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

Tuberculosis (TB) Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03929705
Study type Observational
Source Oxford Immunotec
Contact
Status Completed
Phase
Start date May 2, 2019
Completion date January 23, 2020
View Details
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