December 22, 2015 — Trinity Biotech plc announced submission of its Meritas Point of Care Analyzer and Meritas cardiac troponin-I (cTnI) point-of-care assay for U.S. Food and Drug Administration (FDA) 510(k) clearance. The company is seeking clearance for both systems for use in the diagnosis of myocardial infarction (MI).
The cTnI assay will enable healthcare professionals to quickly determine patient cardiac status in emergency department settings, to accelerate patient care and to reduce overall costs of delivering health care.
The Meritas cTnI assay is run on the Meritas Point of Care Analyzer. The single-use, pre-calibrated cTnI assay is simple to use, and delivers cTnI results in about 15 minutes in both whole blood and plasma samples. The assay combines sensitive antibody reagents and the use of advanced injection molding technologies to create high-fidelity micropillar structures to control sample fluidics. Clinical data was collected at 14 geographically dispersed locations across the United States, and MIs were determined by a panel of independent adjudicators.
Clinical performance results of the product at the time of admission to the hospital emergency room demonstrated 66 percent sensitivity and 84 percent specificity for whole blood; results were 78 percent and 95 percent, respectively, for plasma.
For more information: www.trinitybiotech.com