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临床试验/NCT05899400
NCT05899400已完成不适用

A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

Diascopic, LLC1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s).

研究概览

简要总结

A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory

排除标准

  • No samples from outside Makerere's Domain

结局指标

主要结局

Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s).

时间窗: Study completed over the grant period 2019 - 2022

Sensitivity, specificity, and average analysis time were determined. An image database of \>40,000 images was also created for internal use.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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