Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom
The ongoing outbreaks of mpox highlight the urgent need for a rapid and low-cost diagnostic test to accurately detect and control this emerging disease. We estimated the analytical sensitivity using viral culture of the monkeypox virus clade IIb lineage B1 and clinical diagnostic performance of 3 a...
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| Format: | Article |
| Language: | English |
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Centers for Disease Control and Prevention
2025-06-01
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| Series: | Emerging Infectious Diseases |
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| Online Access: | https://wwwnc.cdc.gov/eid/article/31/6/25-0166_article |
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| author | Elie Ishara-Nshombo Anushri Somasundaran Alessandra Romero-Ramirez Konstantina Kontogianni Daniel Mukadi-Bamuleka Marithé Mukoka-Ntumba Emile Muhindo-Milonde Hugues Mirimo-Nguee Jacob Parkes Yusra Hussain Susan Gould Christopher T. Williams Dominic Wooding Juvenal Nkeramahame Mikaela Watson Hayley E. Hardwick Malcolm G. Semple John Kenneth Baillie Jake Dunning Thomas E. Fletcher Thomas Edwards Devy M. Emperador Hugo Kavunga-Membo Ana Isabel Cubas-Atienzar |
| author_facet | Elie Ishara-Nshombo Anushri Somasundaran Alessandra Romero-Ramirez Konstantina Kontogianni Daniel Mukadi-Bamuleka Marithé Mukoka-Ntumba Emile Muhindo-Milonde Hugues Mirimo-Nguee Jacob Parkes Yusra Hussain Susan Gould Christopher T. Williams Dominic Wooding Juvenal Nkeramahame Mikaela Watson Hayley E. Hardwick Malcolm G. Semple John Kenneth Baillie Jake Dunning Thomas E. Fletcher Thomas Edwards Devy M. Emperador Hugo Kavunga-Membo Ana Isabel Cubas-Atienzar |
| author_sort | Elie Ishara-Nshombo |
| collection | DOAJ |
| description |
The ongoing outbreaks of mpox highlight the urgent need for a rapid and low-cost diagnostic test to accurately detect and control this emerging disease. We estimated the analytical sensitivity using viral culture of the monkeypox virus clade IIb lineage B1 and clinical diagnostic performance of 3 antigen detection rapid diagnostic tests (Ag-RDT) by using skin swab samples and upper-respiratory swab samples from mpox patients in the Democratic Republic of the Congo and the United Kingdom. The analytical limit of detection was 1.0 × 104 plaque-forming units/mL, fulfilling World Health Organization recommendations. Specificity of the 3 Ag-RDTs was 100%, but sensitivity was estimated at 0.00%–15.79% using skin samples and 0.00% using respiratory samples. None of the 3 Ag-RDTs reached the World Health Organization’s target clinical sensitivity, and we do not recommend them as diagnostic or screening tools for suspected mpox cases. Accurate Ag-RDTs for mpox diagnosis remain urgently needed.
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| format | Article |
| id | doaj-art-2ed89d7bba6c4bcbbc8bc5f1d6486ffd |
| institution | OA Journals |
| issn | 1080-6040 1080-6059 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Centers for Disease Control and Prevention |
| record_format | Article |
| series | Emerging Infectious Diseases |
| spelling | doaj-art-2ed89d7bba6c4bcbbc8bc5f1d6486ffd2025-08-20T02:16:50ZengCenters for Disease Control and PreventionEmerging Infectious Diseases1080-60401080-60592025-06-013161140114810.3201/eid3106.250166Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United KingdomElie Ishara-NshomboAnushri SomasundaranAlessandra Romero-RamirezKonstantina KontogianniDaniel Mukadi-BamulekaMarithé Mukoka-NtumbaEmile Muhindo-MilondeHugues Mirimo-NgueeJacob ParkesYusra HussainSusan GouldChristopher T. WilliamsDominic WoodingJuvenal NkeramahameMikaela WatsonHayley E. HardwickMalcolm G. SempleJohn Kenneth BaillieJake DunningThomas E. FletcherThomas EdwardsDevy M. EmperadorHugo Kavunga-MemboAna Isabel Cubas-Atienzar The ongoing outbreaks of mpox highlight the urgent need for a rapid and low-cost diagnostic test to accurately detect and control this emerging disease. We estimated the analytical sensitivity using viral culture of the monkeypox virus clade IIb lineage B1 and clinical diagnostic performance of 3 antigen detection rapid diagnostic tests (Ag-RDT) by using skin swab samples and upper-respiratory swab samples from mpox patients in the Democratic Republic of the Congo and the United Kingdom. The analytical limit of detection was 1.0 × 104 plaque-forming units/mL, fulfilling World Health Organization recommendations. Specificity of the 3 Ag-RDTs was 100%, but sensitivity was estimated at 0.00%–15.79% using skin samples and 0.00% using respiratory samples. None of the 3 Ag-RDTs reached the World Health Organization’s target clinical sensitivity, and we do not recommend them as diagnostic or screening tools for suspected mpox cases. Accurate Ag-RDTs for mpox diagnosis remain urgently needed. https://wwwnc.cdc.gov/eid/article/31/6/25-0166_articlempoxmonkeypox virusMPXVsexually transmitted infectionsOrthopoxvirusPoxviridae |
| spellingShingle | Elie Ishara-Nshombo Anushri Somasundaran Alessandra Romero-Ramirez Konstantina Kontogianni Daniel Mukadi-Bamuleka Marithé Mukoka-Ntumba Emile Muhindo-Milonde Hugues Mirimo-Nguee Jacob Parkes Yusra Hussain Susan Gould Christopher T. Williams Dominic Wooding Juvenal Nkeramahame Mikaela Watson Hayley E. Hardwick Malcolm G. Semple John Kenneth Baillie Jake Dunning Thomas E. Fletcher Thomas Edwards Devy M. Emperador Hugo Kavunga-Membo Ana Isabel Cubas-Atienzar Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom Emerging Infectious Diseases mpox monkeypox virus MPXV sexually transmitted infections Orthopoxvirus Poxviridae |
| title | Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom |
| title_full | Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom |
| title_fullStr | Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom |
| title_full_unstemmed | Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom |
| title_short | Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom |
| title_sort | diagnostic accuracy of 3 mpox lateral flow assays for antigen detection democratic republic of the congo and united kingdom |
| topic | mpox monkeypox virus MPXV sexually transmitted infections Orthopoxvirus Poxviridae |
| url | https://wwwnc.cdc.gov/eid/article/31/6/25-0166_article |
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