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Clinical Chemistry 45: 2136-2141, 1999;
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(Clinical Chemistry. 1999;45:2136-2141.)
© 1999 American Association for Clinical Chemistry, Inc.

Articles

Clinical Efficacy of an Automated High-Sensitivity C-Reactive Protein Assay

Nader Rifai1,a, Russell P. Tracy2 and Paul M. Ridker3

1 Department of Laboratory Medicine, Children’s Hospital and Department of Pathology, Harvard Medical School, Boston, MA 02115.

2 Laboratory for Clinical Biochemistry Research, University of Vermont, Burlington, VT 05446.

3 Divisions of Preventive Medicine and Cardiovascular Disease and Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115.
a Address correspondence to this author at: Children’s Hospital, Department of Laboratory Medicine, 300 Longwood Ave., Boston, MA 02115. Fax 617-355-6081; e-mail rifai{at}a1.tch.harvard.edu

Background: Prospective studies have shown that C-reactive protein (CRP) can be used to predict risk of future cardiovascular events. High-sensitivity methods for CRP (hs-CRP) measurement are needed for this purpose.

Methods: We compared the clinical efficacy of an automated and commercially available latex-enhanced assay (Latex) for hs-CRP (Dade Behring) to a validated in-house ELISA, previously shown to predict future peripheral arterial disease (PAD) in asymptomatic populations. Using a prospective, nested, case-control design, we measured baseline hs-CRP concentrations in 144 apparently healthy men who subsequently developed symptomatic PAD and 144 age- and smoking habit-matched controls who remained free of vascular disease over the follow-up period of 60 months.

Results: The two hs-CRP assays correlated highly (r = 0.95; P <0.001), and all but two participants were classified into concordant quartiles or varied by only one quartile. The median hs-CRP of the case group was significantly higher than that of controls when measured by either the ELISA (1.34 vs 0.99 mg/L; P = 0.034) or the Latex method (1.80 vs 1.20 mg/L; P = 0.042). Furthermore, for both ELISA and the Latex method, the calculated relative risks of developing PAD increased significantly with each increasing quartile of hs-CRP. The calculated interquartile increase in relative risk of PAD was 31% (95% confidence interval, 5.2–62.2%; P = 0.01) for ELISA and 34% (95% confidence interval, 8.2–66.1%; P = 0.007) for the Latex method.

Conclusions: Our findings indicate that the Latex method is equally as efficacious as the validated ELISA in classifying patients into cutoff points established by prospective studies for risk stratification for coronary and cerebrovascular disease.




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