A Pilot Study on feasibility of improving TB Detection using an AI software for CXR screening along with GeneXpert
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cepheid
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- 1.Sensitivity, Specificity of AI based TB reporting
研究概览
简要总结
The project aims to ascertain the benefits of using AI for CXR screening for TB prior to confirmatory testing using GeneXpert. Qure’s product, qXR is an AI based Chest X-Ray interpretation software clinically relevant abnormal findings in a Chest X-ray, including indications for TB and COVID within a minute. Once an individual is flagged by qXR as TB presumptive, they are advised to proceed for confirmatory testing using GeneXpert. This study will compare the process which is currently in place for diagnosis of TB at our institution (which includes Genexpert and Chest Xray) with a new process which will include use of the Qure AI. Through this process, we intend to evaluate the software as well as the gains resulting from qXR as a screening tool for TB.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Presumptive TB patients identified by the clinician/physician based on with symptoms suggestive of TB or with high risk for TB Patients getting their X-Rays recorded for non-TB related reasons and incidentally detected by the software as having radiological signs of TB based on their chest X-Ray.
排除标准
- •Chest Xrays of patients below 6 years not included in the study.
结局指标
主要结局
1.Sensitivity, Specificity of AI based TB reporting
时间窗: 6 months
2.Reduction in time to diagnosis of TB from the chest xray
时间窗: 6 months
次要结局
- 1.Additional TB case notifications(2.Gains in diagnostic yield of GeneXpert test)