我国34个常规化学检验项目性能规范研究

Study on performance specifications of 34 routine chemistry analytes in China

目的为我国34个常规化学检验项目推荐允许总误差(TEa)、允许不精密度(CV)和允许偏倚(Bias)。方法根据意大利米兰会议最新确定的性能规范设定模式,基于生物学变异(BV)和基于当前技术水平模式导出性能规范。通过Clinet-EQA软件收集参加国家卫生健康委临床检验中心2019至2021年常规化学和脂类分析EQA活动实验室的数据(包括EQA数据和IQC数据)。对于有BV数据的检验项目,将各研究项目EQA数据的“百分差值”、IQC数据的“当月在控CV”分别与基于BV导出的3种水平评价标准比较,计算各年份所有批号的百分差值通过率和CV通过率,当通过率达到80%,则该水平的性能规范满足作为该项目推荐性能规范的要求。对于无BV数据的检验项目或者基于BV导出的3种水平性能规范均无法作为推荐标准的检验项目,则基于当前技术水平来导出推荐性能规范。各检验项目在获得推荐TEa和允许CV后,利用公式|Bias|≤TEa-z×CV导出推荐允许Bias。结果34个检验项目推荐的TEa(CV)%结果如下:K4.7(2),Na4(1.5),Cl 4(1.4),Ca5(2),P9.6(3.9),Glu6.4(2.5),Urea8(3),UA12(4.1),Cre11(3.3),TP5(2),Alb5.2(2.4),TC8.6(2.7),TG13.5(5),HDL-C16.5(4.3),LDL-C20.5(6.2),ApoAⅠ16(5.3),ApoB 17.1(5.5),Lp(a)24.1(10.4),TBil 12.4(5),DBil20(7.3),ALT16(5),AST13.5(4.8),ALP17.5(4.8),AMY13.1(3.3),CK11.3(3.8),LDH11(3.9),CHE13.4(5.3),LIP20(6.9),Fe13.3(5.2),Mg14(4.5),Cu17.9(6.8),Zn15.1(6.4),γ-GGT10(3.3),α-HBDH18(5.8)。利用公式|Bias|≤TEa-z×CV导出34个检验项目允许Bias。结论为34个临床常规化学定量检验项目推荐了符合我国实验室当前检测水平的允许总误差、允许不精密度和允许偏倚。

Objective The allowable total error(TEa),allowable imprecision(CV)and allowable bias(Bias)were recommended for 34 routine chemistry analytes in China.Methods According to the performance specification setting mode newly determined at the Milan conference in Italy,the performance specification was derived based on components biological variation(BV)and current state of the art mode.The data(including EQA data and IQC data)of laboratories participating in the routine chemistry and lipids and lipoproteins EQA activities of the national center for clinical laboratories from 2019 to 2021 was collected through clinet-EQA.For the analytes with biological variation(BV)data,compared the'percentage difference′of EQA data and the'in-control coefficient of variation of the month′of IQC data of each research analyte with the three levels evaluation criteria derived based on BV,and calculated the percentage difference passing rate and CV passing rate of all batches in each year.When the passing rate reaches 80%,the performance specifications of this level met the requirements of the recommended performance specifications of the analyte.For the analytes without BV data or analytes whose performance specifications at three levels derived based on BV could not be used as recommended standards,the recommended performance specifications are derived based on the current state of the art.After obtaining the recommended TEa and allowable CV for each analyte,used the formula|Bias|≤TEa-z⨯CV to derive the recommended allowable bias.Results The results of TEa(CV)%recommended by 34 analytes are as follows:K4.7(2),Na4(1.5),Cl4(1.4),Ca5(2),P9.6(3.9),Glu6.4(2.5),Urea8(3),UA12(4.1),Cre11(3.3),TP5(2),Alb5.2(2.4),TC8.6(2.7),TG13.5(5),HDL-C16.5(4.3),LDL-C20.5(6.2),ApoAⅠ16(5.3),ApoB 17.1(5.5),Lp(a)24.1(10.4),TBil 12.4(5),DBil 20(7.3),ALT16(5),AST13.5(4.8),ALP17.5(4.8),AMY13.1(3.3),CK11.3(3.8),LDH11(3.9),CHE13.4(5.3),LIP20(6.9),Fe13.3(5.2),Mg14(4.5),Cu17.9(6.8),Zn15.1(6.4),γ-GGT10(3.3),α-HBDH18(5.8).The formula|Bias|≤TEa-z⨯CV is used to derive the allowable bias of 34 analytes.Conclusions For 34 clinical routine chemistry quantitative analytes,the allowable total error,allowable imprecision and allowable bias that meet the current state of the art of Chinese laboratories are recommended.