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

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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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rapitrade, Cape Town, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-Cell SelectTM Kit

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.

Primary outcomes

Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Oxford Immunotec

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 28, 2019
Registry last updated: Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed