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

NCT07634081 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-06-11

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

SDS-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.

Sponsors & Collaborators

  • Rwanda Biomedical Centre

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Stansile, Rwanda

    collaborator UNKNOWN

  • Division Provinciale de la Santé, Bukavu

    collaborator UNKNOWN

  • Centre de Recherche en Sciences Naturelles, South Kivu

    collaborator UNKNOWN

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634081 on ClinicalTrials.gov