Beckman Coulter Diagnostics Receives CE Mark Clearance for its High-Sensitivity Access hsTnI Assay

Beckman Coulter Diagnostics announced that it has received CE Mark clearance for a new high-sensitivity troponin (hsTnI) assay that aids in diagnosing myocardial infarction for patients presenting with chest pain or other ischemic symptoms.

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

Beckman Coulter Diagnostics is committed to helping clinical partners focus on continuous improvement. The new high-quality hsTnI assay exemplifies this commitment by enabling hospitals to develop fast-track protocols, resulting in early discharge for patients with suspected myocardial infarction.

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“Assays with improved sensitivity for the detection of troponin provide clinicians with opportunity to enhance patient care. In the emergency department, such assays allow safe, streamlined assessment of patients with possible heart attacks. There is significant potential for improved efficiency in management of emergency patients using high sensitivity assays such as the new Beckman Coulter hsTnI assay,” said Louise Cullen, MBBS – emergency department physician and joint principal researcher in the ASPECT and ADAPT trials from Brisbane, Australia.

Because the Access hsTnI assay has excellent low-end sensitivity, it not only reliably measures very low levels of cardiac troponin I (cTnI), but also detects small differences in the cTnI level over time. In comparison to standard troponin assays, high-sensitivity assays demonstrate significantly improved precision at and below the 99th percentile upper reference limit (URL), allowing better discrimination of small differences in troponin values between serial measurements.

More precise determination of the 99th percentile URL has also led to an ability to report distinct reference ranges for men and women. Multiple studies confirm that high-sensitivity assays detect cTnl release earlier, increasing sensitivity for myocardial infarction diagnosis at presentation. This may help physicians to either rule in or rule out myocardial infarction earlier in the course of care.

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