中国输血杂志2023，Vol.36Issue(11)：1049-1054,6.DOI:10.13303/j.cjbt.issn.1004-549x.2023.11.019
血站血液检测实验室ELISA项目性能验证试验建立与探讨
Performance verification experiment for enzyme-linked immunosorbent assay in blood screening laboratory
刘胡敏 1陈雪 1李文骏 1罗颖蓝 1梅静1
作者信息
- 1. 成都市血液中心,四川 成都 610020
- 折叠
摘要
Abstract
Objective To verificate the performance of enzyme-linked immunosorbent assay(ELISA)in blood screening laboratory.Methods The repeatability,precision,sensitivity,specificity,compliance,detection limit and anti-interference of ELISA items in the laboratory detection system were verified.Results The repeatability was 100%.The intra batch impre-cision of each system was less than 10%,and the inter batch imprecision was less than 15%.The sensitivity,specificity and compliance were 100%,with the minimum detection limits of the two reagents at 0.75 NCU/mL and 0.25 NCU/mL respectively,The anti-interference met the requirements of the reagent manual.Conclusion The analysis of the performance verification data of ELISA test items will help continuously improve the per-formance of detection system and ensure the safety of clinical blood use.关键词
性能验证/检测系统/ELISAKey words
performance verification/detection system/ELISA分类
医药卫生引用本文复制引用
刘胡敏,陈雪,李文骏,罗颖蓝,梅静..血站血液检测实验室ELISA项目性能验证试验建立与探讨[J].中国输血杂志,2023,36(11):1049-1054,6.
