Mpox sample collection with SDS-EDTA paper strips in DRC
Official title: Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection
Run by Universitaire Ziekenhuizen KU Leuven · NCT07634081 · Data updated 2026-11-12
A study tests whether SDS-EDTA-treated chromatography paper strips can collect mpox samples as well as standard swabs for lab testing in people with suspected mpox in South Kivu, DRC.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Bukavu) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT07634081 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults and others with suspected mpox presenting with at least two similarly staged skin lesions who can provide informed consent.
✕Probably not a fit
Patients with a single lesion, inconsistent lesion stages, or who cannot safely undergo paired sampling may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study compares a novel SDS-EDTA-treated chromatography paper strip method to the routine swab sampling for mpox detection under field conditions in the Democratic Republic of the Congo. Paired samples are collected from each participant, with both methods tested on locally available molecular diagnostics. The goal is to determine diagnostic yield and practical field applicability of the paper-strip approach. Eligible participants have mpox-compatible signs, at least two lesions of similar evolution, and provide informed consent. Exclusion criteria include inability to consent, only one lesion, uneven lesion stages, or unsafe paired sampling.
Why it matters
Potential benefit: If successful, the paper-strip method could offer a simpler, potentially more scalable way to collect and transport mpox samples in low-resource settings.
How similar studies have gone: Previous research in similar diagnostic comparisons suggests promising results, but this specific SDS-EDTA strip method for mpox is being tested in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu
Bukavu, Democratic Republic of the Congo Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.