Assessing the Ability of the T-SPOT®.TB Test (IQ) (IQ)

Assessing the Ability of the T-SPOT®.TB Test to Identify Those at Risk of Active Mycobacterium Tuberculosis Infection Using the Normalized Tuberculosis (TB) Specific Lymphocyte Response.

The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.

Study Overview

• Status: Completed
• Conditions: Tuberculosis

Detailed Description

This study will enroll up to 202 subjects (assumes 15 % exclusion/drop-out rate). The target number of subjects is 75 active TB (recruited from subjects presenting at TB clinics) and 100 active TB excluded (recruited from subjects in the community).

All subjects enrolled in this study will be men or women, aged 18 years or older.

Duration: 1 year

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• United States
  • Texas
    • Brownsville, Texas, United States, 78520
      • University of Texas Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and Female 18 years of age and older

Description

Subject Inclusion Criteria: Cohort 1A and 1B

• Must be at least 18 years of age
• Must be able to provide informed consent
• Must be able to provide a minimum of 10 mL of whole blood at each visit
• Must be T-SPOT.TB positive
• First visit suspect TB subjects with no prior history of TB diagnosis Subject exclusion criteria: Cohort 1A and 1B
• Negative in the T-SPOT.TB test
• Previous or pre-existing confirmed TB diagnosis
• On anti-TB treatment for less than 1 week*
• Not meeting inclusion criteria

Subject inclusion criteria: Cohort 2A and 2B

• Must be at least 18 years of age
• Must be able to provide informed consent
• Must be able to provide a minimum of 10 mL of whole blood at each visit
• Must be T-SPOT.TB positive
• No prior history of TB diagnosis

Subject exclusion criteria: Cohort 2A and 2B

• Negative T-SPOT.TB test
• Previous or pre-existing confirmed TB diagnosis
• On anti-TB treatment
• Symptoms of active TB
• Not meeting inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Test Arm 1- T-SPOT.TB assay; Test Arm 1: T-SPOT.TB test using density gradient isolation (Leucosep) For each subject recruited in the study, cells will be isolated using Leucosep Tubes and T-Cell Xtend reagent according to package insert. For each subject recruited in the study, the T-SPOT.TB assay will be run according to the assay package insert.
Test Arm 2-QuantiFERON-TB Gold Plus assay; Test Arm 2: QuantiFERON-TB Gold Plus For each subject recruited in the study, the QuantiFERON-TB Gold Plus (QFT-Plus) assay will be run according to the assay package insert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NTBSLR	The primary objective of this study is to demonstrate performance of the normalized Tuberculosis (TB) specific lymphocyte response (NTBSLR) in identifying patients with active Tuberculosis (TB) disease.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGRA	The secondary exploratory objective is to demonstrate that active Tuberculosis (TB) cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based Interferon-Gamma Release Assay (IGRA).	2 year

Collaborators and Investigators

• Sponsor: Oxford Immunotec
• Investigators: Principal Investigator: Blanca Restrepo, MD, UTHealth Houston, School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: TB
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: US TX 153

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