Assessing the Ability of the T-SPOT®.TB Test

NCT03929705 | Completed

• 1 other identifier: AF SA 148
• Study Type: observational
• Target: 676
• 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 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 (TB)

Keywords

TB

Outcome Measures

Primary Outcomes (1)

• T-Spot

  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

Study Arms (2)

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.

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

You may not qualify if:

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

Cape Town, 7925 ZA, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

• Keertan Dheda, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: May 2, 2019
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)