A cheap, fast and reliable diagnostic test for Tuberculosis Infection

Projektinformationen

FastTBItest

ID Finanzhilfevereinbarung: 101207558

DOI

10.3030/101207558

Projekt abgeschlossen

EK-Unterschriftsdatum 22 Februar 2025

Startdatum 1 März 2025

Enddatum 31 August 2026

Finanziert unter

• European Research Council (ERC)

Gesamtkosten

Keine Daten

EU-Beitrag

€ 150 000,00

Koordiniert durch

RIJKSUNIVERSITEIT GRONINGEN
Netherlands

Periodic Reporting for period 1 - FastTBItest (A cheap, fast and reliable diagnostic test for Tuberculosis Infection)

Berichtszeitraum: 2025-03-01 bis 2026-08-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

The project focused on evaluating ProliSpot as a diagnostic test for tuberculosis infection and assessing its technical feasibility for further clinical development. We first optimized the assay workflow, including a simplified PBMC isolation procedure based on red blood cell lysis. This approach gave improved cell yields and was incorporated into the standard protocol. We also demonstrated the feasibility of using small-volume capillary blood samples, although this was not taken forward because it only allowed testing of a single condition. The main technical achievement was the clinical evaluation of ProliSpot. In a Dutch study including 35 patients with TB disease, ProliSpot showed higher sensitivity than QuantiFERON-TB for detection of active TB. In a second study in Indonesia, ProliSpot detected more positive cases among individuals with asymptomatic TBI. These results provided the first clinical evidence supporting the diagnostic potential of the technology. In parallel, the requirements for clinical translation were assessed, including the IVDR, technical documentation, quality management requirements and the steps towards CE certification. This resulted in a defined roadmap for further clinical development and regulatory approval.
Overall, the project demonstrated the clinical potential of ProliSpot and identified improved diagnostic sensitivity as a potentially stronger advantage than the originally targeted reduction in testing time. These results provided the scientific basis for the subsequent EIC Transition proposal, which builds directly on the outcomes of FastTBItest and aims to further validate and translate ProliSpot towards a clinical IVD.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

ProliSpot provides a new approach to TBI diagnostics by measuring antigen-specific T-cell proliferation rather than interferon-gamma release. The project demonstrated the technical feasibility of this approach and its application to clinical samples. The clinical studies provided encouraging evidence of improved diagnostic performance. In the Netherlands, ProliSpot showed higher sensitivity than QuantiFERON-TB for detection of active TB, while in Indonesia it detected more positive cases among individuals with asymptomatic TBI. These findings indicated that improved sensitivity may be the main added value of ProliSpot, particularly in populations where current diagnostics perform poorly. The results also enabled the technology to move beyond the laboratory proof of concept. Limosa Immunodiagnostics B.V. was established as a spin-off and obtained an exclusive licence for ProliSpot. A second patent covering clinical TBI diagnostics was filed, and the technology was further developed into a research-use-only product. Further development now requires larger clinical validation studies, particularly in immunocompromised populations, together with final assay standardisation, software/readout development and completion of the IVDR requirements. Overall, FastTBItest established the clinical potential of ProliSpot, demonstrated a potentially significant improvement in diagnostic sensitivity, and enabled its transition towards clinical and commercial development. These results directly supported the subsequent submission of an EIC Transition proposal.