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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

680 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-03-18

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

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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.

Conditions

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected of having TB infection

These donors are suspected of having TB infection and live in a high endemic area for TB infection

T-Cell SelectTM Kit

Intervention Type DIAGNOSTIC_TEST

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.

No (or minimal) TB risk factors

These donors must have no previous medical record of TB infection and live in low endemic area for TB infection

T-Cell SelectTM Kit

Intervention Type DIAGNOSTIC_TEST

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.

low/intermediate risk of TB infection population

These donors must live in an low/intermediate endemic area for TB infection

T-Cell SelectTM Kit

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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T-Cell SelectTM Kit

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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

* Current/previous TB diagnosis

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes