中生载脂蛋白AI及B液体双试剂性能评价.docVIP

中生载脂蛋白AI及B液体双试剂性能评价 　 作者：李琳，杨镍，何广源，全红兵 【关键词】 载脂蛋白AI；载脂蛋白B；性能评价 ［摘 要］ 目的：对中生北控生物科技股份有限公司生产的载脂蛋白AI、B液体双试剂的性能进行评价。方法：采用中生载脂蛋白AI、B液体双试剂，用免疫透射比浊法测定质控血清和住院病人血清载脂蛋白AI（ApoAI）及载脂蛋白B(ApoB)，分析中生载脂蛋白AI、B液体双试剂的精密度与稳定性、准确度、性线，并与英国Randox试剂作对照。结果：中生的载脂蛋白AI、B液体试剂测定均值偏差小于2％；对高、低血清标本进行精密度测定，批内ApoAI CV值分别为1.011％和2.993％，日间CV值分别为1.010％和2.503％。批内ApoB CV值分别为1.367％和2.492％，日间CV值分别为1.417％和3.746％。与Randox试剂相比，ApoAI的相关系数r＝0.995 685，相关方程为Y=-0.008 85＋1.009 311X，ApoB的相关系数r＝0.994 032，相关方程为Y=0.007 527+0.992 917X，测定结果显著相关（Plt;0.05）。结论：中生载脂蛋白AI、B液体双试剂性能良好达到临床诊断试剂要求，能适用于自动化分析。 　　［关键词］ 载脂蛋白AI；载脂蛋白B；性能评价 　　Evaluation of a Capability for The Liquid Double Reagent Assay Produced By The Zhongsheng Beikong Biotechnology and Science Inc For determine Lipoprotein AI and Lipoprotein B 　　　Abstract：Objective To evaluate the performance of the lipoprotein AI and lipoprotein B liquid double reagent(produced byThe Zhongsheng Beikong BioTechnology and Science Inc) on the automatic chemical analysis instrument TOSBAL TBA40FR.Methods Using the determine lipoprotein AI(ApoAI) and lipoprotein B(ApoB) liquid double reagent(produced by The Zhongsheng )to test ApoAI and ApoB of the quality controlling serum and the serum of the hospitalized.Then make statistics on the basis of the results to analysis its precision,stability,nicety,linear range and its relativity with the reagent produced by British Randox.Results As a result,the deviation of the average data determined by the lipoprotein AI and lipoprotein B liquid double reagent produced by The Zhongsheng was with 2%.When testing the precision of the samples of high and low serum,the withinrun ApoA CV were 1.011% and 2.993% respectively,and its daytimerun CV were 1.010% and 2.503% respectively.The withinrun ApoB CV was 1.367% and 2.492% respectively and its daytimerun CV were 1.417% and 3.746% respectively.Compared with the Randox reagent,the correlation modulus of ApoAI was r=0.995 685 and its regression equation was Y=0.008 85+1.009 311 XAI;the correlation modulus of Apo