29 June 2018 - - Brea, California-based diagnostic equipment specialist Beckman Coulter Diagnostics has received 510(k) clearance from the US FDA for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems, the company said.
The Access hsTnI assay detects troponin I, a protein that is present in circulation during myocardial infarction (MI), giving clinicians important insight into life-threatening cardiac conditions in patients presenting with chest pain.
The design minimizes the effects of pre-analytical variability and known interferences. This helps deliver high-quality results needed to distinguish between MI and other cardiac conditions.
It will help with rapid MI diagnosis and enable physicians to confidently exclude MI in as little as one hour after patient presentation to the emergency department, providing efficiency improvements in cardiac patient management.
The Access hsTnI assay features high-sensitivity performance for excellent low-end sensitivity, providing a reliable measurement of very low levels of cardiac troponin I (cTnI), while also detecting small differences in cTnI levels over time.
Beckman Coulter helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it.
The company's scalable instruments, comprehensive diagnostic tests, and business management services are used by hospitals, laboratories, and other critical care settings around the world.