Evaluation of STANDARDTM M10 SARS-CoV-2 assay as a diagnostic tool for SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples

Parakatselaki, Maria-Eleni; Alexi, Georgia; Zafiropoulos, Alexandros; Sourvinos, George

doi:10.1016/j.jcvp.2022.100129

Cited by 2 publications

(2 citation statements)

References 19 publications

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“…More RT–PCR assays were then marketed, with different characteristics and performances. Papadakis et al compared results obtained using 5 homemade and 11 commercial assays, targeting the Orthopoxvirus genus or Monkeypox virus, finding a good correlation among them; however, clinical samples represented a limited proportion of the total amount [ 22 ]. Similarly, two other groups validated MPXV-specific RT–PCR.…”

Section: Discussionmentioning

confidence: 99%

“…The M10 assay is rapid, user-friendly, and in the single-test format, which allows to return of a result in less than two hours from sample reception to validation. The STANDARD M10 platform was previously evaluated in the context of SARS-CoV-2 detection, also for differential diagnosis with Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV), proving its reliability in terms of PPA, NPA, short time-to-result, and easy usage and an appropriate diagnostic tool for those scenarios requiring a rapid response [ 22 , 27–30 ]. The present study is the first on the use of STANDARD M10 MPX/OPX: as for respiratory pathogens, the assay showed high-quality performance, with a higher concordance with first results as per RealStar® OPX-1, especially when the operator interpretation was used.…”

Section: Discussionmentioning

confidence: 99%

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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

Mancon,

Raccagni,

Gagliardi

et al. 2024

Emerging Microbes & Infections

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Monkeypox virus (MPXV) infection confirmation needs reliable polymerase chain reaction (PCR) assays; in addition, viral clade attribution is a key factor in containment measures, considering a more severe syndrome in clade I and the possibility of simultaneous circulation. This study evaluates the performance of all-in-one STANDARD M10 MPX/OPX (SD BIOSENSOR, South Korea – M10). Frozen samples from 205 subjects were selected and stratified according to routine test results (RealStar® Orthopoxvirus PCR Kit 1.0, Altona DIAGNOTICS, Germany – RS; RS-1): in detail, 100 negative skin lesions (SL) and 200 positive samples at the variable stage of infection were analysed. Positive samples were retested with RS (RS-2). Positive and Negative Percent Agreements (PPA, NPA) were calculated. The median (IQR) C t values of RS and M10 (OPXV target) assays were highly similar. The PPA of M10 compared to RS-1 was 89.5% considering system interpretation, and 96.0% when the operator classified results as positive if any target was detected; NPA was 100%. Comparing the RS-2 run and M10, an overall concordance of 95.3% between assays was found; however, considering operator interpretation, M10 returned more positive results than RS-2. The occurrence of False-Negative results was likely associated with the influence of thawing on low viral concentration; no False-Positive tests were observed. All samples collected at the time of Mpox diagnosis were positive and M10 correctly attributed the clade (West-Africa/II). The M10 MPX/OPX assay demonstrated high reliability in confirming MPXV infection and clade attribution.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

Mancon,

Raccagni,

Gagliardi

et al. 2024

Emerging Microbes & Infections

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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 STANDARDTM M10 SARS-CoV-2 assay as a diagnostic tool for SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples

Cited by 2 publications

References 19 publications

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

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

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

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Evaluation of STANDARDTM M10 SARS-CoV-2 assay as a diagnostic tool for SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples

Cited by 2 publications

References 19 publications

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

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

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

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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

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