Research Methods · Measurement and Statistics

Clinical efficacy of an automated high-sensitivity C-reactive protein assay

Rifai N, Tracy RP, Ridker PM

Published December 10, 1999 Clinical Chemistry, 45(12), 2136-2141
DOI 10.1093/clinchem/45.12.2136 PMID 10585345

Abstract

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.

Topics

By this author

Research Methods › Measurement and Statistics › Instrument Development and Validation
Paul M Ridker
P Ridker
PMID 10585345 10585345 DOI 10.1093/clinchem/45.12.2136 10.1093/clinchem/45.12.2136 Rifai et al. 1999, Rifai 1999

Cite this article

Rifai, N., Tracy, R. P., & Ridker, P. M. (1999). Clinical efficacy of an automated high-sensitivity C-reactive protein assay. Clinical Chemistry, 45(12), 2136-2141. https://doi.org/10.1093/clinchem/45.12.2136