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Abbott High Sensitivity Troponin-I Blood Test Gains FDA Clearance

NEW YORK – Abbott announced today that its high-sensitivity troponin-I blood test to detect heart attacks has received clearance from the US Food and Drug Administration.

The Architect Stat blood test measures low levels of troponin to help doctors in emergency rooms diagnose patients with heart attacks within two to four hours of admission to the hospital. The test is cleared for use on Abbott's Architect analyzer, and the company said it should be used with other diagnostic information, such as electrocardiograms and clinical observations.

The test could "help hospitals with more rapid triage and management of those diagnosed with a heart attack, as well as being able to safely discharge patients earlier on, resulting in savings to the healthcare system," said Fred Apple, co-director of the clinical and forensic toxicology laboratory at Hennepin Healthcare/Hennepin County Medical Center in Minneapolis.

Women may be best served by the test because they often have lower levels of troponin, leading to higher levels of undiagnosed heart attacks, Abbott said in a statement.

The troponin test isn't affected by biotin interference, which the FDA warned could impact certain lab tests.

Abbott also announced it will introduce the Heart Partnership Program to help hospitals implement the test into their workflows.

The blood test has been used in research for more than 200 studies, including a recent Circulation study that combined the test with a new algorithm to aid in heart attack detection.