| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
Special Report |
1 Department of Laboratory Medicine and Pathology, Hennepin County Medical Center, Minneapolis, MN.
2 Laboratorio Analisi Chimico Cliniche 1, Azienda Ospedaliera Spedali Civili, Brescia, Italy.
3 Department of Cardiology, Skejby Hospital, Aarhus University Hospital, Aarhus, Denmark.
4 Clinical Division of Cardiology, Medical University Innsbruck, Innsbruck, Austria.
5 Department of Laboratory Medicine, University of California, San Francisco, San Francisco General Hospital, San Francisco, CA.
6 Department of Chemical Pathology, Queensland Health Pathology Service, Princess Alexandra Hospital, Brisbane, Australia.
7 Department of Pathology, University of Maryland, Baltimore, MD.
8 Department of Laboratory Medicine and Cardiology, Mayo Clinic, Rochester, MN.
aAddress correspondence to this author at: Hennepin County Medical Center, Clinical Laboratories P4, 701 Park Ave., Minneapolis, MN 55415. Fax 612-904-4229; e-mail fred.apple{at}co.hennepin.mn.us.
Background: The objective of this report is to improve the quality of immunochemical measurements of B-type natriuretic peptide (BNP) and its N-terminal propeptide (NT-proBNP). The recommendations proposed are intended for use by manufacturers of commercial assays, by clinical laboratories using those assays, by clinical trial groups and research investigators, and by regulatory agencies, such as the United States Food and Drug Administration.
Methods: A group of cardiac biomarker experts reviewed and abstracted the scientific literature to provide recommendations pertaining to the quality specifications for BNP/NT-proBNP assays.
Results: The evidence-based recommendations encourage manufacturers to endorse and consistently follow the proposed recommendations; encourage that all package inserts for BNP/NT-proBNP immunoassays include uniform information on assay design, preanalytical performance characteristics, analytical performance characteristics, and clinical performance; and encourage regulatory agencies to adopt a minimal and uniform set of criteria for manufacturers to provide when seeking clearance for new and/or improved assays.
Conclusions: These recommendations address the use of BNP and NT-proBNP as cardiac biomarkers and not their physiologic and/or pathophysiologic relevance.
The following articles in journals at HighWire Press have cited this article:
|
|
 |
|
  E. C H J Michielsen, J. A Bakker, R. R J V. Kimmenade, Y. M Pinto, and M. P V. Dieijen-Visser The diagnostic value of serum and urinary NT-proBNP for heart failure Ann Clin Biochem, July 1, 2008; 45(4): 389 - 394. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. W. Waldo, J. Beede, S. Isakson, S. Villard-Saussine, J. Fareh, P. Clopton, R. L. Fitzgerald, and A. S. Maisel Pro-B-Type Natriuretic Peptide Levels in Acute Decompensated Heart Failure J. Am. Coll. Cardiol., May 13, 2008; 51(19): 1874 - 1882. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 K. N. Luckenbill, R. H. Christenson, A. S. Jaffe, J. Mair, J. Ordonez-Llanos, F. Pagani, J. Tate, A. H. B. Wu, R. Ler, and F. S. Apple Cross-Reactivity of BNP, NT-proBNP, and proBNP in Commercial BNP and NT-proBNP Assays: Preliminary Observations from the IFCC Committee for Standardization of Markers of Cardiac Damage Clin. Chem., March 1, 2008; 54(3): 619 - 621. [Full Text] [PDF]
|
|
|
|
 |
|
 J. K. Dunnick, K. A. Thayer, and G. S. Travlos Inclusion of Biomarkers for Detecting Perturbations in the Heart and Lung and Lipid/Carbohydrate Metabolism in National Toxicology Program Studies Toxicol. Sci., November 1, 2007; 100(1): 29 - 35. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F. S. Apple, A. H.B. Wu, A. S. Jaffe, M. Panteghini, R. H. Christenson, NACB COMMITTEE MEMBERS, R. H. Christenson, F. S. Apple, C. P. Cannon, G. Francis, et al. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical Issues for Biomarkers of Heart Failure Circulation, July 31, 2007; 116(5): e95 - e98. [Full Text] [PDF]
|
|
|
|
|
|
M. Emdin, C. Passino, C. Prontera, M. Fontana, R. Poletti, A. Gabutti, C. Mammini, A. Giannoni, L. Zyw, G. Zucchelli, et al. Comparison of Brain Natriuretic Peptide (BNP) and Amino-Terminal ProBNP for Early Diagnosis of Heart Failure Clin. Chem., July 1, 2007; 53(7): 1289 - 1297. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Clerico, M. Fontana, L. Zyw, C. Passino, and M. Emdin Comparison of the Diagnostic Accuracy of Brain Natriuretic Peptide (BNP) and the N-Terminal Part of the Propeptide of BNP Immunoassays in Chronic and Acute Heart Failure: A Systematic Review Clin. Chem., May 1, 2007; 53(5): 813 - 822. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. R. Seferian, N. N. Tamm, A. G. Semenov, K. S. Mukharyamova, A. A. Tolstaya, E. V. Koshkina, A. N. Kara, M. I. Krasnoselsky, F. S. Apple, T. V. Esakova, et al. The Brain Natriuretic Peptide (BNP) Precursor Is the Major Immunoreactive Form of BNP in Patients with Heart Failure Clin. Chem., May 1, 2007; 53(5): 866 - 873. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. S. Apple, L. A. Pearce, A. Chung, R. Ler, and M. M. Murakami Multiple Biomarker Use for Detection of Adverse Events in Patients Presenting with Symptoms Suggestive of Acute Coronary Syndrome Clin. Chem., May 1, 2007; 53(5): 874 - 881. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. S.P. Lam, J. C. Burnett Jr, L. Costello-Boerrigter, R. J. Rodeheffer, and M. M. Redfield Alternate Circulating Pro-B-Type Natriuretic Peptide and B-Type Natriuretic Peptide Forms in the General Population J. Am. Coll. Cardiol., March 20, 2007; 49(11): 1193 - 1202. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Liang, J. O'Rear, U. Schellenberger, L. Tai, M. Lasecki, G. F. Schreiner, F. S. Apple, A. S. Maisel, N. S. Pollitt, and A. A. Protter Evidence for Functional Heterogeneity of Circulating B-Type Natriuretic Peptide J. Am. Coll. Cardiol., March 13, 2007; 49(10): 1071 - 1078. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Sakhuja, S. Green, E. M. Oestreicher, P. M. Sluss, E. Lee-Lewandrowski, K. B. Lewandrowski, and J. L. Januzzi Jr. Amino-Terminal Pro-Brain Natriuretic Peptide, Brain Natriuretic Peptide, and Troponin T for Prediction of Mortality in Acute Heart Failure Clin. Chem., March 1, 2007; 53(3): 412 - 420. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Coste, P. Jourdain, and J. Pouchot A Gray Zone Assigned to Inconclusive Results of Quantitative Diagnostic Tests: Application to the Use of Brain Natriuretic Peptide for Diagnosis of Heart Failure in Acute Dyspneic Patients Clin. Chem., December 1, 2006; 52(12): 2229 - 2235. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. Aspromonte, V. Ceci, A. Chiera, C. Coletta, A. D'Eri, M. Feola, P. Giovinazzo, L. Milani, F. Noventa, A. B. Scardovi, et al. Rapid Brain Natriuretic Peptide Test and Doppler Echocardiography for Early Diagnosis of Mild Heart Failure Clin. Chem., September 1, 2006; 52(9): 1802 - 1808. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. R. Fokkema, Z. Herrmann, F. A.J. Muskiet, and J. Moecks Reference change values for brain natriuretic peptides revisited. Clin. Chem., August 1, 2006; 52(8): 1602 - 1603. [Full Text] [PDF]
|
|
|
|
|
|
A. S. Jaffe, L. Babuin, and F. S. Apple Biomarkers in Acute Cardiac Disease: The Present and the Future J. Am. Coll. Cardiol., July 4, 2006; 48(1): 1 - 11. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
I. Giuliani, F. Rieunier, C. Larue, J.-F. Delagneau, C. Granier, B. Pau, M. Ferriere, M. Saussine, J.-P. Cristol, A.-M. Dupuy, et al. Assay for Measurement of Intact B-Type Natriuretic Peptide Prohormone in Blood Clin. Chem., June 1, 2006; 52(6): 1054 - 1061. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. S. Vasan Biomarkers of Cardiovascular Disease: Molecular Basis and Practical Considerations Circulation, May 16, 2006; 113(19): 2335 - 2362. [Full Text] [PDF]
|
|
|
|
|
|
A. Gegenhuber, J. Struck, W. Poelz, R. Pacher, N. G. Morgenthaler, A. Bergmann, M. Haltmayer, and T. Mueller Midregional Pro-A-Type Natriuretic Peptide Measurements for Diagnosis of Acute Destabilized Heart Failure in Short-of-Breath Patients: Comparison with B-Type Natriuretic Peptide (BNP) and Amino-Terminal proBNP Clin. Chem., May 1, 2006; 52(5): 827 - 831. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Gruson, M. F. Rousseau, V. de Coninck, S. A. Ahn, and J.-M. Ketelslegers Influence of sampling and storage conditions on B-type natriuretic Peptide immunoreactivity for 3 automated assays. Clin. Chem., April 1, 2006; 52(4): 766 - 767. [Full Text] [PDF]
|
|
|
|
|
|
J. V. St. Peter, G. G. Hartley, M. M. Murakami, and F. S. Apple B-Type Natriuretic Peptide (BNP) and N-Terminal Pro-BNP in Obese Patients without Heart Failure: Relationship to Body Mass Index and Gastric Bypass Surgery Clin. Chem., April 1, 2006; 52(4): 680 - 685. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F. S. Apple Clinical Biomarkers of Cardiac Injury: Cardiac Troponins and Natriuretic Peptides Toxicol Pathol, January 1, 2006; 34(1): 91 - 93. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
I. Brandt, A.-M. Lambeir, J.-M. Ketelslegers, M. Vanderheyden, S. Scharpe, and I. De Meester Dipeptidyl-Peptidase IV Converts Intact B-Type Natriuretic Peptide into Its des-SerPro Form Clin. Chem., January 1, 2006; 52(1): 82 - 87. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. M. Hawkridge, D. M. Heublein, H. R. Bergen III, A. Cataliotti, J. C. Burnett Jr., and D. C. Muddiman Quantitative mass spectral evidence for the absence of circulating brain natriuretic peptide (BNP-32) in severe human heart failure PNAS, November 29, 2005; 102(48): 17442 - 17447. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. Prontera, S. Storti, M. Emdin, C. Passino, L. Zyw, G. C. Zucchelli, and A. Clerico Comparison of a Fully Automated Immunoassay with a Point-of-Care Testing Method for B-Type Natriuretic Peptide Clin. Chem., July 1, 2005; 51(7): 1274 - 1276. [Full Text] [PDF]
|
|
|
|
|
|
C. G. Fraser Quality Specifications for Imprecision of B-Type Natriuretic Peptide Assays Clin. Chem., July 1, 2005; 51(7): 1307 - 1309. [Full Text] [PDF]
|
|
|
|
 |
|
 U. Poge, T. M. Gerhardt, R. P. Woitas, C. Kragelund, L. Kober, and P. Hildebrandt N-Terminal Pro-B-Type Natriuretic Peptide and Mortality in Coronary Heart Disease N. Engl. J. Med., May 12, 2005; 352(19): 2025 - 2026. [Full Text] [PDF]
|
|
|
|
|
|
F. S. Apple, A. H.B. Wu, J. Mair, J. Ravkilde, M. Panteghini, J. Tate, F. Pagani, R. H. Christenson, M. Mockel, O. Danne, et al. Future Biomarkers for Detection of Ischemia and Risk Stratification in Acute Coronary Syndrome Clin. Chem., May 1, 2005; 51(5): 810 - 824. [Abstract] [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
