Clinical efficacy of an automated high-sensitivity C-reactive protein assay.
Clinical efficacy of an automated high-sensitivity C-reactive protein assay.
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DOI：
10.1093/clinchem/45.12.2136
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发表时间：
1999-12
影响因子：
9.3
通讯作者：
N. Rifai;R. Tracy;P. Ridker
中科院分区：
文献类型：
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作者：
N. Rifai;R. Tracy;P. Ridker
背景前瞻性研究表明，C反应蛋白（CRP）可用于预测未来心血管事件的风险。为此，需要用于CRP（HS-CRP）测量的高敏性方法。方法我们将HS-CRP（Dade Behring）的自动化和市售乳胶增强测定法（乳胶）与经过验证的内部ELISA进行了比较，以前证明可以预测非症状的人群中未来的外周动脉疾病（PAD）。使用前瞻性，嵌套的病例对照设计，我们测量了144名显然健康的男性的基线HS-CRP浓度60个月。结果两个HS-CRP分析高度相关（r = 0.95； p <0.001），除两个参与者以外的所有参与者都被分类为一致的四分位数，或者仅由一个四分位数变化。当通过ELISA测量（1.34 vs 0.99 mg/l; p = 0.034）或乳胶方法（1.80 vs 1.20 mg/l; p = 0.042）时，病例组的中值HS-CRP明显高于对照组的中位数。 。此外，对于ELISA和乳胶方法，随着HS-CRP的每个四分位数的增加，计算出的开发PAD的相对风险显着增加。乳胶的相对风险相对风险的相对风险相对风险计算出的相对风险增加为31％（95％置信区间，5.2-62.2％； P = 0.01），乳胶的置信度为34％（95％置信区间，8.2-66.1％; P = 0.007）方法。结论我们的发现表明，乳胶方法与经过验证的ELISA同样有效，在将患者分类为前瞻性研究确定的冠状动脉和脑血管疾病风险分层确定的截止点。
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.