System information

For cobas e 411 analyzer: test number 2570 cobas e 601 and cobas e 602 analyzers: Application Code Number 574

Intended use

Immunoassay for the in vitro quantitative determination of N‑terminal pro B‑type natriuretic peptide in human serum and plasma. This assay is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure and detection of mild forms of cardiac dysfunction.1,2,3,4,5,6,7,8 The test also aids in the assessment of heart failure severity in patients diagnosed with congestive heart failure.9,10 This assay is further indicated for the risk stratification of patients with acute coronary syndrome11,12,13,14,15 and congestive heart failure, and it can also be used for monitoring the treatment in patients with left ventricular dysfunction.1,2,16,17,18,19,20 The test can help in the cardiovascular risk assessment of patients with type 2 diabetes mellitus.21,22,23,24,25,26,27,28,29 The test is further indicated to aid in the identification of patients at risk with type 2 diabetes mellitus, without known history of cardiovascular disease, to optimize cardioprotective treatment.30 This test can be used to identify elderly individuals at high-risk for atrial fibrillation.31 The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.