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

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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Key information

Conditions

Mpox Animal Diseases DNA Virus Infections Infections Mpox, Monkeypox Poxviridae Infections Primate Diseases Rodent Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bukavu, Democratic Republic of the Congo

Location status: Recruiting

Location contact

Leandre Murhula Masirika

CONTACT

[email protected]

+243976256802

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: Laboratory analysis of collected samples up to 6 months after collection

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

Centre de Recherche en Sciences Naturelles, South Kivu
Division Provinciale de la Santé, Bukavu
Erasmus Medical Center
Rwanda Biomedical Centre
Stansile, Rwanda

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 8, 2026
Registry last updated: Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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