流式细胞术检测VEGF的方法学性能评价  

EVALUATION OF THE METHOD FOR DETERMINATION OF VEGF WITH FLOW CYTOMETRY

作　　者：黄山[1] 孟宪辉[2] 许健[1] 令狐颖[1] 刘志琴[2] 袁军[2] 

机构地区：[1]贵州省临床检验中心,贵阳550002 [2]贵州省人民医院

出　　处：《现代预防医学》2010年第23期4501-4502,4505,共3页Modern Preventive Medicine

基　　金：贵州省科学技术基金(黔科合J字[2007]2113号);贵州省科技计划课题(黔科合S字[2007]1057号)资助

摘　　要：[目的]对流式细胞术(FCM)检测血管内皮生长因子(VEGF)进行方法学性能评价。[方法]参考美国临床和实验室标准化协会(CLSI)系列文件,结合工作实际,设计验证方案,对BD Aria流式细胞仪检测系统测定血浆VEGF的精密度、准确度、分析灵敏度、分析测量范围和生物可参考区间5大分析性能进行验证和评价,并将实验结果与厂家(美国BD公司)提供的分析性能或公认的质量指标进行比较。[结果]VEGF含量在9.77 ng/L和625.00ng/L时,批内变异系数分别为4.70%和4.32%,批间变异系数分别为4.87%和6.76%,准确度检测相对偏倚分别为2.10%和3.58%;检测灵敏度为1.58 ng/L,分析测量范围为1.58～2 190.00 ng/L,生物参考区间验证为59.30～96.80 ng/L。[结论]BD Aria流式细胞仪检测系统检测血浆VEGF的分析性能符合厂家提供的性能指标和公认的质量指标。[Objective]To carry out performance evaluation of methodology og flow cytometry（FCM）detection on vascular endothelial growth factor（VEGF）.[Methods]Reference to the U.S.Institute of Clinical and Laboratory Standards（CLSI）series of documents,combined with practical work,designed verification program,verified and evaluated the 5 performances that precision,accuracy,analytical sensitivity,analytical measurement range and biological interval of determination of plasma VEGF with BD Aria flow cytometry,and compared the experimental results with the performance provided by manufacturer（U.S.BD company）and recognized quality indicators.[Results]When VEGF levels were 9.77 ng/L and 625.00 ng/L,the intraassay coefficients of variation were 4.70% and 4.32%,the coefficients of variation were 4.87% and 6.76%,VEGF in the two concentrations of the relative bias were 2.10% and 3.58%;detection sensitivity was 1.58 ng/L,analytical measurement range was 1.58-2190.0 0ng/L,reference interval validation was the 59.30-96.80 ng/L.[Conclusion]Analyticity of detection of plasma VEGF with BD Aria flow cytometry meets the performance indicators provided by manufacturers and accepted quality indicators.

关 键 词：流式细胞术 方法学评价 血管内皮生长因子(VEGF) 

分 类 号：R446[医药卫生—诊断学]