摘要:目的根据意大利米兰 会议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，为我国18 个肿瘤标志物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)。方法通 过Clinet-EQA软件收集参加国家卫生健康委临床检验中心2019- -2021 年肿瘤标志物室间质评( EQA)活动实验室的数据[包括EQA数据和室内质控(IQC)数据]。对于有BV数据的检验项目,将各项目EQA数据的“百分差值=(测量结果-靶值)/靶值X 100%"、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:TEa当前= 1/2x( Poo-P),“当月在控CV"的P80 可作为该批号基于当前技术水平推导出的允许CV。利用公式| Bias |≤TEa-zxCV导出推荐允许Bias。结果18 个检验项目推荐的TEa/CV如下:AFP( 21%/7%)，CEA( 20.5%/6.8%) ,HCG( 23.4%/ 7.8%)，β-HCG(20.4%/6.8%),T-PSA和F-PSA( 24.4%/7.5%) ,CA125( 20.9%/6.5%) ,CA15-3(20.8%/ 7%) ,CA19-9( 25%/ 7.8%) ,CA50和CA242( 24%/8%) ,CA72-4( 22.8%/7.6%) ,HE4和CYFRA21-1 (21.9%/7.3%) , NSE ( 20.9%/8.2% ) , SCCA (22.9%/7.7%) , Feritin( 25%/7.1%),β2-MG(21.3%/7.1%)。结论为18个肿瘤标志物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。
Abstract: Objective According to the setting mode of performance specifications determined by the Milan Conference in Italy, the performance specifications are derived based on the biological variation ( BV) and current technological level mode to recommend the allowable total error ( TEa)，allowable imprecision ( CV) and allowable bias ( Bias) of 18 tumor marker tests in China. Methods The extemal quality assessment ( EQA) and internal quality control ( IQC) data of laboratories participating in the EQA activity of tumor markers implemented by the National Center for Clinical Laboratories during 2019 and 2021 were collected using the clinet-EQA software. For the tests with BV data, the percentage difference [ ( measurement result - target value )/ target valueX 100% ] of EQA data and the in-control coefficient of variation ( CV) of the current month of IQC data for each test were compared with the evaluation criteria of three levels derived based on BV. Then, the passing rates of the percentage difference and CV of all batches in each year were calculated. When the passing rate reached 80%, the performance specifications of this level met the requirements of the recommended per- formance specifications of the test. For the tests without BV data or tests whose performance specifications at three levels derived based on BV could not be used as recommended criteria, the recommended performance specifications were derived based on the current technological level. The TEa。，em [ 1/2x(P∞-P1)], P80 of in-control CV of the current month and| Bias |(≤TEa-zxCV) could be used as the allowable TE, CV and bias, respectively. Results The recommended TEa/CV of 18 tests were as follows: AFP (21%/7%),CEA (20.5%/6.8%)， HCG ( 23.4%/7. 8%)，β-HCG ( 20. 4%/6.8%)，T-PSA and F-PSA ( 24. 4%/7.5%)，CA125 ( 20.9%/6.5%)，CA15-3 (20. 8%/ 7%)，CA19-9 ( 25%/7.8%)，CA50 and CA242 ( 24%/8%)，CA72-4 ( 22. 8%/7.6%)，HE4 and CYFRA21-1 (21 .9%/7.3%)，NSE ( 20.9%/8.2%), SCCA ( 22.9%/7.7%), FEeritin (25%/ 7.1%), and β2-MG (21.3%/7.1%).Conclusion The allowable total error, imprecision and bias of 18 tumor marker tests that meet the current detection level of Chinese laboratories are recommended.