【摘要】 目的探讨终点法三酰甘油(TG)测量不确定度评定的合理方式。方法利用现成室内质控及室间质评标本,对高、低浓度的TG室内质控标本在同一天内各检测20次,同时收集2012年5—10月的TG室内质控数据及2010—2012共45次室间质评结果。计算其批内及批间变异系数、系统偏倚变异系数,确定其相应的标准不确定度分量,进而计算出TG的高、低浓度扩展不确定度。结果同一天内高、低浓度的TG室内质控批内变异系数分别为1.682%、1.775%;2012年5—10月共157个工作日的高、低浓度的TG批间变异系数分别为1.891%、1.859%;2010—2012年卫生部临床检验中心室间质评高、低浓度共45个检测数据的系统偏倚变异系数为4.099%。合成批内、批间及系统偏倚因素后,TG高、低浓度的扩展不确定度分别为9.634%、9.676%,高、低浓度报告结果分别为(2.022±0.195)、(1.023±0.099)mmol/L。结论对终点法测TG测量不确定度的评价,利用现有室内、外质控数据,无须额外测试,简单易行,成本低,是医学检验实验室较为实用的一种测量不确定度的评价方式。更多还原

【Abstract】 Objective To study the rational way to evaluate the measurement uncertainty in detecting triglyceride(TG)with end point assay.Methods The internal quality control and the external quality assessment specimens were used.The high and low concentrations of TG internal quality control samples were respectively detected for 20 times on the same day.The data of the internal quality control from May to October 2012 and the 45 times external quality assessment results from 2010 to 2012 were collected.The intra-assay and inter-assay variation coefficients and the system bias variation coefficients were calculated for determining the corresponding standard uncertainty and the expanded uncertainty in the high and low concentrations of TG.Results The intra-assay variation coefficients on the same day in the high and low concentrations of TG internal quality control samples were 1.682% and 1.775% respectively,and the inter-assay variation coefficients in 157-workday high and low concentrations of TG inter-assay quality control specimens from May to October 2012 were 1.891% and 1.859% respectively.The variation coefficient of system bias in 45 external quality assessment specimens detected by the Clinical Laboratory Center of the Ministry of Health from 2010 to 2012 was 4.099%.After synthetizing the factors of intra-assay,inter-assay and system bias,the expanded uncertainties in the high and low concentrations of TG were 9.634% and 9.676% respectively,their report results were 2.0220.195 mmol/L and 1.0230.099 mmol/L respectively.Conclusion Evaluating the TG measurement uncertainty by using the end point assay can utilize the existing data of internal quality control and external quality assessment without additional test,which is simple and easy to operate with low cost,and is a practical evaluation way of the measurement uncertainty in clinical laboratory.更多还原