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临床试验/NCT07634081
NCT07634081招募中不适用

Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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