临床生化酶类测定应用保证西格玛与长期缺陷率在统计质量控制策略中的应用  

Use of Assured Sigma and Defects Per Million in Statistical Quality Control Strategies in Clinical Enzymes Measurements

作　　者：王辉[1] 徐克和[1] 唐书强[1] 黄亨建[1] WANG Hui;XU Ke-he;TANG Shu-qiang;HUANG Heng-jian(Department of Laboratory Medicine,West China Hospital of Sichuan University,Chengdu 610041,China)

机构地区：[1]四川大学华西医院实验医学科,成都610041

出　　处：《现代检验医学杂志》2020年第1期143-145,共3页Journal of Modern Laboratory Medicine

摘　　要：目的应用实验室生化酶学测定项目的短期西格玛(Sigmashort-term)估算其保证西格玛SigmaAssured,并依据系统误差功效图得出相应的统计质量控制(statistical quality control,SQC)规则,估计生化酶学测定项目的长期缺陷率(defects per million,DPM),确保实验室生化酶学测定项目结果的可靠。方法计算公式Sigma=(TEa–Bias)/CV;Sigmalong-term=Sigmashort-term-1.5;SigmaAssured=SigmaObserved–SigmaSQC,SigmaAssured=1.65,SQC规则为13s/22s/R4s/41s/8x,N=2。结果计算得到实验室丙氨酸氨基转移酶(ALT)的Sigmashort-term=3.6,DPM=274253;天门冬氨酸氨基转移酶(AST)的Sigmashort-term=7.9,DPM<3.4;谷氨酰基转移酶(GGT)的Sigmashort-term=5.6,DPM=4661;碱性磷酸酶(ALP)的Sigmashort-term=7.4,DPM=5;淀粉酶(AMY)Sigmashort-term=17.7,DPM<3.4;肌酸激酶(CK)Sigmashort-term=9.3,DPM≤3.4;乳酸脱氢酶(LDH)的Sigmashort-term=6.1,DPM=968;脂肪酶(LPS)的Sigmashort-term=5.3,DPM=10724。结论实验室生化酶学测定项目期望的长期缺陷率在误差检出率(Ped)达到90%,其SigmaAssured在1.65,相同的SQC规则13s/22s/R4s/41s/8x,N=2,的情况下,其Sigma short-term越大,长期DPM越低,才能确保生化酶学测定项目的结果可靠。Objective To estimate the assured Sigma by using the short term Sigma,obtain the statistical quality control(SQC)procedure according to the power function graph,and estimate the defects per million(DPM)of those items.These procedures can ensure reliable results in the laboratory.Methods The computationalformula were:Sigma=(TEa–Bias)/CV;Sigmalong-term=Sigmashort-term–1.5;SigmaAssured=SigmaObserved–SigmaSQC,SigmaAssured=1.65,and SQC procedure was 13s/22s/R4s/41s/8x,N=2.Results For alanine aminotransferase(ALT),Sigmashort-term=3.6,DPM=274 253.For aspartate amino transferase(AST),Sigmashort-term=7.9,DPM<3.4.For gamma-glutamyl transpeptidase(GGT),Sigmashort-term=5.6,DPM=4661.For alkaline phosphatase(ALP),Sigmashort-term=7.4,DPM=5.For amylase(AMY),Sigmashort-term=17.7,DPM<3.4.For creatine kinase(CK),Sigmashort-term=9.3,DPM≤3.4.For lactic dehydrogenase(LDH),Sigmashort-term=6.1,DPM=968.For lipase(LPS),Sigmashort-term=5.3,DPM=10 724.Conclusion When the probability of error detection(Ped)was≥90%,assured Sigma was 1.65 and the SQC procedure was 13s/22s/R4s/41s/8x,N=2.It was found that the long term DPM was lower when the Sigmashort-termwas higher,and this enabled reliable results in clinical enzymes measurements.

关 键 词：西格玛 统计质量控制 短期西格玛 保证西格玛 长期缺陷率 

分 类 号：R446[医药卫生—诊断学]