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Clinical Chemistry 52: 760-764, 2006. First published February 23, 2006; 10.1373/clinchem.2005.064337
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Right arrow Lipids, Lipoproteins, and Cardiovascular Risk Factors
(Clinical Chemistry. 2006;52:760-764.)
© 2006 American Association for Clinical Chemistry, Inc.

Technical Briefs

Analytical Performance and Diagnostic Accuracy of Immunometric Assays for the Measurement of Circulating Oxidized LDL

Paul Holvoet1,a, Elizabeth Macy2, Michele Landeloos1, Dan Jones2, Jenny S. Nancy2, Frans Van de Werf1 and Russell P. Tracy2

(1 Department of Cardiovascular Diseases, Katholieke Universiteit Leuven, Leuven, Belgium;2 Laboratory for Clinical Biochemistry Research and Department of Pathology, University of Vermont College of Medicine, Burlington, VT;

aaddress correspondence to this author at: Atherosclerosis and Metabolism Unit, Department of Cardiovascular Diseases, Katholieke Universiteit Leuven, Herestraat 49, PB 705, B-3000 Leuven, Belgium; fax 32-16-347114, e-mail paul.holvoet{at}med.kuleuven.be)


Abstract

Background: Oxidized LDL (ox-LDL) plays an important role in the pathogenesis of coronary heart disease (CHD). Several tests for circulating ox-LDL have been published. We believe it is critical to carefully evaluate these assays because small differences in performance may have profound effects when results are compared; we therefore compared the analytical and clinical performances of 2 assays: one developed in our laboratory and a commercial assay (Mercodia) that uses the same monoclonal antibody (4E6).

Methods: We determined the variance of ox-LDL in both tests, including its longitudinal stability (n = 225; 3 time points per person) and its diagnostic accuracy, by ROC analysis of 95 consecutive CHD patients and 20 controls.

Results: The between-person variability was 77% for the in-house assay (with the remaining 23% being within-person and analytical variance) and 74% for the commercial assay. For comparison, previously reported values were 66% for high-sensitivity C-reactive protein and 82% for total cholesterol. The areas under the curves for CHD in the 2 assays were identical (0.85). The odds ratios (logistic regression) for CHD among persons with high ox-LDL (≥15 mg/L) compared with persons with low ox-LDL were not different: 4.3 (95% confidence interval, 1.4–12) for the in-house assay and 3.3 (1.1–10) for the commercial assay.

Conclusions: The longitudinal stability of ox-LDL, as assessed by multiple measures in people over time, is similar to that of total cholesterol and high-sensitivity C-reactive protein. Both assays tested similarly distinguish between healthy controls and CHD patients.




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