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

• Sponsor: Oxford Immunotec (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04141982
• Collaborator: (none)
• Enrollment: 680
• Locations: 4
• Actual Duration (Months): 4.4
• Patients Per Site: 170
• Patients Per Site Per Month: 38.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Diagnostic Test: T-Cell SelectTM Kit

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 680 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Nov 4, 2019
• Actual Primary Completion Date: Mar 18, 2020
• Actual Study Completion Date: Mar 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Suspected of having TB infection These donors are suspected of having TB infection and live in a high endemic area for TB infection	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.
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	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.
low/intermediate risk of TB infection population These donors must live in an low/intermediate endemic area for TB infection	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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NECCR Primacare Research, LLC	Fall River	Massachusetts	United States	02721
2	Ohio State University	Columbus	Ohio	United States	43210
3	University of Texas Health Science Center at Houston, School of Public Health in Brownsville	Brownsville	Texas	United States	78520
4	Rapitrade	Cape Town		South Africa

Sponsors and Collaborators

• Oxford Immunotec

Investigators

• Principal Investigator: Andre Trollip, PhD, Rapitrade
• Principal Investigator: Blanca Restrepo, PhD, The University of Texas Health Science Center, Houston
• Principal Investigator: Ehab Sorial, MD, NECCR Primacare Research, LLC
• Principal Investigator: Shu-Hua Wang, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oxford Immunotec
• ClinicalTrials.gov Identifier: NCT04141982
• Other Study ID Numbers: OI-18-01-IP-0001
• First Posted: Oct 28, 2019
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tuberculosis

Study Results

No Results Posted as of Mar 3, 2022