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

October 22, 2020 updated by: Oxford Immunotec

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

The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response 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

Detailed Description

The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 680 subjects (based on previous enrolment rates of approximately 300-350 subjects enrolled for 50 active TB and 50 active TB excluded).

Study Duration: 6 months

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

Study Type

Observational

Enrollment (Actual)

676

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa, 7925 ZA
        • University of Cape Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 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

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 (16mL for immunocompromised i.e. HIV+)
    • Must be T-SPOT.TB positive
    • First visit suspect TB subjects with no prior history of TB diagnosis 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 (16mL for immunocompromised i.e. HIV+)
    • Must be T-SPOT.TB positive
    • No prior history of TB diagnosis

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 more than 1 week*
    • Not meeting inclusion criteria 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Test Arm 1- T-SPOT.TB assay
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
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
T-Spot
Time Frame: 6 month study
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.
6 month study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford Immunotec

Investigators

  • Principal Investigator: Keertan Dheda, PhD, University of Cape Town

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF SA 148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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