Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC
Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习地点
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Bukavu、刚果民主共和国
- 招聘中
- Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu
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接触：
- Leandre Murhula Masirika
- 电话号码：+243976256802
- 邮箱：leandremurhula@gmail.com
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Paired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples.
大体时间：Laboratory analysis of collected samples up to 6 months after collection
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Laboratory analysis of collected samples up to 6 months after collection
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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