ANYTEST时间分辨免疫荧光仪性能验证  

Performance verification of ANYTEST time-resolved immune-fluorescence analyzer

作　　者：赵英 徐红星[1] ZHAO Ying;XU Hongxing(The Affiliated Suzhou Municipal Hospital of Nanjing Medical University,Suzhou 215002,China)

机构地区：[1]南京医科大学附属苏州市立医院本部检验科,江苏苏州215002

出　　处：《国际检验医学杂志》2017年第A02期54-56,共3页International Journal of Laboratory Medicine

摘　　要：目的对时间分辨免疫荧光仪ANYTEST的主要分析性能进行验证,确保该仪器在本实验室能准确、稳定地用于临床标本的检测。方法参照相关的文献资料以及美国临床实验室标准化协会(CLSI)提供的标准化文件,对在ANYTEST时间分辨免疫荧光仪上进行的乙型肝炎病毒表面抗原(HBsAg)定量检测这一指标的准确度、线性范围、精密度、参考范围、检测灵敏度等指标进行验证和评价。结果时间分辨免疫荧光仪ANYTEST的主要性能分析指标精密度、准确度、线性范围、参考范围、检测灵敏度与厂家所标性能指标相符。结论时间分辨免疫荧光仪ANYTEST定量检测HBsAg方法学性能良好,测定结果准确、重复性好,他能满足临床需要。Objective The aim of this article was to verify the performance of ANYTEST time-resolved immune-fluorescence analyzer in order to ensure the instrument to be used accurately and steadily in our laboratory.Methods According to the American Clinical and Laboratory Standards Institute(CLSI)documents and other associated literatures,the analytical performance of ANYTEST time-resolved immune-fluorescence analyzer was verified and evaluated by precision,accuracy,linearity and reference range of quantitative detection of Hepatitis B Surface Antigen(HBsAg).Results The precision,accuracy,linearity,reference range and sensitivity of ANYTEST time-resolved immune-fluorescence analyzer in the quantitative determination of HBsAg were in accordance with the performance parameters of manufacturers.Conclusion ANYTEST time-resolved immune-fluorescence analyzer has a good performance,accurate measurement and a high repeatability in detecting HBsAg,which can satisfy the need in clinics.

关 键 词：时间分辨免疫荧光仪 乙型肝炎病毒表面抗原 性能验证 

分 类 号：R446.62[医药卫生—诊断学]