Assessing the Ability of the T-SPOT®.TB Test

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 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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The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 680 subjects (based on previous enrolment rates of approximately 300-350 subjects enrolled for 50 active TB and 50 active TB excluded). Study Duration: 6 months All subjects enrolled in this study will be men or women, aged 18 years or older.

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 TB Specific Lymphocyte Response

Conditions
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Tuberculosis (TB)

Participation Criteria
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Eligibility Criteria
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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 (16mL for immunocompromised i.e. HIV+) Must be T-SPOT.TB positive First visit suspect TB subjects with no prior history of TB diagnosis 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 (16mL for immunocompromised i.e. HIV+) Must be T-SPOT.TB positive No prior history of TB diagnosis 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 more than 1 week* Not meeting inclusion criteria 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>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>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 |
| --- | --- | --- |
| T-Spot | 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. | 6 month study | 

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