An evaluation framework for new tests that predict progression from tuberculosis infection to clinical disease

SV Kik, S Schumacher, DM Cirillo, G Churchyard, C Boehme, D Goletti, MX Rangaka, CM Denkinger, C Lienhardt, C Gilpin, Alberto Matteelli, F Cobelens

Research output: Contribution to journalArticle

Abstract

Novel accurate tests are needed that identify individuals infected with Mycobacterium tuberculosis who have incipient disease and are likely to develop clinical tuberculosis (TB) in the near future to allow for targeted preventive treatment beyond the current risk groups. Recently, a target product profile was developed that outlines the minimal and optimal characteristics for such an incipient TB test. We describe an evaluation framework for generating evidence to inform the development of policy guidance for the use of such a new test by the World Health Organization. Two research objectives are addressed. 1) The predictive ability of an incipient TB test should be assessed in clinical evaluation studies that include the intended target population and follow-up of sufficient duration to observe whether individuals do or do not progress to clinical TB disease. 2) Studies are needed to evaluate the test under routine programmatic conditions and measure its impact on patient- or health-system-important outcomes. For both research objectives, study designs, methods and analysis are described, with the intent to inform the clinical development plans of test manufacturers, researchers and funders. The content of this work is copyright of the authors or their employers. Design and branding are copyright ©ERS 2018.
Original languageEnglish
Article number1800946
JournalEuropean Respiratory Journal
Volume52
Issue number4
DOIs
Publication statusPublished - 2018

Fingerprint Dive into the research topics of 'An evaluation framework for new tests that predict progression from tuberculosis infection to clinical disease'. Together they form a unique fingerprint.

  • Cite this

    Kik, SV., Schumacher, S., Cirillo, DM., Churchyard, G., Boehme, C., Goletti, D., Rangaka, MX., Denkinger, CM., Lienhardt, C., Gilpin, C., Matteelli, A., & Cobelens, F. (2018). An evaluation framework for new tests that predict progression from tuberculosis infection to clinical disease. European Respiratory Journal, 52(4), [1800946]. https://doi.org/10.1183/13993003.00946-2018