Validation of SDS-EDTA-treated Chromatography Paper Strips for Sampling, Transportation and Laboratory Detection of Mpox Under Field Conditions in the Democratic Republic of the Congo

June 2, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

USE OF SDS/EDTA-TREATED CHROMATOGRAPHY STRIPS FOR SAMPLING, TRANSPORTATION AND LABORATORY CONFIRMATION OF MPOX VIRUS INFECTION

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected mpox infection in South Kivu, DRC.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Laboratory analysis of collected samples up to 6 months after collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S72060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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