流式细胞术检测VCAM-1的方法学性能评价  

Evaluation of the Method for Determination of VCAM-1 with Flow Cytometry

作　　者：黄山[1] 许健[1] 令狐颖[1] 孟宪辉[2] 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,贵阳550002

出　　处：《贵州医药》2010年第10期871-873,共3页Guizhou Medical Journal

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

摘　　要：目的对流式细胞术(FCM)检测血管细胞黏附分子-1(VCAM-1)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BDAria流式细胞仪检测系统测定血浆VCAM-1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 VCAM-1含量在39.06和10 000.00 ng/L时,批内变异系数分别为4.28%和7.97%,批间变异系数分别为4.76%和10.32%,准确度相对偏倚分别为4.72%和6.52%;检测灵敏度为5.84 ng/L,分析测量范围为5.84~762 590.00 ng/L,生物参考区间验证为4 765.00 ng/L^15 725.00 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 evaluate the methodology on flow cytometry（FCM） detection vascular cell adhesion molecule-1（VCAM-1.Methods Combined with practical work and the U.S.Institute of Clinical and Laboratory Standards（CLSI） series of documents were reference.Design verification program,on BD Aria flow cytometry for determination of plasma VCAM-1 of precision,accuracy,analytical sensitivity,analytical measurement range and can refer to biological interval of 5 Great performance of verification and evaluation,and compared the experimental results with the manufacturer（U.S.BD company） to provide analysis of performance or recognized quality indicators.Results When VCAM-1 levels were 39.06 ng / L and 10000.00 ng / L,the intraassay coefficients of variation were 4.28% and 7.97%,the coefficients of variation were 4.76% and 10.32%,VCAM-1 in the two concentrations of the relative bias were 4.72% and 6.52%;The detection sensitivity was 5.84 ng / L,analytical measurement range was 5.84 - 762590.00 ng / L,reference interval validation was the 4765.00ng / L - 15725.00 ng / L.Conclusion BD Aria flow cytometry analysis of system performance plasma VCAM-1 meet the manufacturers to provide performance indicators and accepted quality indicators.

关 键 词：流式细胞术 方法学评价 血管细胞黏附分子-1 

分 类 号：R446.1[医药卫生—诊断学]