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

Recruitingn/aAges any - anyAllUniversitaire Ziekenhuizen KU Leuven
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In plain words

What the trial is, and whether it could suit you

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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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • SDS-EDTA-treated chromatography strip
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Where

1 site
Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu
Bukavu, Democratic Republic of the Congo
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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