顺磁性微粒子化学发光免疫分析法检测血清维生素B_(12)的性能评价  

Performance evaluation of paramagnetic particles chemiluminescence micro-particle immunoassay for determination of serum vitamin B_(12)

作　　者：安崇文[1] 李海霞[1] 孟群 胡建平 徐向东 

机构地区：[1]北京大学第一医院检验科,北京100034 [2]国家卫生和计划生育委员会统计信息中心,北京100044

出　　处：《中国免疫学杂志》2014年第11期1508-1513,共6页Chinese Journal of Immunology

基　　金：国家科技支撑计划基金资助项目(No.2012BAH24F01)

摘　　要：目的：评估顺磁性微粒子化学发光免疫分析法（Chemiluminescence microparticle immunoassay,CMIA）检测血清维生素B12（Vitamin B12,VitB12）的分析性能。方法：应用美国临床和实验室标准化协会（CLSI）EP5-A2、EP15-A2、EP7-A2、EP6-A、C28-A3c方法评价CMIA检测VitB12的精密度、正确度、抗干扰性、分析测量范围（AMR）、临床可报告范围（CRR）、生物参考区间。采用美国国家标准技术研究所（National Institute of Standards and Technology,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（K-C）、校准验证/线性评价物（LN5-B）评估CMIA系统检测VitB12正确度。结果：VitB12在108.84~874.43 pmol/L时,批内、批间精密度均小于厂家声明的标准。正确度验证显示测定有证参考物质NIST SRM1955,结果符合验证要求;检测CAP室间质评物（K-C）、校准验证/线性评价物（LN5-B）显示,结果均符合CAP校准验证/线性评价误差界限所规定的标准,VitB12浓度在89~1 057 pmol/L范围内通过线性验证,95%验证区间也包含其指定均值,相对偏差均小于卫生部临床检验中心室间质量评价标准（TEa：靶值±25%）。抗干扰性评估显示在TG≤20 mmol/L、Bil≤300μmol/L、Vit C≤1.5 g/L时对VitB12检测系统（CMIA）无显著干扰。AMR验证判断最佳拟合方程为二元一次多项式,VitB12浓度在0~1 107 pmol/L范围内存在线性关系。CRR上限为110 700 pmol/L,最大稀释倍数为100倍。生物参考区间验证显示本研究选择的参考个体VitB12水平符合厂家试剂说明书给定参考区间,女性略高于男性,但无显著差异。结论：CMIA检测血清VitB12的各项性能指标基本满足实验室要求,其可为实验室提供可靠的VitB12结果,为实验室评价人群VitB12营养状况提供信息。Objective： To evaluate the performance of paramagnetic particles chemiluminescence microparticle immunoassay（ CMIA） for detection of serum Vitamin B12（ VitB12）. Methods： Analysed CMIA system precision,accuracy,anti-interference,analytical measuring range（ AMR）,clinical reportable range（ CRR） and biological reference interval were evaluated,according to the clinical and laboratory standards institude（ CLSI） EP5-A2,EP15-A2,EP7-A2,EP6-A,C28-A3 c guidelines. To assess the accuracy,we used the reference material SRM 1955 from national institute of standards and technology（ NIST） and external quality assessment（ EQA）samples（ LN5-B and K-C） from CAP. Results： The precisions of within-run and between-run were less than standard of manufacturer when the concentration of VitB12 was 108. 84-874. 43 pmol /L. The results of SRM1955 met the allowable range of the target value. The results of EQA samples（ K-C and LN5-B） also up to the CAP calibration and validation /linear evaluation error limits stipulated standards,and the results through linear verification when the concentration of VitB12 was 89- 1 057 pmol /L. The 95% verification interval contains the specified value also. The relative deviation was less than external quality assessment standard from national center for clinical laboratory（ TEa： target value ± 25%）. Anti-interference evaluation showed without significant interferenc when TG ≤ 20 mmol /L,Bil ≤ 300 μmol /L VitC ≤ 1. 5 g /L to the VitB12 detection system（ CMIA）. AMR validation showed determines the best fit equation was linear equation polynomial. There was the linear relationship when the concentration of VitB12 was 0- 1 107 pmol /L. The upper limit of CRR was 110 700 pmol /L,the maximum dilution was 100 times. Biological reference interval validation showed that the overall level of VitB12 in this study reference individuals conform to the standard of manufacturer statement for the population,the overall level of VitB12 in female little higher tha

关 键 词：维生素B12 微粒子化学发光免疫法 微粒子化学发光免疫分析仪 

分 类 号：R392[医药卫生—免疫学]