Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.

What this Trial Is About

Researchers are evaluating new immunodiagnostic tests to better detect tuberculosis (TB) disease in children and to identify biomarkers that can distinguish between TB infection and active disease. The study focuses on children and adolescents under 18 years old who are undergoing evaluation for TB exposure, infection, or disease. The goal is to improve current testing methods and gain a clearer understanding of TB in this young population. The study compares currently available immunodiagnostic tests with novel tests that include several new TB-specific antigens and highly expressed cytokines. Blood samples are collected to measure immune responses using secreted cytokine assays and intracellular cytokine assays, which involve specialized laboratory techniques like flow cytometry and multiplex assay readers. These tests aim to identify unique markers of TB infection and disease. Participants will provide blood samples for analysis, which will be compared to the current diagnostic standards or a clinical consensus definition when standard tests are inconclusive. Researchers will assess immune markers, cytokine production, and metabolic signatures in the samples. The primary outcome is the improvement of immunodiagnostic tests over 27 months, with secondary outcomes focusing on identifying biomarkers that differentiate TB infection from disease. The study will monitor participants throughout this period to collect and analyze data.

Diagnosis of Tuberculosis in Swiss Children