摘要
目的对化学发光免疫分析法检测甲状腺功能五项的性能进行验证,以评估检测系统检测甲状腺功能五项的准确性和稳定性。方法采用迈瑞CL6000i全自动化学发光免疫分析仪,依照美国临床和实验室标准协会标准,对分析仪检测数据的精密度、正确度、线性、生物参考区间、最低检出限、携带污染进行验证和评价。结果游离三碘甲状腺原氨酸(FT 3)、游离甲状腺素(FT 4)、三碘甲状腺原氨酸(T 3)、甲状腺素(T 4)、促甲状腺激素(TSH)的批内精密度均小于1/4 TEa(CLIA′88),批间精密度小于1/3 TEa(CLIA′88)。正确度的能力验证实验成绩为100%。线性验证显示,T 3、T 4、TSH的相关系数≥0.990,斜率为0.95~1.05,线性良好,线性范围与厂商声明参数相符;20例健康者检测值100%在生物参考区间内。最低检出限、携带污染均小于厂商声明参数。结论FT 3、FT 4、T 3、T 4、TSH性能验证数据均与厂商声明性能一致,符合CLIA′88和ISO15189实验室认可标准的要求。迈瑞CL6000i全自动化学发光免疫分析仪检测甲状腺功能五项的稳定性好,准确性高,能够满足临床检验的需求。
Objective To verify the performance of chemiluminescent immunoassay in the detection of thyroid function,and to evaluate the accuracy and stability of the detection system in the detection of thyroid function.Methods According to the standards of American Clinical and Laboratory Standards Institute,the precision,accuracy,linearity,biological reference range,minimum detection limit and carrying pollution of the analyzer were verified and evaluated by using Mindray CL6000i automatic chemiluminescent immunoanalyzer.Results The intraassay precision of free triiodothyronine(FT 3),free thyroxine(FT 4),triiodothyronine(T 3),thyroxine(T 4),thyrotropin(TSH)was less than 1/4 TEa(CLIA′88),and the inter assay precision was less than 1/3 TEa(CLIA′88).The accuracy of the ability verification experiment was 100%.The linear validation showed that the correlation coefficients of T 3,T 4 and TSH were≥0.990,0.95≤b≤1.05,the linearity was good,and the linear range was consistent with the manufacturer′s stated parameters.The detection values of 20 healthy people were 100%in the biological reference range.The minimum detection limit and carried pollution were less than the manufacturer′s declared parameters.Conclusion The performance verification data of FT 3,FT 4,T 3,T 4 and TSH are consistent with the performance declared by the manufacturer,and meet the requirements of CLIA′88 and ISO15189 laboratory accreditation standards.The Mindray CL6000i automatic chemiluminescent immunoanalyzer has good stability and high accuracy in detecting thyroid function,which can meet the needs of clinical examination.
作者
吴卫星
吴宗勇
张丽
张晓煜
党秀敏
齐军
WU Weixing;WU Zongyong;ZHANG Li;ZHANG Xiaoyu;DANG Xiumin;QI Jun(National Cancer Center/National Clinical Research Center for Cancer/Department of Clinical Laboratory,Cancer Hospital&Shenzhen Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Shenzhen,Guangdong 518116 China;National Cancer Center/National Clinical Research Center for Cancer/Department of Clinical Laboratory,Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)
出处
《检验医学与临床》
CAS
2020年第15期2135-2139,共5页
Laboratory Medicine and Clinic
基金
深圳市医疗卫生三名工程项目(SZSM201812062)。
关键词
全自动化学发光免疫分析仪
性能验证
精密度
正确度
甲状腺功能
automatic chemiluminescent immunoanalyzer
performance verification
precision
accuracy
thyroid function
