人类细小病毒B19免疫球蛋白M抗体检测试剂盒性能评估  

Performance evaluation of human parvovirus B19 IgM antibody detection kit

作　　者：于鹏鹤 贾慧婕[1] 徐壮壮 李世豪 刘永香 齐钦 YU Penghe;JIA Huijie;XU Zhuangzhuang;LI Shihao;LIU Yongxiang;QI Qin(Xinxiang Medical College,Xinxiang,Henan 453000,China;Zhengzhou Antu Biotechnology Co.,Ltd.,Zhengzhou,Henan 450000,China)

机构地区：[1]新乡医学院,河南新乡453000 [2]郑州安图生物工程股份有限公司,河南郑州450000

出　　处：《中国医学工程》2025年第2期8-11,共4页China Medical Engineering

摘　　要：目的 该文主要对郑州安图生物工程股份有限公司新研发的人类细小病毒B19 (简称B19病毒)免疫球蛋白M(IgM)检测试剂盒的性能进行评估,评估内容主要包括检测限、线性范围、准确度、精密度等。通过对一批产品的分析性能评估结果进行统计分析,验证各项指标是否符合实验设计和临床要求。方法 按照美国临床实验室标准委员会(NCCLS)标准EP17-A中性能确认(建立)的方法,进行空白限(LoB)、检测限(LoD)的建立。按照美国临床和实验室标准协会(CLSI)标准EP6-A的方法,建立试剂的线性范围;按照CLSI EP5-A2文件要求评估分析间(天间)变异和总不精密度。结果 该批试剂盒临床0值样本的LoB为0.1893。试剂盒临床标本的LoD为0.76。试剂盒的线性范围为4.74~256.93 AU/mL。检测限和线性满足对应文件指标要求。结论 与市面试剂盒对临床样本的检测表明,该新研发试剂盒可以胜任B19病毒的体外诊断用途。【Objective】 The analytical performance evaluation of the newly developed human parvovirus B19(B19 virus)immunoglobulin M(IgM) detection kit by Zhengzhou Antu Biotechnology Co.,Ltd.mainly includes detection limit,linear range,accuracy,precision,etc.By conducting statistical analysis on the performance evaluation results of a batch of products,whether all indicators meet the experimental design and clinical requirements was verified.【Methods】 According to the performance confirmation(establishment) method of National Committee for Clinical Laboratory Standards(NCCLS) standard EP17-A,limit of blank(LoB) and limit of deletion(LoD) were established.According to the Clinical and Laboratory Standards Institute(CLSI)standard EP6-A,the linear range of the reagent was established.The inter day variability and total imprecision were evaluated according to the requirements of CLSI EP5-A2 document.【Results】 The LoB of the clinical 0-value samples in this batch of reagent kits was 0.1893.The LoD of clinical specimens in the reagent kit was 0.76.The linear range of the reagent kit was 4.74 to 256.93 AU/mL.The detection limit and linearity meet the corresponding file index requirements.【Conclusion】 The detection of clinical samples using the newly developed Antu reagent kit and the market interview reagent kit indicates that the newly developed reagent can be used for in vitro diagnosis of B19 parvovirus.

关 键 词：试剂盒 人类细小病毒B19 性能评估 体外诊断 

分 类 号：R446.6[医药卫生—诊断学]