Clinical Concordance Evaluation of T-SPOT®.TB Assay Performance (T-Cell SelectTM Study)

Study Overview
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Brief Summary
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The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture

Detailed Description
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In this study, clinical concordance between results of the T-SPOT.TB assay, using cells stored for 0-8 hours post venepuncture and isolated via density gradient separation and positive selection with magnetic bead isolation using the T-Cell SelectTM Kit will be assessed. Concordance between results of the T-SPOT.TB assay at 0-8 hours post venepuncture and using cells isolated with density gradient centrifugation and results obtained from cells isolated using the T-Cell Select Kit, following storage between 0-55 hours post venepuncture, will be assessed.

Official Title
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Clinical Concordance Evaluation of the T-SPOT®.TB Assay Performance Using Positive Selection With the T-Cell SelectTM Kit and Density Gradient Cell Isolation Methods

Conditions
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Tuberculosis

Intervention / Treatment
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* Diagnostic Test: T-Cell SelectTM Kit


Participation Criteria
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Eligibility Criteria
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Subjects presenting at sites enrolling suspected of having TB infection population Inclusion Criteria Be able to provide informed consent Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood. Have suspected TB infection. Be at least 18 years of age. Live in a high endemic area for TB infection Exclusion Criteria • Unable to meet inclusion criteria Subjects presenting at sites enrolling no (or minimal) TB risk factors population Inclusion Criteria Be able to provide informed consent Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood. Have no suspicion TB infection. Be at least 18 years of age. Live in low endemic area for TB infection Have no previous medical record of TB infection Exclusion Criteria Unable to meet inclusion criteria Current/previous TB diagnosis Subjects presenting at sites enrolling low/intermediate TB risk factors population Inclusion Criteria Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood. Have no suspicion TB infection. Be at least 18 years of age. Live in an low/intermediate endemic area for TB infection Exclusion Criteria Unable to meet 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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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 |
| --- | --- |
| Suspected of having TB infection<br>These donors are suspected of having TB infection and live in a high endemic area for TB infection | Diagnostic Test: T-Cell SelectTM Kit<br>* The T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay.<br>|
| No (or minimal) TB risk factors<br>These donors must have no previous medical record of TB infection and live in low endemic area for TB infection | Diagnostic Test: T-Cell SelectTM Kit<br>* The T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay.<br>|
| low/intermediate risk of TB infection population<br>These donors must live in an low/intermediate endemic area for TB infection | Diagnostic Test: T-Cell SelectTM Kit<br>* The T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture | Achieving 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture | 1 year |