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

N/ACompletedNCT04141982

Oxford Immunotec680 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

680

Conditions

Tuberculosis

Interventions

T-Cell SelectTM KitDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

NECCR Primacare Research, LLC

Fall River, Massachusetts, United States

Ohio State University

Columbus, Ohio, United States

University of Texas Health Science Center at Houston, School of Public Health in Brownsville

Brownsville, Texas, United States

Rapitrade

Cape Town, South Africa

Outcomes

Primary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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