System information

For cobas e 411 analyzer: test number 2590 For cobas e 601 and cobas e 602 analyzers: Application Code Number 576

Intended use

Immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma. This assay can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis e.g. acute myocardial infarction (AMI), and as an aid for early discharge and outpatient management for patients suspected of acute coronary syndrome (ACS). The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac troponin T (cTnT). In addition, this test can be used in the context of non‑cardiac surgeries to predict pre‑operatively the perioperative risk of major adverse cardiac events and in diagnosis of perioperative myocardial infarction (PMI) and myocardial injuries after non-cardiac surgeries (MINS). The cTnT‑hs values may also be used, in conjunction with clinical and diagnostics findings, to aid in stratifying the long-term risk of cardiovascular death, myocardial infarction, coronary revascularization, heart failure or ischemic stroke, and all-cause mortality in asymptomatic individuals. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.