尿素氮和肌酐在不同生化检测系统上检测结果可比性探讨  

A comparative study on the results of BUN and Crea with different biochemical detecting systems

作　　者：陈美珺[1] 马泽粦 CHEN Meijun;MA Zelin(Department of Clinical Laboratory,Zhongshan Hospital Affiliated to Xiamen University,Xiamen 361005,Fujian,China;Department of Dermatology,The Sixth People's Hospital of Dongguan City,Dongguan 523000,Guangdong,China)

机构地区：[1]厦门大学附属中山医院检验科,福建厦门361005 [2]广东省东莞市第六人民医院皮肤科,广东东莞523000

出　　处：《右江医学》2020年第11期848-852,共5页Chinese Youjiang Medical Journal

摘　　要：目的探讨同一临床实验室不同检测系统间尿素氮(BUN)及肌酐(Crea)检测结果的可比性,为实验室检测结果的标准化提供实验数据。方法参考美国临床实验室标准化委员会(NCCLS)的EP9-A2文件,以Cobas 8000生化分析仪、罗氏原装试剂、c.f.a.s校准品和质控品组成的检测系统为比较方法,以Cobas 501生化分析仪、罗氏原装试剂、c.f.a.s校准品和质控品组成的检测系统为实验方法,用患者新鲜血清同时在两个检测系统上对BUN和Crea进行双份平行测定。计算实验方法(Y)和比较方法(X)之间的相对偏倚,以允许总误差规定的室间质量评价允许范围的1/2为标准,判断不同检测系统的可比性。结果实验系统Cobas 501和比较系统Cobas 8000具有良好的相关性,除BUN其医学决定水平低值处的相对偏倚超出临床可接受范围,BUN和Crea其余测定结果在两个检测系统之间的误差均在临床可接受范围。结论两个检测系统测定BUN和Crea结果具有可比性。当同一实验室同一项目在两个以上的检测系统检测时,应进行方法比对和偏倚评估,以保证同一检测项目在不同检测系统上检验结果的可比性。Objective To explore the comparability of the results of blood urea nitrogen(BUN)and creatinine(Crea)among different detection systems in the same clinical laboratory,so as to provide experimental data for the standardization of laboratory test results.Methods According to EP9-A2 file of National committee for Clinical Laboratory standards(NCCLS),the detection system composed of Roche original reagent,c.f.a.s calibrator and controller of Roche was used as comparative method,and the detection system composed of Cobas 501 biochemical analyzer,Roche original reagent,c.f.a.s calibrator and controller of Roche was used as experimental method,and two parallel measurements of BUN and Crea were performed simultaneously on two detection systems using fresh serum from patients.Then relative bias between experimental method(Y)and comparison method(X)was calculated,and the comparability of different detection systems was judged by allowing 1/2 of the range of interventricular quality evaluation specified by total allowable error.Results The experimental system Cobas 501 had a good correlation with comparison system Cobas 8000.Except the relative bias of BUN at the low value of medical decision level was beyond the clinical acceptable range,the errors of other detection results of BUN and Crea between the two detection systems were within clinical acceptable ranges.Conclusion The results of BUN and Crea determined by the two detection systems are comparable.When the same item is tested in more than two detection systems in the same laboratory,the method comparison and bias evaluation should be carried out to ensure the comparability of the detection results of the same test item on different detection systems.

关 键 词：BUN CREA Cobas 8000 Cobas 501 可比性 

分 类 号：R446[医药卫生—诊断学]