June 28, 2018—Beckman Coulter Diagnostics received 510(k) clearance from the FDA for its high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI, and the Access family of immunoassay systems. The Access hsTnI assay detects troponin I, a protein present in circulation during myocardial infarction, and aids in diagnosing myocardial infarction in as little as one hour after a patient presents with chest pain or other ischemic symptoms.
The Access hsTnI assay features high-sensitivity performance for excellent low-end sensitivity, the company says, providing a measurement of very low levels of cardiac troponin I while also detecting small differences in cTnI levels over time.
“The most common cause of death in women is heart disease. Women sometimes do not exhibit the same symptoms as men when experiencing a heart attack. Because women tend to have lower troponin levels than men, their treatment may be delayed,” Michael Samoszuk, MD, VP and chief medical officer, Beckman Coulter Diagnostics, said in a release. “Access hsTnI enables more accurate identification of women with myocardial infarction by providing separate sex-specific upper reference limits.”
The assay utilizes a robust design to minimize the effects of preanalytical variability and known interferences and to deliver the results needed to distinguish between MI and other cardiac conditions.