Overview
- The primary objective is to improve the sensitivity of novel immunodiagnostic tests for detection of TB disease in children.
- The secondary objective is to determine biomarkers that discriminate children with TB infection and disease.
Description
- This will be done by measuring a variety of parameters in the blood samples and compare them with the current diagnostic gold standard for TB or for culture/NAAT non-confirmed TB cases a consensus case definition is used.
Currently available immunodiagnostic tests (IGRA/TST) will be compared to novel immunodiagnostic tests which will include:
- several novel, additional M. tuberculosis-specific Antigens
- cytokines that are highly expressed 2. Since there is no diagnostic gold standard for TB infection we will rely on a clinical
composite reference standard for diagnosing TB infection. Biomarkers will be determined
- by
- including M. tuberculosis-specific antigens that are specifically expressed in either TB infection or disease,
- measuring phenotypes and cytokine production of M. tuberculosis-specific cells.
Eligibility
Inclusion Criteria:
- all children / adolescents < 18 years of age undergoing evaluation for TB exposure, infection or disease.
Exclusion Criteria:
- children / adolescents with TB infection or disease who have already been started on anti-mycobacterial treatment, children who have been treated for TB previously.