FDA approves AccuTnI

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FDA approves AccuTnI Fri, 08 Jun 2001 21:00:00










Fullerton, CA - Beckman Coulter (Fullerton, CA), Inc has announced FDA approval of its Access® AccuTnI? test for cardiac troponin I. The test has been approved as an aid in the diagnosis and treatment of MI and cardiac muscle damage.

According to the company press release, the test, which runs 12 minutes, accurately and reliably measures levels of cardiac troponin I, and virtually never responds to other substances in the blood that might cause false positives. The AccuTnI uses antibodies that recognize troponin even in its degraded state, and therefore is effective in patients who present days after their event.

According to Beckmam Coulter, new guidelines from both the ACC and ESC call for the use of cardiac troponin tests to improve diagnosis of MI.



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