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Beckman Coulter’s hsTnI assay gets CE mark

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Nov. 8, 2017Beckman Coulter Diagnostics has received CE mark clearance for a high-sensitivity troponin (hsTnI) assay that aids in diagnosing myocardial infarction for patients presenting with chest pain or other ischemic symptoms.

With excellent low-end sensitivity, the Access hsTnI assay measures very low levels of cardiac troponin I (cTnI) and detects small differences in the cTnI level over time. In comparison with standard troponin assays, high-sensitivity assays demonstrate significantly improved precision at and below the 99th percentile upper reference limit, allowing better discrimination of small differences in troponin values between serial measurements. The assay aims to enable hospitals to develop fast-track protocols, resulting in early discharge for patients with suspected myocardial infarction.

The Access hsTnI assay is available for use on the Access 2, DxI, and the family of Access immunoassay systems.

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