Actively Recruiting
Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-06-08
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
R
Rwanda Biomedical Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new method for collecting and transporting samples to detect mpox virus infection. This study compares SDS-EDTA-treated chromatography paper strips with the routine swab-based sampling method to see which is better at identifying the virus under real field conditions in the Democratic Republic of the Congo. The study focuses on patients suspected of having mpox who visit healthcare facilities in South Kivu, DRC. Participants will have paired samples taken at the same time using both the standard swab method and the SDS-EDTA strip method. The SDS-EDTA strip contains chemicals that inactivate the virus and stabilize its genetic material, making transport safer and less dependent on refrigeration. Both types of samples are then analyzed using molecular diagnostic tools available locally. During the study, researchers collect samples from patients with at least two skin lesions suitable for paired sampling. The main goal is to compare how often each sampling method detects the mpox virus. Laboratory analysis of the samples may continue for up to six months after they are collected. Participants provide written consent, and the study monitors the diagnostic accuracy and practicality of the new strip method in field settings.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants have paired samples collected using SDS-EDTA-treated chromatography strips and routine swab samples for laboratory analysis of mpox infection.
1 visit for sample collection
Duration - Up to 6 months after sample collection
Laboratory analysis of collected samples to determine mpox positivity.
No additional visits required
Trial Site Locations
Total: 1 location
1
Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu
Bukavu, Democratic Republic of the Congo
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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