Evaluation of the Diagnostic Accuracy of Xpert® Mpox and STANDARD™ M10 MPX/OPX for the Detection of Monkeypox Virus

Overview

Journal J Infect

Date 2025 Jan 17

PMID 39824291

Authors

Alessandra Romero-Ramirez

Anushri Somasundaran

Konstantina Kontogianni

Jacob Parkes

Yusra Hussain

Susan Gould

Christopher T Williams

Dominic Wooding

Richard Body

Hayley E Hardwick

J Kenneth Baillie

Jake Dunning

Malcolm G Semple

Tom E Fletcher

Thomas Edwards

Devy Emperador

Ana I Cubas-Atienzar

Affiliations

Soon will be listed here.

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.

References

Evans C . GeneXpert--a game-changer for tuberculosis control?. PLoS Med. 2011; 8(7):e1001064. PMC: 3144196. DOI: 10.1371/journal.pmed.1001064. View

Tarin-Vicente E, Alemany A, Agud-Dios M, Ubals M, Suner C, Anton A . Clinical presentation and virological assessment of confirmed human monkeypox virus cases in Spain: a prospective observational cohort study. Lancet. 2022; 400(10353):661-669. PMC: 9533900. DOI: 10.1016/S0140-6736(22)01436-2. View

Palich R, Burrel S, Monsel G, Nouchi A, Bleibtreu A, Seang S . Viral loads in clinical samples of men with monkeypox virus infection: a French case series. Lancet Infect Dis. 2022; 23(1):74-80. PMC: 9534074. DOI: 10.1016/S1473-3099(22)00586-2. View

Ouafi M, Regueme A, Alcaraz I, Riviere P, Bazus H, Salmon-Rousseau A . Oropharyngeal samples versus lesion specimens at diagnosis in patients infected with monkeypox virus in Northern France. J Med Virol. 2022; 95(1):e28276. DOI: 10.1002/jmv.28276. View

Wu F, Oghuan J, Gitter A, Mena K, Brown E . Wide mismatches in the sequences of primers and probes for monkeypox virus diagnostic assays. J Med Virol. 2022; 95(1):e28395. DOI: 10.1002/jmv.28395. View

Pan D, Nazareth J, Sze S, Martin C, Decker J, Fletcher E . Transmission of monkeypox/mpox virus: A narrative review of environmental, viral, host, and population factors in relation to the 2022 international outbreak. J Med Virol. 2023; 95(2):e28534. PMC: 10107822. DOI: 10.1002/jmv.28534. View

Adler H, Gould S, Hine P, Snell L, Wong W, Houlihan C . Clinical features and management of human monkeypox: a retrospective observational study in the UK. Lancet Infect Dis. 2022; 22(8):1153-1162. PMC: 9300470. DOI: 10.1016/S1473-3099(22)00228-6. View

Thompson C, Torres P, Kontogianni K, Byrne R, Noguera S, Luna-Muschi A . Multicenter Diagnostic Evaluation of OnSite COVID-19 Rapid Test (CTK Biotech) among Symptomatic Individuals in Brazil and the United Kingdom. Microbiol Spectr. 2023; 11(3):e0504422. PMC: 10269675. DOI: 10.1128/spectrum.05044-22. View

Breman J, Steniowski M, Zanotto E, GROMYKO A, ARITA I . Human monkeypox, 1970-79. Bull World Health Organ. 1980; 58(2):165-82. PMC: 2395797. View

10.

Ham S, Jeong H, Jung J, Kim E, Park K, Kim H . Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab. Infect Chemother. 2022; 54(2):360-363. PMC: 9259922. DOI: 10.3947/ic.2022.0047. View

11.

Pan Z, Wu Y, Zeng Y, Lin H, Xie T, Li Y . Pooled Analysis of the Accuracy of Xpert Ebola Assay for Diagnosing Ebola Virus Infection. Biomed Res Int. 2021; 2021:5527505. PMC: 8147515. DOI: 10.1155/2021/5527505. View

12.

Cubas-Atienzar A, Kontogianni K, Edwards T, Wooding D, Buist K, Thompson C . Limit of detection in different matrices of 19 commercially available rapid antigen tests for the detection of SARS-CoV-2. Sci Rep. 2021; 11(1):18313. PMC: 8443584. DOI: 10.1038/s41598-021-97489-9. View

13.

McCollum A, Damon I . Human monkeypox. Clin Infect Dis. 2013; 58(2):260-7. DOI: 10.1093/cid/cit703. View

14.

Titanji B, Tegomoh B, Nematollahi S, Konomos M, Kulkarni P . Monkeypox: A Contemporary Review for Healthcare Professionals. Open Forum Infect Dis. 2022; 9(7):ofac310. PMC: 9307103. DOI: 10.1093/ofid/ofac310. View

15.

Rossney A, Herra C, Brennan G, Morgan P, OConnell B . Evaluation of the Xpert methicillin-resistant Staphylococcus aureus (MRSA) assay using the GeneXpert real-time PCR platform for rapid detection of MRSA from screening specimens. J Clin Microbiol. 2008; 46(10):3285-90. PMC: 2566096. DOI: 10.1128/JCM.02487-07. View

16.

Li Y, Olson V, Laue T, Laker M, Damon I . Detection of monkeypox virus with real-time PCR assays. J Clin Virol. 2006; 36(3):194-203. PMC: 9628957. DOI: 10.1016/j.jcv.2006.03.012. View

17.

. WHO Director-General declares mpox outbreak a public health emergency of international concern. Saudi Med J. 2024; 45(9):1002-1003. PMC: 11376700. View

18.

Li Y, Zhao H, Wilkins K, Hughes C, Damon I . Real-time PCR assays for the specific detection of monkeypox virus West African and Congo Basin strain DNA. J Virol Methods. 2010; 169(1):223-7. PMC: 9628942. DOI: 10.1016/j.jviromet.2010.07.012. View

19.

Michel J, Targosz A, Rinner T, Bourquain D, Brinkmann A, Sacks J . Evaluation of 11 commercially available PCR kits for the detection of monkeypox virus DNA, Berlin, July to September 2022. Euro Surveill. 2022; 27(45). PMC: 9650706. DOI: 10.2807/1560-7917.ES.2022.27.45.2200816. View

20.

Gavina K, Franco L, Khan H, Lavik J, Relich R . Molecular point-of-care devices for the diagnosis of infectious diseases in resource-limited settings - A review of the current landscape, technical challenges, and clinical impact. J Clin Virol. 2023; 169:105613. DOI: 10.1016/j.jcv.2023.105613. View