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FDA Clears Beckman Coulter Troponin Assay

NEW YORK (360Dx) – Beckman Coulter Diagnostics announced today that the US Food and Drug Administration has cleared the company's high-sensitivity troponin assay.

The Access hsTnI assay was cleared for use on Beckman Coulter's Access 2, Dxl, and the entire Access family of immunoassay systems. It detects troponin I, a protein present in circulation during myocardial infarction, to provide clinicians insight into life-threatening cardiac conditions in patients presenting with chest pain.

According to the company, Access hsTnI demonstrates a coefficient of variation of less than 10 percent at the upper reference limits for men and women and detects troponin in more than half of the healthy population. An independent study demonstrated that the assay detects more than 99 percent of troponin values for healthy men and women, Beckman Coulter added.

The assay received CE marking late last year.

"This test may help physicians with both the early diagnosis of myocardial infarction and future risk stratification in and outside the acute coronary syndrome setting," Peter Kavsak, an associate professor in the department of pathology and molecular medicine at McMaster University, said in a statement.