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临床试验/NCT04734236
NCT04734236Unknown不适用

Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis by Using New Sample Preparation and Detection Technique

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
The effectiveness of new diagnostic technique

研究概览

简要总结

This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are suspected with pulmonary tuberculosis, tuberculosis meningitis, tuberculosis peritonitis, tuberculosis pleurisy

排除标准

  • Under 18 years

结局指标

主要结局

The effectiveness of new diagnostic technique

时间窗: Time Frame: An average of 2 year

sensitivity and specificity of new test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sei Won Lee

Dr

Asan Medical Center

研究点 (2)

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