Assessing the Ability of the T-SPOT®.TB Test (IQ)

Study Overview
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Brief Summary
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The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.

Detailed Description
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This study will enroll up to 202 subjects (assumes 15 % exclusion/drop-out rate). The target number of subjects is 75 active TB (recruited from subjects presenting at TB clinics) and 100 active TB excluded (recruited from subjects in the community). All subjects enrolled in this study will be men or women, aged 18 years or older. Duration: 1 year

Official Title
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Assessing the Ability of the T-SPOT®.TB Test to Identify Those at Risk of Active Mycobacterium Tuberculosis Infection Using the Normalized Tuberculosis (TB) Specific Lymphocyte Response.

Conditions
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Tuberculosis

Participation Criteria
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Eligibility Criteria
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Subject Inclusion Criteria: Cohort 1A and 1B Must be at least 18 years of age Must be able to provide informed consent Must be able to provide a minimum of 10 mL of whole blood at each visit Must be T-SPOT.TB positive First visit suspect TB subjects with no prior history of TB diagnosis Subject exclusion criteria: Cohort 1A and 1B Negative in the T-SPOT.TB test Previous or pre-existing confirmed TB diagnosis On anti-TB treatment for less than 1 week* Not meeting inclusion criteria Subject inclusion criteria: Cohort 2A and 2B Must be at least 18 years of age Must be able to provide informed consent Must be able to provide a minimum of 10 mL of whole blood at each visit Must be T-SPOT.TB positive No prior history of TB diagnosis Subject exclusion criteria: Cohort 2A and 2B Negative T-SPOT.TB test Previous or pre-existing confirmed TB diagnosis On anti-TB treatment Symptoms of active TB Not meeting inclusion criteria

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test Arm 1- T-SPOT.TB assay<br>Test Arm 1: T-SPOT.TB test using density gradient isolation (Leucosep) For each subject recruited in the study, cells will be isolated using Leucosep Tubes and T-Cell Xtend reagent according to package insert. For each subject recruited in the study, the T-SPOT.TB assay will be run according to the assay package insert. | |
| Test Arm 2-QuantiFERON-TB Gold Plus assay<br>Test Arm 2: QuantiFERON-TB Gold Plus For each subject recruited in the study, the QuantiFERON-TB Gold Plus (QFT-Plus) assay will be run according to the assay package insert. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NTBSLR | The primary objective of this study is to demonstrate performance of the normalized Tuberculosis (TB) specific lymphocyte response (NTBSLR) in identifying patients with active Tuberculosis (TB) disease. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGRA | The secondary exploratory objective is to demonstrate that active Tuberculosis (TB) cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based Interferon-Gamma Release Assay (IGRA). | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TB