Improved Detection of Cardiac Troponin

Abbott plans to introduce and distribute the new assay worldwide, replacing the current AxSym Troponin test. The test was cleared by the U.S. Food and Drug Administration (FDA) in September 2004. The AxSym system can process 80-120 tests per hour, allowing high-to-medium volume clinical laboratories to process a variety of immunodiagnostic tests simultaneously.

The new assay is standardized to the new U.S. National Institute of Standards and Technology (NIST) Standard Reference Material, developed in cooperation with a subcommittee from the American Association of Clinical Chemistry (AACC). Assay standardization is a way to provide doctors with more comparable test results, making it easier to interpret results across medical institutions using different test methods.

"Part of an acute cardiac diagnostic menu, doctors consider troponin assays to be one of the most important tests to use when diagnosing heart attacks,” noted William Brown, Ph.D., vice president, Diagnostic Assays and Systems Development, Abbott Laboratories.




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