Validation of SDS-EDTA-treated Chromatography Paper Strips for Sampling, Transportation and Laboratory Detection of Mpox Under Field Conditions in the Democratic Republic of the Congo

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    150
  • sponsor
    Universitaire Ziekenhuizen KU Leuven
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Updated on 9 June 2026
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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.

Details
Condition Mpox
Clinical Study IdentifierNCT07634081
SponsorUniversitaire Ziekenhuizen KU Leuven
Last Modified on9 June 2026

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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