免疫透射比浊法及干化学法测定血清白蛋白方法学比较及偏倚评估

《免疫透射比浊法及干化学法测定血清白蛋白方法学比较及偏倚评估》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、免疫透射比浊法及干化学法测定血清白蛋白方法学比较及偏倚评估【摘要】目的通过评估免疫透射比浊法与干化学法测定ALB的偏倚,探讨两种方法检测ALB结果间的偏差是否在允许的范围,保证检测结果的可比性。方法依据NCCLS标准化文件EP9-A2[1],每天取临床样本8份,分别用免疫透射比浊法与干化学法进行双份测定,共测定5d,去除离群点,计算相关系数及预期偏差,以CLIA’88规定的室间质评(ALB+10%)允许误差的1/2作为方法比较结果系统误差的允许限值,进行偏倚的评估。结果干化学法与免疫透射比浊法比较,r�2=0.934

2、,在医学决定水平20g/L,35g/L,52g/L时,干化学法的预期相对偏倚分别10.4%,6.8%,3.2%,在Xc=20g/L及Xc=35g/L时,两种方法存在统计学差异。结论以免疫透射比浊法作为比较方法,干化学法测定ALB的结果存在正偏差,测定结果的偏差随着ALB浓度的减低而增大,在低浓度时差异更显著,两者相关性差。因此,实验室内使用不同分析方法检测同一分析物时,建议对各方法进行方法学比较及偏倚评估,明确方法间的差异,并建立各方法的参考范围,特别是建立不同方法在不同医学决定水平浓度的参考值,以保证检测结果的可比

3、性。【关键词】血清白蛋白;免疫透射比浊法;干化学;11偏倚TurbidimetricImmunoassayMethodandDry-slideBromocresolGreenMethodin(ALB)SerumAlbuminDetermination:AMethodologicalComparisonandBiasAssessmentFENGPin-ning,GAOLing,YUXiong-wen,etal.LaboratoryMedicineDepartmentoftheFirstAffiliatedHospita

4、lofSunYat-senUniversity,Guangzhou510080,China【Abstract】ObjectiveThearticlecomparesthebiasassessmentsofturbidimetricimmunoassaymethodanddry-slidebromocresolgreenmethodinALBdetection,anddiscusseswhetherthebiasofthetwodetectionresultsarewithintherangepermitted,soa

5、stoensurethecomparabilityoftheresults.MethodAccordingtoNCCLSstandardizationdocumentEP9-A2[1],firstly8clinicalsamplesaredailytakenandtestedduplicatesundereachmethod,altogetherfivedays.Nexttheoutlierpointsareexcludedandcorrelationcoefficientsandexpecteddeviations

6、arecalculated.Thevalueisrestricted11by1/2oftheerrorthatexternalqualityassessmentallows(ALB+10%)byCLIA’88asthemethodcomparisonresultsystemerror,andthenitisbiasassessed.ResultsTheresultsofcomparisonbetweendry-slidebromocresolgreenmethodandturbidimetricimmunoassay

7、methodareasfollows:r�2=0.934,whenmedicaldecisionsare20g/L,35g/Land52g/L,theexpectedrelativedeviationsofdry-slidebromocresolgreenmethodare10.4%,6.8%,3.2%respectively.WhenXc=20g/LandXc=35g/L,therearesignificantdifferencesbetweentheresultsoftwomethods.ConclusionTu

8、rbidimetricimmunoassayisregardedasthemethodologyincomparison.Dry-slidebromocresolgreenmethod,however,provespositivedeviationsintheresultsofALBdetermination.Itsvalueofbiasinc