Roberts W L, Moulton L, Law T C, Farrow G, Cooper-Anderson M, Savory J, Rifai N
Department of Pathology, University of Utah Health Sciences Center, Salt Lake City, UT 84132, USA.
Clin Chem. 2001 Mar;47(3):418-25.
C-Reactive protein (CRP) can provide prognostic information about risk of future coronary events in apparently healthy subjects. This application requires higher sensitivity assays than have traditionally been available in the clinical laboratory.
Nine high-sensitivity CRP (hs-CRP) methods from Dade Behring, Daiichi, Denka Seiken, Diagnostic Products Corporation, Iatron, Kamiya, Olympus, Roche, and Wako were evaluated for limit of detection, linearity, precision, prozone effect, and comparability with samples from 388 apparently healthy individuals.
All methods had limits of detection that were lower than the manufacturers' claimed limit of quantification except for the Kamiya, Roche, and Wako methods. All methods were linear at 0.3-10 mg/L. The Diagnostic Products Corporation, Kamiya, Olympus, and Wako methods had imprecision (CVs) >10% at 0.15 mg/L. The Iatron, Olympus, and Wako methods demonstrated prozone effects at hs-CRP concentrations of 12, 206, and 117 mg/L, respectively. hs-CRP concentrations demarcating each quartile in a healthy population were method-dependent. Ninety-two to 95% of subjects were classified into the same quartile of hs-CRP established by the Dade Behring method by the Denka Seiken, Diagnostic Products Corporation, Iatron, and Wako methods. In contrast, 68-77% of subjects were classified into the same quartile by the Daiichi, Kamiya, Olympus, and Roche methods. No subject varied by more than one quartile by any method.
Four of the nine examined hs-CRP methods classified apparently healthy subjects into quartiles of hs-CRP similar to the classifications assigned by the comparison method. Additional standardization efforts are required because an individual patient's results will be interpreted using population-based cutpoints.
C反应蛋白（CRP）可为表面健康的受试者提供未来发生冠状动脉事件风险的预后信息。此应用需要比临床实验室传统可用方法具有更高灵敏度的检测方法。
对来自达德拜灵、第一制药、电気化学工业、诊断产品公司、医创、神谷、奥林巴斯、罗氏和和光的九种高灵敏度CRP（hs-CRP）方法进行检测限、线性、精密度、前带效应评估，并与388名表面健康个体的样本进行可比性分析。
除神谷、罗氏和和光的方法外，所有方法的检测限均低于制造商声称的定量限。所有方法在0.3 - 10mg/L范围内呈线性。诊断产品公司、神谷、奥林巴斯和和光的方法在0.15mg/L时精密度（CV）>10%。医创、奥林巴斯和和光的方法分别在hs-CRP浓度为12、206和117mg/L时显示前带效应。健康人群中划分每个四分位数的hs-CRP浓度取决于方法。92%至95%的受试者通过电気化学工业、诊断产品公司、医创和和光的方法被分类到达德拜灵方法确定 的hs-CRP同一四分位数中。相比之下，第一制药、神谷、奥林巴斯和罗氏的方法将68% - 77%的受试者分类到同一四分位数中。任何方法对受试者的分类差异均不超过一个四分位数。
九种检测的hs-CRP方法中有四种将表面健康的受试者分类到与比较方法指定分类相似的hs-CRP四分位数中。由于将使用基于人群的切点来解释个体患者的结果，因此需要进一步的标准化工作。
