The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory detection of mpox virus compared with the routine swab-based sampling method under field conditions in the Democratic Republic of the Congo (DRC).
The study is conducted among patients with suspected mpox infection presenting to healthcare facilities in South Kivu, DRC. For each participant, paired samples are collected simultaneously using the standard swab method and the SDS-EDTA strip method. Samples are analyzed using locally available molecular diagnostic platforms.
Patients presenting with clinical signs compatible with mpox infection according to national case definition.
Written informed consent obtained.
Presence of at least two skin lesions in a similar stage of evolution suitable for paired sampling.
Refusal or inability to provide informed consent.
Presence of only one suitable lesion for sampling.
Lesions at markedly different stages of evolution.
Inability to safely obtain paired samples.
Patients with suspected mpox infection in South Kivu, DRC.
Cohort
Prospective
SDS-EDTA-treated chromatography strip
Diagnostic testChromatography strip treated with a buffer containing SDS and EDTA. SDS inactivates the virus and reduces biosafety constraints during transport, while EDTA stabilizes nucleic acids and reduces dependence on cold-chain conditions.
Paired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples.
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Rwanda Biomedical Centre
Collaborator
Erasmus Medical Center
Collaborator
Stansile, Rwanda
Collaborator
Division Provinciale de la Santé, Bukavu
Collaborator
Centre de Recherche en Sciences Naturelles, South Kivu
Collaborator