Evaluation of Nine Automated High-Sensitivity C-Reactive Protein Methods: Implications for Clinical and Epidemiological Applications. Part 2

Evaluation of Nine Automated High-Sensitivity C-Reactive Protein Methods: Implications for... Abstract Background: C-Reactive protein (CRP) can provide prognostic information about risk of future coronary events in apparently healthy subjects. This application requires higher sensitivity assays than have traditionally been available in the clinical laboratory. Methods: Nine high-sensitivity CRP (hs-CRP) methods from Dade Behring, Daiichi, Denka Seiken, Diagnostic Products Corporation, Iatron, Kamiya, Olympus, Roche, and Wako were evaluated for limit of detection, linearity, precision, prozone effect, and comparability with samples from 388 apparently healthy individuals. Results: All methods had limits of detection that were lower than the manufacturers’ claimed limit of quantification except for the Kamiya, Roche, and Wako methods. All methods were linear at 0.3–10 mg/L. The Diagnostic Products Corporation, Kamiya, Olympus, and Wako methods had imprecision (CVs) >10% at 0.15 mg/L. The Iatron, Olympus, and Wako methods demonstrated prozone effects at hs-CRP concentrations of 12, 206, and 117 mg/L, respectively. hs-CRP concentrations demarcating each quartile in a healthy population were method-dependent. Ninety-two to 95% of subjects were classified into the same quartile of hs-CRP established by the Dade Behring method by the Denka Seiken, Diagnostic Products Corporation, Iatron, and Wako methods. In contrast, 68–77% of subjects were classified into the same quartile by the Daiichi, Kamiya, Olympus, and Roche methods. No subject varied by more than one quartile by any method. Conclusions: Four of the nine examined hs-CRP methods classified apparently healthy subjects into quartiles of hs-CRP similar to the classifications assigned by the comparison method. Additional standardization efforts are required because an individual patient’s results will be interpreted using population-based cutpoints. © 2001 The American Association for Clinical Chemistry « Previous | Next Article » Table of Contents This Article Clinical Chemistry March 2001 vol. 47 no. 3 418-425 » Abstract Full Text PDF A correction has been published Erratum Classifications Heart Health and the Clinical Laboratory Services Email this article to a friend Alert me when this article is cited Alert me if a correction is posted Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Download to citation manager Responses No responses published Citing Articles Load citing article information Citing articles via Web of Science Citing articles via Google Scholar Google Scholar Articles by Roberts, W. L. Articles by Rifai, N. Search for related content PubMed PubMed citation Articles by Roberts, W. L. Articles by Rifai, N. Related Collections Clinical Immunology Heart Health and the Clinical Laboratory Endocrinology and Metabolism Related Content Load related web page information Follow Us Clinical Chemistry Trainee Council Register Today! www.traineecouncil.org Information for Authors Submit a Manuscript Editorial Board Clinical Case Studies Clinical Chemistry Guide to Scientific Writing Journal Club Podcasts Translated Content Annual Meeting Abstracts Permissions and Reprints Advertising Copyright © 2012 by the American Association for Clinical Chemistry http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Clinical Chemistry American Association for Clinical Chemistry

Evaluation of Nine Automated High-Sensitivity C-Reactive Protein Methods: Implications for Clinical and Epidemiological Applications. Part 2

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Publisher
American Association for Clinical Chemistry
Copyright
Copyright © 2001 by the American Association for Clinical Chemistry.
ISSN
0009-9147
eISSN
1530-8561
Publisher site
See Article on Publisher Site

Abstract

Abstract Background: C-Reactive protein (CRP) can provide prognostic information about risk of future coronary events in apparently healthy subjects. This application requires higher sensitivity assays than have traditionally been available in the clinical laboratory. Methods: Nine high-sensitivity CRP (hs-CRP) methods from Dade Behring, Daiichi, Denka Seiken, Diagnostic Products Corporation, Iatron, Kamiya, Olympus, Roche, and Wako were evaluated for limit of detection, linearity, precision, prozone effect, and comparability with samples from 388 apparently healthy individuals. Results: All methods had limits of detection that were lower than the manufacturers’ claimed limit of quantification except for the Kamiya, Roche, and Wako methods. All methods were linear at 0.3–10 mg/L. The Diagnostic Products Corporation, Kamiya, Olympus, and Wako methods had imprecision (CVs) >10% at 0.15 mg/L. The Iatron, Olympus, and Wako methods demonstrated prozone effects at hs-CRP concentrations of 12, 206, and 117 mg/L, respectively. hs-CRP concentrations demarcating each quartile in a healthy population were method-dependent. Ninety-two to 95% of subjects were classified into the same quartile of hs-CRP established by the Dade Behring method by the Denka Seiken, Diagnostic Products Corporation, Iatron, and Wako methods. In contrast, 68–77% of subjects were classified into the same quartile by the Daiichi, Kamiya, Olympus, and Roche methods. No subject varied by more than one quartile by any method. Conclusions: Four of the nine examined hs-CRP methods classified apparently healthy subjects into quartiles of hs-CRP similar to the classifications assigned by the comparison method. Additional standardization efforts are required because an individual patient’s results will be interpreted using population-based cutpoints. © 2001 The American Association for Clinical Chemistry « Previous | Next Article » Table of Contents This Article Clinical Chemistry March 2001 vol. 47 no. 3 418-425 » Abstract Full Text PDF A correction has been published Erratum Classifications Heart Health and the Clinical Laboratory Services Email this article to a friend Alert me when this article is cited Alert me if a correction is posted Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Download to citation manager Responses No responses published Citing Articles Load citing article information Citing articles via Web of Science Citing articles via Google Scholar Google Scholar Articles by Roberts, W. L. Articles by Rifai, N. Search for related content PubMed PubMed citation Articles by Roberts, W. L. Articles by Rifai, N. Related Collections Clinical Immunology Heart Health and the Clinical Laboratory Endocrinology and Metabolism Related Content Load related web page information Follow Us Clinical Chemistry Trainee Council Register Today! www.traineecouncil.org Information for Authors Submit a Manuscript Editorial Board Clinical Case Studies Clinical Chemistry Guide to Scientific Writing Journal Club Podcasts Translated Content Annual Meeting Abstracts Permissions and Reprints Advertising Copyright © 2012 by the American Association for Clinical Chemistry

Journal

Clinical ChemistryAmerican Association for Clinical Chemistry

Published: Mar 1, 2001

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