Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SDS-EDTA-treated chromatography strip.
- Who it may be relevant to
- Registry conditions: Mpox. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Democratic Republic of the Congo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection
Overview
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.
Interventions
- Diagnostic test SDS-EDTA-treated chromatography strip
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 outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Democratic Republic of the Congo · 1 center
- Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu — Bukavu
Identifiers
NCT: NCT07634081 · S72060