Operational characteristics.

In 2014, the World Health Organization (WHO) published target product profiles (TPPs) which detailed minimal and optimal criteria to address high-priority TB diagnostic needs. Since then, the TB community’s needs have evolved; there has been a surge in new and innovative platforms suggesting use of alternative non-invasive specimens for TB diagnosis. This updated TPP used evidence-based modelling to guide the decision-making process for specific characteristics which was a novel approach to this process. This document focusses on point of care, near point of care and low complexity assays using sputum and non-sputum-based specimens. The standard WHO protocol was followed for this TPP document including Delphi process, public comments and TPP development group consultations. Our modelling work suggests that lower accuracy estimates for point of care, easily accessible tests are acceptable to achieve comparable or better case detection than the current standard of care. In this document, we describe the process of updating the TPP for TB diagnostic tests at peripheral settings, highlight key updates, use of modelling to inform this update, and discuss guidance regarding technical and operational specifications.