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

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

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

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 680

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Rapitrade
• United States
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR Primacare Research, LLC
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Texas
    • Brownsville, Texas, United States, 78520
      • University of Texas Health Science Center at Houston, School of Public Health in Brownsville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This evaluation will collect blood samples from subjects suspected of having TB infection and, samples from a low risk control population with no (or minimal) TB risk factors. All subjects presenting at participating clinics will be eligible for enrolment into the study provided they meet the inclusion/exclusion criteria outlined in section 4. Based on previous experience and the medical profile of the patient attending each of clinics at the four study sites, it is expected that the sites will individually, and collectively, yield a range of positive and negative assay results required to assess the impact of the T-Cell Select kit on positive and negative agreements of the T-SPOT.TB test.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: OI-18-01-IP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No