HOB SMART 6500检测抗谷氨酸脱羧酶抗体的性能验证及评价  

The Validation and Evaluation of HOB SMART 6500 for Detecting Anti-glutamic Acid Decarboxylase(GAD)Antibody

作　　者：董赓 符俊超 DONG Geng;FU Junchao(Zhengzhou Key Laboratory of Childhood Infection and Immunity,Children’s Hospital Affiliated to Zhengzhou University,Henan Children’s Hospital,Zhengzhou Children’s Hospital,Zhengzhou 450001,China;Department of Clinical Laboratory,Guangdong Academy of Medical Sciences,Guangdong General Hospitall,Guangzhou 510080,China)

机构地区：[1]郑州大学附属儿童医院,河南省儿童医院,郑州儿童医院,郑州市儿童感染与免疫重点实验室,河南郑州450001 [2]广东省人民医院,广东省医学科学院检验科,广东广州510080

出　　处：《标记免疫分析与临床》2023年第7期1234-1237,共4页Labeled Immunoassays and Clinical Medicine

基　　金：河南省医学科技攻关计划联合共建项目(编号:LHGJ20210665)。

摘　　要：目的对HOB SMART 6500磁微粒化学发光法检测抗谷氨酸脱羧酶(GAD)抗体的性能进行验证。方法参考中国合格评定国家认可委员会(CNAS)、美国临床实验室标准化协会(CLSI)系列文件,制订方法学验证方案,对HOB SMART 6500检测抗GAD抗体的正确度、精密度、线性区间、可报告范围和参考范围进行验证。结果正确度偏倚<±10%;室内质控品QC1和QC2的重复性CV分别为3.75%和3.83%,中间精密度的CV分别为5.29%和4.40%;在试剂说明书给定的线性范围0.5~2000IU/mL内线性良好,线性相关系数R 2为0.9976;可报告范围为0.5~10000IU/mL;参考区间为0.5~10.00IU/mL。结论HOB SMART 6500磁微粒化学发光法检测抗GAD抗体的性能验证良好,能够满足临床检测的需求。Objective To evaluate the performance of HOB SMART 6500 magnetic particle chemiluminescence detection system in detecting glutamate decarboxylase(GAD)antibody.Methods According to a series of documents from CLSI,a methodology evaluation scheme was developed to evaluate the accuracy,precision,linear interval,reportable range and reference range of the HOB SMART 6500 test system.Results Accuracy bias was<±10%;The repeatability of QC1 and QC2 were 3.75%and 3.83%,and the inter-batch precision were 5.29%and 4.40%,respectively.The reportable range was 0.5-10000IU/mL;In the reagent reference range,the linear correlation coefficient R 2 was 0.9976.The reference range was 0.5-10.00IU/mL.Conclusion HOB SMART 6500 magnetic particle chemiluminescence assay has demonstrated an excellent performance in detecting anti-GAD antibodies,making it suitable for clinical usage.

关 键 词：性能验证 磁微粒化学发光法 抗谷氨酸脱羧酶抗体 

分 类 号：R-331[医药卫生]