Beckman Coulter Diagnostics, Brea, Calif, has received the CE mark 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,” says Michael Samoszuk, MD, vice president and chief medical officer at Beckman Coulter Diagnostics. “This gives clinicians greater confidence in interpreting test results from patients seeking emergency care due to chest pain.”
The assay enables hospitals to develop fast-track rule-in/rule-out protocols for patients presenting with suspected myocardial infarction, making early discharge possible when the test results are negative.
“Assays with improved sensitivity for the detection of troponin provide clinicians with opportunity to enhance patient care,” says Louise Cullen, MBBS, emergency department physician and joint principal researcher in the Aspect and Adapt trials from Brisbane, Australia. “In the emergency department, such assays allow safe, streamlined assessment of patients with possible heart attacks.”
The Access hsTnI assay was designed to measure very low levels of cardiac troponin I (cTnI) with reliability, while also detecting 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.
The hsTnI assay is available for use on the Beckman Coulter Access 2 and DxI instruments, and on the company’s entire family of Access immunoassay instruments.
For more information, visit Beckman Coulter.