【摘要】 目的通过两种方法检测血清Lp(a)浓度的对比分析,探讨不同检测方法之间血清Lp (a)结果的偏倚。方法依据美国临床实验室标准化委员会EP9-A文件要求,每天留取患者新鲜血清8份,分别用免疫透射比浊法和胶乳增强免疫比浊法测定血清Lp(a)浓度,共测定5 d,记录检验结果,对两种方法进行相关分析和偏倚估计。结果在进行患者新鲜血清样本Lp(a)测定时,通过直线相关回归分析r~2=0.96,>0.95,表明两种方法相关性良好,测定结果的相对偏倚在线性范围内能被接受,其结果具有可比性,但胶乳增强免疫比浊法在线性、稳定性、灵敏度等方面比常规免疫比浊法好;在测定不同的质控品Lp(a)时,两种方法测定结果的相对偏倚可达40.0%以上。结论两种方法在测定血清样本Lp(a)时,测定结果的相对偏倚在线性范围内能被接受;在测定不同的质控品时,其相对偏倚随产品不同而不同,最大可达40.0%。更多还原

【Abstract】 Objective To compare the difference of serum Lp(a)results,and to explore the bias estimation of two detection methods.Methods According to NCCLS EP9-A file.8 cases of fresh serum samples were collected each day.Turbidimetric immunoassay and latex enhanced turbidimetric immunoassay (LETIA)were applied to examining the conxentration of serum LP(a)in 5 operating days.Correlation analysis and bias estimation were carried out for the above methods.Results Linear correlation regression analysis(r~2>0.95)indicated there existed close correlation between the different methods,and the relativity bias could be accepted in the linear range.By comparison,LETIA was superior to turbidimetric immunoassay in linearity,stability and sensitivity.In case of different Lp(a) quality control serum,the relativity bias of the two methods could be more than 40.0%.Conclusion When measuring serum Lp(a)with turbidimetric immunoassay and latex enhanced turbidimetrie Immunoassay, their relativity bias can be accepted in the linear range.On the other hand,for different quality control sera the relativity bias is different,and the largest bias value can reach 40.0%.更多还原