ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.

This device will be investigated for use as a screening tool to facilitate diagnosis of ATB in conjunction with risk assessment, clinical context and diagnostic information. Whole blood samples will be collected in Tempus™ Blood RNA Tubes and processed on an automatized platform. The detection of a combination of under or over-expressed selected genes, constituting a transcriptional signature, will allow the characterization of ATB.

Inclusion Criteria:

• Symptoms suggestive of TB disease: cough for more than two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite.
• Willingness to give consent to take part in the study.
• Aged >18 years old.
• Healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease, no history of close contacts of active pulmonary TB patients.

Exclusion Criteria:

• Pregnant woman
• A person who has received treatment for active TB or LTBI in the past 24 months

Active TB cases will be prospectively recruited from the primary care TB clinics and participating hospitals. Healthy adults will be recruited using the healthy participant database of the participating hospitals. For LTBI population, individuals presenting to primary care facilities for reasons other than suspected TB will be approached and invited to participate as possible LTBI should they be assessed as being at increased risk for TB infection as described in the inclusion/exclusion criteria. Non-infectious respiratory disease controls will be recruited from the participing hospitals.