Analytical performance of the Synchron LX®20 Pro, BN™ II and IMMAGE® high sensitivity C-reactive protein assays and concordance in cardiovascular risk stratification
Analytical performance of the Synchron LX®20 Pro, BN™ II and IMMAGE® high sensitivity C-reactive protein assays and concordance in cardiovascular risk stratification
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DOI：
10.1016/j.cccn.2004.03.034
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发表时间：
2004-09-01
影响因子：
5
通讯作者：
Butch, AW
中科院分区：
文献类型：
--
作者：
McWhorter, VC;Ford, LC;Butch, AW
背景：C-反应蛋白（CRP）可以为心血管事件的风险提供有价值的预后信息。目前有几种自动化高灵敏度CRP免疫测定可用于风险评估。研究方法：对Synchron LX（R）20 Pro、BN（TM）II和IMMAGE（R）高灵敏度CRP检测试剂盒的分析性能进行了评价，并对529份血清样本的心血管风险三分位数内的一致性进行了检查。结果如下：所有三种检测试剂盒均显示出令人满意的运行间不精密度，基于在广泛的CRP浓度范围内CV小于或等于9.0%。LX 20 Pro和BN II在广泛的测量范围内呈线性，而IMMAGE在CRP水平为0.7至2.6 mg/l时显示出与线性产生结果的轻微偏差，且存在正偏倚。中度溶血样本干扰LX 20 Pro和IMMAGE CRP检测，而中度脂血症干扰BN II。相关性研究显示，与BN II相比，LX 20 Pro和IMMAGE的结果分别低8.2%和5.1%。心血管风险评估的方法之间有很好的一致性。结论：所有三种CR-P检测试剂盒在心血管风险评估中均表现出可接受的分析性能。尽管LX 20 Pro和IMMAGE的结果低于BN II，但在每个心血管风险评估三分位数内具有良好的一致性。(C)2004 Elsevier B. V.保留所有权利。
Background: C-reactive protein (CRP) can provide valuable prognostic information for risk of cardiovascular events. Several automated high sensitivity CRP immunoassays are currently available for risk assessment. Methods: The analytical performance of the Synchron LX(R)20 Pro, BN(TM)II and IMMAGE(R) high sensitivity CRP assays were evaluated and concordance within cardiovascular risk tertiles was examined for 529 serum samples. Results: All three assays exhibited satisfactory between-run imprecision based on CVs less than or equal to 9.0% over a wide range of CRP concentrations. The LX20 Pro and BN II were linear over an extensive measuring range, whereas the IMMAGE exhibited a slight deviation from linearity producing results with a positive bias at CRP levels between 0.7 and 2.6 mg/l. Moderately hemolyzed samples interfered with the LX20 Pro and IMMAGE CRP assays, whereas moderate lipemia interfered with the BN II. Correlation studies revealed that the LX20 Pro and IMMAGE produced results 8.2% lower and 5.1% lower, respectively, compared with the BN II. There was good agreement among methods for cardiovascular risk assessment. Conclusions: All three CR-P assays exhibited acceptable analytical performance for cardiovascular risk assessment. Although results by the LX20 Pro and IMMAGE were lower than the BN II, there was good agreement within each cardiovascular risk assessment tertile. (C) 2004 Elsevier B.V. All rights reserved.