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

Tuberculosis 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 Tuberculosis (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 (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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03973970
Study type Observational
Source Oxford Immunotec
Contact
Status Completed
Phase
Start date September 23, 2019
Completion date June 30, 2020
View Details
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