Ortho's VITROS® High Sensitivity Troponin I Assay for the Diagnosis of Heart Attack Now CE Marked, Available in EU Countries

Next-generation assay aids in diagnosing heart attacks faster and more accurately, and is enabled on the company's newest analyzer, the VITROS® XT 7600 Integrated System

RARITAN, New Jersey, April 16, 2019 -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced CE Mark for its next-generation VITROS® High Sensitivity Troponin I assay. This new assay is the latest addition to the company's robust 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. Ortho's VITROS High Sensitivity Troponin I assay also aids in identifying low-risk patients who may be safely discharged to help reduce the cost of care and alleviate the burden on hospital resources.

"We're proud to bring the VITROS High Sensitivity Troponin I assay to market in providing hospitals with more reliable and precise diagnostics for cardiac care," said Heidi Casaletto, head of portfolio strategy and marketing at Ortho. "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 disease1. In the U.S. alone, 750,000 patients suffer from a heart attack every year2. 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 the VITROS® ECi/ECiQ Immunodiagnostic Systems, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System.

The VITROS High Sensitivity Troponin I assay is available commercially in all countries that accept CE Mark, including Chile and Australia.


  1. WHO Disease burden and mortality estimates, 2016. Downloaded from https://www.who.int/healthinfo/global_burden_disease/GHE2016_Deaths_Glob... January 8 2019
  2. Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133:e38-e360.