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即时检测C反应蛋白检测法的性能特征

Performance characteristics of a point of care C-reactive protein assay.

作者信息

Roberts W L, Schwarz E L, Ayanian S, Rifai N

机构信息

Department of Pathology, University of Utah Health Sciences Center, Salt Lake City, UT 84132, USA.

出版信息

Clin Chim Acta. 2001 Dec;314(1-2):255-9. doi: 10.1016/s0009-8981(01)00657-x.

DOI:10.1016/s0009-8981(01)00657-x
PMID:11718705
Abstract

BACKGROUND

C-reactive protein (CRP) is a non-specific marker of inflammation that can be used for atherosclerotic risk assessment. This application requires increased precision at low CRP concentrations compared to traditional assays.

METHODS

The Micros CRP analyzer (ABX Diagnostics) is a small bench top device. Its limit of detection, limit of quantitation, linearity and imprecision were assessed. Method comparison studies were performed using samples both inside and outside the reference interval. Anticoagulant effects and the prozone effect were also evaluated.

RESULTS

The limit of detection was 0.1 mg/l. The method was linear from 2 to 60 and 0.3 to 60 mg/l using systematic error limits of 10% and 20%, respectively. The total imprecision was <8% for CRP concentrations from 0.7 to 9.1 mg/l. A prozone effect was seen at CRP concentrations >500 mg/l. Using samples from 120 apparently healthy adults, the Micros CRP method demonstrated excellent concordance with the BN II high sensitivity CRP (hs-CRP) method. The Micros CRP method compared well with a nephelometric method using samples with elevated CRP concentrations.

CONCLUSIONS

The Micros CRP method is adequate for atherosclerotic risk prediction in clinical practice but does not have adequate accuracy at CRP concentrations <2 mg/l for epidemiological studies.

摘要

背景

C反应蛋白(CRP)是一种炎症非特异性标志物,可用于动脉粥样硬化风险评估。与传统检测方法相比,该应用在低CRP浓度时需要更高的精密度。

方法

Micros CRP分析仪(ABX诊断公司)是一种小型台式设备。评估了其检测限、定量限、线性和不精密度。使用参考区间内外的样本进行方法比较研究。还评估了抗凝剂效应和前带效应。

结果

检测限为0.1mg/l。分别使用10%和20%的系统误差限,该方法在2至60mg/l和0.3至60mg/l范围内呈线性。对于0.7至9.1mg/l的CRP浓度,总不精密度<8%。在CRP浓度>500mg/l时可见前带效应。使用120名明显健康成年人的样本,Micros CRP方法与BN II高敏CRP(hs-CRP)方法显示出极好的一致性。使用CRP浓度升高的样本,Micros CRP方法与比浊法比较良好。

结论

Micros CRP方法在临床实践中足以用于动脉粥样硬化风险预测,但对于流行病学研究,在CRP浓度<2mg/l时准确性不足。

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引用本文的文献

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Clin Diagn Lab Immunol. 2003 Jul;10(4):652-7. doi: 10.1128/cdli.10.4.652-657.2003.