中生载脂蛋白AI与B液体双试剂性能评价

Evaluation of a Capability for The Liquid Double Reagent Assay Produced By The Zhongsheng Beikong Bio-technology and Science Inc For determine Lipoprotein AI and Lipoprotein B

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ApoAICV值分别为1.011%和2.993%,日间CV值分别为1.010%和2.503%。批内ApoBCV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=0.995685,相关方程为Y=-0.00885+1.009311X,ApoB的相关系数r=0.994032,相关方程为Y=0.007527+0.992917X,测定结果显著相关(P<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。

Objective To evaluate the performance of the lipoprotein AI and lipoprotein B liquid double reagent（produced by The Zhongsheng Beikong Bio-Technology and Science Inc） on the automatic chemical analysis instrument TOSBAL TBA-40FR. 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 within-run ApoA CV were 1. 011% and 2. 993% respectively,and its daytime-run CV were 1. 010% and 2. 503% respectively. The within-run ApoB CV was 1. 367% and 2. 492 % respectively and its daytime-run 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 ApoB was r=0. 994 032 and its regression equation was Y=0. 007 527＋0. 992 917XB. It turned out that there was significant correlation. Conclusion The performance of the lipoprotein AI and lipoprotein B liquid double reagent produced by The Zhongsheng is good. It is qualified for clinical diagnosis,andcan be used in automatie analysis.