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Clinical Chemistry 45: 822-828, 1999;
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(Clinical Chemistry. 1999;45:822-828.)
© 1999 American Association for Clinical Chemistry, Inc.

Articles

Impact of Antibody Specificity and Calibration Material on the Measure of Agreement between Methods for Cardiac Troponin I

David J. Newman1,1, Yemi Olabiran1, William D. Bedzyk2, Suzette Chance2, Eileen G. Gorman2 and Christopher P. Price1,a

1 Department of Clinical Biochemistry, St. Bartholomew's and the Royal London School of Medicine and Dentistry, Turner Street, London E1 2AD, UK.

2 Dade Behring Incorporated, Glasgow Research Laboratory, Bldg. 700, P.O. Box 6101, Newark, DE 19714-6101.
a Author for correspondence. Fax 44 171 377 1544; e-mail c.p.price{at}mds.qmw.ac.uk

Background: Available assays for cardiac troponin I (cTnI) yield numerically different results. The aim of this study was to compare patient values obtained from four cTnI immunoassays.

Methods: We studied the Stratus® II assay, the Opus® II assay, the Access® assay, and a research-only cTnI heterogeneous immunoassay that uses the Dade Behring aca® plus immunoassay system equipped with two new noncommercial monoclonal antibodies. Because the aca plus cTnI assay is for research only, we first evaluated and analytically validated it for serum and citrated plasma. Initially, each method was calibrated using the method-specific calibrator supplied by each manufacturer; however, the aca plus cTnI assay was calibrated using patient serum pools containing cTnI and selected on the basis of increased creatine kinase MB isoenzyme and with values assigned by use of the Stratus cTnI assay. For method comparisons, individual patient sample cTnI values were determined and compared with the Stratus II assay.

Results: Passing and Bablock regression analysis yielded slopes of 1.44 (r = 0.96; n = 72) for the Opus II vs Stratus II assays; 0.07 (r = 0.91; n = 72) for the Access vs Stratus II assays; and 0.90 (r = 0.91, n = 72) for the aca plus vs Stratus II assays. The recalibration of each method with a Stratus II-assigned serum pool improved, but did not entirely eliminate, the slope differences between the different assays (range, 1.00–1.16). The observed scatter in the correlation curves remained.

Conclusion: There is a need to further explore the specificities of these assays with respect to the different circulating forms of cTnI.© 1999 American Association for Clinical Chemistry




The following articles in journals at HighWire Press have cited this article:


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S. Eriksson, M. Junikka, P. Laitinen, K. Majamaa-Voltti, H. Alfthan, and K. Pettersson
Negative Interference in Cardiac Troponin I Immunoassays from a Frequently Occurring Serum and Plasma Component
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D. Uettwiller-Geiger, A. H.B. Wu, F. S. Apple, A. W. Jevans, P. Venge, M. D. Olson, C. Darte, D. L. Woodrum, S. Roberts, and S. Chan
Multicenter Evaluation of an Automated Assay for Troponin I
Clin. Chem., June 1, 2002; 48(6): 869 - 876.
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T. M. Welsh, G. D. Kukes, and L. M. Sandweiss
Differences of Creatine Kinase MB and Cardiac Troponin I Concentrations in Normal and Diseased Human Myocardium
Ann. Clin. Lab. Sci., January 1, 2002; 32(1): 44 - 49.
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R. Labugger, L. Organ, C. Collier, D. Atar, and J. E. Van Eyk
Extensive Troponin I and T Modification Detected in Serum From Patients With Acute Myocardial Infarction
Circulation, September 12, 2000; 102(11): 1221 - 1226.
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P. Datta, K. Foster, and A. Dasgupta
Comparison of Immunoreactivity of Five Human Cardiac Troponin I Assays toward Free and Complexed Forms of the Antigen: Implications for Assay Discordance
Clin. Chem., December 1, 1999; 45(12): 2266 - 2269.
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