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 -
