When a suspected heart incident occurs, usually after chest pain complaint, emergency responders turn to an immediate ECG, complemented by blood tests for the cardiac markers troponin I or T, to diagnose AMI. The troponin element of diagnosis is problematic: While troponin levels from damaged heart muscle rise rapidly after AMI and become easy to detect, the challenge is early detection when levels are very low. Because of this, where possible, medics turn to high sensitivity tests. These high sensitivity troponin tests have been in use in parts of the world outside the U.S. for over 7 years and have substantially assisted the safe rule-in or rule-out of AMI. The U.S. has now approved and adopted the assays, with the first next generation troponin T test approved by the FDA in early 2017.
These tests are performed on state of the art central laboratory analyzers. However they are expensive and typically take, after assessment, transport and interpretation times at least an hour to turn around results – when minutes are vital.
To meet this need the market requires a device capable of conducting high sensitivity troponin tests at the Point of Care (“POC”); rapidly, cost effectively, and easily – taking high sensitivity laboratory quality testing to the patient in emergency settings for the first time.