Public consultation on TPPs for diagnostics

Public consultation on TPPs for diagnostics

  • 05/09/2019

WHO has published target product profiles for diagnostics against antibacterial resistance identified as priorities. Until 29th September a public consultation process is open.

Based on a WHO Technical Consultation on In Vitro Diagnostics for AMR which took place on
27 – 28 March 2019 in Geneva, Switzerland a draft landscape of diagnostics against antibacterial resistance with lists of gaps and priorities has been reviewed (https://apps.who.int/iris/bitstream/handle/10665/326481/WHO-MVP-EMP-IAU-2019.08-eng.pdf). The landscape is now published (https://apps.who.int/iris/bitstream/handle/10665/326480/9789241516280-eng.pdf).

As a follow up to that consultation it was also agreed to develop target product profiles (TPPs) for diagnostics identified as priorities. Since then, two TPPs have been drafted and already reviewed and refined following feedback from many stakeholders. The TPPs are now being placed on the WHO web site for a 1 month public consultation period until 29th September.

WHO is thus requesting feedback on two draft target product profiles (TPPs) for diagnostic platforms to help fill testing gaps at primary and secondary healthcare facilities in low- and middle-income countries (LMICs) in the context of ABR. These diagnostic platforms are: (i) a multiplex diagnostic platform to identify WHO prioritized bacterial pathogens associated with clinical syndromes and to determine genetic determinants of antibiotic resistance/susceptibility or phenotypic antimicrobial susceptibility (AST) with respect to the pathogens identified, and (ii) a simple, easy-to-use reflex test to detect AST of prioritized bacterial pathogens performed following identification of bacterial pathogens on a separate test or test platform.

Additional background on the project is provided in the attached TPPs . All stakeholders are invited to provide feedback. An overview of the entire TPP development process is summarized here: https://www.who.int/medicines/access/antimicrobial_resistance/tpps-abr-diagnostics/en/

Please submit your comments to Dr Francis Moussy (moussyf@who.int ) by COB on 29 September 2019 using the Comment Forms provided by WHO.