Clinical Efficacy of an Automated High-Sensitivity C-Reactive Protein Assay
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.
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“CRP is widely accepted as a biochemical marker of systemic inflammation [8] and routinely used as a marker of infection, inflammation or tissue damage in clinical practice [6].”
BackgroundCardiovascular biomarkers in clinical studies of type 2 diabetes
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- Authors
- Rifai, N., Tracy, R. P., & Ridker, P. M.
- Affiliations
- Boston Children's Hospital (US)
- University of Vermont (US)
- Brigham and Women's Hospital (US)
- Corresponding author
- Rifai, Nader
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 1999-12-01
- Volume
- 45
- Issue
- 12
- Pages
- 2136-2141
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- OpenAlex
- W2148322270
- Cited by
- 613
- References
- 15
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 3 · 2023: 7 · 2022: 6 · 2021: 10 · 2020: 15 · 2019: 11 · 2018: 17 · 2017: 16 · 2016: 15 · 2015: 19 · 2014: 18 · 2013: 33 · 2012: 25
- FWCI
- 26.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Heart, Lung, and Blood Institute (R01HL058755, HL-58755)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Immunology and Microbiology › Immunology › Biomarkers in Disease Mechanisms
- Health Sciences › Medicine › Surgery › Peripheral Artery Disease Management
- Keywords
- high-sensitivity C-reactive protein, ELISA comparison, peripheral arterial disease, cardiovascular risk prediction, risk stratification, automated immunoassay, asymptomatic men
- MeSH terms
- Aged, Aged, 80 and over, Antioxidants, Aspirin, C-Reactive Protein, Double-Blind Method, Enzyme-Linked Immunosorbent Assay, Humans, Immunoassay, Latex, Male, Middle Aged, Myocardial Infarction, Platelet Aggregation Inhibitors, Prospective Studies, Risk Factors, Sensitivity and Specificity, Case-Control Studies, Peripheral Vascular Diseases, beta Carotene, Stroke
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