摘要
探讨基于高通量流式荧光技术的全自动免疫分析系统在临床实验室检测自身免疫性抗体的性能及评价。依据中国合格评定国家认可委员会(China National Accreditation Commission for Conformity Assessment,CNAS)发布及实施的实验室认可准则,采用流式荧光技术检测自身抗体,分析其精密度、线性范围、正确度及空白限(limit of blank,LOB)等。在对低浓度和高浓度两个水平质控品进行重复性验证时,计算16项抗体谱各抗体水平的均值、标准差、变异系数(coefficient of variation,CV),各抗体CV值分别低于7%和5%,均小于厂家声明的小于10%范围。对抗C1q-Ab和抗dsDNA-Ab进行定量的线性范围验证时,两者一阶多项式直线回归系数分别为0.999和0.996,相关系数均在0.999以上,偏差分布均在3%以内,两者回收试验结果分别为91.56%、105.60%。以欧蒙公司印迹法为参考方法,16项自身抗体谱各抗体验证项目的符合率均在92%以上。对抗C1q-Ab和抗dsDNA-Ab进行LOB验证时,检测所得抗dsDNA-Ab的LoB均在3 IU/mL以内,检测所得抗C1q-Ab的LoB均在0.5 U/mL以内。流式荧光技术检测自身抗体的各项性能验证均符合厂家声明,全部通过验证,可以满足临床对检测结果的需求,可以替代进口同类仪器。
This study aimed to evaluate the performance and property of a fully automated ultra-high speed immunoassay system based on high-throughput flow fluorescence technology for detecting autoimmune antibodies in clinical laboratories.According to the laboratory accreditation guidelines issued and implemented by the China National Accreditation Commission for Conformity Assessment(CNAS),flow fluorescence technology was used to detect the autoantibodies and evaluations were made on parameters including the precision,linear range,accuracy,and limit of blank(LOB).When conducting repeatability validation on quality control products at both low and high concentrations,the average standard deviation and coefficient of variation(CV)were calculated of each antibody level in the 16 antibody profiles.The CV of all antibodies were lower than 7%and 5%,respectively,which were within the less than 10%range as declared by the manufacturer.The first-order polynomial linear regression coefficients for resistance to anti-Clq-Ab and resistance to anti-dsDNA-Ab were 0.999 and 0.996,respectively,with correlation coefficient above 0.999.The deviation distributions were all within 3%and the results of the 2 recovery experiments were 91.56%and 105.60%,respectively.When Oumeng company imprinting method was used as a reference,the compliance rates of the validation projects were all above 92%.Values of LoB for anti-Clq-Ab and anti-dsDNAAb were both within 0.5 U/ml and 3 IU/ml,respectively.In conclusion,all performance parameters of the flow cytometry fluorescence technology for autoantibody detection are consistent with the manufacturer's specifications and pass the standard of clinical requirements.It can replace similar imported instruments.
作者
汪海霞
冯扬帆
陈晴
杜伟鹏
梁靖宜
李佳薇
赵莹莹
WANG Haixia;FENG Yangfan;CHEN Qing;DU Weipeng;LIANG Jingyi;LI Jiawei;ZHAO Yingying(Clinical laboratory,Nanyang Central Hospital,Nanyang 473000,China)
出处
《现代免疫学》
2025年第4期409-414,456,共7页
Current Immunology
基金
南阳市科技攻关项目(KJGG091)
2021-2022年度河南省医学科技攻关省部共建重点项目(SBGJ20212222)。
关键词
流式荧光技术
自身抗体
性能验证
实验室检测
flow fluorescence technique
autoantibody
performance verification
laboratory testing
