应用σ理论进行不同生化检测系统间比对的探讨  

Exploration of the comparison between different biochemical detection systems based on sigma metrics

作　　者：李佳 高佳 崔婵娟 于梦瑶 张浩 崔巍 Li Jia;Gao Jia;Cui Chanjuan;Yu Mengyao;Zhang Hao;Cui Wei(Department of Clinical Laboratory,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院检验科,北京100021

出　　处：《中华检验医学杂志》2022年第5期536-542,共7页Chinese Journal of Laboratory Medicine

基　　金：中国癌症基金会北京希望马拉松专项基金(LC2021L02);中国医学科学院肿瘤医院管理研究课题(LC2021D02)。

摘　　要：目的探索利用室内质控数据计算σ值进行不同生化分析仪间分析性能比对的可行性。方法顺序收集2021年2月1日至7月31日中国医学科学院北京协和医学院肿瘤医院检验科生化分析仪上25个项目的室内质控检测结果。利用公式σ=[允许总误差(TEa)-偏倚]/不精密度(CV)计算白蛋白、碱性磷酸酶、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、钙、胆固醇、肌酸激酶、氯、肌酐、γ-谷氨酰转肽酶、血糖、高密度脂蛋白胆固醇、免疫球蛋白A、免疫球蛋白G、免疫球蛋白M、钾、乳酸脱氢酶、低密度脂蛋白胆固醇、钠、无机磷、总胆红素、甘油三酯、总蛋白、尿素、尿酸2个不同水平的σ值。CV利用室内质控的变异系数获得,偏倚为比对仪器室内质控均值与靶机室内质控均值之间的平均百分偏差,TEa采用中华人民共和国卫生行业标准(WS/T403-2012)和国家卫健委临床检验中心室间质量评价标准,从而得到比对仪器相对于靶机的σ值,将此σ值与传统比对方法得出的平均百分偏倚进行比较,并利用质量目标指数分析性能不佳的原因并进行比对结果的判断。结果比对仪器Beckman AU5800-1与靶机Beckman AU5800-3比对,2个水平的σ值均>6的共10个项目,占所有项目的40%,均>3的项目有23个,占所有项目的92%,只有白蛋白和血糖这2个项目的σ值<3。通过分析,比对均通过。比对仪器Beckman AU5800-2与靶机Beckman AU5800-3比对,2个水平的σ值均>6的共8个项目,占所有项目的32%,均>3的项目有20个,占所有项目的80%,碱性磷酸酶、钙、乳酸脱氢酶、总蛋白和尿素这5个项目的σ值<3。通过分析,γ-谷氨酰转肽酶和免疫球蛋白M比对不通过。而对于传统比对方法,比对仪器AU5800-1和AU5800-2与靶机AU5800-3比对的偏倚均在评价标准范围内,但σ值与传统仪器间比对方法的平均偏倚之间无相关性,而偏倚之间有相关性。结论应用室内质控Objective To explore the feasibility of using the sigma metrics calculated with the data of internal quality control for the comparison of the analytical performance between different biochemical analyzers.Methods The internal quality control results of twenty-five biochemical assays in the biochemical analyzers of the department of clinical laboratory in Cancer Hospital from February 1,2021 to July 31,2021 were collected.The formula sigma=(TEa-Bias)/CV was used to calculate the sigma metrics of two different levels of the biochemical assays including albumin,alkaline phosphatase,alanine aminotransferase,aspartate aminotransferase,calcium,cholesterol,creatine kinase,chlorine,creatinine,γ-glutamyltranspeptidase,blood glucose,high density lipoprotein cholesterol,immunoglobulin A,immunoglobulin G,immunoglobulin M,potassium,lactate dehydrogenase,low density lipoprotein cholesterol,sodium,inorganic phosphorus,total bilirubin,triglyceride,total protein,urea,uric acid.The imprecision was obtained by the coefficient of variation of internal quality control.The bias was calculated by the deviation between the mean of internal quality control of the comparison instrument and the target instrument.The allowable total error(TEa)was based on People's Republic of China Health Industry Standard(WS/T403-2012)or EQA standard of National Center for Clinical Laboratories(NCCL).Compared the sigma values of the comparison instrument relative to the target instrument with the average percentage bias obtained by the traditional comparison method.Quality goal index was used to analyze the causes of poor performance and judge the results of comparison.Results Compared with the target instrument Beckman AU5800-3,the comparison instrument Beckman AU5800-1 had 10 assays withσ>6,accounting for 40%,23 assays withσ>3,accounting for 92%,and only albumin and blood glucose showedσ<3.Through statostical analysis,the comparisons of all assays were passed.The comparison instrument Beckman AU5800-2 had 8 assays withσ>6,accounting for 32%,20 assa

关 键 词：质量控制 σ理论 可比性 检测系统 

分 类 号：R446.1[医药卫生—诊断学]