临床实验室基于EQA和IQC数据设定生物化学检验常规项目分析性能规范  

Analytical Performance Specifications for Routine Items of Biochemical Inspection Based on EQA and IQC Data in Clinical Laboratory

作　　者：吴风 孔丽蕊 张艳 何大海[1,2] 黄英 周朝琼 刘燕群[1,2] 余林 WU Feng;KONG Lirui;ZHANG Yan;HE Dahai;HUANG Ying;ZHOU Chaoqiong;LIU Yanqun;YU Lin(Department of Clinical Laboratory,Traditional Chinese Medicine Hospital of Chengdu Pidu District,Chengdu 611730,China;Department of Clinical Laboratory,the Third Affiliated Hospital of Chengdu University of Chinese Medicine,Chengdu 610031,China)

机构地区：[1]成都市郫都区中医医院检验科,成都611730 [2]成都中医药大学附属第三医院检验科,成都610031

出　　处：《现代检验医学杂志》2024年第4期203-207,212,共6页Journal of Modern Laboratory Medicine

基　　金：成都中医药大学“杏林学者”医院专项课题(XJ2023013901);成都市医学科研课题(2022376)。

摘　　要：目的基于室间质量评估(external quality assessment,EQA)和室内质量控制(internal quality control,IQC)数据,设定生物化学检验常规项目分析性能规范(analytical performance specifications,APS)。方法收集成都市郫都区中医医院检验科2021~2023年参加国家卫生健康委员会临床检验中心生物化学检验常规项目EQA和IQC数据,将EQA数据的百分差值与IQC在控不精密度[以变异系数(coefficient of variation,CV)表示]与基于生物学变异(biological variation,BV)导出的三个标准进行比较,计算EQA数据百分差值通过率和在控CV通过率,以达到80%及以上为该水平质控品的APS设定为实验室常规生化检验项目的质量目标。对于未达到BV导出三个标准APS或达到标准而不适用的检验项目,采用WS/T 403-2012行业标准或基于当前技术水平设定APS。结果生物化学检验常规项目推荐的TEa/允许CV分别为:钾(K)2.4%/1.9%,钠(Na)4.0%/0.9%,氯(Cl)4.0%/0.9%,钙(Ca)3.4%/1.8%,磷(P)9.6%/1.9%,镁(Mg)3.8%/2.0%,血糖(Glu)6.1%/2.3%,肌酐(Crea)3.9%/2.2%,尿素(Urea)8.6%/3.3%,总蛋白(TP)4.9%/2.0%,清蛋白(Alb)3.3%/1.9%,总胆红素(TBil)6.3%/2.4%,丙氨酸氨基转移酶(ALT)9.3%/2.9%,天门冬氨酸氨基转移酶(AST)6.2%/2.1%,γ-谷氨酰基转移酶(GGT)9.2%/2.1%,乳酸脱氢酶(LDH)6.8%/2.2%,碱性磷酸酶(ALP)7.2%/3.3%,总胆固醇(TC)8.3%/2.6%,三酰甘油(TG)12.9%/4.9%,淀粉酶(AMY)5.9%/1.6%,肌酸激酶(CK)4.3%/1.6%和尿酸(UA)2.9%/1.0%。结论基于BV或当前技术水平设定的APS可作为实验室生物化学检验常规项目的质量目标,实验室根据实际情况选择适合自己的APS。Objective To establish the analytical performance specifications(APS)for routine items of biochemical inspection based on the external quality assessment(EQA)and internal quality control(IQC)data.Methods The EQA data and IQC data of routine items of biochemistry inspection in clinical laboratory center of national health commission from 2021 to 2023 were collected from the Department Clinical Laboratory of Traditional Chinese Medicine Hospital of Chengdu Pidu District.Comparing the percentage difference of the EQA data and the IQC in control imprecision[expressed as the coefficient of variation(CV)]data with the 3-level evaluation criteria derived based on biological variation(BV),the percentage pass rate of EQA data and the pass rate of CV under control were calculated,so as to achieve the quality target of APS with 80%or more as the quality control product of this level as the routine biochemical test items of the laboratory.For the inspection items that did not reach BV standard APS or were not applicable to meet the standard,the APS would be set to the WS/T 403-2012 industry standard or based on current technical level.Results TEa/allowable CV of biochemical inspection items were as follows:Potassium(K)2.4%/1.9%,Sodium(Na)4.0%/0.9%,Chloride(Cl)4.0%/0.9%,Calcium(Ca)3.4%/1.8%,Phosphate(P)9.6%/1.9%,Magnesium(Mg)3.8%/2.0%,Glucose(Glu)6.1%/2.3%,Creatinine(Crea)3.9%/2.2%,Urea(Urea)8.6%/3.3%,Total protein(TP)4.9%/2.0%,Albumin(Alb)3.3%/1.9%,Total bilirubin(TBil)6.3%/2.4%,Alanine transaminase(ALT)9.3%/2.9%,Asparpartate transaminase(AST)6.2%/2.1%,γ-glutamyl transferase activity(GGT)9.2%/2.1%,Lactate dehydrogenase(LDH)6.8%/2.2%,Alkaline phosphatase(ALP)7.2%/3.3%,Total cholesterol(TC)of 8.3%/2.6%,Triglyceride(TG)12.9%/4.9%,Amylase(AMY)5.9%/1.6%,Creatine kinase(CK)4.3%/1.6%and Uric acid(UA)2.9%/1.0%.Conclusion The APS set based on BV or current technical level can be used as a quality target for routine laboratory clinical biochemistry testing programs,and the laboratory can select the suitable APS according to the actua

关 键 词：生物学变异 允许总误差 允许不精密度 允许偏移 分析性能规范 生物化学检验项目 

分 类 号：R446[医药卫生—诊断学]