3种不同C反应蛋白测定试剂盒的性能评价

Performance evaluation of 3 different C-reactive protein assay kits

目的对A、B、C3种不同C-反应蛋白(CRP)试剂盒在全自动生化分析仪上进行测定性能评价。方法 A试剂为普通免疫透射比浊法CRP,B试剂为高敏CRP(hs-CRP),C试剂为宽范围hs-CRP。检测3种试剂的测定范围、精密度、抗干扰能力和临床标本测定结果相关性。结果测定范围:A试剂为6.0～160.0mg/L,B试剂为0.1～20.0mg/L,C试剂为0.1～320.0mg/L;B、C试剂精密度优于A试剂;B、C试剂均有较好的重复性和稳定性;C试剂抗脂血和溶血能力强。结论 C试剂是根据免疫增强透射比浊法的原理,采用大小不同的2种胶乳颗粒为载体,因此同时具备高敏感性和宽测定范围的特点,更具有临床应用价值。

Objective To make performance evaluation of 3 different C-reactive protein（CRP） assay kits,that was A,B and C,in automatic biochemical analyzer.Methods A reagent was ordinary CRP using immune enhancing transmission turbidity method,B reagent was high sensitivity CRP（hs-CRP）,and C reagent was wide range of hs-CRP.The determination ranges,degree of precision,ability of anti-interference and correlation of determination results of clinical specimens were detected.Results Determination range of A reagent was 6.0～160.0mg/L,and that of B reagent and C reagent was 0.1～20.0mg/L and 0.1～320.0mg/L respectively. The degree of precision of B reagent and C reagent was better than that of A reagent. B reagent and C reagent were all of good repeatability and stability.C reagent had strong action on anti-lipohemia and anti-hemolysis.Conclusion According to the principle of immune enhancing transmission turbidity method,C reagent adopts 2 kinds of latex particles,which are of different sizes,as the carrier,so it has both the features of high sensitivity and wide determination range,and it is of more clinical application value.