Evidence map›Paper›PMID 39824291›Full record

ArticleThe Journal of infection2025

Evaluation of the diagnostic accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the detection of monkeypox virus.

Alessandra Romero-Ramirez, Anushri Somasundaran, Konstantina Kontogianni, Jacob Parkes, Yusra Hussain, Susan Gould, Christopher T Williams, Dominic Wooding, Richard Body, Hayley E Hardwick and 9 more

Abstract readEvaluation Study
In one paragraph

Article in The Journal of infection, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Alessandra Romero-RamirezCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Anushri SomasundaranCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Konstantina KontogianniCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Jacob ParkesCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Yusra HussainCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Susan GouldDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, UK; Royal Liverpool University Hospital NHS Foundation Trust, UK.
Christopher T WilliamsCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Dominic WoodingCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Richard BodyManchester University NHS Foundation Trust, UK.
Hayley E HardwickNIHR Health Protection Research Unit in Emerging and Zoonotic Infections, Department of Clinical Infection, Microbiology and Immunology, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.
J Kenneth BaillieBaillie Gifford Pandemic Science Hub, Institute for Regeneration and Repair, University of Edinburgh, UK.
Jake DunningPandemic Sciences Institute, University of Oxford, UK; Infectious Diseases Department, Royal Free London NHS Foundation Trust, London, UK.
Malcolm G SempleNIHR Health Protection Research Unit in Emerging and Zoonotic Infections, Department of Clinical Infection, Microbiology and Immunology, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.
CONDOR steering group
ISARIC 4C Investigators
Tom E FletcherDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, UK; Royal Liverpool University Hospital NHS Foundation Trust, UK.
Thomas EdwardsCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK.
Devy EmperadorFoundation of Innovative Diagnostics, Geneva, Switzerland.
Ana I Cubas-AtienzarCentre for Drugs and Diagnostics, Liverpool School of Tropical Medicine, UK. Electronic address: Ana.CubasAtienzar@lstmed.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 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.

resultsThe 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.

Indexed as

Molecular Diagnostic TechniquesMonkeypox virusMpox, MonkeypoxAdultCOVID-19FemaleHumansMaleMiddle AgedPoint-of-Care TestingReal-Time Polymerase Chain ReactionSARS-CoV-2Sensitivity and SpecificityDiagnosticsMonkeypoxMpoxMPXVOrthopoxvirusPCRPoint-of-care (POC)

Identifiers

PMID39824291
PMCPMC11825380

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.