Generating high-quality evidence for policy on WHO high-priority target product profiles for TB diagnostics

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.


Denkinger JID 2019.pdf (190.6 KB)

Schumacher JID 2019.pdf (715.7 KB)

Drain JID 2019.pdf (2.2 MB)

Nathavitharana JID 2019.pdf (2.7 MB)

Georghiou JID 2019.pdf (389.3 KB)


This is an excellent summary of detailed guidance for TB Dx studies, that we will put to use immediately. Appreciations to all of the co-authors for their excellent scholarship, and to Madhu for posting the papers outside the paywall. Salut!

Thanks Madhu for posting and Puneet for the positive feedback. Just to say that these are all open access!