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

Tuberculosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141982
• Other study ID #: OI-18-01-IP-0001
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: March 18, 2020

Study information

• Verified date: March 2022
• Source: Oxford Immunotec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
South Africa	Rapitrade	Cape Town
United States	University of Texas Health Science Center at Houston, School of Public Health in Brownsville	Brownsville	Texas
United States	Ohio State University	Columbus	Ohio
United States	NECCR Primacare Research, LLC	Fall River	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Immunotec

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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