The Era for High-Sensitivity Cardiac Troponin Has Begun in the US (Finally)

On January 19, 2017, the Food and Drug Administration (FDA)3 announced the clearance of Roche Diagnostics Gen 5 STAT cardiac troponin T assay in the US (1). This is the first of what is likely to be many next-generation or perhaps high-sensitivity (hs) cardiac troponin (cTn) assays released in the next few years. The Roche Diagnostics Gen 5 assay has been available in Europe, Asia, Australia, and Canada for 7 years. The 99th percentile cutoff limit has been changed from <0.010 ng/mL (10 ng/L) for the 4th generation cardiac troponin T (cTnT) assay to sex-specific cutoffs of 14 ng/L (0.014 ng/mL) for women, 22 ng/L (0.022 ng/mL) for men, and 19 ng/L (0.019 ng/mL) for both sexes for the 5th generation. (Note: a value of 10 ng/L with the 4th generation assay will read closer to 30 ng/L with the 5th generation assay.) As with assays for other analytes, each hospital may need to establish their own sex-specific cutoffs based on their study population. …