高选择性的小而密低密度脂蛋白胆固醇匀相分析新方法建立及评价  

Establishment and evaluation of a new method for highly selective homogeneous analysis of small and dense low-density lipoprotein cholesterol

作　　者：郑睿颖 连烨 潘利琴 张娜[1] 连国军[1] ZHENG Ruiying;LIAN Ye;PAN Liqin;ZHANG Na;LIAN Guojun(School of Laboratory Medicine and Life Science,Wenzhou Medical University,Wenzhou 325035,China;College of Science,Mathematics and Technology,Wenzhou-Kean University,Wenzhou 325060,China;Department of Laboratory Tests,the Third Clinical College of Wenzhou Medical University,Wenzhou People’s Hospital,Wenzhou 325041,China)

机构地区：[1]温州医科大学检验医学院(生命科学学院),浙江温州325035 [2]温州肯恩大学理工学院,浙江温州325060 [3]温州医科大学温州市第三临床学院温州市人民医院检验科,浙江温州325041

出　　处：《温州医科大学学报》2025年第2期134-138,共5页Journal of Wenzhou Medical University

摘　　要：目的:建立高选择性的小而密低密度脂蛋白胆固醇(sdLDL-C)匀相分析新方法,并进行方法学评价。方法:首先利用嵌合酯酶和非离子型表面活性剂聚氧乙烯苄基苯醚衍生物、聚氧乙烯苯乙烯苯醚衍生物的共同作用,将样本内的非sdLDL-C特异性酶解并清除,然后用TritonX-100将样本中的sdLDL-C颗粒被打开并与胆固醇酶试剂反应而显色,与同样处理的校准品比较后定量。结果:批内不精密度(CV)为0.90%~2.36%,批间CV 1.29%~3.12%,精密度良好;线性范围为0.10~2.59 mmol/L,最低检出限(LOD)为0.029 mmol/L,最低定量限(LOQ)为0.098 mmol/L;sd LDL-C检测的回收率为98.67%~104.00%,平均回收率为101.22%;测定sdLDL-C浓度为0.82 mmol/L的样本时,允许的主要干扰物质浓度为:血红蛋白≤520 mg/dL,维生素C≤55 mg/dL,结合胆红素≤32 mg/dL,脂肪乳≤650 mg/dL。与浙江夸烨生物科技有限公司提供的sdLDL-C测定试剂方法进行比较,回归方程及相关系数分别为y=1.013x-0.016,r=0.986。结论:本研究所建立的方法特异性好,批内和批间CV值较小,线性范围宽,回收率较高,抗干扰能力较强。Objective:To establish a new method for highly selective homogeneous analysis of small and dense low-density lipoprotein cholesterol(sdLDL-C)and to conduct methodological evaluation.Methods:Firstly,the non-sdLDL-C-specific enzymes in the sample were hydrolyzed and cleared by the combined action of the chimeric-esterase and non-ionic surfactants such as polyoxyethylene benzyl phenyl ether derivatives and polyoxyethylene styrene phenyl ether derivatives.Then,using TritonX-100 the sdLDL-C particles in the sample were opened,which reacted with cholesterol enzyme reagents to develop color and compared with calibration samples treated with the same method before quantification.Results:The intra-batch imprecision(CV)was 0.90%-2.36%,and the inter-batch imprecision(CV)was 1.29%-3.12%,indicating good precision.The linear range was 0.10-2.59 mmol/L,with the minimum detection limit(LOD)being 0.029 mmol/L and the minimum quantification limit(LOQ)0.098 mmol/L.The recovery rate of sdLDL-C detection was 98.67%-104.00%,with an average recovery rate of 101.22%.When measuring samples with a sdLDL-C concentration of 0.82 mmol/L,the allowable main interfering substance concentrations were as follows:hemoglobin≤520 mg/dL,vitamin C≤55 mg/dL,conjugated bilirubin≤32 mg/dL,and fat emulsion≤650 mg/dL.Compared with the sdLDL-C determination reagent method provided by Zhejiang Kuaye Biotechnology Co.,Ltd.,the regression equation and correlation coefficient were y=1.013x-0.016,r=0.986,respectively.Conclusion:The method established in this study has good promotional application value in that it has good specificity,small intra-and inter-batch CV values,wide linear range,high recovery rate and strong anti-interference ability.

关 键 词：小而密低密度脂蛋白胆固醇 高选择性 匀相分析法 

分 类 号：R446[医药卫生—诊断学]