分析批长度Westgard西格玛规则在临床生化检验项目中的应用

Application of Westgard Sigma Rules of Analysis Batch Length in Clinical Biochemical Tests

目的:利用分析批长度Westgard西格玛(Sigma)规则帮助本实验室临床生化检验项目选择合适的室内质控规则。方法:收集本院检验科2019年1月~3月的临床生化检测项目室内质控数据的CV值及2018年卫生部室间质评实验数据中的Bias值,再根据WS/T403-2012的临床允许总误差(TEa)来计算Sigma值,公式为Sigma=(TEa-Bias)/CV,从而设计本实验室临床生化检验项目的质控规则。结果:Sigma度量值>6的项目有天门冬氨酸氨基转移酶(AST)、肌酸激酶(CK)、乳酸脱氢酶(LDH)、总胆红素(TBIL)、肌酐(Crea)、尿酸(UA)、总胆固醇(TC),应该使用单规则13s,检测2个水平的质控品(N=2),分析批长度R1=1000个。5<Sigma度量值<6的项目有丙氨酸氨基转移酶(ALT)、碱性磷酸酶(ALP)、血淀粉酶(AMY)和甘油三酯(TG),应采用多规则13s/22s/R4s,运行中只检测2个水平的质控品(N=2),分析批长度R1=450个。4<Sigma度量值<5的项目仅有γ-谷氨酰基转移酶(GGT),应采用多规则13s/22s/R4s/41s,运行中只检测2个水平的质控品2次(N=2×2),分析批长度R1=200个。Sigma度量值<4的项目有总蛋白(TP)、白蛋白(Alb)、血糖(Glu)、尿素(Urea)、氯(Cl)、钾(K)、钙(Ca),应采用多规则13s/22s/R4s/6x,运行中只检测2个水平的质控品3次(N=2×3),分析批长度R1=45个。结论:分析批长度的Westgard Sigma规则流程图是一种实用的质控工具,可通过计算本实验室部分临床生化检验项目的Sigma值,为选择合适的质控规则提供依据。

Objective:To select suitable internal quality control for clinical biochemical test items using Westgard Sigma rules of analysis batch length in our laboratory.Methods:The CV value of the laboratory quality control data of clinical biochemical testing projects in our department from January to March 2019,and the Bias value in the laboratory quality assessment data of The Ministry of Health in 2018 were collected.Then the sigma value was calculated according to the allowable total error(TEa)of WS/T403-2012,using the formula of sigma=(TEa-Bias)/CV.Therefore,the quality control rules for clinical biochemical test items were designed in our laboratory.Results:The items with sigma value greater than 6 included aspartate aminotransferase(AST),creatine kinase(CK),lactate dehydrogenase(LDH),total bilirubin(TBIL),creatinine(Crea),uric acid(UA)and total cholesterol(TC).Single rule 13s should be used to detect two levels of quality control products(N=2),with analysis batch length R1=1000.The items with sigma value greater than 5 and less than 6 included alanine aminotransferase(ALT),alkaline phosphatase(ALP),blood amylase(AMY)and triglyceride(TG).Multiple rules 13s/22s/R4s should be used.Only two levels of quality control products(N=2)were detected in operation,and the length of analysis batch was R1=450.Onlyγ-glutamyltransferase(GGT)was found in the items with sigma value greater than 4 and less than 5.Multiple rules 13s/22s/R4s/41s should be adopted.During the operation,only 2 levels of quality control products were tested 2 times(N=2×2).Items with sigma value less than 4 included total protein(TP),albumin(Alb),blood glucose(Glu),urea(Urea),chlorine(Cl),potassium(K)and calcium(Ca).Multiple rules 13s/22s/R4s/6x should be used.Only two levels of quality control products were detected three times(n=2×3)in operation,and the analysis batch length was R1=45.Conclusion:Westgard Sigma rules of analysis batch length is a practical quality control tool,which could provide the basis of selecting appropriate quality control rules by calculate the sigma value of some clinical biochemical tests in our laboratory.