Troponin Assays Meet ESC Standards

Two new troponin I (TnI-ultra) assays are the first fully-automated troponin assays that meet the European Society of Cardiology/American College of Cardiology (ESC/ACC) recommendation of less than or equal to a 10% level of imprecision in 99% of a healthy population. Meeting the ESC/ACC criteria is a criterion in the definition of a high-sensitivity troponin test. The new assays have also been cleared by the U.S. Food and Drug Administration (FDA).

Bayer Healthcare, Diagnostics Division (Tarrytown, New York, USA), announced that the two tests, for use on the Advia IMS 800i and Advia Centaur immunoassay systems, are fully automated, high-sensitivity, and high-precision troponin assays. They have the same 99 percentile value and show the equivalent precision at a very low level. The strong concordance between assays allows for equivalent results in core and satellite laboratory situations. The high degree of precision of the TnI-Ultra assays is expected to show an increased level of accuracy and to help physicians diagnose myocardial infarction and assess risk in patients with acute coronary syndrome.

"The addition of TnI-Ultra to the cardiovascular menu meets customers' needs for a troponin assay that meets ESC/ACC guidelines,” said Tom Warekois, senior vice-president of global strategic marketing for Bayer Healthcare's Diagnostic Division.

This allows for "workstation consolidation and rapid turnaround of results on highly productive immunoassay systems,” he concluded.


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Bayer Healthcare, Diagnostics Division