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

Completed

• Conditions: Tuberculosis

• Registration Number: NCT03973970
• Lead Sponsor: Oxford Immunotec

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

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Study Start: 2019-09-23
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NTBSLR	2 year	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.

Secondary Outcome Measures

Name	Time	Method
IGRA	2 year	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).

Trial Locations

Locations (1)

University of Texas Health; 🇺🇸 Brownsville, Texas, United States