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.
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
Enrollment
201
University of Texas Health
Brownsville, Texas, United States
NTBSLR
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.
Time frame: 2 year
IGRA
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).
Time frame: 2 year
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