News | Point of Care Testing | December 22, 2015

Trinity Biotech Submits High Sensitivity Troponin I Product to FDA

Assay and analyzer work together to diagnose myocardial infarction in the emergency department within 15 minutes

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:

Related Content

Florida Medical Center First in State to Offer High Sensitive STAT Blood Test
News | Blood Testing | September 07, 2017
In July, The Heart Institute at Florida Medical Center became the first hospital in the state of Florida to offer the U...
Patients With Low Corus CAD Test Score Less Likely to Undergo Cardiac Referra
News | Blood Testing | May 02, 2017
CardioDx Inc. recently announced the publication of results from the multi-center, community-based PRESET Registry in...
New Blood Test Predicts Major Cardiac Events Better Than Clinical Evaluation of Other Common Risk Factors
News | Blood Testing | April 28, 2017
Prevencio Inc. announced the publication of data demonstrating that a simple new blood test is more accurate than...
New Study Pursues Universal Sample Bank for Troponin Tests
News | Blood Testing | April 13, 2017
April 13, 2017 — A study published recently in the American Association for Clinical Chemistry’s (AACC)...
PTS Diagnostics, FDA 510k clearance, extended HDL range, lipid panel test strips
News | Blood Testing | April 05, 2017
PTS Diagnostics announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded top range for...
heart attack evaluation, blood test, HEART Score, ER, emergency room, Circulation Cardiovascular Quality and Outcomes study
News | Blood Testing | March 01, 2017
Up to 40 percent of emergency room (ER) patients with chest pain can safely go home in a little under 2 hours, using a...
troponin blood test, heart disease risk, heart attack, British Heart Foundation, BHF
News | Blood Testing | January 04, 2017
A high-sensitivity blood test could be used to predict which patients are at risk of a heart attack according to new...
Alere, INRatio PT/INR Monitor, voluntary recall, FDA
News | Blood Testing | July 12, 2016
July 12, 2016 — Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc.
News | Blood Testing | March 22, 2016
March 22, 2016 — Critical Diagnostics announced that it entered into a license agreement for the exclusive worldwide
Overlay Init