Beckman Coulter receives CE Mark for Access hsTnI Assay

Beckman Coulter

Beckman Coulter is a trusted partner for laboratory professionals, helping to advance scientific research and patient care with focus on innovation, reliability and efficiency. The company's diagnostics division recently announced that it has received CE Mark clearance for its new high-sensitivity troponin (hsTnI) assay. This assay helps in diagnosing myocardial infarction for patients presenting with chest pain or other ischemic symptoms, and can improve cardiac patient management.

This high quality assay enables hospitals to develop fast-track protocols, resulting in early discharge for patients with suspected myocardial infarction. Several studies have proven that hsTnI assays detect cTnl release earlier, increasing sensitivity for myocardial infarction diagnosis at presentation, which helps physicians to either rule in or rule out myocardial infarction earlier in the course of care. While early detection allows patients to be provided with the appropriate care pathway, ruling out earlier can lead to faster discharge.

Compared to standard troponin assays, high-sensitivity assays demonstrate significantly improved precision at and below the 99th percentile upper reference limit (URL), which allows better discrimination of small differences in troponin values between serial measurements. With its excellent low-end sensitivity, Beckman's Access hsTnI assay can

  • reliably measure very low levels of cardiac troponin I (cTnI), and
  • detect small differences in the cTnI level over time

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

Michael Samoszuk, M.D, vice president and chief medical officer, Beckman Coulter Diagnostics says, "The new, high-sensitivity assay provides much greater precision at very low levels of troponin. This gives clinicians greater confidence in interpreting test results from patients seeking emergency care due to chest pain."

Beckman Coulter manufactures premium quality hematology analyzers, flow cytometers and coagulation analyzers and is committed to helping clinical partners focus on continuous improvement.

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