Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis

BioMérieux722 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

722

Conditions

TUBERCULOSIS, PULMONARY

Interventions

ISIT-TB prototypeDIAGNOSTIC_TEST

Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Cape Town Lung Institute

Cape Town, South Africa

Outcomes

Primary Outcomes

Evaluation of performance of the diagnostic tool

Determination of the specificity and sensitivity of the diagnostic assay ISIT-TB Prototype for TB in a population living in a high-burden country

Time frame: Time to bacteriological confirmation 60 days

Data from ClinicalTrials.gov

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