High-priority target product profiles for new tuberculosis diagnostics
Report of a consensus meeting
Diagnostic manufacturers are increasingly expressing the need to be informed about the type of TB diagnostics they should invest in, as well as the potential market size for these products. The development of target product profiles (TPPs) is therefore an important step to align the needs of end-users with the specifications and targets that product developers should meet in terms of the performance and operational characteristics of such tests. In April 2014, the WHO Global TB Programme convened a meeting on behalf of the Global Laboratory Initiative (GLI) and New Diagnostics Working Group (NDWG) to develop consensus on the minimal and optimal specifications of four different types of TB diagnostic tests that were identified by multiple stakeholders to be high priority. Extensive work by McGill University, FIND, Medécins Sans Frontières (MSF), the New Diagnostics Working Group of the Stop TB Partnership and the GLI informed this process.