6种允许总误差对20个生化项目建立个性化质量控制方案的影响

The influence of 6 different specifications of allowable total error on the establishment of a personalized quality control scheme for 20 biochemical items

目的比较6种允许总误差(TEa)对20个临床生化项目检测的分析性能量化的差异,建立20个生化项目的个性化质量控制方案。方法应用6σ分析20个生化项目的σ水平。偏倚(Bias)来自于2019年国家卫生健康委员会临床检验中心组织的室间质量评价。不精确度(CV%)由2019年1—10月室内质量控制结果计算。6种TEa规范分别来自于生物学变异(Bio)最低、适中和最佳TEa、美国临床实验室改进法案修正案(CLIA'88)、我国行业规范临床生物化学检验常规项目分析质量指标(WS/T403-2012)、国家胆固醇教育计划(NCEP)、德国RiliBAK质控指南(RiliBAK 2008)及澳大利亚皇家病理学家学院(RCPA)的质量保证项目。同时,计算质量目标指数(QGI)来评价检验项目性能不佳的原因。结果来自于Bio(最佳TEa)的标准最严格,而RiliBAK 2008标准最宽松。总胆固醇(CHOL)和三酰甘油(TG)的TEa选自NCEP,清蛋白(ALB)和氯(Cl)的TEa选自CLIA'88,总蛋白(TP)的TEa选自Bio(最低TEa),其余生化项目的TEa来自于WS/T403-2012。其中,丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、TP、γ-谷氨酰基转移酶(GGT)、乳酸脱氢酶(LDH)、ALB、钾(K)和钠(Na)需要改进准确度和精密度,总胆红素(TBIL)、葡萄糖(GLU)、肌酐(CREA)、尿素(UREA)、Cl和钙(Ca)需要改进精密度。根据各项目不同的σ水平,选择不同的质量控制规则。结论选择合适的TEa,可以得到正确的σ度量,从而对整个实验过程进行全面的质量评价。

Objective To compare the quantitative differences in the analytical performance of six allowable total error(TEa)tests for 20 clinical biochemical items,and to establish a personalized quality control scheme for 20 biochemical items.Methods The biases of the 20 assays were obtained from the external quality control organized by the National Center for Clinical Laboratories(NCCL,China)in 2019.The imprecision(CV%)was calculated by the two-level internal quality control of the clinical laboratory in 2019.The six TEa specifications were from biological variation(minimum,desirable and optimal),the Clinical Laboratory Improvements Amendments of 1988(CLIA'88),the Analytical Quality Specification for Routine Analytes in Clinical Chemistry(WS/T403-2012,China)requirements,the National Cholesterol Education Program(NCEP),the guidelines of the German medical association for the quality assurance of laboratory medical examinations(RiliBAK 2008),and the Royal College of Pathologists of Australasia(RCPA)quality assurance programs.The quality goal index(QGI)was calculated to evaluate the poor performance of the inspection item.Results TEa from biological variation(optimal)was the strictest,and the TEa from RiliBAK 2008 was the easiest.The TEa of TC and CHOL were taken from the NCEP,the TEa values for ALB and Cl were taken from CLIA'88,the TEa for TP was taken from the biominimum,and the TEa values of other projects were taken from WS/T403-2012.ALT,AST,TP,GGT,LDH,ALB,K and Na require improved accuracy and precision.TBIL,GLU,CREA,UREA,Cl and Ca require improved precision.Individual quality control rules were used according to their sigma metrics.Conclusion Choosing a proper TEa will result in a correct sigma metric,and then a comprehensive quality evaluation of the whole experimental process can be conducted.