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Received on December 5, 2005
Accepted on February 17, 2006
Proteomics and Protein Markers |
1 Department of Medical Sciences, Cardiology, Uppsala Clinical Research Centre, Uppsala, Sweden
2 Clinical Chemistry, Uppsala University, Uppsala, Sweden
3 Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
* To whom correspondence should be addressed. E-mail: per.venge{at}akademiska.se.
Background: Previous studies have shown superior clinical performance of the cardiac troponin I (cTnI) assay from Beckman-Coulter Diagnostics. This assay had a unique combination of monoclonal antibodies with 2 monoclonal antibodies directed against epitopes near the NH2 terminus of the heart-specific region of troponin I. The approach has been adopted by the new cTnI assay from Abbott Diagnostics. The aim of our study was to investigate whether this approach affects the clinical performance of cTnI assays.
Methods: Cardiac troponin concentrations were measured in a random sample of patients with unstable coronary artery disease included in the GUSTO IV trial (n = 696) by the AccuTnI (Beckman-Coulter Diagnostics), Architect cTnI (Abbott Diagnostics), Immulite 2500 cTnI (Diagnostics Products Corporation), and Elecsys 2010 cTnT (Roche Diagnostics) assays and related to the 1-year mortality. The primary cutoff concentrations were based on the 99th percentile upper reference limits and an imprecision (CV) 
10%.
Results: The sensitivities of the AccuTnI and Architect cTnI assays in identifying patients who died within 1 year were equal and were significantly higher (P <0.05) than those of the Immulite 2500 cTnI and the Elecsys cTnT assays. The concordance between the AccuTnI and Architect cTnI assays was 97%, but concordances between the Architect cTnI and the Elecsys cTnT assays were 89%-92% with more at-risk patients (P <0.01 to P <0.001) identified by the Architect cTnI assay.
Conclusions: The Architect cTnI assay has clinical performance similar to that of the AccuTnI, probably as a result of the inclusion of a monoclonal antibody against troponin I epitope 41-49 in the assay.
The following articles in journals at HighWire Press have cited this article:
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  P. Venge, N. Johnston, B. Lindahl, and S. James Normal plasma levels of cardiac troponin I measured by the high-sensitivity cardiac troponin I access prototype assay and the impact on the diagnosis of myocardial ischemia. J. Am. Coll. Cardiol., September 22, 2009; 54(13): 1165 - 1172. [Abstract] [Full Text] [PDF]
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 T. Tsutamoto, C. Kawahara, M. Yamaji, K. Nishiyama, M. Fujii, T. Yamamoto, and M. Horie Relationship between renal function and serum cardiac troponin T in patients with chronic heart failure Eur J Heart Fail, July 1, 2009; 11(7): 653 - 658. [Abstract] [Full Text] [PDF]
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 P. Venge, S. James, L. Jansson, and B. Lindahl Clinical Performance of Two Highly Sensitive Cardiac Troponin I Assays Clin. Chem., January 1, 2009; 55(1): 109 - 116. [Abstract] [Full Text] [PDF]
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C.M. Cobbaert, C.W. Weykamp, E.C.H.J. Michielsen, H. Baadenhuijsen, and M.P. van Dieijen-Visser Time-Dependent Instability of Cardiac Troponins in Human Plasma Spiked with NIST Reference Material 2921 Clin. Chem., December 1, 2008; 54(12): 2078 - 2079. [Full Text] [PDF]
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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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T. Ilva, J. Lassus, K. Siirila-Waris, J. Melin, K. Peuhkurinen, K. Pulkki, M. S. Nieminen, H. Mustonen, P. Porela, and V.-P. Harjola Clinical significance of cardiac troponins I and T in acute heart failure Eur J Heart Fail, August 1, 2008; 10(8): 772 - 779. [Abstract] [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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 S. E.F. Melanson, M. J. Tanasijevic, and P. Jarolim Cardiac Troponin Assays: A View From the Clinical Chemistry Laboratory Circulation, October 30, 2007; 116(18): e501 - e504. [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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