Evaluation of novel diagnostic methods for detection of progression from latent to active tuberculosis

Tuberculosis (TB) is the leading single infectious disease in terms of mortality worldwide. In low-income countries one-fifth of adult deaths are associated with TB. If left untreated, each person with active TB is estimated to infect 10 to 15 new individuals annually.

Therefore, interrupting disease transmission by accurate early detection/diagnosis, paired with appropriate treatment is of major importance.

One quarter of the world´s population is estimated to be latently infected with Mycobacterium tuberculosis (Mtb) and as such are at lifelong risk of progressing to active TB. It is estimated that 10% of latently infected develop active TB. However, no tests currently exist that can accurately predict who will progress from latent to active TB.

The purpose of this project is to evaluate two novel methods to detect progression from latent TB to active disease; 1) a multiplex FluoroSpot assay that is a further development of the clinically used single-plex T-Spot assay, and 2) immune response signatures based on cell and plasma profiling.

This proposal takes advantage of a recently initiated EDCTP-funded prospective multicenter study (called ERASE-TB) that is designed to sample 2100 household contacts to individuals with active TB in Tanzania, Zimbabwe, and Mozambique.

Samples will be collected at several timepoints over two years after confirmed exposure to Mtb, providing an optimal setting to evaluate the proposed diagnostic methods.