WHO target product profile for TB detection at peripheral settings: 2024 update

Area of Science:

• Infectious Diseases
• Public Health
• Medical Diagnostics

Background:

• The World Health Organization (WHO) established Target Product Profiles (TPPs) for TB diagnostics in 2014.
• Evolving needs and innovative platforms necessitate updated criteria for TB diagnostic tests, including non-sputum specimens.

Purpose of the Study:

• To update the TPPs for tuberculosis diagnostic tests, focusing on point-of-care, near point-of-care, and low-complexity assays.
• To incorporate evidence-based modeling into the TPP development process for the first time.

Main Methods:

• Followed standard WHO TPP development protocols, including Delphi process and public consultations.
• Utilized evidence-based modeling to inform decisions on assay characteristics.
• Focused on assays using both sputum and non-sputum specimens for peripheral settings.

Main Results:

• Modeling suggests that reduced accuracy for point-of-care tests is acceptable.
• Achieving comparable or better case detection than the current standard of care is feasible with updated criteria.
• Key updates focus on technical and operational specifications for peripheral TB diagnostics.

Conclusions:

• The updated TPP provides guidance for developing effective TB diagnostic tests for peripheral settings.
• The use of modeling represents a novel approach to TPP development.
• The updated profiles aim to improve TB diagnosis accessibility and effectiveness globally.