Trials / Completed
CompletedNCT02624024
Clinical Performance Evaluation of AQT90 FLEX TnI and TnT
AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,743 (actual)
- Sponsor
- Radiometer Medical ApS · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.
Conditions
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2015-12-08
- Last updated
- 2017-07-02
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02624024. Inclusion in this directory is not an endorsement.