Tuberculosis (TB) remains a major global health problem, with latent tuberculosis infection (TBI) affecting a substantial proportion of the population. Identifying TBI is essential to prevent progression to active TB, particularly in high-risk groups such as immunocompromised individuals and people from TB-endemic regions. However, current diagnostic methods, including tuberculin skin testing and interferon-gamma release assays (IGRAs), have important limitations in terms of sensitivity, speed, variability and cost. FastTBItest aimed to evaluate ProliSpot, a novel blood-based test that detects antigen-specific T-cell proliferation rather than interferon-γ release. The project assessed its clinical feasibility for TBI testing, including sensitivity, specificity, variability, testing time and cost, and investigated the requirements for IVDR certification and further commercial development. The project generated encouraging clinical results. ProliSpot showed higher sensitivity than QuantiFERON-TB in a Dutch cohort and detected more positive TBI cases in a study in Indonesia. These results indicated that improved sensitivity, rather than speed alone, could be the key advantage of ProliSpot, particularly for immunocompromised patients in whom current tests perform poorly. The results provided the basis for further clinical and commercial development and directly supported the submission of an EIC Transition proposal. The follow-up project aims to validate ProliSpot in immunocompromised populations and advance the technology towards an IVDR-compliant clinical diagnostic.
