Trials / Completed
CompletedNCT03973970
Assessing the Ability of the T-SPOT®.TB Test (IQ)
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 201 (actual)
- Sponsor
- Oxford Immunotec · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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
Conditions
Timeline
- Start date
- 2019-09-23
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
- First posted
- 2019-06-04
- Last updated
- 2021-02-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03973970. Inclusion in this directory is not an endorsement.