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Consensus Meeting Report: Development of a Target Product Profile...

共识会议报告:为预测从结核病感染到活动性疾病进展的测试制定目标产品简介(TPP)和评估框架

【作       者】:

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【机       构】: 世界卫生组织
【承研机构】:

【原文地址】: https://www.who.int/publications/i/item/WHO-HTM-TB-2017.18
【发表时间】:

2017-12-01

摘要

In May 2015, an Expert Consultation was convened by the World Health Organization (WHO) Geneva on behalf of the New Diagnostics Working Group, Stop TB Partnership (NDWG) and FIND to identify the operational and performance characteristics of tests that could predict progression from latent TB infection to active TB disease. The document presents a Target Product Profile (TPP) for a test of progression of LTBI that defines key specifications, such as intended use, performance and operational characteristics, and pricing; along with a framework for the evaluation of tests that predict progression to active TB disease using standard study designs and evaluation protocols. The TEG evaluated the findings from two sets of evidence during the meeting and performed a final review of the performance characteristic in the TPP. Evidence from a systematic review of commercially available sample transport products and the findings from a study conducted by FIND for the use of OMNIgene?SPUTUM solution were assessed by the TEG. This meeting report provides a summary of the evidence for the use of individual commercial sample transport products.

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