of symptoms.

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Evaluation of the diagnostic accuracy and analytical sensitivity of the novel Xpert® Mpox (Cepheid®) and STANDARD™ M10 MPX/OPX (SD Biosensor) molecular point-of-care assays for the detection of Mpox virus in skin lesion swabs and upper-respiratory swab samples

Romero-Ramirez,

Somasundaran,

Kontogianni

et al. 2024

Preprint

View full text Add to dashboard Cite

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Will mpox disease caused by the human Mpox virus (MPXV) result in a pandemic-like situation similar to the COVID-19 pandemic

Kandi

2024

Discov Public Health

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The threat of the emergence of potential pandemics in the future has been looming ever since the world witnessed the worst-ever public health catastrophe following the coronavirus disease 2019 (COVID-19) pandemic caused by the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The COVID-19 pandemic affected billions of people killing millions of people throughout the world. Now, we have been noticing an alarming rise in the cases of mpox disease caused by Mpox virus (MPXV). Although discovered in 1958, mpox was largely confined to monkeys before causing the first human infection in 1970. The MPXV is demonstrating a complex transmission behavior as noted by its discovery first in Denmark in monkeys imported from Singapore (Asia) and later spreading to humans causing repeated re-emergence. The virus was confined to the African nations including the Democratic Republic of Congo (DRC) before reemerging in the United States of America in 2003 affecting several people who had a history of contact with animals. Following scattered reports from endemic regions, the virus appears to have remerged after approximately two decades in 2022 involving the United States of America (USA) and European countries. The virus has been spreading across the globe as evidenced by its discovery in 60 countries in 2022 to more than 120 countries in the current year. It is therefore essential to improve the understanding of the MPXV, its epidemiology, pathogenicity and virulence, clinical features, and control and preventive measures and increase preparedness to efficiently tackle any future public health emergency.

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Evaluation of analytical performance of the STANDARD ^TM M10 MPX/OPX assay for the simultaneous DNA detection and clade attribution of Monkeypox virus

Cited by 2 publications

References 30 publications

Evaluation of the diagnostic accuracy and analytical sensitivity of the novel Xpert® Mpox (Cepheid®) and STANDARD™ M10 MPX/OPX (SD Biosensor) molecular point-of-care assays for the detection of Mpox virus in skin lesion swabs and upper-respiratory swab samples

Evaluation of the diagnostic accuracy and analytical sensitivity of the novel Xpert® Mpox (Cepheid®) and STANDARD™ M10 MPX/OPX (SD Biosensor) molecular point-of-care assays for the detection of Mpox virus in skin lesion swabs and upper-respiratory swab samples

Will mpox disease caused by the human Mpox virus (MPXV) result in a pandemic-like situation similar to the COVID-19 pandemic

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Evaluation of analytical performance of the STANDARD TM M10 MPX/OPX assay for the simultaneous DNA detection and clade attribution of Monkeypox virus

Cited by 2 publications

References 30 publications

Evaluation of the diagnostic accuracy and analytical sensitivity of the novel Xpert® Mpox (Cepheid®) and STANDARD™ M10 MPX/OPX (SD Biosensor) molecular point-of-care assays for the detection of Mpox virus in skin lesion swabs and upper-respiratory swab samples

Evaluation of the diagnostic accuracy and analytical sensitivity of the novel Xpert® Mpox (Cepheid®) and STANDARD™ M10 MPX/OPX (SD Biosensor) molecular point-of-care assays for the detection of Mpox virus in skin lesion swabs and upper-respiratory swab samples

Will mpox disease caused by the human Mpox virus (MPXV) result in a pandemic-like situation similar to the COVID-19 pandemic

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Evaluation of analytical performance of the STANDARD ^TM M10 MPX/OPX assay for the simultaneous DNA detection and clade attribution of Monkeypox virus