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目的 :对日本OLYMPUSAU40 0全自动生化分析仪进行应用评价。方法 :采用两种不同浓度质控血清和患者及其健康人的血清分别就ALT、TG、Urea和TBiL四项指标对该仪器进行精密度对照试验、准确度试验、线性范围及预期偏倚测试。结果 :该仪器所测ALT、TG、Urea批内及总CV <3 % ;TBiL批内 <3 % ,总CV <10 % ;三种试剂比较r在 0 .984~ 0 .9992间 ,ALT、TG、TBiL、Urea相对偏倚分别小于 3 .5 %、3 .5 %、9.5 %、8.6%。结论 :参照NCCLS文件 ,该仪器主要性能指标评价符合文件要求 ,OLYMPUSAU40 0全自动生化分析仪具有良好的精密度、准确度、线性范围、试剂开放特点 ,能适应临床生化实验室和科研需要
Abstract:Objective: To use and evaluate Olympus AU400 automated chemistry analyzer which is made in Japan. Methods: The precision,accuracy,the linear range and deviation index of ALT,TG,Urea and TBil in the serums of two kinds of control quality,patients and health people were detected. Results: The withinrun cv and total withinrun cv of ALT,TG,Urea are both less than 3%,The withinrun cv of TBil is less than 3%,total withinrun cv is less than 10%,the correlation coefficients of three kinds of reagents is 0.984 ~ 0.9992 ,the deviation index is less than 3.5% , 3.5% , 9.5% and 8.6% .Conclusion: The precision,accuracy,recovery rate and linear range of Olympus AU400 are satisfaction.It can suit for clinical biochemistry laboratory and scientific research.
[1] NCCLS (EP5T2).EvaluationofPrecisionofClinicalChemistryDevicesSecondEdition;Tentativeguideline[S].
[2]NCCLS (EP9A).NationalCommitteeforClinicalLabo ratoryStandards.MetholdofComparisionandBaisEsti mationUsingPatientSample;ApprovedGuideline[S].
[3]NCCLS (EP6P).NationalCommitteeforClinicalLabo ratoryStandards.EvaluationoftheLinearityofQuanti tativeAnalyticalMethods;ProposedGuidline[S].
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DOI:
中图分类号:R446.11
引用信息:
[1]张洪波.OLYMPUS AU400全自动生化分析仪的应用评价[J].江汉大学学报(医学版),2002(03):41-43.
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