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

NCT07634081 | Recruiting

• 1 other identifier: S72060
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Mpox

Outcome Measures

Primary Outcomes (1)

• Paired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples.

  Laboratory analysis of collected samples up to 6 months after collection

Interventions

SDS-EDTA-treated chromatography strip DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected mpox infection in South Kivu, DRC.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Rwanda Biomedical Centre: collaborator
• Erasmus Medical Center: collaborator
• Centre de Recherche en Sciences Naturelles, South Kivu: collaborator
• Stansile, Rwanda: collaborator
• Division Provinciale de la Santé, Bukavu: collaborator

Study Sites (1)

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

Bukavu, Democratic Republic of the Congo

RECRUITING

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

DE (1)