Beckman Coulter新一代雌二醇的检测性能验证

The performance verification of new generation estradiol detection by Beckman Coulter

目的:对Beckman Coulter新一代雌二醇检测的分析性能进行验证,保证检测系统达到所需的标准,确保检测结果准确可靠。方法:选取质控分析物及本院患者新鲜血清,依据中国合格评定国家认可委员会(CNAS)指南以及实验室程序文件等制定验证方案,使用Beckman Coulter DXI800全自动免疫分析仪对Beckman Coulter新一代雌二醇检测试剂盒的正确度、精密度、线性区间、生物参考区间等性能进行评估。结果:两浓度水平的校准品偏倚为8.19%和2.86%,均小于1/2TEa;批内精密度性分别为3.75%和2.27%,均小于1/4TEa,批间精密度分别为4.53%和3.47%,均小于1/3Tea且符合厂家声明;在20.73~4371.47 ng/L区间内检测系统呈线性相关,相关系数r2为0.9995;男性、未孕及绝经后的女性参考区间验证符合实验室要求。结论:Beckman Coulter新一代雌二醇检测的正确度、精密度、线性区间、生物参考区间均在要求范围内,符合要求,可满足实验室及临床需求。

Objective:To verify the performance of new generation estradiol hormone detection by Beckman Coulter,so as to ensure that the detection system meets the required standards and the detection results are accurate and reliable.Methods:The quality control analytes and fresh serum of patients in our hospital were selected,and the verification scheme was developed according to the guidelines of China National Accreditation Service for Conformity Assessment(CNAS)and laboratory procedure documentx.The accuracy,precision,linear interval,and biological reference interval of the new Beckman Coulter estradiol assay kit were evaluated using the Beckman Coulter DXI800 automatic immunoanalyzer.Results:The bias of calibrators at two concentration levels were&19%and 2.86%,both less than 1/2 TEa.The repeating precision of serum samples at the two levelswere 3.75%and 2.27%,both less than 1/4 TEa.The intermediate precisions of serum samples at the two levels were 4.53%and 3.47%,both less than 1/3 TEA.The detection system showed a linear correlation between 20.73M371.47ng/L,and the correlation coefficient R2 was 0.9995.The reference interval is verified to meet laboratory requirements.ConClusiOn:The precision,accuracy,linear interval and biological reference interval of Beckman Coulter new generation estradiol detection system can meet the requirements of relevant standards,consistent with the manufacturers claims,and can meet the laboratory and clinical needs.