The New Diagnostics Working Group and its Task Force on tests for progression of LTBI to active disease have recently launched an online consultation to gather input on a draft Target Product Profile (TPP) for a test of progression of latent tuberculosis infection (LTBI).
Reactivation of LTBI is the source of the vast majority of new TB cases in low transmission areas. As global TB incidence declines, preventing progression from LTBI to active TB will be crucial for cutting transmission and reaching the goal of TB elimination. The introduction of targeted and cost-effective treatment of individuals with LTBI requires a diagnostic test to identify the small proportion of latently infected persons who will progress to active disease.
A prognostic test for determining the risk of progression from LTBI to active disease is currently unavailable. To support the development of this new test, FIND has defined a draft TPP with contribution from the NDWG LTBI Task Force and other experts in the field. This document will provide guidance to diagnostic developers as to the key characteristics that the test needs to fulfill in order to meet requirements.
The NDWG is conducting an online survey to gather input from a group of stakeholders representing researchers, endemic countries, governmental and non-governmental organizations, test developers and the patient community. Participants will have the opportunity to evaluate the key performance and operational characteristics as defined in the TPP in order to build large consensus. Results will be discussed by an expert group which will be convened by the NDWG Task Force on LTBI on July 1st 2016 in Milan, Italy, in order to finalize the TPP and submit the document to WHO for endorsement.