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

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

Detailed Description
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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.

Official Title
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Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis With the ISIT-TB Prototype in Adults Living in a High Burden Setting

Conditions
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TUBERCULOSIS, PULMONARY

Intervention / Treatment
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* Diagnostic Test: ISIT-TB prototype


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active TB ATB<br>Participants with active tuberculosis with diagnosis confirmed by GeneXpert and/or culture positivity | Diagnostic Test: ISIT-TB prototype<br>* Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour<br>|
| Latent Tuberculosis Infections LTBI<br>Participants with presumed latent TB infection | Diagnostic Test: ISIT-TB prototype<br>* Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour<br>|
| Healthy controls HC<br>Participants who do not have Active or Latent tuberculosis or other pathologies investigated in this study | Diagnostic Test: ISIT-TB prototype<br>* Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour<br>|
| Non-tuberculous symptomatic participants<br>This cohort refers to participants who are known with chronic respiratory conditions and present with one or more signs and symptoms suggestive of TB, but in whom microbiological testing is negative. | Diagnostic Test: ISIT-TB prototype<br>* Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 to bacteriological confirmation 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Mycobacterium infections, Bacterial infections, Diagnosis