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

NCT07634081 — Recruiting, 150 participants, Universitaire Ziekenhuizen KU Leuven

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

Registry	NCT07634081
Status	Recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Universitaire Ziekenhuizen KU Leuven (Other); collaborators: Rwanda Biomedical Centre, Erasmus Medical Center, Stansile, Rwanda, Division Provinciale de la Santé, Bukavu, Centre de Recherche en Sciences Naturelles, South Kivu
Conditions	Mpox
Interventions	SDS-EDTA-treated chromatography strip (Diagnostic test)
Dates	start 2026-05-01, primary completion 2026-07-31 (estimated), completion 2026-07-31 (estimated), first posted 2026-06-08, last updated 2026-06-11
Locations	1 site in Democratic Republic of the Congo

-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.

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+Arms and 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.

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu	Bukavu	Democratic Republic of the Congo	Recruiting