Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC

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.

NCT Number	NCT07634081
Lead Sponsor	Universitaire Ziekenhuizen KU Leuven Collaborators: Rwanda Biomedical Centre, Erasmus Medical Center, Stansile, Rwanda, Division Provinciale de la Santé, Bukavu, Centre de Recherche en Sciences Naturelles, South Kivu
Conditions	Mpox
Enrollment	150 participants
Start Date	2026-05-01
Primary Completion	2026-07-31 (estimated)
Study Completion	2026-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-11