Journal article
Guidance for the Evaluation of Tuberculosis Diagnostics That Meet the World Health Organization (WHO) Target Product Profiles: An Introduction to WHO Process and Study Design Principles
Abstract
Existing high-priority target product profiles (TPPs) of the World Health Organization (WHO) establish important needs for tuberculosis (TB) diagnostic development. Building on this earlier work, this guidance series aims to provide study guidance for performing accuracy studies of novel diagnostic products that may meet the 4 high-priority WHO TPPs and thus enable adequate evidence generation to inform a WHO evidence review process. Diagnostic …
Authors
Denkinger CM; Schumacher SG; Gilpin C; Korobitsyn A; Wells WA; Pai M; Leeflang M; Steingart KR; Bulterys M; Schünemann H
Journal
The Journal of Infectious Diseases, Vol. 220, No. Supplement_3, pp. s91–s98
Publisher
Oxford University Press (OUP)
Publication Date
October 8, 2019
DOI
10.1093/infdis/jiz097
ISSN
0022-1899