For in vitro diagnostic use. Others Elecsys proBNP II STAT IVD Elecsys® proBNP II STAT CPS_000500 09315276190 proBNP G2 STAT Elecsys cobas e 100 V2.1 Elecsys proBNP II STAT 07613336191514 Reagents, kits 100 tests cobas e 601/602 true 09315276500 Elecsys proBNP II STAT en 3 FF0000000630920E FF0000000477010E 09315276190 2325 cobas e 602 619 cobas e 601 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useImmunoassay 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.LREFPonikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure.Eur J Heart Fail 2016;18(8):891-975.,LREFYancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology. Foundation/American Heart Association Task Force on practice guidelines. Circulation 2013 15;128(16):1810-1852.,LREFTaylor CJ, Rutten FH, Brouwer JR, et al. Practical guidance on heart failure diagnosis and management in primary care: recent EPCCS recommendations. Br J Gen Pract. 2017;67(660):326-327.,LREFMueller T, Gegenhuber A, Poelz W, et al. Head-to-head comparison of the diagnostic utility of BNP and NT-proBNP in symptomatic and asymptomatic structural heart disease. Clin Chim Acta 2004;341:41-48.,LREFMcGrady M, Reid CM, Shiel L, et al. NT-proB natriuretic peptide, risk factors and asymptomatic left ventricular dysfunction: results of the SCReening Evaluation of the Evolution of New Heart Failure study (SCREEN-HF). Int J of Card 2013;169(2):133-138.,LREFCostello-Boerrigter LC, Boerrigter G, Redfield MM, et al. Amino- terminal pro-B-type natriuretic peptide and B-type natriuretic peptide in the general community: determinants and detection of left ventricular dysfunction. J Am Coll Cardiol 2006;47(2):345-353.,LREFO'Donoghue M, Chen A, Baggish AL, et al. The effects of ejection fraction on N-terminal ProBNP and BNP levels in patients with acute CHF: analysis from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) study. Journ of Card Fail 2005;11(5):9-14.,LREFMureddu GF, Tarantini L, Agabiti N, et al. Evaluation of different strategies for identifying asymptomatic left ventricular dysfunction and pre-clinical (stage B) heart failure in the elderly. Results from ‘PREDICTOR’, a population based-study in central Italy European Journal of Heart Failure 2013;15:1102-1112.The test also aids in the assessment of heart failure severity in patients diagnosed with congestive heart failure.LREFHunt PJ, Richards AM, Nicholls MG, et al. Immunoreactive amino terminal pro-brain natriuretic peptide (NT-PROBNP): a new marker of cardiac impairment. Clin Endocrinol 1997;47(3):287-296.,LREFJanuzzi JL, van Kimmenade R, Lainchbury J, et al. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled analysis of 1256 patients The International Collaborative of NT-proBNP Study Euro Heart Journ 2006;27(3):330-337. This assay is further indicated for the risk stratification of patients with acute coronary syndromeLREFRichards AM, Nicholls GM, Yandle TG, et al. Plasma N-Terminal Pro- Brain Natriuretic Peptide and Adrenomedullin: New Neurohormonal Predictors of Left Ventricular Function and Prognosis After Myocardial Infarction. Circulation 1998;97:1921-1929.,LREFGalvani M, Ferrini D, Ottani F. Natriuretic peptides for risk stratification of patients with acute coronary sydromes. Eur J Heart Fail 2004;6:327-333.,LREFNørgaard BL, Terkelsen CJ, Riiskjaer M, et al. Risk prediction in acute coronary syndrome from serial inhospital measurements of N-terminal pro-B-type natriuretic peptide. Acute Card Care 2008;10:159-166.,LREFDallmeier D, Pencina MJ, Rajman I, et al. Serial measurements of N-terminal pro-brain natriuretic peptide in patients with coronary heart disease. PLoS One 2015;28;10(1):e0117143.,LREFJames SK, Lindahl B, Siegbahn A, et al. NT proBNP and other Risk Markers for the Separate Prediction of Mortality and Subsequent Myocardial Infarction in Patients with Unstable Coronary Artery Disease. GUSTO IV Substudy. Circulation 2003;108:275-281. and congestive heart failure, and it can also be used for monitoring the treatment in patients with left ventricular dysfunction.LREFPonikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure.Eur J Heart Fail 2016;18(8):891-975.,LREFYancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology. Foundation/American Heart Association Task Force on practice guidelines. Circulation 2013 15;128(16):1810-1852.,LREFBettencourt P, Azevedo A, Pimenta J, et al. N-Terminal-Pro-Brain Natriuretic Peptide Predicts Outcome After Hospital Discharge in. Circulation 2004;110(15):2168-2174.,LREFMasson S, Latini R, Anand IS, et al. Prognostic value of changes in N-terminal pro-brain natriuretic peptide in Val-HeFT (Valsartan Heart Failure Trial). J Am Coll Cardiol 2008;16;52(12):997-1003.,LREFJanuzzi JL, Throughton R. Are Serial BNP Measurements Useful in Heart Failure Management? Serial Natriuretic Peptide Measurements Are Useful in Heart Failure Management. Circulation 2013;127:500-508.,LREFMair J, Lindahl B, Giannitsis E, et al. Will sacubitril-valsartan diminish the clinical utility of B-type natriuretic peptide testing in acute cardiac care? 2016 12. Eur Heart J Acute Cardiovasc Care. 2017;6(4):321-328.,LREFZile MR, Claggett BL, Prescott MF, et al. Prognostic Implications of changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardiol 2016;68:2425-2436.The test can help in the cardiovascular risk assessment of patients with type 2 diabetes mellitus.LREFScirica BM, Braunwald E, Raz I, et al. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014;130:1579-88.,LREFBergmark BA, Morrow DA, Bhatt DL, et al. Natriuretic peptides versus a clinical history of heart failure for risk prediction in patients with diabetes. J Am Coll Cardiol. 2019; 73(19):681.,LREFBidadkosh A, Lambooy SPH, Heerspink HJ, et al. Predictive Properties of Biomarkers GDF-15, NTproBNP, and hs-TnT for Morbidity and Mortality in Patients With Type 2 Diabetes With Nephropathy. Diabetes Care. 2017;40(6):784-792.,LREFHamano K, Nakadaira I, Suzuki J, et al. N-terminal fragment of probrain natriuretic peptide is associated with diabetes microvascular complications in type 2 diabetes. Vasc Health Risk Manag. 2014;10:585-589.,LREFHillis GS, Welsh P, Chalmers J, et al. The relative and combined ability of high-sensitivity cardiac troponin T and N-terminal pro-B-type natriuretic peptide to predict cardiovascular events and death in patients with type 2 diabetes. Diabetes Care. 2014;37(1):295-303.,LREFBruno G, Landi A, Barutta F, et al. N-terminal probrain natriuretic peptide is a stronger predictor of cardiovascular mortality than C-reactive protein and albumin excretion rate in elderly patients with type 2 diabetes: The Casale Monferrato population-based study. Diabetes Care. 2013;36(9):2677-2682.,LREFNeuhold S, Resl M, Huelsmann M, et al. Repeat measurements of glycated haemoglobin A(1c) and N-terminal pro-B-type natriuretic peptide: divergent behaviour in diabetes mellitus. Eur J Clin Invest. 2011;41(12):1292-8.,LREFWolsk E, Claggett B, Diaz R, et al. Increases in Natriuretic Peptides Precede Heart Failure Hospitalization in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. Circulation. 2017;136(16):1560-1562.,LREFJarolim P, White WB, Cannon CP, et al. Serial measurement of natriuretic peptides and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE trial. Diabetes Care. 2018; 41(7): 1510-1515. 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.LREFHuelsmann M, Neuhold S, Resl M, et al. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial. J Am Coll Cardiol. 2013;62(15):1365-72.This test can be used to identify elderly individuals at high-risk for atrial fibrillation.LREFKemp Gudmundsdottir K, Fredriksson T, Svennberg E, et al. Stepwise mass screening for atrial fibrillation using N-terminal B-type natriuretic peptide: the STROKESTOP II study. Europace 2020;22(1):24-32.The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e 601 and cobas e 602 immunoassay analyzers. en