A cheap, fast and reliable diagnostic test for Tuberculosis Infection

Descripción del proyecto

Análisis de sangre más rápido, barato y eficaz para detectar la infección por tuberculosis

La tuberculosis está presente en todos los países y, aunque se puede curar y prevenir, constituye la principal causa de muerte en el mundo por un único agente infeccioso. Su detección temprana podría marcar la diferencia. Se calcula que cerca de una cuarta parte de la población mundial está infectada por la bacteria de la tuberculosis, y entre el 8-10 % de estas personas desarrollarán la enfermedad. Hoy en día, el diagnóstico de la infección se hace con una prueba de sangre cara y compleja, que necesita entre dos y cuatro días de incubación. El proyecto FastTBItest, financiado por el Consejo Europeo de Investigación, ha desarrollado una alternativa pendiente de patente que detecta la infección en cuestión de horas. Su equipo evaluará la viabilidad clínica de la prueba como diagnóstico «in vitro», determinará la normativa de la Unión Europea a cumplir y avanzará hacia su comercialización.

Objetivo

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.