Troponin Assay Based on New Performance Standards

A cardiac troponin assay, designed to aid the diagnosis and treatment of myocardial infarction, is based on the new performance standards recommended by the U.S. National Association of Clinical Biochemistry (NACB) as well as the joint committee of the European Society of Cardiology, and the American College of Cardiology.

The new assay can detect troponin levels as low as 0.01 ng/ml. The test has been engineered to virtually eliminate response to interferences, including heterophile interferences, rheumatoid factor, and human anti-mouse antibodies (HAMA). These inferences can lead to false-positive results. Developed by Beckman Coulter (Fullerton, CA, USA), the assay is now available on the company's Access immunoassay systems.

The test increases the reliability of results by using antibodies that target the most stable region of the cardiac troponin I molecule. This allows the assay to detect both the intact molecule as well as forms of the molecule that have been degraded. In contrast, many other assays detect only intact molecules and thus may have difficulty detecting troponin I levels if the molecules are in a degraded state. Beckman Coulter has received approval from the French government's health agency to market the assay, called Access AccuTnI. The assay has also been cleared by the U.S. Food and Drug Administration (FDA).

"Access AccuTnI features new design characteristics based on nearly a decade of advances in troponin research and represents a significant improvement in troponin I testing,” said Russ Bell, vice president-director of the immunodiagnotics development center at Beckman Coulter.




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