RT Journal Article
SR Electronic
T1 An evaluation framework for new tests that predict progression from tuberculosis infection to clinical disease
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1800946
DO 10.1183/13993003.00946-2018
A1 Sandra V. Kik
A1 Samuel Schumacher
A1 Daniela Maria Cirillo
A1 Gavin Churchyard
A1 Catharina Boehme
A1 Delia Goletti
A1 Molebogeng X. Rangaka
A1 Claudia M. Denkinger
A1 Christian Lienhardt
A1 Christopher Gilpin
A1 Alberto Matteelli
A1 Frank Cobelens
YR 2018
UL http://erj.ersjournals.com/content/early/2018/07/12/13993003.00946-2018.abstract
AB 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. First, 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. Secondly, 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.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Schumacher has nothing to disclose.Conflict of interest: Dr. Churchyard has nothing to disclose.Conflict of interest: Dr. BOEHME has nothing to disclose.Conflict of interest: Dr. GOLETTI has nothing to disclose.Conflict of interest: Dr. RANGAKA has nothing to disclose.Conflict of interest: Dr. Denkinger reports and FIND is a non-for-profit foundation, whose mission is to find diagnostic solutions to overcome diseases of poverty inConflict of interest: Dr. Lienhardt has nothing to disclose.Conflict of interest: Dr. Gilpin has nothing to disclose.Conflict of interest: Dr. Matteelli has nothing to disclose.Conflict of interest: Dr. Cobelens has nothing to disclose.Conflict of interest: Dr. Cirillo has nothing to disclose.Conflict of interest: Dr. Kik has nothing to disclose.