Ortho Clinical Diagnostics, Raritan, NJ, has received a CE mark for its Vitros High-Sensitivity Troponin I assay.

The new assay is the latest addition to the company’s cardiology menu and is a critical tool for clinicians who are seeking improved strategies to more rapidly and accurately identify patients suffering from a heart attack. To help reduce the cost of care and alleviate the burden on hospital resources, the Vitros High-Sensitivity Troponin I assay also aids in identifying low-risk patients who may be safely discharged.

Heidi Casaletto, Ortho Clinical Diagnostics.

Heidi Casaletto, Ortho Clinical Diagnostics.

“We’re proud to bring the Vitros High-Sensitivity Troponin I assay to market, providing hospitals with more reliable and precise diagnostics for cardiac care,” says Heidi Casaletto, head of portfolio strategy and marketing at Ortho Clinical Diagnostics. “Improved analytical performance complies with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) definition of high sensitivity, enabling use with rapid rule-in/rule-out diagnostic protocols, and allowing hospitals to more quickly diagnose and treat patients.”

According to the World Health Organization, there are 9.4 million deaths per year due to ischemic heart disease.1 In the United States alone, 750,000 patients suffer from a heart attack every year.2 A heart attack is an urgent, time-critical emergency that requires the fastest intervention possible to preserve the best patient outcomes possible.

The Vitros High-Sensitivity Troponin I assay can run on Ortho’s latest analyzer, the Vitros XT 7600 integrated system, as well as on Vitros ECi/ECiQ immunodiagnostic systems, the Vitros 3600 immunodiagnostic system, and the Vitros 5600 integrated system. The assay is now commercially available in all countries that accept the CE mark.

For further information, visit Ortho Clinical Diagnostics.


  1. Global health estimates, 2016: deaths by cause, age, sex, by country, and by region, 2000–2016. Geneva: World Health Organization, 2018. Available at: www.who.int/healthinfo/global_burden_disease/ghe2016_deaths_global_2000_2016.xls?ua=1. Accessed June 10, 2019.
  1. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics, 2016 update: a report from the American Heart Association. Circulation. 2016;133(4):e38–e360; doi: 10.1161/cir.0000000000000350.

Featured image: A technician loads patient samples into the microwells of a Vitros XT 7600 analyzer for stat processing with the Vitros High-Sensitivity Troponin I assay.