BeckmanCoulter第三代促甲状腺激素检测系统性能评价

Performance evaluation of the third generation thyroid stimulating hormone measuring systemof Beckman Coulter

目的:对BeckmanCoulter第三代促甲状腺激素(TSH3rd)检测系统的主要性能进行验证及评价,以保证检测系统性能符合质量标准。方法:参考中国合格评定国家认可委员会(CNAS)及国家卫生行业标准的有关文件和相关文献,对BeckmanCoulter新一代TSH检测系统的精密度、正确度、线性区间、定量限、参考区间进行验证评价。结果:两个浓度水平血清样本重复性分别为1.56%和3.70%,均小于1/4TEa,实验室内精密度分别为1.65%和3.89%,均小于1/3TEa,且实验室内精密度符合厂家声明;两个浓度水平的工作校准品偏倚分别为0.93%和-8.33%,均小于1/2TEa;检测系统在0.005~49.162区间呈线性相关,相关系数r 2为0.9965;确立检测系统定量限为0.0051mIU/L,符合厂家声明;生物参考区间符合实验室要求。结论:BeckmanCoulter第三代促甲状腺激素检测系统的精密度、正确度、线性区间、定量限、生物参考区间均可达到相关标准要求,与厂家声明一致,可以满足临床需求。

Objective:To verify and evaluate the main performance of the third generation thyroid stimulating hormone measuring system of Beckman Coulter in order to ensure that the performance of the measuring system meets the quality standard.Methods:The precision,trueness,linear range,limit of quantitation and reference range of the new generation TSH measuring system of Beckman Coulter were verified and evaluated by referring to the relevant documents and related literature of China National Accreditation Service for Conformity Assessment and National Health Industry Standard.Results:The repeatability of two levels of serum samples were 1.56%and 3.70%,less than 1/4TEa.The within-laboratory precision were 1.65% and 3.89%,less than 1/3TEa.And the within-laboratory precision was in accordance with the manufacturer's statement.The bias of two levels of the working calibrator were 0.93% and-8.33%,which were less than 1/2TEa.The linear correlation of the measuring system was found in the range of 0.005 to 49.162,and the correlation coefficient R2 was 0.9965.The limit of quantitation of the measuring system was determined to be 0.0051mIU/L,which met the manufacturer's statement,and the biological reference range was in accordance with the laboratory requirements.Conclusion:The precision,trueness,linear range,limit of quantitation and biological reference range of the third generation thyroid stimulating hormone measuring system of Beckman Coulter can meet the requirements of relevant standards,and consistent with the manufacturer's statement and can meet the clinical needs.