Abbott Laboratories announced a 510(k) clearance with the US FDA for a Troponin-I (TnI) test for use on Abbott's Architect i2000SR Immunoassay System and Architect ci8200 Immunochemistry System. TnI is a protein that is released from dead or severely injured heart muscle cells following a cardiac event.
Abbott expects the Architect Stat Troponin-I test to be available later this month. In April, Abbott introduced the test in major markets outside of the United States.
"Our Architect Stat Troponin-I test has excellent functional sensitivity and precision," said William Brown, vice president, Diagnostic Assays and Systems Development, Abbott Laboratories. "This is the second test in our acute cardiac panel for the Architect platform with additional cardiac assays in development," he added.
"Based on the American College of Cardiology's new criteria for diagnosing myocardial infarction, troponin has become the gold standard in diagnostic testing," said Michael S Parmacek, chief of cardiovascular medicine, University of Pennsylvania.
According to the World Health Organization, an estimated 17 million people die of cardiovascular diseases, particularly heart attacks and strokes, every year. Symptoms of a heart attack may include pain in the chest, arm, wrist or jaw sometimes accompanied by nausea, vomiting and shortness of breath.
Providing stat results within 18 minutes, the Architect i2000SR is an automated immunoassay system that can perform up to 200 tests per hour. The stat functionality enables rapid turnaround time of TnI results enabling doctors to quickly diagnose and treat patients with chest pain.
Combining immunoassay and clinical chemistry on one integrated platform, the ci8200 system runs up to 200 immunoassay tests and up to 1200 clinical chemistry tests an hour.