迈瑞BS-300全自动生化分析仪性能评价  

Performance evaluation of Mairui BS-300 automatic biochemical analyzer

作　　者：王艳秋[1,2] 谢玲玲[1,2] 徐志伟[1,2] 施秀英[3] 季伙燕[3] 王惠民[3] 

机构地区：[1]南通大学公共卫生学院 [2]南通大学检验医学研究所,南通226019 [3]南通大学附属医院检验科

出　　处：《南通大学学报（医学版）》2012年第1期15-17,共3页Journal of Nantong University(Medical sciences)

基　　金：南通大学教学研究课题(2010A05;2011B79)

摘　　要：目的:对本实验室的BS-300全自动生化分析仪的主要性能进行评价。方法:使用国家标准物质中心提供的"生化分析仪检定用溶液标准物质"对吸光度准确度、重复性、线性误差、杂散光、交叉污染率和比色杯间吸光度差异进行评价;使用新鲜血清对批内不精密度进行评价。结果:标准物质1-1和1-2的吸光度均值分别为0.407和0.912;吸光度重复性的极差为0.008 4;标准物质3-1、3-2、3-3、3-4和3-5的吸光度线性误差分别为-4.15%、0.46%、2.60%、0.67%、0.42%;标准物质2的杂散光为6.880 6;标准物质4从高浓度到低浓度以及从低浓度到高浓度的交叉污染率分别为-1.58%和-0.26%;比色杯间吸光度变异系数(CV)为1.42%;碱性磷酸酶(ALP)低值和高值的CV分别为1.14%和0.78%。结论:根据JJG464-2005文件的评价标准,本实验室BS-300全自动生化分析仪的杂散光、批内精密度、比色杯间吸光度差异及吸光度线性误差四项指标符合标准;仪器的吸光度准确度、重复性及交叉污染率三项指标均不符合标准。Objective： To evaluate the main characteristics of BS-300 automatic biochemistry analyzer in our laboratory.Methods： Evaluating the accuracy,repeatability and linearity of absorbance,stray light,cross contamination by standard solutions offered by the centre of national standard substances.Examining the absorbance difference between cuvettes by potassium dichromate solution.Observing intra imprecision by patients＇ serum.Results： The mean absorbance of standard material 1-1 and 1-2 were 0.407 and 0.912,respectively,the repeatability of absorbance was 0.008 4.The linearity errors of standard solutions 3-1,3-2,3-3,3-4 and 3-5 were-4.15%,0.46%,2.60%,0.67%,0.42%,respectively.The stray light of standard solution 2 was 6.880 6.The probability of cross-contamination of standard solution 4 were-1.58% and-0.26%,respectively.The CV of the absorbance between cuvettes was 1.35%.The CV of ALP at low level was 1.14%,and at high level was 0.78%.Conclusion： According to the document of JJG464-2005,the absorbance difference between cuvettes,intra imprecision,stray light and linearity errors meet the requirements.But the accuracy,repeatability and the probability of cross contamination can not meet the requirements.

关 键 词：BS-300全自动生化分析仪 JJG464-2005 性能评价 

分 类 号：R446[医药卫生—诊断学]