4种总胆红素检测系统的性能评价  

Performance evaluation of four detection systems for total bilirubin

作　　者：安崇文[1] 曹晨影 焦莉莉[1] 李海霞[1] 

机构地区：[1]北京大学第一医院检验科,北京100034

出　　处：《临床检验杂志》2014年第3期230-235,共6页Chinese Journal of Clinical Laboratory Science

基　　金：国家科技支撑计划基金(2012BAH24F00)

摘　　要：目的评价A^D 4种总胆红素(total bilirubin,T-Bil)检测系统的分析性能。方法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文件方法评价4种T-Bil检测系统的精密度、正确度、抗干扰性、分析测量范围(AMR)及与Beckman Coulter DXC800重氮法结果的相关性和相对偏差。用美国病理学家协会(CAP)发放的室间质评物(N-A和N-B)评价D系统检测T-Bil正确度,质评物可溯源至临床化学参考方法程序定值。回归分析用Passing-Bablok法,回归线性检测用Cusum法,相关分析用Pearson相关,偏差分析用Bland-Altman法。结果 T-Bil在17~258μmol/L时,4种检测系统(A^D)的不精密度均小于各厂家声明的标准。测定CAP室间质评物显示4种检测系统的相对偏差均小于各厂家声明的标准。Hb、TG、Vit C对各系统均有不同程度干扰。AMR评价浓度分别为733.58、230.18、710.09、459.78μmol/L。A、B、C与D系统比较相关性较好,平均绝对偏差分别为-16.6、3.4、-0.8μmol/L,平均相对偏差分别为-25.32%、-3.49%、-11.75%。结论 T-Bil各检测系统间存在一定偏差,且钒酸氧化法较重氮法检测结果偏低。Objective To evaluate the performance of four detection systems for total bilirubin. Methods The precision, trueness, anti-interference, analytical measuring range （AMR） were evaluated according to EPS-A2, EP15-A2, EPT-A2, EP6-A and EP9-A2 guidelines of Clinical and Laboratory Standards Institute （CLSI） and the correlation and deviation of the results were compared with Di- azo J-G of Beckman coulter DXC800 system. The EQA samples （ N-A and N-B） from College of American Pathologist （CAP） were used to assess the trueness of D system. The qualitative evaluation content was traced back to the reference method program setting of clinical chemistry. The regression was analyzed using Passing-Bablok method and the linear regression was detected by Cusum method. Pearson correlation analysis and Bland-Ahman deviation analysis were performed. Results The precision of the four detection systems （A-D） were less than the standard of each manufacturer statement when the concentration of total bilirubin was in 17 to 258 p^mol/L. The measurements of CAP EQA samples showed that the relative deviation of the four detection systems were less than the standard of each manufacturer statement. Hemoglobin, triglyceride and vitamin C may cause interference to different extents for the four systems. The upper limits of AMR for A, B, C and D system were 733.58, 230.18, 710.09 and 459.78 p.mol/L respectively. The A, B, C system showed better correlation with D system, Compared with D system, the Bland-Ahman results showed that the average absolute deviation were - 16.6, 3.4 and - 0.8 μmol/L, and the average relative devation were - 25.32% , - 3.49% and - 11.75% for the A, B and C system, respectively. ConcLusion Certain differences of performance among the four systems for total bilirubin detection were found. The results of Vanadate oxidation were lower than those of Diazo J-G method.

关 键 词：总胆红素 重氮法 钒酸氧化法 全自动生化分析仪 

分 类 号：R446.1[医药卫生—诊断学]