溶血对41个生化免疫项目的影响评估及溶血警告指数的确立  

The effect of hemolysis on 41 chemistry and immunology tests and determination of hemolysis alert index

作　　者：夏良裕[1] 徐二木[1] 曹新策 刘荔[1] 刘茜[1] 程歆琦[1] 胡莹莹[1] 张麟[1] 邱玲[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院检验科,100730 [2]邵阳市第一人民医院检验科

出　　处：《中华检验医学杂志》2017年第12期947-952,共6页Chinese Journal of Laboratory Medicine

摘　　要：目的 评估溶血对41个生化免疫项目的影响,并确定项目及检测系统特异的溶血警告指数,为制定样本拒收标准和报告审核提供依据.方法 方法学评价研究.配对收集日常工作中采自同一患者相同时点的正常和溶血血清样本,平行测定两份样本的41个生化免疫项目及溶血指数（HI）,比较不同程度溶血样本与正常样本检测结果的差异.由高年资技师、医师结合公认的质量要求进行讨论评估后确定每个项目的溶血警告指数.结果 共收集52对血清样本,其中HI为1、2、3、4的分别有24、17、7、4对.AST、CK、钾（K）、乳酸脱氢酶（LD）、无机磷（iP）、总胆红素（TBil）6个项目受溶血影响升高.碱性磷酸酶（ALP）、氯（Cl）、Cr、免疫球蛋白M（IgM）、钠（Na）、前白蛋白（PA）、类风湿因子（RF）、甘油三酯（TG）、尿酸（UA）等9个项目受溶血影响降低.确定AST、K、Na、LD的溶血警告指数为1,Cr的警告指数为2,CK、iP、PA、TBil的警告指数为3,其余32个项目警告指数为4.结论 本研究确定了适用于本实验室41个生化免疫项目的溶血警告指数.溶血对生化免疫项目的影响与项目和检测系统有关,实验室应针对自身检测系统评估溶血对检验结果的影响,并结合预期质量要求确定适用于特定检测系统的溶血警告指数.Objective To evaluate hemolyticinfluence on 41 chemistry and immunology tests and define the hemolysis alert index, which can be used as evidence for sample rejection and test report verification.Methods Method evaluation.As a pair, both hemolyzed and non-hemolyzed serum samples were collected from the same patient at the same time.Hemolysis index and 41 tests were analyzed.The effect of hemolysis in different hemolysis level was evaluated by comparing results of the paired samples.The alertindex were defined by senior laboratory techniciansand clinical professionals based on discussion of widely accepted quality requirements.Results The number of sample with hemolysis index of 1,2,3 and 4was 24, 17, 7 and 4 respectively.Of the 41 analytes, 6 analytes increased in hemolyzed samples comparing to non-hemolyzed samples, namelyaspartate aminotransferase（AST）, creatine kinase（CK）, potassium（K）,lactate dehydrogenase（LD）,inorganic phosphorus（iP）and total bilirubin（TBil）.Another 9 analytesdecreased in hemolyzed samples comparing to non-hemolyzed samples.These analytes are alkaline phosphatase（ALP）, chloride（Cl）, creatinine（Cr）, immunoglobin M（IgM）, sodium（Na）, prealbumin （PA）,rheumatoid factor（RF）,triglyceride（TG）,uric acid（UA）.Hemolysis alert index was defined as 1 for AST,K,Na and LD;2 for Cr;3 for CK,iP,PA and TBil; and 4 for the other 32 tests.Conclusions Hemolysisalertindex were defined based on the investigation of hemolyticinfluence on 41 chemistry and immunology tests in ourlaboratory.However, hemolytic influence on clinical laboratory tests are closely related to the assay systems.So clinical laboratory should evaluate the hemolytic influence on its own analysis system,and define assay specific hemolysis alert index.

关 键 词：血红蛋白类 溶血 标本制备 临床化学试验 免疫测定 评价研究 

分 类 号：R446.6[医药卫生—诊断学]