Last updated on April 2020

Assessing the Ability of the T-SPOT .TB Test

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03929705

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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