TUBERCULOSIS, PULMONARY
Conditions
Keywords
Tuberculosis, Mycobacterium infections, Bacterial infections, Diagnosis
Brief summary
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTISIT-TB prototype
Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour
Sponsors
BioMérieux
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of performance of the diagnostic tool | Time to bacteriological confirmation 60 days | Determination of the specificity and sensitivity of the diagnostic assay ISIT-TB Prototype for TB in a population living in a high-burden country |
Countries
South Africa
Outcome results
None listed