CAJ | 학술논문

目的探讨对2项分子生物学诊断指标HBV-DNA及HCV-RNA测量不确定度的评定.方法利用实时荧光定量PCR法检测HBV-DNA及HCV-RNA室内质控及室间质控标本,收集2012年4月至9月工作日内的HBV-DNA及HCV-RNA室内质控数据及2011年至2012年室间质控结果.依据《化学分析中不确定度的评估指南》评定检测项目测量不确定度的准则,计算HBV-DNA及HCV-RNA的批内及批间变异系数,结果总体偏差变异系数,进而计算出HBV-DNA及HCV-RNA标准不确定度及扩展不确定度.结果同一天内16次HBV-DNA室内质控的检测批内变异系数为4.89％,12次HCV-RNA室内质控的检测批内变异系数为2.55％,2012年4月至9月共129天的HBV-DNA检测批间变异系数为9.54％,155天的HCV-RNA检测批间变异系数为5.80％；2011年至2012年卫生部临检中心HBV-DNA及HCV-RNA室间质评共40个检测数据,其结果总体偏差变异系数分别为5.33％和6.12％,剔除检测为零的数据后重新计算变异系数分别为5.83％和7.06％.批内、批间及结果总体偏差的因素合成后,两者的扩展不确定度分别为±24.02％和±17.62％,剔除检测为零的数据分别后为±24.41％和±18.97％.结论分子生物学指标检测过程影响因素多,因素间相关程度高,不确定度来源的数学模型定型困难,计算繁复.利用现有室内外质控数据进行测量不确定度评价,可极大简化操作步骤,操作性较强.
목적 탐토대2항분자생물학진단지표HBV-DNA급HCV-RNA측량불학정도적평정.방법 이용실시형광정량PCR법검측HBV-DNA급HCV-RNA실내질공급실간질공표본,수집2012년4월지9월공작일내적HBV-DNA급HCV-RNA실내질공수거급2011년지2012년실간질공결과.의거《화학분석중불학정도적평고지남》평정검측항목측량불학정도적준칙,계산HBV-DNA급HCV-RNA적비내급비간변이계수,결과총체편차변이계수,진이계산출HBV-DNA급HCV-RNA표준불학정도급확전불학정도.결과 동일천내16차HBV-DNA실내질공적검측비내변이계수위4.89％,12차HCV-RNA실내질공적검측비내변이계수위2.55％,2012년4월지9월공129천적HBV-DNA검측비간변이계수위9.54％,155천적HCV-RNA검측비간변이계수위5.80％；2011년지2012년위생부림검중심HBV-DNA급HCV-RNA실간질평공40개검측수거,기결과총체편차변이계수분별위5.33％화6.12％,척제검측위령적수거후중신계산변이계수분별위5.83％화7.06％.비내、비간급결과총체편차적인소합성후,량자적확전불학정도분별위±24.02％화±17.62％,척제검측위령적수거분별후위±24.41％화±18.97％.결론 분자생물학지표검측과정영향인소다,인소간상관정도고,불학정도래원적수학모형정형곤난,계산번복.이용현유실내외질공수거진행측량불학정도평개,가겁대간화조작보취,조작성교강.
Objective To study the evaluation of uncertainty measurement about 2 diagnostic indexes of molecular biology.Methods According to Guidance on Evaluating the Uncertainty in Chemical Analysis Criterion,HBV-DNA and HCV-RNA internal quality control and external quality assessment specimens were detected with real-time fluorescence quantitative PCR assay,then we collected internal quality control data from April to September,2012,and external quality assessment results from 2011 to 2012.The coefficient of variations about intra-assay,inter-assay and bias were calculated,determined the standard uncertainty and the expanded uncertainty.Results In the same day,the coefficient of variation about intra-assay was 4.89％ by detecting 16 HBV-DNA specimens of internal quality control,and that was 2.55％ in 12 HCV-RNA detecting; the coefficient of variation of inter-assay was 9.54％ by detecting 129 days HBV-DNA specimens of internal quality control from April to September,2012,and that was 5.80％ by detecting 155 days HCV-RNA specimens of in temal quality control from April to September,2012; the coefficient of variation of bias about HBV-DNA and HCV-RNA were 5.33％ and 6.12％ by detecting 40 external quality assessment specimens distributed by national center for clinical laboratory from 2011 to 2012.After removing the data of zero,the data was recalculated as 5.83％ and 7.06％.After synthesized fiactors about intra-assay,inter-assay and bias,the expanded uncertainty of HBV-DNA and HCV-RNA were 24.02％ and 17.62％,and excluding the data of zero,which were 24.41％ and 18.97％.Conclusions There were various influencing factors in detecting molecular biology indexes.It is digicult in mathsort and counting.Using the existing data of internal quality control and external quality assessment to evaluate the uncertainty measurement of diagnostic index about molecular biology is a rational way,which is a simple and facile method in clinical laboratory.