System information

For cobas e 411 analyzer: test number 860 For cobas e 601 and cobas e 602 analyzers: Application Code Number 113

Intended use

Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. This assay is intended to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin I determinations aid in the risk stratification of patients with unstable angina pectoris or non‑ST‑segment elevation acute coronary syndrome with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.