六种同型半胱氨酸循环酶法检测系统的分析性能评价  

Performance evaluation of six homocysteine cycle enzymatic detection systems

作　　者：安崇文[1] 李海霞[1] 

机构地区：[1]北京大学第一医院检验科,100034

出　　处：《中华检验医学杂志》2014年第3期173-178,共6页Chinese Journal of Laboratory Medicine

基　　金：国家科技支撑计划基金资助项目（2012BAH24F00）

摘　　要：目的 评估6种同型半胱氨酸（Hcy）循环酶法检测系统的分析性能.方法 方法学评价研究.应用美国临床和实验室标准化协会（CLSI） EP5-A2、EP15-A2、EP7-A2、EP6-A 、EP9-A2方法验证6种甲基转移酶循环法检测系统的精密度、正确度、抗干扰性、分析测量范围（AMR）、以及其与雅培（Abbott）化学发光微粒子免疫检测系统（CMIA）的相关性和偏差.采用美国国家标准技术研究所（NIST）有证参考物质SRM 1955、美国病理学家协会（CAP）发放的室间质评物（CR-B和CR-A）以及卫生部临床检验中心发放的室间质评物验证不同系统检测Hcy正确度.回归分析采用PassingBablok,回归线性检测采用Cusum方法,相关分析采用Pearson,偏差分析应用Bland-Altman.结果 Hcy浓度（10～ 22 μmol/L）时除A1系统低水平外,其他批内均＜5％,批间均＜6.7％.正确度验证显示A1 ～ D2、CMIA系统测定NIST SRM 1955在低、中、高水平的最大绝对偏倚分别为-3.36、1.43、2.24 μmol/L.测定CAP和卫生部临检中心室间质评物显示除A1系统外,其他系统偏倚均＜总允许误差（TEa）2.50 μmol/L或靶值±20％.干扰分析显示Hb和TBil对测定干扰较明显.A1～D2系统AMR上限分别为47.30、69.76、72.10、73.96、46.23、48.98 μtmol/L.相关分析显示6种系统与CMIA系统检测结果间相关性较好,r均＞0.975（P ＜0.01,n＞40）.6种系统与CMIA系统的平均绝对偏差最大为2.9 μmol/L.结论 应用自动生化仪的循环酶法检测Hcy具有良好的精密度、线性范围和抗干扰能力,但部分检测系统性能需要进一步改进,且与CMIA系统间存在一定偏差,同时循环酶法检测系统不适用于尿液样本.Objective To evaluate the performance of six homocysteine （Hcy） analysis systems.Methods This is a methodological evaluation study.We analyzed six cycle enzymatic systems,and their correlation and deviation compared with chemiluminescence microparticle immunoassay （CMIA） from Abbott Architect plus i2000 system.Precision,accuracy,anti-interference and analytical measuring range （AMR）were evaluated,according to the CLSI EP5-A2,EP15-A2,EP7-A2,EP6-A,EP9-A2 guidelines.To assess the accuracy,we used the reference material SRM 1955 from National Institute of Standards and Technology （NIST）,and EQA samples from CAP and National Center of Clinical Laboratory.Regression analysis was conducted using Passing-Bablok method.Linear regression measurement was performed using Cusum method,with a statistical significance level set at P 〈 0.05.Correlation analysis was conducted using Pearson coefficient,with P 〈0.05 indicating significant difference.Deviation analysis was performed using Bland-Altman method.Results In the six systems （A1-D2） except A1,the within-run CVs were all 〈 5% and the between-run CVs were all 〈 6.7% at the Hey concentration range of 10-22 μmol/L.The accuracy validation of NIST SRM 1955 showed that the maximum absolute bias were-3.36,1.43,2.24 μmol/L at low,medium and high levels respectively.Measurement of EQA samples from CAP and National Center of Clinical Laboratory showed that the relative bias were all 〈 TEa （2.5 μmol/L or target value ±20%） in the six systems （A1-D2） except A1.Hb and TBIL interference were significant.The upper limit of AMR for six systems were 47.3,69.76,72.1,73.96,46.23 and 48.98 μmol/L respectively.The measurement results of six systems conelated well with that of CMIA system,with Pearson correlation coefficient （r） 〉 0.975 （P 〈0.01,n 〉40）.Compared with CMIA system,the Bland-Altman results showed that the maximum average absolute deviation was 2.9 μmol/L.Conclusions The cycle enzymatic method used to measure homocysteine has

关 键 词：高半胱氨酸 临床酶试验 免疫测定 

分 类 号：R446.1[医药卫生—诊断学]