均相法检测脂蛋白残粒胆固醇的建立及初步临床应用  

Establishment and preliminary clinical application of homogeneous method for the determination of remnant lipoprotein-cholesterol

作　　者：王蓉[1] 黄克亮 张建华 张欣 WANG Rong;HUANG Keliang;ZHANG Jianhua;ZHANG Xin(Department of Clinical Laboratory,Huangpu Branch,the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China;Department of Chemistry,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China)

机构地区：[1]上海交通大学医学院附属第九人民医院黄浦分院检验科,上海200011 [2]上海交通大学医学院化学教研室,上海200025

出　　处：《检验医学》2020年第5期464-469,共6页Laboratory Medicine

基　　金：上海市黄浦区卫生健康委员会科研项目(HKM201815)。

摘　　要：目的建立均相法检测脂蛋白残粒胆固醇(RLP-C)的方法,并进行初步评估。方法以聚氧乙烯-聚氧丁烯嵌段共聚物(POE-POB)为屏蔽剂,特异性屏蔽非脂蛋白残粒,以此为基础,优化实验条件,建立检测RLP-C的均相法。将自建方法与参比方法[日本协和公司RLP-C试剂(均相法)]进行比对,采用自建方法测定116例混合性高脂血症患者和130名正常对照者的血清RLP-C浓度,同时测定血清三酰甘油(TG)、总胆固醇(TC)、载脂蛋白C2(apo C2)浓度。采用Pearson相关分析评估各项目之间的相关性。结果自建方法的最佳缓冲体系为3-(N-玛代琳)丙磺酸(MOPS)缓冲体系,最适pH值为6.8,POE-POB最适浓度为8g/L,检测延迟时间为5min,测定时间为5min。自建方法的批内平均变异系数(CV)为3.37%,批间平均CV为4.91%,试剂在4℃条件下可稳定1个月。参比方法与自建方法的检测结果稍有差异,但2种方法的相关性良好(r=0.980),Bland-Altman散点图显示,98例样本中仅有4例(4.08%)不在±1.96s范围内。混合性高脂血症组血清RLP-C、TG、apo C2、TC浓度均高于正常对照组(P<0.001)。RLP-C与TG呈正相关(r=0.496,P<0.001),与apo C2、TC均无相关性(r值分别为0.157、-0.090,P>0.05)。结论自建方法简便、快捷,可用于全自动生化分析仪,适用于临床常规检测。Objective To establish homogeneous method for determining remnant lipoprotein-cholesterol(RLP-C),and to evaluate it primarily.Methods A homogeneous method for the determination of RLP-C was established based on the screening of non-lipoproteins with polyoxyethylene-polyethylene oxide butene(POEPOB)as screening agent.The self-established method was compared with the reference method[RLP-C reagent(homogeneous method)of Japan Concorde company].Serum RLP-C and triglyceride(TG),total cholesterol(TC),apolipoprotein C2(apo C2)were determined in 116 patients with mixed hyperlipidemia and 130 healthy controls.Pearson correlation analysis was used to evaluate their correlations.Results The optimal buffer system was 3-morpholinopropanesulfonic acid(MOPS)buffer system.The optimal pH value was 6.8,the optimal concentration of POE-POB was 8 g/L,and the determination delay time was 5 min.Intra-self established method coefficient of value(CV)was 3.37%,and inter-CV was 4.91%.The reagent was stable for 1 month at 4℃.The results of reference method and self-established method were slightly different,but the correlation between the 2 methods was good(r=0.980).Bland-Altman scatter plot showed that 4(4.08%)samples were not within±1.96s.The concentrations of RLP-C,TG,apo C2 and TC in mixed hyperlipidemia group were higher than those in healthy control group(P<0.001).RLP-C was positively correlated with TG(r=0.496,P<0.001),but it was not correlated with apo C2 and TC(r=0.157 and-0.090,P>0.05).Conclusions The self-established method is simple and rapid,which can be used in automatic biochemical analyzer and be used as clinical routine test.

关 键 词：脂蛋白残粒胆固醇 均相法 聚氧乙烯-聚氧丁烯嵌段共聚物 高脂血症 

分 类 号：R446.1[医药卫生—诊断学]