Rothkrantz-Kos Snjezana, Bekers Otto, Gubbels Armand, Drent Marjolein, Schmitz Maria P J, van Dieijen-Visser Marja P
Department of Clinical Chemistry, University Hospital Maastricht, 6202 AZ Maastricht, The Netherlands.
Ann Clin Biochem. 2003 Jul;40(Pt 4):398-405. doi: 10.1258/000456303766477057.
The implementation of a high-sensitivity C-reactive protein (hs-CRP) assay as a routine laboratory parameter may be necessary. It would be most practical to use one CRP method giving reliable results for the whole concentration range. We report here the evaluation of two new hs-CRP methods, which cover both the low and the high concentration ranges.
The BN ProSpec hs-CRP (Dade Behring) and Synchron LX 20 PRO hs-CRP methods were compared with the existing hs-CRP IMMAGE method (taken as a reference) and, for the high concentration range, also with the routine Synchron LX 20 CRP method (all from Beckman). Agreement among methods was examined for 521 samples. Reference values were estimated in 291 blood donors. Additionally, the influence of sample turbidity, a major problem of the present Synchron LX20 CRP method, was evaluated.
Measurement of CPR by the BN ProSpec was linear down to 0.2 mg/L, whereas the linearity of Synchron LX20 PRO showed some systematic discrepancies. Over the whole measured range (0.2-250 mg/L), precision (coefficient of variation, CV) was < or =3.7% for the BN ProSpec and < or =6.1% for the LX20 PRO. The Synchron LX20 PRO hs-CRP method was found to be superior to the current routine Synchron LX20 CRP method with regard to precision in the low concentration range and the influence of sample turbidity. Both in the low concentration range and especially in the high concentration range, large discrepancies between methods were observed.
Although acceptable performance was found for the Synchron LX20 PRO hs-CRP method, overall the performance of the BN ProSpec hs-CRP method was superior. However, standardization among assays needs further improvement in both the low and the high concentration ranges.
将高敏C反应蛋白（hs-CRP）检测作为一项常规实验室指标或许很有必要。采用一种能在整个浓度范围内给出可靠结果的CRP检测方法最为实用。我们在此报告两种新的hs-CRP检测方法的评估情况，这两种方法涵盖了低浓度和高浓度范围。
将BN ProSpec hs-CRP（德灵公司）和Synchron LX 20 PRO hs-CRP检测方法与现有的hs-CRP IMMAGE检测方法（作为参考）进行比较，对于高浓度范围，还与常规的Synchron LX 20 CRP检测方法（均来自贝克曼公司）进行比较。对521份样本检测方法之间的一致性进行了检验。在291名献血者中估计了参考值。此外，还评估了样本浊度的影响，样本浊度是当前Synchron LX20 CRP检测方法的一个主要问题。
BN ProSpec检测CRP的线性范围低至0.2mg/L，而Synchron LX20 PRO的线性存在一些系统差异。在整个测量范围（0.2 - 250mg/L）内，BN ProSpec的精密度（变异系数，CV）≤3.7%，LX20 PRO的精密度≤6.1%。发现Synchron LX20 PRO hs-CRP检测方法在低浓度范围的精密度和样本浊度的影响方面优于当前常规的Synchron LX20 CRP检测方法。在低浓度范围以及特别是高浓度范围内，各检测方法之间均观察到较大差异。
尽管Synchron LX20 PRO hs-CRP检测方法表现出可接受的性能，但总体而言BN ProSpec hs-CRP检测方法的性能更优。然而，在低浓度和高浓度范围内，各检测方法之间的标准化仍需进一步改进。
