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Proteomics and Protein Markers |
1 Laboratorio Analisi Chimico Cliniche 1, Azienda Ospedaliera ‘Spedali Civili’, 25125 Brescia, Italy.
2 Department of Pathology, Dartmouth-Hitchcock Medical Center and Dartmouth Medical School, Lebanon, NH 03756.
3 Department of Laboratory Medicine and Pathology, Clinical Laboratories, Hennepin County Medical Center and the University of Minnesota School of Medicine, Minneapolis, MN 55415.
4 Department of Pathology, University of Maryland Medical School of Medicine, Baltimore, MD 21201.
5 IVD Consulting, D-35041 Marburg, Germany.
6 Department of Internal Medicine, Division of Cardiology, University of Innsbruck School of Medicine, 6020 Innsbruck, Austria.
7 Department of Cardiology, Aalborg University Hospital, DK-9100 Aalborg, Denmark.
8 Clinical Chemistry Laboratory, Hartford Hospital, Hartford, CT 06102.
aAuthor for correspondence. Fax 39-030-3995369; e-mail panteghi{at}bshosp.osp.unibs.it.
Background: The European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction (MI) has recommended that an increased cardiac troponin should be defined as a measurement above the 99th percentile value of the reference group. A total imprecision (CV) at the decision limit of 
10% is recommended. However, peer-reviewed data on assay imprecision are lacking. The purpose of this study was to construct the clinically relevant imprecision profiles for each of the commercially available cardiac troponin assays. Pools of human sera containing cardiac troponin concentrations around the MI decision limit were assessed to identify the lowest concentration associated with a 10% CV.
Methods: Eight serum pools targeting different concentrations of cardiac troponin (I and T) were prepared and stored at -70 °C until usage. The cardiac troponin measurement protocol consisted of two replicates per specimen per run, and one run per day for 20 days, using two reagent lots and three calibrations. Manufacturers of each cardiac troponin assay directly performed the measurements. Data analysis for each assay was centralized and performed according to the NCCLS EP5-A guideline.
Results: The lowest concentrations (µg/L) providing a 10% CV were as follows: AxSYM, 1.22; ACS:180, 0.37; Centaur, 0.33; Immuno 1, 0.34; Access, 0.06; Vidas, 0.36; Liaison, 0.065; Dimension, 0.26; Opus, 0.90; Stratus CS, 0.10; Immulite, 0.32; Vitros ECi, 0.44; Elecsys, 0.04; AIA 21, 0.09.
Conclusion: No cardiac troponin assay was able to achieve the 10% CV recommendation at the 99th percentile reference limit defined by the manufacturer.
The following articles in journals at HighWire Press have cited this article:
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  F. S. Apple, M. M. Murakami, R. Ler, D. Walker, M. York, and for the HESI Technical Committee of Biomarkers Wor Analytical Characteristics of Commercial Cardiac Troponin I and T Immunoassays in Serum from Rats, Dogs, and Monkeys with Induced Acute Myocardial Injury Clin. Chem., December 1, 2008; 54(12): 1982 - 1989. [Abstract] [Full Text] [PDF]
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 M. S. Sabatine, D. A. Morrow, J. A. de Lemos, P. Jarolim, and E. Braunwald Detection of acute changes in circulating troponin in the setting of transient stress test-induced myocardial ischaemia using an ultrasensitive assay: results from TIMI 35 Eur. Heart J., November 8, 2008; (2008) ehn504v1. [Abstract] [Full Text] [PDF]
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K. M. Eggers, T. Kempf, T. Allhoff, B. Lindahl, L. Wallentin, and K. C. Wollert Growth-differentiation factor-15 for early risk stratification in patients with acute chest pain Eur. Heart J., October 1, 2008; 29(19): 2327 - 2335. [Abstract] [Full Text] [PDF]
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 H. D White Evolution of the definition of myocardial infarction: what are the implications of a new universal definition? Heart, June 1, 2008; 94(6): 679 - 684. [Full Text] [PDF]
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 J. R Tate, W. Ferguson, R. Bais, K. Kostner, T. Marwick, and A. Carter The determination of the 99th centile level for troponin assays in an Australian reference population Ann Clin Biochem, May 1, 2008; 45(3): 275 - 288. [Abstract] [Full Text] [PDF]
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D. v. d. Kerkhof, B. Peters, and V. Scharnhorst Performance of the Advia Centaur second-generation troponin assay TnI-Ultra compared with the first-generation cTnI assay Ann Clin Biochem, May 1, 2008; 45(3): 316 - 317. [Abstract] [Full Text] [PDF]
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 K. Thygesen, J. S. Alpert, H. D. White, and on behalf of the Joint ESC/ACCF/AHA/WHF Task Force Universal Definition of Myocardial Infarction J. Am. Coll. Cardiol., November 27, 2007; 50(22): 2173 - 2195. [Full Text] [PDF]
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 K. Thygesen, J. S. Alpert, H. D. White, on behalf of the Joint ESC/ACCF/AHA/WHF Task Force, TASK FORCE MEMBERS: Chairpersons: Kristian Thygese, Biomarker Group: Allan S. Jaffe, Coordinator (USA), ECG Group: Bernard Chaitman, Co-ordinator (USA), P, Imaging Group: Richard Underwood, Coordinator (UK), Intervention Group: Jean-Pierre Bassand, Co-ordina, Clinical Investigation Group: Paul W. Armstrong, C, et al. Universal Definition of Myocardial Infarction Circulation, November 27, 2007; 116(22): 2634 - 2653. [Full Text] [PDF]
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Task Force Members, K. Thygesen, J. S. Alpert, H. D. White, Biomarker Group, A. S. Jaffe, F. S. Apple, M. Galvani, H. A. Katus, L. K. Newby, et al. Universal definition of myocardial infarction: Kristian Thygesen, Joseph S. Alpert and Harvey D. White on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction Eur. Heart J., October 2, 2007; 28(20): 2525 - 2538. [Full Text] [PDF]
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C. Prontera, A. Fortunato, S. Storti, A. Mercuri, G. Longombardo, G. C. Zucchelli, M. Emdin, and A. Clerico Evaluation of Analytical Performance of the Siemens ADVIA TnI Ultra Immunoassay Clin. Chem., September 1, 2007; 53(9): 1722 - 1723. [Full Text] [PDF]
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J. L. Anderson, C. D. Adams, E. M. Antman, C. R. Bridges, R. M. Califf, D. E. Casey Jr, W. E. Chavey II, F. M. Fesmire, J. S. Hochman, T. N. Levin, et al. ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine J. Am. Coll. Cardiol., August 14, 2007; 50(7): e1 - e157. [Full Text] [PDF]
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J. L. Anderson, C. D. Adams, E. M. Antman, C. R. Bridges, R. M. Califf, D. E. Casey Jr, W. E. Chavey II, F. M. Fesmire, J. S. Hochman, T. N. Levin, et al. ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction) Developed in Collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine J. Am. Coll. Cardiol., August 14, 2007; 50(7): 652 - 726. [Full Text] [PDF]
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 B. H. Cuthbertson, A. R. Amiri, B. L. Croal, S. Rajagopalan, O. Alozairi, J. Brittenden, and G. S. Hillis Utility of B-type natriuretic peptide in predicting perioperative cardiac events in patients undergoing major non-cardiac surgery Br. J. Anaesth., August 1, 2007; 99(2): 170 - 176. [Abstract] [Full Text] [PDF]
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NACB Writing Group Members, F. S. Apple, R. L. Jesse, L. K. Newby, A. H.B. Wu, and R. H. Christenson National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical Issues for Biochemical Markers of Acute Coronary Syndromes Circulation, April 3, 2007; 115(13): e352 - e355. [Full Text] [PDF]
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C L Hu, Y B Li, Y G Zou, J M Zhang, J B Chen, J Liu, Y H Tang, Q Z Tang, and C X Huang Troponin T measurement can predict persistent left ventricular dysfunction in peripartum cardiomyopathy Heart, April 1, 2007; 93(4): 488 - 490. [Abstract] [Full Text] [PDF]
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NACB WRITING GROUP MEMBERS, F. S. Apple, R. L. Jesse, L. K. Newby, A. H.B. Wu, R. H. Christenson, NACB COMMITTEE MEMBERS, R. H. Christenson, F. S. Apple, C. P. Cannon, et al. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical Issues for Biochemical Markers of Acute Coronary Syndromes Clin. Chem., April 1, 2007; 53(4): 547 - 551. [Full Text] [PDF]
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L. T. Cooper Jr, G. A. Mensah, L. M. Baddour, S. B. Dunbar, E. L. Kaplan, W. R. Wilson, and P. K. Shah Task Force III: Prevention and Control of Cardiovascular Complications of Emerging Infectious Diseases and Potential Biological Terrorism Agents and Diseases J. Am. Coll. Cardiol., March 27, 2007; 49(12): 1398 - 1406. [Full Text] [PDF]
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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]
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P. A. Kavsak, A. M. Newman, V. Lustig, A. R. MacRae, G. E. Palomaki, D. T. Ko, J. V. Tu, and A. S. Jaffe Long-Term Health Outcomes Associated with Detectable Troponin I Concentrations Clin. Chem., February 1, 2007; 53(2): 220 - 227. [Abstract] [Full Text] [PDF]
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 M. S. Willis, J. A. Snyder, R. H. Poppenga, and D. G. Grenache Bovine cardiac troponin T is not accurately quantified with a common human clinical immunoassay J Vet Diagn Invest, January 1, 2007; 19(1): 106 - 108. [Abstract] [Full Text] [PDF]
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D. A. Waxman, S. Hecht, J. Schappert, and G. Husk A Model for Troponin I as a Quantitative Predictor of In-Hospital Mortality J. Am. Coll. Cardiol., November 7, 2006; 48(9): 1755 - 1762. [Abstract] [Full Text] [PDF]
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A. H.B. Wu, N. Fukushima, R. Puskas, J. Todd, and P. Goix Development and preliminary clinical validation of a high sensitivity assay for cardiac troponin using a capillary flow (single molecule) fluorescence detector. Clin. Chem., November 1, 2006; 52(11): 2157 - 2159. [Full Text] [PDF]
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P. A. Kavsak, A. R. MacRae, G. E. Palomaki, A. M. Newman, D. T. Ko, V. Lustig, J. V. Tu, and A. S. Jaffe Health Outcomes Categorized by Current and Previous Definitions of Acute Myocardial Infarction in an Unselected Cohort of Troponin-Naive Emergency Department Patients Clin. Chem., November 1, 2006; 52(11): 2028 - 2035. [Abstract] [Full Text] [PDF]
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R. H. Christenson, S. H. Duh, F. S. Apple, G. S. Bodor, D. M. Bunk, M. Panteghini, M. J. Welch, A. H.B. Wu, S. E. Kahn, and for the American Association for Clinical Chemistr Toward Standardization of Cardiac Troponin I Measurements Part II: Assessing Commutability of Candidate Reference Materials and Harmonization of Cardiac Troponin I Assays Clin. Chem., September 1, 2006; 52(9): 1685 - 1692. [Abstract] [Full Text] [PDF]
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V. L. Roger, J. M. Killian, S. A. Weston, A. S. Jaffe, J. Kors, P. J. Santrach, H. Tunstall-Pedoe, and S. J. Jacobsen Redefinition of Myocardial Infarction: Prospective Evaluation in the Community Circulation, August 22, 2006; 114(8): 790 - 797. [Abstract] [Full Text] [PDF]
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D. T. Holmes and K. Buhr Mathematical Modeling: Assumptions Affect Results. Clin. Chem., August 1, 2006; 52(8): 1606 - 1608. [Full Text] [PDF]
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O. Schulz, K. Kirpal, J. Stein, R. Bensch, G. Berghofer, I. Schimke, and A. S. Jaffe Importance of low concentrations of cardiac troponins. Clin. Chem., August 1, 2006; 52(8): 1614 - 1615. [Full Text] [PDF]
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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]
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N. A. Khan, B. R. Hemmelgarn, M. Tonelli, C. R. Thompson, and A. Levin Response to Letter Regarding Article by Khan et al, "Prognostic Value of Troponin T and I Among Asymptomatic Patients With End-Stage Renal Disease: A Meta-Analysis" Circulation, May 23, 2006; 113(20): e776 - e776. [Full Text] [PDF]
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 W. Lim, D. J. Cook, L. E. Griffith, M. A. Crowther, and P. J. Devereaux Elevated Cardiac Troponin Levels in Critically Ill Patients: Prevalence, Incidence, and Outcomes Am. J. Crit. Care., May 1, 2006; 15(3): 280 - 288. [Abstract] [Full Text] [PDF]
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A. R. MacRae, P. A. Kavsak, V. Lustig, R. Bhargava, R. Vandersluis, G. E. Palomaki, M.-J. Yerna, and A. S. Jaffe Assessing the Requirement for the 6-Hour Interval between Specimens in the American Heart Association Classification of Myocardial Infarction in Epidemiology and Clinical Research Studies Clin. Chem., May 1, 2006; 52(5): 812 - 818. [Abstract] [Full Text] [PDF]
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S. James, M. Flodin, N. Johnston, B. Lindahl, and P. Venge The Antibody Configurations of Cardiac Troponin I Assays May Determine Their Clinical Performance Clin. Chem., May 1, 2006; 52(5): 832 - 837. [Abstract] [Full Text] [PDF]
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P. Kupchak, A. H.B. Wu, F. Ghani, L. K. Newby, E. M. Ohman, and R. H. Christenson Influence of Imprecision on ROC Curve Analysis for Cardiac Markers Clin. Chem., April 1, 2006; 52(4): 752 - 753. [Abstract] [Full Text] [PDF]
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S. J. Howell, J. P. Thompson, A. F. Nimmo, C. Snowden, N. D. Edwards, J. Carlisle, M.-S. Suleiman, and A. Baumbach Relationship between perioperative troponin elevation and other indicators of myocardial injury in vascular surgery patients Br. J. Anaesth., March 1, 2006; 96(3): 303 - 309. [Abstract] [Full Text] [PDF]
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M. N. Fahie-Wilson, D. J. Carmichael, M. P. Delaney, P. E. Stevens, E. M. Hall, and E. J. Lamb Cardiac Troponin T Circulates in the Free, Intact Form in Patients with Kidney Failure Clin. Chem., March 1, 2006; 52(3): 414 - 420. [Abstract] [Full Text] [PDF]
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Q. Lam, M. Black, O. Youdell, H. Spilsbury, and H.-G. Schneider Performance Evaluation and Subsequent Clinical Experience with the Abbott Automated Architect STAT Troponin-I Assay Clin. Chem., February 1, 2006; 52(2): 298 - 300. [Abstract] [Full Text] [PDF]
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F. S. Apple, R. Ler, A. Y. Chung, M. J. Berger, and M. M. Murakami Point-of-Care i-STAT Cardiac Troponin I for Assessment of Patients with Symptoms Suggestive of Acute Coronary Syndrome, Clin. Chem., February 1, 2006; 52(2): 322 - 325. [Abstract] [Full Text] [PDF]
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N. A. Khan, B. R. Hemmelgarn, M. Tonelli, C. R. Thompson, and A. Levin Prognostic Value of Troponin T and I Among Asymptomatic Patients With End-Stage Renal Disease: A Meta-Analysis Circulation, November 15, 2005; 112(20): 3088 - 3096. [Abstract] [Full Text] [PDF]
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 L. Babuin and A. S. Jaffe Troponin: the biomarker of choice for the detection of cardiac injury Can. Med. Assoc. J., November 8, 2005; 173(10): 1191 - 1202. [Abstract] [Full Text] [PDF]
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F. S. Apple, C. A. Parvin, K. F. Buechler, R. H. Christenson, A. H.B. Wu, and A. S. Jaffe Validation of the 99th Percentile Cutoff Independent of Assay Imprecision (CV) for Cardiac Troponin Monitoring for Ruling Out Myocardial Infarction Clin. Chem., November 1, 2005; 51(11): 2198 - 2200. [Full Text] [PDF]
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N. A. Abbas, R. I. John, M. C. Webb, M. E. Kempson, A. N. Potter, C. P. Price, S. Vickery, and E. J. Lamb Cardiac Troponins and Renal Function in Nondialysis Patients with Chronic Kidney Disease Clin. Chem., November 1, 2005; 51(11): 2059 - 2066. [Abstract] [Full Text] [PDF]
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P.J. Devereaux, L. Goldman, S. Yusuf, K. Gilbert, K. Leslie, and G. H. Guyatt Surveillance and prevention of major perioperative ischemic cardiac events in patients undergoing noncardiac surgery: a review Can. Med. Assoc. J., September 27, 2005; 173(7): 779 - 788. [Abstract] [Full Text] [PDF]
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M. Panteghini Standardization of Cardiac Troponin I Measurements: The Way Forward? Clin. Chem., September 1, 2005; 51(9): 1594 - 1597. [Full Text] [PDF]
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 H. H. Jung Reply Nephrol. Dial. Transplant., June 1, 2005; 20(6): 1271 - 1271. [Full Text] [PDF]
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W. B. Gibler, C. P. Cannon, A. L. Blomkalns, D. M. Char, B. J. Drew, J. E. Hollander, A. S. Jaffe, R. L. Jesse, L. K. Newby, E. M. Ohman, et al. Practical Implementation of the Guidelines for Unstable Angina/Non-ST-Segment Elevation Myocardial Infarction in the Emergency Department: A Scientific Statement From the American Heart Association Council on Clinical Cardiology (Subcommittee on Acute Cardiac Care), Council on Cardiovascular Nursing, and Quality of Care and Outcomes Research Interdisciplinary Working Group, in Collaboration With the Society of Chest Pain Centers Circulation, May 24, 2005; 111(20): 2699 - 2710. [Abstract] [Full Text] [PDF]
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M. Panteghini Selection of Antibodies and Epitopes for Cardiac Troponin Immunoassays: Should We Revise Our Evidence-Based Beliefs? Clin. Chem., May 1, 2005; 51(5): 803 - 804. [Full Text] [PDF]
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S. Eriksson, T. Ilva, C. Becker, J. Lund, P. Porela, K. Pulkki, L.-M. Voipio-Pulkki, and K. Pettersson Comparison of Cardiac Troponin I Immunoassays Variably Affected by Circulating Autoantibodies Clin. Chem., May 1, 2005; 51(5): 848 - 855. [Abstract] [Full Text] [PDF]
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M. C. Kontos Reply J. Am. Coll. Cardiol., November 2, 2004; 44(9): 1934 - 1934. [Full Text] [PDF]
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F. Pagani, F. Stefini, G. Micca, M. Toppino, F. Manoni, L. Romano, P. Hoffer, A. Iervasi, M. Caputo, R. Dorizzi, et al. Multicenter Evaluation of the TOSOH AIA-Pack Second-Generation Cardiac Troponin I Assay Clin. Chem., September 1, 2004; 50(9): 1707 - 1709. [Full Text] [PDF]
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F. S. Apple and M. M. Murakami Serum 99th Percentile Reference Cutoffs for Seven Cardiac Troponin Assays Clin. Chem., August 1, 2004; 50(8): 1477 - 1479. [Full Text] [PDF]
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A. S. Jaffe and H. Katus Acute Coronary Syndrome Biomarkers: The Need for More Adequate Reporting Circulation, July 13, 2004; 110(2): 104 - 106. [Full Text] [PDF]
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M. Panteghini Role and importance of biochemical markers in clinical cardiology Eur. Heart J., July 2, 2004; 25(14): 1187 - 1196. [Abstract] [Full Text] [PDF]
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F. Pagani, F. Stefini, and M. Panteghini Innotrac Aio! Second-Generation Cardiac Troponin I Assay: Imprecision Profile and Other Key Characteristics for Clinical Use Clin. Chem., July 1, 2004; 50(7): 1271 - 1272. [Full Text] [PDF]
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K A A Fox, J Birkhead, R Wilcox, C Knight, and J Barth British Cardiac Society Working Group on the definition of myocardial infarction Heart, June 1, 2004; 90(6): 603 - 609. [Abstract] [Full Text] [PDF]
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M. Panteghini The Interfering Component in Cardiac Troponin I Immunoassays: Need for Further Experimental Evidence Clin. Chem., March 1, 2004; 50(3): 676 - 677. [Full Text] [PDF]
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