Trinity Biotech has obtained CE mark approval for its landmark, high sensitivity Meritas Troponin I (TnI) point-of-care (POC) test, designed for use with Meritas POC analyzer.
The Meritas Troponin I test enables fast, accurate triage and intervention for patients presenting at the emergency department with a possible myocardial infarction (MI).
Results, which are traceable to NIST SRM 2921, are comparable to those obtained using traditional top performing laboratory analyzers, and are available in just 15 minutes.
Turnaround times, patient care and outcomes are improved, helping to maximize the use of precious hospital resources and generate significant cost savings.
It is claimed to be the only POC product capable of meeting all the guidelines stipulated by the world’s leading cardiac organizations for the detection of heart attacks.
With this CE mark, Trinity intends to immediately launch the product for sale in Europe and other selected markets through its specialist Cardiology Distributor network and direct selling teams.
The company is currently developing additional assays to extend the test menu further.