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

NCT ID: NCT03973970

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 201 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2020-06-30

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.

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

Conditions

Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

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

• Negative T-SPOT.TB test
• Previous or pre-existing confirmed TB diagnosis
• On anti-TB treatment
• Symptoms of active TB

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford Immunotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blanca Restrepo, MD

Role: PRINCIPAL_INVESTIGATOR

UTHealth Houston, School of Public Health

Locations

University of Texas Health

Brownsville, Texas, United States

Countries

United States

Other Identifiers

US TX 153

Identifier Type: -

Identifier Source: org_study_id