Actively Recruiting

All Genders
ID07634081

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

All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

Loading map...

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

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here