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Department of Pathology, University of Maryland School of Medicine, 22 S. Greene St., Baltimore, MD 21201.
2
Department of Laboratory Medicine and Pathology,
Hennepin County Medical Center, and the University of Minnesota School
of Medicine, Minneapolis, MN 55415.
3
Denver Health Medical Center, Denver, CO 80204.
4
Analytical Chemistry Division, National Institute of
Standards and Technology, Gaithersburg, MD 20899.
5
Clinical Chemistry Laboratory, Azienda Ospedaliera
’Spedali Civili, 25125 Brescia, Italy.
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Department of Pharmacology, University of Miami School
of Medicine, Miami, FL 33101.
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Department of Pathology and Laboratory Medicine,
Hartford Hospital, Hartford, CT 06102.
8
Departments of Pathology, Cell Biology, Neurobiology,
and Anatomy, Loyola University Medical Center, Maywood, IL 60153.
a Author for correspondence. Fax 410-328-8672; e-mail
rchriste{at}umaryland.edu.
Background: Cardiac troponin I (cTnI) results vary 100-fold among assays. As a step toward standardization, we examined the performance of 10 candidate reference materials (cRMs) in dilution studies with 13 cTnI measurement systems.
Methods: Solutions of 10 cTnI cRMs, each characterized by NIST, were shipped to the manufacturers of 13 cTnI measurement systems. Manufacturers used their respective diluents to prepare each cRM in cTnI concentrations of 1, 10, 25, and 50 µg/L. For the purpose of ranking the cRMs, the deviation of each cTnI measurement from the expected response was assessed after normalization with the 10 µg/L cTnI solution. Normalized deviations were examined in five formats. Parameters from linear regression analysis of the measured cTnI vs expected values were also used to rank performance of the cRMs.
Results: The three cRMs demonstrating the best overall rankings were complexes of troponins C, I, and T. The matrices for these three cRMs values differed; one was reconstituted directly from the lyophilized form submitted by the supplier; one was submitted in liquid form, lyophilized at NIST, and subsequently reconstituted; and the third was evaluated in the liquid form received from the supplier. The cRM demonstrating the fourth best performance was a binary complex of troponins C and I supplied in lyophilized form and reconstituted before distribution.
Conclusions: The cRMs demonstrating the best performance characteristics in 13 cTnI analytical systems will be included in subsequent activities of the cTnI Standardization Committee of the AACC.
The following articles in journals at HighWire Press have cited this article:
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  E. Kuhn, T. Addona, H. Keshishian, M. Burgess, D.R. Mani, R. T. Lee, M. S. Sabatine, R. E. Gerszten, and S. A. Carr Developing Multiplexed Assays for Troponin I and Interleukin-33 in Plasma by Peptide Immunoaffinity Enrichment and Targeted Mass Spectrometry Clin. Chem., June 1, 2009; 55(6): 1108 - 1117. [Abstract] [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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 D. C Gaze and P. O Collinson Multiple molecular forms of circulating cardiac troponin: analytical and clinical significance Ann Clin Biochem, July 1, 2008; 45(4): 349 - 355. [Abstract] [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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 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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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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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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D. M. Bunk and M. J. Welch Characterization of a New Certified Reference Material for Human Cardiac Troponin I Clin. Chem., February 1, 2006; 52(2): 212 - 219. [Abstract] [Full Text] [PDF]
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 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]
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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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D. L. Crimmins Human N-Terminal proBNP Is a Monomer Clin. Chem., June 1, 2005; 51(6): 1035 - 1038. [Full Text] [PDF]
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D. H. Wilson, G. Williams, R. Herrmann, D. Wiesner, and P. Brookhart Issues in Immunoassay Standardization: The ARCHITECT Folate Model for Intermethod Harmonization Clin. Chem., April 1, 2005; 51(4): 684 - 687. [Full Text] [PDF]
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 M. Kemp, J. Donovan, H. Higham, and J. Hooper Biochemical markers of myocardial injury Br. J. Anaesth., July 1, 2004; 93(1): 63 - 73. [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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K. B. Wallace, E. Hausner, E. Herman, G. D. Holt, J. T. Macgregor, A. L. Metz, E. Murphy, I.Y. Rosenblum, F. D. Sistare, and M. J. York Serum Troponins as Biomarkers of Drug-Induced Cardiac Toxicity Toxicol Pathol, January 1, 2004; 32(1): 106 - 121. [PDF]
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M. Panteghini Performance of Today's Cardiac Troponin Assays and Tomorrow's Clin. Chem., June 1, 2002; 48(6): 809 - 810. [Full Text] [PDF]
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C. Cavalli, R. M. Dorizzi, M. Caputo, and P. Biban Serendipitous Detection of Umbilical Venous Catheter Displacement by Cardiac Troponin I Measurement Clin. Chem., July 1, 2001; 47(7): 1328 - 1329. [Full Text] [PDF]
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