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.
Study Type
OBSERVATIONAL
Enrollment
150
Chromatography 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.
Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu
Bukavu, Democratic Republic of the Congo
RECRUITINGPaired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples.
Time frame: Laboratory analysis of collected samples up to 6 months after collection
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