SuperFlex^™ NT-proBNP Kit

NT-proBNP or N-terminal pro b-type natriuretic peptide is an essential biomarker used to diagnose heart failure in both acute and chronic presentations, which is recommended by the International Guidelines. This product is used for the in vitro quantitative determination of N terminal pro brain natriuretic peptide (NT proBNP) in human serum, plasma or venous blood. When the capacity load and pressure load of cardiac myocytes are increased, proBNP is secreted into the blood. ProBNP is cleaved into the biologically inactive NT proBNP and the biologically active BNP [1,2]. The elevation of NT proBNP concentration in blood is related to the degree of heart failure and ventricular dysfunction. It can be used in the diagnosis, prevention, treatment, monitoring and prognosis evaluation of heart failure, as well as in the assessment of heart function [3].

The SuperFlex^™ NT-proBNP Assay automated on the SuperFlex^™ Automated Chemiluminescence Analyzer delivers high-sensitivity and specificity with results in only 15 minutes.

Performance Characteristics

• Used the 95th percentile as the reference value, SuperFlex NT-proBNP assay reference value is 125 pg/mL
• ESC Guideline recommended (NT-proBNP) <125 pg/mL as the cutoff to make a diagnosis of HF unlikely
• LOD ≤7 pg/mL
• Linear range: 15 to 30000 pg/mL, the linear correlation coefficient (r) ≥ 0.9900. Clinical Values of NT-proBNP assays
• Key Indicator for Early diagnosis: NT-proBNP assay are recommended as initial diagnostic tests in patients with symptoms suggestive of HF to rule out the diagnosis.
• Important marker for Primary Care Exclusion: A substantial evidence base exists that supports the use of natriuretic peptide biomarkers to assist in the diagnosis or exclusion of HF as a cause of symptoms (e.g., dyspnea, weight gain) in the setting of chronic ambulatory HF [4-6] or in the setting of acute care with decompensated HF [7], especially when the cause of dyspnea is unclear.
• Emergency Unit Setting: NT-proBNP testing can be very useful for triage of patient by excluded acute HF with high negative predictive value, about 98% at independent cut-point of 300 pg/mL [8]
• Prognostication: Measurement of NT-proBNP is useful for establishing prognosis or disease severity in chronic HF [9], such as Measurement of baseline levels of natriuretic peptide biomarkers and cardiac troponin on admission to the hospital is useful to establish a prognosis in acutely decompensated HF [10].
• Storage temperature：2-8℃

References:

1. Hunt P J, Richards A M, Nicholls M G, et al. Immunoreactive amino-terminal pro-brain natriuretic peptide (NT-proBNP): a new marker of cardiac impairment[J]. Clinical endocrinology, 1997, 47(3): 287-296.
2. Januzzi J L, 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[J]. European heart journal, 2005, 27(3): 330-337.
3. Ponikowski P, Voors A A, Anker S D, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC[J]. European heart journal, 2016, 37(27): 2129-2200.
4. Balion C, Don-Wauchope A, Hill S, et al. Use of Natriuretic Peptide Measurement in the Management of Heart Failure [Internet]. 13(14)-EHC118-EF ed.Rockville, MD: 2013.
5. Maisel AS, Krishnaswamy P, Nowak RM, et al. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002;347:161–7
6. Tang WH, Girod JP, Lee MJ, et al. Plasma B-type natriuretic peptide levels in ambulatory patients with established chronic symptomatic systolic heart failure.Circulation. 2003;108:2964–
7. Santaguida PL, Don-Wauchope AC, Ali U, et al.Incremental value of natriuretic peptide measurement in acute decompensated heart failure (ADHF): a systematic review. Heart Fail Rev. 2014;19:507–19.
8. Januzzi JL 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. Eur Heart J 2006;27:330-7
9. Maeda K, Tsutamoto T, Wada A, et al. High levels of plasma brain natriuretic peptide and interleukin-6 after optimized treatment for heart failure are independent risk factors for morbidity and mortality in patients with congestive heart failure. J Am Coll Cardiol. 2000;36:1587–93.
10. Cheng V, Kazanagra R, Garcia A, et al. A rapid bedside test for B-type peptide predicts treatment outcomes in patients admitted for decompensated heart failure: a pilot study. J Am Coll Cardiol. 2001;37:386–91.