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

NCT03973970 | Completed

• 1 other identifier: US TX 153
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis

Keywords

TB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• IGRA

  2 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and Female 18 years of age and older

You may qualify if:

• 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

You may not qualify if:

• Negative in the T-SPOT.TB test
• Previous or pre-existing confirmed TB diagnosis
• On anti-TB treatment for less than 1 week\*
• 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
• Negative T-SPOT.TB test
• Previous or pre-existing confirmed TB diagnosis
• On anti-TB treatment
• Symptoms of active TB

Sponsors & Collaborators

• Oxford Immunotec: lead

Study Sites (1)

University of Texas Health

Brownsville, Texas, 78520, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells (PBMCs) and plasma will be retained and stored at the Lung Infection and Immunity laboratory Biobank for 3 years

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Blanca Restrepo, MD

  UTHealth Houston, School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 4, 2019
• Study Start: September 23, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 24, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)