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学科主题: 临床检验诊断学
题名:
常规尿白蛋白检测系统的分析与性能评价
其他题名: Performance evaluation of nine commonly used urine albumin assay systems
作者: 王学晶; 徐国宾; 张捷
关键词: 诊断试验,常规 ; 白蛋白尿 ; 尿分析 ; 参考值 ; 散射测浊法和比浊法 ; Diagnostic tests,routine ; Albuminuria ; Urinalysis ; Reference values ; Nephelometry and turbidimetry
刊名: 中华检验医学杂志
发表日期: 2012
DOI: 10.3760/cma.j.issn.1009-9158.2012.11.015
期: 11, 页:1038-1044
收录类别: 中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型: Journal Article
摘要: 目的 通过对8个免疫透射比浊法和1个免疫散射比浊法尿液内白蛋白(U-Alb)检测系统的精密度、线性区间、准确度和检测结果一致性调查,了解现行分析方法的质量.方法 参考美国临床和实验室标准协会(CLSI) EP15-A2文件,配制U-Al6浓度为20 mg/L和200 mg/L的混匀尿液,验证检测系统的精密度;参考CLSI EP14-A2文件,选取40份常规检测剩余样本,评估生理盐水稀释的欧洲参考物质(ERM)-DA 470和尿液的基质效应,同时反映系统间变异;参考EP6-A文件,配制10个浓度生理盐水稀释的尿液,验证检测系统的线性区间;配制10个浓度生理盐水精准稀释的ERM-DA 470理论浓度为靶值,评估各检测系统的准确度.以国际临床化学学会(IFCC)和美国国家肾脏病教育计划(NKDEP)推荐的15%作为最大允许变异系数(CV)评价精密度,以美国病理学家学会能力验证(CAP-PT)采用的25%作为最大允许误差评价准确度.结果 9个系统在微量U-Alb水平(20 ~200 mg/L)的总CV均≤15%;生理盐水稀释的尿液和ERM-DA 470无基质效应和干扰;A、B、E、F、G和I系统验证的线性区间与声明的线性区间接近;C、D和H系统验证的线性区间下限(分别为18.7、3.6、12.0 mg/L)高于试剂盒声明的下限(分别为0、0.9、5.0 mg/L);B和C系统验证的线性区间下限接近试剂盒声明的参考区间上限.当U-Alb≤12.6 mg/L时,A、E、F、G和I系统的准确度较好,绝对偏差均<3 mg/L,D系统有较大正偏差(5.0~ 14.4 mg/L),B、C和H系统因批内精密度不良(B系统CV≥18.1%,C系统CV≥14.5%,H系统CV≥39.1%)而未分析偏差;U-Alb水平在25.2~201.0 mg/L范围内,除D系统存在较大正偏差外(15.9% ~44.3%),各检测系统的偏差均≤25%.系统间结果在微量U-Alb水平一致性良好,CV< 15%;当U-Alb< 20 mg/L时,系统间CV随浓度下降而增大,主要的变异来源为线性区间下限较高的B、C和H系统.结论 在20~ 200 mg/L微量U-Alb范围内,除D系统外,其余8个系统的精密度和准确度良好;在U-Alb< 20 mg/L,尤其<10 mg/L时,部分系统(B、C和H系统)精密度和准确度有待改善. Objective By investigating precision,linearity and accuracy of 9 commonly urine albumin assay systems (8 of immuno-turbidimetric assays and 1 of immuno-nephlometric assay),and comparing the concordance of measurement results,to elucidate the quality of the existing analytical systems.Methods Referring to Clinical and Laboratory Standards Institute (CLSI) EP15-A2,two mixed urines with U-Alb levels of 20 mg/L and 200 mg/L were made to validate precision; Referring to CLSI EP14-A2,fourty fresh urines were selected to evaluate matrix effect of saline diluted European Reference Materials (ERM) DA 470 and saline diluted urine,also to reflect the variation of measurement results among systems; Referring to EP6-A,saline diluted urines (10 levels) were made to validate linearity; Taking the theoretical concentration of precisely saline-diluted ERM-DA 470 as the target value,accuracy of each assay system was evaluated.Maximal allowable coefficient variation (CV) of ≤ 15% was taken as the acceptable precision for each assay system,as rccommcnded by International Federation of Clinical Chemistry (IFCC)-and National Kidney Disease Education Program (NKDEP) ; maximum allowable bias of ≤25% was taken as criteria for accuracy evaluation as used in Proficiency Test (PT) sponsored by College of American Pathologists (CAP).Results At level of micro-albuminuria(20-200 mg/L),all 9 systems total CVs were ≤ 15% ; No matrix effect or interference were found in saline diluted ERM DA 470 and saline diluted urine.For A,B,E,F,G and I systems,validated linear regions were close to those stated in kit instruction;For C,D and H systems,the lower limits of validated linear region (18.7,3.6 and 12.0 mg/L,respectively) were higher than those stated in kits instruction (0,0.9 and 5.0 mg/L,respectively) ;For B and C systems,the lower limits of validated linear region were close to the upper limits of reference interval stated in kit instruction.When urine albumin was ≤ 12.6 mg/L,A,E,F,G and I systems showed good accuracy,absolute biases at all dilution were below 3 mg/L,D system showed higher positive bias (5.0-14.4 mg/L),B,C and H systems' biases were not evaluated because of high in-batch CV (the CV of B system≥ 18.1%,of C system ≥ 14.5%,of H system ≥ 39.1%); when U-Alb ranged in 25.2-201.0 mg/L,all 8 systems' relative biases were ≤25%,except D systems,which showed an un-acceptable positive bias (15.9%-44.3%).Good concordance among systems' results was present at level of microalbuminuria(20-200 mg/L),with CV among systems < 15% ;when urine albumin was < 20 mg/L,CV among systems increased as allumin concentration decreased.The main contribution of variation came from B,C and H systems,which lower limits of linearity were relatively high.Conclusions At level of microalbuminuria(20-200 mg/L),except D system,the other 8 systems show good precision and accuracy;at low level of urine albumin(<20 mg/L,especially < 10 mg/L),precision and accuracy of some systems(B,C and H system) needs to be improved.
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/71528
Appears in Collections:北京大学第三临床医学院_检验科_期刊论文

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作者单位: 1.100191,北京大学第三医院检验科
2.北京大学肿瘤医院检验科

Recommended Citation:
王学晶,徐国宾,张捷. 常规尿白蛋白检测系统的分析与性能评价[J]. 中华检验医学杂志,2012(11):1038-1044.
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