Troponin I point-of-care test has obtained CE marking
The ESC, ACCF, AHA and WHF stipulate that Troponin assays should demonstrate a coefficient of variation (CV) of 10% or less at the 99th percentile of the normal population, which no prior POC device could do. The high sensitivity Meritas test achieves a CV of 10% at 36pg/ml which is the 99th percentile. Results are available patient-side within 15 minutes and the Meritas analyser uses only a single drop of whole blood in a one-step process. This test will, for the first time, allow doctors to evaluate potential MI patients quickly and accurately. With CE marking achieved, Trinity Biotech now intends to release the product for sale in Europe and other carefully selected markets through its specialist cardiology distributor network.