RecruitingNCT07634081

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

Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

150 participants

Start Date

May 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying SDS-EDTA-treated chromatography strip for people with mpox. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSDS-EDTA-treated chromatography strip

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.


Locations(1)

Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu

Bukavu, Democratic Republic of the Congo

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NCT07634081


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