Assessing the Ability of the T-SPOT®.TB Test (IQ) (IQ)
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|ClinicalTrials.gov Identifier: NCT03973970|
Recruitment Status : Suspended (Enrollment into this study is on hold due to Covid19)
First Posted : June 4, 2019
Last Update Posted : April 27, 2020
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||202 participants|
|Official Title:||Assessing the Ability of the T-SPOT®.TB Test to Identify Those at Risk of Active Mycobacterium Tuberculosis Infection Using the Normalized Tuberculosis (TB) Specific Lymphocyte Response.|
|Actual Study Start Date :||September 23, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
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.
- T Spot [ Time Frame: 1 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.
- T Spot [ Time Frame: 1 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).
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973970
|United States, Texas|
|University of Texas Health|
|Brownsville, Texas, United States, 78520|
|Principal Investigator:||Blanca Restrepo, MD||UTHealth Houston, School of Public Health|