生化酶学检测指标分析批长度的统计质量控制策略分析  

Statistical quality control strategy for designing analysis batch length of enzymology tests

作　　者：黄志刚[1] 贺勇[1] 何訸[1] 梁珊珊 黄亨建[1] HUANG Zhigang;HE Yong;HE He;LIANG Shanshan;HUANG Hengjian(Department of Laboratory Medicine,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China)

机构地区：[1]四川大学华西医院实验医学科,四川成都610041

出　　处：《国际检验医学杂志》2020年第20期2450-2453,共4页International Journal of Laboratory Medicine

基　　金：四川省科技计划项目(2019YFS0320)。

摘　　要：目的分析西格玛(Sigma)度量值与质控规则、每次质控测定数量以及分析批长度之间的关系,为生化酶学检测指标分析仪提供科学客观的统计质量控制(SQC)策略,以达到患者风险最小化的目标。方法应用公式Sigma=(TEa-Bias)/CV,根据分析批长度Westgard Sigma规则流程图,列出相应质控规则、单次质控测定数量以及分析批长度的SQC策略。为生化酶学各指标选择假失控率≤5.00%,误差检出率≥90.00%的候选质控规则、质控测定次数及适当的分析批长度。结果肌酸激酶(CK)、淀粉酶(AMY)的SQC策略:(1)1∶3s N2,最大分析批长度1000个样本;(2)1∶3s N4,最大分析批长度1000个样本;(3)MR N2,最大分析批长度1000个样本;(4)1∶2.5s N1,最大分析批长度1000个样本;(5)1∶2s N1,最大分析批长度1000个样本。丙氨酸氨基转移酶(ALT)、γ-谷氨酰转肽酶(GGT)的SQC策略:(1)MR N4,最大分析批长度1000个样本;(2)1∶3s N4,最大分析批长度900个样本;(3)MR N2,最大分析批长度470个样本;(4)1∶2s,最大分析批长度370个样本。天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH)的SQC策略:(1)MR N4,最大分析批长度800个样本;(2)1∶3s N4,最大分析批长度220个样本。碱性磷酸酶(ALP)、脂肪酶(LIP)因Sigma度量值较低,无满足条件的质控策略,因此需进一步改进分析方法性能。结论分析方法的Sigma度量值大小决定了分析批长度或质控频率,Sigma度量值越小,所需质控频率越高,因此,应尽可能提高检测系统的性能,降低实验室成本。Objective To provide a scientific and objective statistical quality control(SQC)strategy for continuous biochemical analyzers,we used the relationships among Sigma,quality control rules,quantity of each quality control and analysis batch length,so as to achieve the goal of minimizing the risks of patients.Methods Using the formula Sigma=[total allowable error(TEa)-Bias]/coefficient of variation(CV),we designed the corresponding SQC strategies,including quality control rules,the number of single quality control and analysis batch length,according to the flow chart of Westgard Sigma rules of analysis batch length.Then we selected the candidate SQC strategies for enzymology items with the probability of false rejection≤5.00%and the probability of error detection≥90.00%.Results The SQC strategies of creatine kinase(CK)and amylase(AMY)were as follows:(1)1∶3s N2,with analysis batch length of 1000 samples;(2)1∶3s N4,with analysis batch length 1000 samples;(3)MR N2,with analysis batch length 1000 samples;(4)1∶2.5s N1,with analysis batch length 1000 samples;(5)1∶2s N1,with analysis batch length 1000 samples.For alanine aminotransferase(ALT)and Gamma glutamyl transpeptidase(GGT),SQC strategies were:(1)MR N4,with analysis batch length 1000 samples;(2)1∶3s N4,with analysis batch length 900 samples;(3)MR N2,with analysis batch length 470 samples;(4)1∶2s,with analysis batch length 370 samples.The SQC strategies of aspartate aminotransferase(AST)and lactate dehydrogenase(LDH)included MR N4,with analysis batch length 800 samples,and 1∶3s N4,with analysis batch length 220 samples.The SQC of alkaline phosphatase(ALP)and lipase(LIP)were not available due to low Sigma,therefore,the performance of the analytical method needed to be further improved.Conclusion Sigma,the performance of the analytical method,determines the analytical batch length or the frequency of quality control.The smaller the Sigma,the higher the frequency of quality control.Therefore,we should improve the performance of the detection system to re

关 键 词：西格玛度量值 最大分析批长度 统计质量控制 

分 类 号：R446.9[医药卫生—诊断学]