中国医学工程2025，Vol.33Issue(2)：8-11,4.DOI:10.19338/j.issn.1672-2019.2025.02.002
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
于鹏鹤 1贾慧婕 1徐壮壮 2李世豪 2刘永香 2齐钦2
作者信息
- 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
- 折叠
摘要
Abstract
[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Key words
reagent kit/human parvovirus B19/performance evaluation/in vitro diagnosis分类
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于鹏鹤,贾慧婕,徐壮壮,李世豪,刘永香,齐钦..人类细小病毒B19免疫球蛋白M抗体检测试剂盒性能评估[J].中国医学工程,2025,33(2):8-11,4.
