Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom

ISARIC 4; C Investigators,; 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

doi:10.3201/eid3106.250166

Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom

ISARIC 4
, C Investigators,
, 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

Institut National de Recherche Biomédicale
Liverpool School of Tropical Medicine
Royal Liverpool University Hospital
Foundation for Innovative New Diagnostics, Switzerland
University of Liverpool
University of Edinburgh
University of Oxford
Royal Free London NHS Foundation Trust
Liverpool Royal Hospitals NHS Foundation Trust

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	1140-1148
Number of pages	9
Journal	Emerging Infectious Diseases
Volume	31
Issue number	6
DOIs	https://doi.org/10.3201/eid3106.250166
Publication status	Published - 2 May 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Democratic Republic of the Congo
diagnostic
evaluation
lateral flow assay
lateral flow test
LFA
LFT
monkeypox virus
mpox
MPXV
Orthopoxvirus
POCT
point-of-care test
Poxviridae
rapid diagnostic test
RDT
sexually transmitted infections
United Kingdom

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10.3201/eid3106.250166

scienceletterfinalAccepted author manuscript, 223 KBLicence: CC BY

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ISARIC 4, C Investigators,, Ishara-Nshombo, E., Somasundaran, A., Romero-Ramirez, A., Kontogianni, K., Mukadi-Bamuleka, D., Mukoka-Ntumba, M., Muhindo-Milonde, E., Mirimo-Nguee, H., Parkes, J., Hussain, Y., Gould, S., Williams, C. T., Wooding, D., Nkeramahame, J., Watson, M., Hardwick, H. E., Semple, M. G., ... Cubas-Atienzar, A. I. (2025). Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom. Emerging Infectious Diseases, 31(6), 1140-1148. https://doi.org/10.3201/eid3106.250166

@article{d0027459da7c483aa34d24396618a103,

title = "Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom",

abstract = "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.",

keywords = "Democratic Republic of the Congo, diagnostic, evaluation, lateral flow assay, lateral flow test, LFA, LFT, monkeypox virus, mpox, MPXV, Orthopoxvirus, POCT, point-of-care test, Poxviridae, rapid diagnostic test, RDT, sexually transmitted infections, United Kingdom",

author = "\{ISARIC 4\} and \{C Investigators,\} and Elie Ishara-Nshombo and Anushri Somasundaran and Alessandra Romero-Ramirez and Konstantina Kontogianni and Daniel Mukadi-Bamuleka and Marith{\'e} Mukoka-Ntumba and Emile Muhindo-Milonde and Hugues Mirimo-Nguee and Jacob Parkes and Yusra Hussain and Susan Gould and Williams, \{Christopher T.\} and Dominic Wooding and Juvenal Nkeramahame and Mikaela Watson and Hardwick, \{Hayley E.\} and Semple, \{Malcolm G.\} and Baillie, \{John Kenneth\} and Jake Dunning and Fletcher, \{Thomas E.\} and Thomas Edwards and Emperador, \{Devy M.\} and Hugo Kavunga-Membo and Cubas-Atienzar, \{Ana Isabel\}",

year = "2025",

month = may,

day = "2",

doi = "10.3201/eid3106.250166",

language = "English",

volume = "31",

pages = "1140--1148",

journal = "Emerging Infectious Diseases",

issn = "1080-6040",

publisher = "Centers for Disease Control and Prevention (CDC)",

number = "6",

}

ISARIC 4, C Investigators, Ishara-Nshombo, E, Somasundaran, A, Romero-Ramirez, A, Kontogianni, K, Mukadi-Bamuleka, D, Mukoka-Ntumba, M, Muhindo-Milonde, E, Mirimo-Nguee, H, Parkes, J, Hussain, Y, Gould, S , Williams, CT , Wooding, D, Nkeramahame, J, Watson, M, Hardwick, HE, Semple, MG, Baillie, JK, Dunning, J, Fletcher, TE , Edwards, T, Emperador, DM, Kavunga-Membo, H & Cubas-Atienzar, AI 2025, 'Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom', Emerging Infectious Diseases, vol. 31, no. 6, pp. 1140-1148. https://doi.org/10.3201/eid3106.250166

TY - JOUR

T1 - Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom

AU - ISARIC 4

AU - C Investigators,

AU - Ishara-Nshombo, Elie

AU - Somasundaran, Anushri

AU - Romero-Ramirez, Alessandra

AU - Kontogianni, Konstantina

AU - Mukadi-Bamuleka, Daniel

AU - Mukoka-Ntumba, Marithé

AU - Muhindo-Milonde, Emile

AU - Mirimo-Nguee, Hugues

AU - Parkes, Jacob

AU - Hussain, Yusra

AU - Gould, Susan

AU - Williams, Christopher T.

AU - Wooding, Dominic

AU - Nkeramahame, Juvenal

AU - Watson, Mikaela

AU - Hardwick, Hayley E.

AU - Semple, Malcolm G.

AU - Baillie, John Kenneth

AU - Dunning, Jake

AU - Fletcher, Thomas E.

AU - Edwards, Thomas

AU - Emperador, Devy M.

AU - Kavunga-Membo, Hugo

AU - Cubas-Atienzar, Ana Isabel

PY - 2025/5/2

Y1 - 2025/5/2

N2 - 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.

AB - 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.

KW - Democratic Republic of the Congo

KW - diagnostic

KW - evaluation

KW - lateral flow assay

KW - lateral flow test

KW - LFA

KW - LFT

KW - monkeypox virus

KW - mpox

KW - MPXV

KW - Orthopoxvirus

KW - POCT

KW - point-of-care test

KW - Poxviridae

KW - rapid diagnostic test

KW - RDT

KW - sexually transmitted infections

KW - United Kingdom

U2 - 10.3201/eid3106.250166

DO - 10.3201/eid3106.250166

M3 - Article

C2 - 40314794

AN - SCOPUS:105007118233

SN - 1080-6040

VL - 31

SP - 1140

EP - 1148

JO - Emerging Infectious Diseases

JF - Emerging Infectious Diseases

IS - 6

ER -

Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom

Abstract

UN SDGs

Keywords

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