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1. Specificity of B-Type Natriuretic Peptide Assays: Cross-Reactivity with Different BNP, NT-proBNP, and proBNP Peptides

Author

Saenger, AK, Rodriguez-Fraga, O, Ler, R, Ordonez-Llanos, J, Jaffe, AS, Goetze, JP, and Apple, FS

Abstract

BACKGROUND: B-type natriuretic peptides (BNPs) are used clinically to diagnose and monitor heart failure and are present in the circulation as multiple proBNP-derived fragments. We investigated the specificity of BNP immunoassays with glycosylated and nonglycosylated BNP, N-terminal proBNP (NT-proBNP), and proBNP peptides to probe the cross-reactivity of each assay. METHODS: Nine B-type natriuretic peptides were studied, including synthetic and recombinant BNP (Shionogi, Scios, Mayo), human and synthetic glycosylated and nonglycosylated NT-proBNP (HyTest, Roche Diagnostics), and human glycosylated and nonglycosylated proBNP (HyTest, Scios). Five BNP [Abbott, Abbott POC, Alere, Beckman Coulter, Siemens (Centaur)], 9 NT-proBNP [Ortho-Clinical Diagnostics, Roche, Response, bioMerieux, "Siemens (Dimension, Immulite, Stratus CS), Mitsubishi] and 3 research-use-only proBNP immunoassays [Biosite (Alere), Bio-Rad, Goe-tze] were evaluated. Specificity was assessed by calculating the recovery between baseline and peptide-spiked human plasma pools at target concentrations of 100 ng/L BNP, 300 ng/L proBNP, or 450 ng/L NT-proBNP. All assays were performed in duplicate. RESULTS: BNP and NT-proBNP assays demonstrated substantial cross-reactivity with proBNP peptides. NT-proBNP assays do not detect glycosylated forms of either NT-proBNP or proBNP. proBNP assays preferentially detect the BNP 1-32 peptide and have minimal cross reactivity with BNP peptides and glycosylated proBNP. CONCLUSIONS: BNP or NT-proBNP results are not transferable among the current existing immunoassays owing to their differences in cross-reactivity and ability to detect various glycosylated forms of proBNP-derived fragments. Opportunities remain to standardize and harmonize BNP and NT-proBNP assays, as well as to develop specific proBNP assays, to widen their clinical scope of use. (C) 2016 American Association for Clinical Chemistry

Published
2017

2. Cardiac Troponin Assays: Guide to Understanding Analytical Characteristics and Their Impact on Clinical Care

Author

Apple, FS, Sandoval, Y, Jaffe, AS, and Ordonez-Llanos, J

Abstract

BACKGROUND: Cardiac troponin I (cTnI) and cardiac troponin T (cTnT) determinations are fixtures in clinical practice and research. Cardiac troponin testing has been the standard of practice for the diagnosis of acute myocardial infarction (AMI), early rule-out, risk stratification, and outcomes assessment in patients presenting with acute coronary syndrome (ACS) and non -ACS myocardial injury. We recognize from reading the literature over the past several years how poorly understood the analytical characteristics are for cTnI and cTnT assays by laboratorians, clinicians, and scientists who use these assays. CONTENT: The purposes of this mini-review are (a) to define limit of blank, limit of detection, limit of quantification, and imprecision, (b) overview the analytical characteristics of the existing cardiac troponin assays, (c) recommend approaches to define a healthy (normal) reference population for determining the 99th percentile and the appropriate statistic to use for this calculation, (d) clarify how an assay becomes designated as "high sensitivity," and (e) provide guidance on determining delta (Delta) change values. SUMMARY: This review raises important educational information regarding-cTnI and cTnT assays, their 99th percentile upper reference limits (URL) differentiated by sex, and specifically addresses high-sensitivity (hs)-assays used to measure low concentrations. Recommendations are made to help clarify the nomenclature and analytical and clinical characteristics to define hs-assays. The review also identifies challenges for the evolving implementation of hs-assays into clinical practice. It is hoped that with the introduction of these concepts, laboratorians, clinicians and researchers can develop a more unified view of how these assays should be used worldwide. (c) 2016 American Association for Clinical Chemistry

Published
2017

3. Third universal definition of myocardial infarction

Author

Thygesen, K, Alpert, Js, Jaffe, As, Simoons, Ml, Chaitman, Br, White, Hd, the Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Authors/Task Force Members Chairpersons, Biomarker, Subcommittee, Katus, Ha, Apple, Fs, Lindahl, B, Morrow, Da, Ecg, Subcommittee, Clemmensen, Pm, Johanson, P, Hod, H, Imaging, Subcommittee, Underwood, R, Bax, Jj, Bonow, Ro, Pinto, F, Gibbons, Rj, Classification, Subcommittee, Fox, Ka, Atar, D, Newby, Lk, Galvani, M, Hamm, Cw, Intervention, Subcommittee, Uretsky, Bf, Gabriel Steg, P, Wijns, W, Bassand, Jp, Menasché, P, Ravkilde, J, Trials, Registries, Subcommittee, Ohman, Em, Antman, Em, Wallentin, Lc, Armstrong, Pw, Heart Failure Subcommittee, Januzzi, Jl, Nieminen, Ms, Gheorghiade, M, Filippatos, G, Epidemiology, Subcommittee, Luepker, Rv, Fortmann, Sp, Rosamond, Wd, Levy, D, Wood, D, Global Perspective Subcommittee, Smith, Sc, Hu, D, Lopez Sendon JL, Robertson, Rm, Weaver, D, Tendera, M, Bove, Aa, Parkhomenko, An, Vasilieva, Ej, Mendis, S, ESC Committee for Practice Guidelines, Baumgartner, H, Ceconi, Claudio, Dean, V, Deaton, C, Fagard, R, Funck Brentano, C, Hasdai, D, Hoes, A, Kirchhof, P, Knuuti, J, Kolh, P, Mcdonagh, T, Moulin, C, Popescu, Ba, Reiner, Z, Sechtem, U, Sirnes, Pa, Torbicki, A, Vahanian, A, Windecker, S, Document, Reviewers, Morais, J, Aguiar, C, Almahmeed, W, Arnar, Do, Barili, F, Bloch, Kd, Bolger, Af, Bøtker, He, Bozkurt, B, Bugiardini, R, Cannon, C, de Lemos, J, Eberli, Fr, Escobar, E, Hlatky, M, James, S, Kern, Kb, Moliterno, Dj, Mueller, C, Neskovic, An, Pieske, Bm, Schulman, Sp, Storey, Rf, Taubert, Ka, Vranckx, P, Wagner, D. R., Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Torbicki A, Vahanian A, Windecker S, Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR., Cardiology, lLindahl B, K. Thygesen, J. S. Alpert, A. S. Jaffe, M. L. Simoon, B. R. Chaitman, H. D. White, H. A. Katu, F. S. Apple, B. Lindahl, D. A. Morrow, P. M. Clemmensen, P. Johanson, H. Hod, R. Underwood, J. J. Bax, R. O. Bonow, F. Pinto, R. J. Gibbon, K. A. Fox, D. Atar, L. K. Newby, M. Galvani, C. W. Hamm, B. F. Uretsky, P. Gabriel Steg, W. Wijn, J.-P. Bassand, P. Menasche, J. Ravkilde, E. M. Ohman, E. M. Antman, L. C. Wallentin, P. W. Armstrong, J. L. Januzzi, M. S. Nieminen, M. Gheorghiade, G. Filippato, R. V. Luepker, S. P. Fortmann, W. D. Rosamond, D. Levy, D. Wood, S. C. Smith, D. Hu, J.-L. Lopez-Sendon, R. M. Robertson, D. Weaver, M. Tendera, A. A. Bove, A. N. Parkhomenko, E. J. Vasilieva, S. Mendi, H. Baumgartner, C. Ceconi, V. Dean, C. Deaton, R. Fagard, C. Funck-Brentano, D. Hasdai, A. Hoe, P. Kirchhof, J. Knuuti, P. Kolh, T. McDonagh, C. Moulin, B. A. Popescu, Z. Reiner, U. Sechtem, P. A. Sirne, A. Torbicki, A. Vahanian, S. Windecker, J. Morai, C. Aguiar, W. Almahmeed, D. O. Arnar, F. Barili, K. D. Bloch, A. F. Bolger, H. E. Botker, B. Bozkurt, R. Bugiardini, C. Cannon, J. de Lemo, F. R. Eberli, E. Escobar, M. Hlatky, S. Jame, K. B. Kern, D. J. Moliterno, C. Mueller, A. N. Neskovic, B. M. Pieske, S. P. Schulman, R. F. Storey, K. A. Taubert, P. Vranckx, D. R. Wagner, Thygesen, K, Alpert, J, Jaffe, A, Simoons, Ml, Chaitman, Br, White, Hd, Katus, Ha, Apple, F, Lindahl, B, Morrow, Da, Clemmensen, Pm, Johanson, P, Hod, H, Underwood, R, Bax, Jj, Bonow, Jj, Pinto, F, Gibbons, Rj, Fox, Ka, Atar, D, Newby, Lk, Galvani, M, Hamm, Cw, Uretsky, Bf, Steg, Pg, Wijns, W, Bassand, Jp, Menasche, P, Ravkilde, J, Ohman, Em, Antman, Em, Wallentin, Lc, Armstrong, Pw, Januzzi, Jl, Nieminen, M, Gheorghiade, M, Filippatos, G, Luepker, Rv, Fortmann, Sp, Rosamond, Wd, Levy, D, Wood, D, Smith, Sc, Hu, D, Lopez-Sendon, Jl, Robertson, Rm, Weaver, D, Tendera, M, Bove, Aa, Parkhomenko, An, Vasilieva, Ej, Mendis, S, Baumgartner, H, Ceconi, C, Dean, V, Deaton, C, Fagard, R, Funck-Brentano, C, Hasdai, D, Hoes, A, Kirchhof, P, Knuuti, J, Kolh, P, Mcdonagh, T, Moulin, C, Popescu, Ba, Reiner, Z, Sechtem, U, Sirnes, Pa, Torbicki, A, Vahanian, A, Windecker, S, Morais, J, Aguiar, C, Almahmeed, W, Arnar, Do, Barili, F, Bloch, Kd, Bolger, Af, Botker, He, Bozkurt, B, Bugiardini, R, Cannon, C, de Lemos, J, Eberli, Fr, Escobar, E, Hlatky, M, James, S, Kern, Kb, Moliterno, Dj, Mueller, C, Neskovic, An, Pieske, Bm, Schulman, Sp, Storey, Rf, Taubert, Ka, Vranckx, P, and Wagner, Dr

Subjects
High-sensitivity troponin, Ticagrelor, Chest pain unit, Quality Assurance, Health Care, Epidemiology, medicine.medical_treatment, Myocardial Infarction, Myocardial ischaemia, Global Health, Early invasive strategy, Electrocardiography, Stent, Myocardial Revascularization, Myocardial infarction, Coronary Artery Bypass, Intraoperative Complications, Left bundle branch block, Health Policy, Electrocardiography in myocardial infarction, Cangrelor, Stents, Acute coronary syndrome, Cardiology and Cardiovascular Medicine, Prasugrel, Diagnostic Imaging, medicine.medical_specialty, Public Policy, Risk Assessment, Vorapaxar, Percutaneous Coronary Intervention, Physiology (medical), Terminology as Topic, Humans, Enoxaparin, Bypass surgery, Community and Home Care, Heart Failure, Rhythm monitoring, Aspirin, Unstable angina, Angioplasty, Recommendation, ta3121, medicine.disease, Myocardial infarction diagnosis, Bivalirudin, Biomarkers, Time Factors, Platelet inhibition, Consensus Development Conferences as Topic, Diagnostic Techniques, Cardiovascular, Myocardial Ischemia, Guideline, Diabete, Nitrate, Left ventricular hypertrophy, Coronary artery disease, Rivaroxaban, Recurrence, Apixaban, Clinical Trials as Topic, Graft Occlusion, Vascular, Atherothrombosi, Acute cardiac care, Right bundle branch block, Clopidogrel, Dabigatran, Prosthesis Failure, AHA Scientific Statements, Practice Guidelines as Topic, Cardiology, Biological Markers, Radiology, Critical Care, Glycoprotein IIb/IIIa inhibitor, European Society of Cardiology, Diagnosis, Differential, Anticoagulation, Internal medicine, medicine, Beta-blocker, cardiovascular diseases, Heparin, business.industry, Revascularization, Cardiovascular Surgical Procedures, MYOCARDIAL INFARCTION, Statin, Percutaneous coronary intervention, Arrhythmias, Cardiac, Cardiac Imaging Techniques, Fondaparinux, Heart failure, Non-ST-elevation myocardial infarction, business
Abstract

ACCF : American College of Cardiology Foundation ACS : acute coronary syndrome AHA : American Heart Association CAD : coronary artery disease CABG : coronary artery bypass grafting CKMB : creatine kinase MB isoform cTn : cardiac troponin CT : computed tomography CV : coefficient of variation ECG : electrocardiogram ESC : European Society of Cardiology FDG : fluorodeoxyglucose h : hour(s) HF : heart failure LBBB : left bundle branch block LV : left ventricle LVH : left ventricular hypertrophy MI : myocardial infarction mIBG : meta-iodo-benzylguanidine min : minute(s) MONICA : Multinational MONItoring of trends and determinants in CArdiovascular disease) MPS : myocardial perfusion scintigraphy MRI : magnetic resonance imaging mV : millivolt(s) ng/L : nanogram(s) per litre Non-Q MI : non-Q wave myocardial infarction NSTEMI : non-ST-elevation myocardial infarction PCI : percutaneous coronary intervention PET : positron emission tomography pg/mL : pictogram(s) per millilitre Q wave MI : Q wave myocardial infarction RBBB : right bundle branch block sec : second(s) SPECT : single photon emission computed tomography STEMI : ST elevation myocardial infarction ST–T : ST-segment –T wave URL : upper reference limit WHF : World Heart Federation WHO : World Health Organization Myocardial infarction (MI) can be recognised by clinical features, including electrocardiographic (ECG) findings, elevated values of biochemical markers (biomarkers) of myocardial necrosis, and by imaging, or may be defined by pathology. It is a major cause of death and disability worldwide. MI may be the first manifestation of coronary artery disease (CAD) or it may occur, repeatedly, in patients with established disease. Information on MI rates can provide useful information regarding the burden of CAD within and across populations, especially if standardized data are collected in a manner that …

Published
2012

4. Kinetic Characterization of Human Heart and Skeletal Muscle CK Isoenzymes

Author

G. A. Stull, C. Schneider, and Apple Fs

Subjects
medicine.medical_specialty, Creatine, Biochemistry, Isozyme, Mitochondria, Heart, chemistry.chemical_compound, Internal medicine, Mole, medicine, Humans, Myocardial infarction, Creatine Kinase, biology, Muscles, Myocardium, Skeletal muscle, Human heart, medicine.disease, Phosphate, Mitochondria, Muscle, Isoenzymes, Kinetics, Endocrinology, medicine.anatomical_structure, chemistry, biology.protein, Creatine kinase
Abstract

The purpose of this study was to investigate the kinetic properties of human creatine kinase (CK) isoenzymes partially purified from heart and skeletal muscle. Utilizing the backward CK-catalyzed reaction of creatine phosphate + ADP in equilibrium creatine + ATP, Km values for heart and skeletal muscle CK MM (3.7 mmol/l) were significantly (p less than 0.05) greater than CK MB (2.1 mmol/l) which were significantly (p less than 0.05) greater than mitochondrial CK (1.8 mmol/l) at variable creatine phosphate and fixed ADP concentrations. However, Km values for similar isoenzymes from the two different tissues, i.e., CK MB from heart vs. skeletal muscle, were not different. These results show that kinetic analysis of CK isoenzymes cannot differentiate the tissue source of elevated blood CK isoenzymes after the acute stress of long distance running or after acute myocardial infarction.

Published
1988

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