Assays Approved to Diagnose Myocardial Infarction, Risk Assessment

 

June 29, 2006

Two new assays that aid physicians in the diagnosis of myocardial infarction and the assessment of risk in patients with acute coronary syndrome have just received FDA clearance.

The TnI-Ultra assays have been cleared on the ADVIA IMS 800i and ADVIA Centaur Immunoassay System. These assays are the first fully-automated Troponin assays to meet both the European Society of Cardiology and ACC recommendations of a less than or equal to 10 percent level of imprecision at the 99th percentile of a healthy population.

This strong concordance between assays allows for equivalent results in core and satellite laboratory situations. The high degree of precision seen with the TnI-Ultra assays is expected to show an increased level of accuracy, contributing to improved patient care in those suspected of MI.