Piéroni Laurence, Chahbani Najette, Hainque Bernard
Service de Biochimie Métabolique, Groupe Hospitalier Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Paris, France.
Clin Chem Lab Med. 2009;47(1):109-11. doi: 10.1515/CCLM.2009.013.
The aim of this study was to verify the analytical range of the DIAgam XS Cardio NanoGold C-reactive protein (CRP) method proposed as a full-range assay.
For this purpose, analytical specifications were verified according to the Clinical and Laboratory Standards Institute specifications and a comparison was made with the reference method for the cardiovascular risk assessment, the CardioPhase high sensitivity CRP from Siemens Healthcare Diagnostics.
Our results showed that the immunoturbidimetric assay of CRP using reagents from DIAgam laboratory gave accurate and precise measurements from 0.42 to 265 mg/L. The performances in limits of detection and linearity allowed a full-range determination of CRP concentrations. The comparison with the reference method for the determination of cardiovascular risk was also accurate.
In conclusion, the DIAgam reagents might be used in a routine laboratory for the detection of acute inflammation as well as for evaluation of cardiovascular risk.
本研究的目的是验证被提议作为全范围检测方法的DIAgam XS Cardio NanoGold C反应蛋白（CRP）方法的分析范围。
为此，根据临床和实验室标准协会的规范对分析规范进行了验证，并与心血管风险评估的参考方法——西门子医疗诊断公司的CardioPhase高敏CRP进行了比较。
我们的结果表明，使用DIAgam实验室试剂进行的CRP免疫比浊法在0.42至265 mg/L范围内给出了准确且精确的测量结果。检测限和线性方面的性能使得能够对CRP浓度进行全范围测定。与用于确定心血管风险的参考方法的比较也很准确。
总之，DIAgam试剂可用于常规实验室检测急性炎症以及评估心血管风险。
