Assessing the Ability of the T-SPOT®.TB Test (IQ)
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|ClinicalTrials.gov Identifier: NCT03929705|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : May 22, 2019
|Condition or disease|
The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 235 subjects (assumes 15 % exclusion/drop-out rate).
Study Duration: 6 months
All subjects enrolled in this study will be men or women, aged 18 years or older.
|Study Type :||Observational|
|Estimated Enrollment :||235 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 TB Specific Lymphocyte Response|
|Actual Study Start Date :||May 2, 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
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.
- 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929705
|Contact: Maya Peltzfirstname.lastname@example.org|
|Contact: Rick Competielloemail@example.com|
|University of Cape Town||Recruiting|
|Cape Town, South Africa, 7925 ZA|
|Contact: Keertan Dheda, PhD +27 21 404 7654 firstname.lastname@example.org|
|Contact: Ali Esmail, MD +27 21 406 6229 A.Esmail@uct.ac.za|
|Principal Investigator:||Keertan Dheda, PhD||University of Cape Town|