CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Beckman Coulter’s FDA-cleared Access AccuTnI+3 troponin I assay is available for use on the company’s Access 2 immunoassay system.
In accordance with FDA requirements, the company conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay that enrolled more than 1,900 subjects. The trial confirmed that the assay provides the clinical performance necessary for optimal patient management. The data from the trial show that the assay delivers the precision, clinical sensitivity, and clinical specificity necessary to assist physicians with the diagnosis of myocardial infarction.
Beckman Coulter, 800-742-2345