中生载脂蛋白AI与B液体双试剂性能评价

互联网2015-01-05

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作者：李琳，杨镍，何广源，全红兵

［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<a target="_blank">免疫</a>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（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。

［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 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 automatic analysis.

Key words:Evaluation of capability;Lipoprotein AI;Lipoprotein B

顺德中西医结合医院<a target="_blank">检验科</a>因试剂国产化及降低成本的需要，准备自2002年8月起使用中生载脂蛋白AI、B液体双试剂，我们于当月对该公司生产的血清载脂蛋白AI（ApoAI）和载脂蛋白B(ApoB)的液体双试剂盒进行了某些性能的评价，并与英国Randox公司（以下简称Randox）的同类试剂进行比较，现将结果报告如下。

1 材料与方法

1.1 材料血清均取自顺德中西医结合医院住院病人当天空腹标本。ApoaAI测定试剂盒：Randox(批号5534H)；中生（批号1172J）。ApoB测定试剂盒：Randox( 批号5535H)；中生（批号8040H）。Randox质控血清（批号243UN/40）；中生质控血清（批号291lp）。检测仪器采用日本东芝TBA40FR全自动<a target="_blank">生化</a>分析仪。

1.2 方法

1.2.1 ApoAI和ApoB测定均按试剂盒生产厂商提供测定参数、测定方法进行。对中生试剂进行精密度、准确度、相关性、性线、稳定性等性能进行测试。

1.2.2 精密度与稳定性方法［2］用中生试剂分别对2个不同浓度的样品（质控血清）进行ApoaAI和ApoB测定，1 d之内，分时间段各测定20次，计算日内批内SD、CV，估计短期内随机误差。每天上午、下午分别测定上述2个样品，每个样品每天平行测定2次取均值。同一开盖试剂24 h置于试剂仓内（4 ℃~8 ℃），连续测定20个工作日，计算日间SD、CV。

1.2.3 准确度方法用中生试剂多次测定中生质控血清与Randox质控血清,测定值与靶值比较，计算偏差系数CB％［CB％＝(平均值－靶值)/靶值×100％］。

1.2.4 测定范围及性线方法将中生定值血清ApoAI(标定值2.38 g/L)，ApoB(标定值2.18 g/L)系列稀释成9个样品，标定值与稀释比例（90％、80％、70％、60％、50％、40％、30％、20％、10％）的乘积为预期值。用中生ApoAI，ApoB液体双试剂分别测定上述样品各2次，先从低浓度到高浓度测定，然后再从高浓度到低浓度测定。计算每一浓度的测定值均值，此为实际测定值，计算相关系数，得出回归方程，绘出线性图。

1.2.5 与Randox试剂相关性方法使用中生和Randox的ApoAI，ApoB液体双试剂，同时对同一组病人血清样品共100例进行平行对比测定［1］。