摘要
目的对新购置的德国罗氏MODULRA E170电化学发光免疫分析仪乙肝试剂进行验证。方法参照美国临床实验室标准化协会(CLSI)的EP15-A标准,对乙肝试剂的最低检出限、线性范围、精密度和准确度(符合率)进行验证。结果MODULRA E170电化学发光免疫分析仪乙肝试剂的批内不精密度和总不精密度、HBsAb线性范围、HBsAg和HBeAg项目最低检出限均达到厂家声称的性能。结论 MODULRA E170电化学发光免疫分析仪乙肝试剂的性能优异,能满足临床诊断与治疗的需要。
Objective To verify the performance of HBV detection reagents for Roche MODULRA E170 electrochemical luminescence analyzer.Methods Referring to CLSI EP15-A document,the minimum detection limit,linear range,precision and accuracy of the HBV detection reagents were verified.Results The intra-assay coefficient of variation,total coefficient of variation,linear range of HBsAb,and minimum detection limits of HBsAg and HBeAg of the HBV detection reagents for MODULRA E170 electrochemical luminescence analyzer all reached the performance claimed by manufacturer.Conclusion The performance of HBV detection reagents for MODULRA E170 electrochemical luminescence analyzer is excellent,and it can meet the needs of clinical diagnosis and treatment.
出处
《国际检验医学杂志》
CAS
2014年第21期2955-2956,共2页
International Journal of Laboratory Medicine
关键词
电化学发光
乙肝
试剂
质量控制
性能验证
electrochemical luminescence
hepatitis B
reagents
quality control
performance verification
