A cheap, fast and reliable diagnostic test for Tuberculosis Infection

ongoing

Latent tuberculosis infection (TBI) occurs when someone is infected with Mycobacterium tuberculosis but does not have active TB disease. Those with TBI are at risk of developing active TB, with 8–10% progressing without antibiotic treatment, causing significant societal and economic impacts. Testing higher-risk groups, including immunocompromised individuals (e.g., those on immunosuppressive therapy, HIV-positive), close contacts with active TB cases, healthcare workers, and people from high TB prevalence countries (e.g., refugees), is crucial for TB control. The interferon-gamma release assay (IGRA) is a primary TBI test, detecting T cell immune responses to M. tuberculosis in blood. However, IGRA is technically challenging, requires long incubation times (24–48 hours), and incurs high costs (>100 EUR/test). These factors hinder the widespread screening of high-risk populations recommended by the WHO. We have developed a new technique, ProliSpot (patent pending), which detects antigen-specific T cell responses within several hours after collecting a blood sample and potentially overcomes the limitations of IGRA. This project's goal is to determine ProliSpot's in vitro diagnostic (IVD) potential for TBI testing. To achieve this, we will assess clinical feasibility by testing blood samples from TB patients and control subjects and compare the results with IGRA. Moreover, we will identify the subsequent steps needed for clinical development, particularly for the Investigational Medical Device Dossier (IMDD) and other requirements of the EU in vitro diagnostics regulations (IVDR). We will also perform pre-commercialization studies and define funding and networking strategies. Given that TBI testing is crucial for TB control, tens of thousands are screened annually in Europe, there is a societal need for increased TBI screening, and improved TBI testing methods are needed, the project's societal and economic impact is expected to be significant.