ABI7500+BKV-DNA检测系统的性能评价
Performance evaluation of ABI7500+BKV-DNA detection system
刘德军 1田向永1
作者信息
- 1. 河南省人民医院,郑州大学河南省人民医院检验科,郑州 450003
- 折叠
摘要
目的 评估ABI7500+BKV-DNA检测系统,对该系统进行性能验证,确认该检测系统是否符合要求.方法 按中国合格评定国家认可委员会(CNAS)系列文件要求,对ABI7500+BKV-DNA检测系统的正确度、精密度、线性范围、最低检出限、特异性等性能参数进行验证.结果 ABI7500+BKV-DNA检测系统的正确度符合要求,批内精密度(s批内)分别为3.11％、1.93％,批间精密度(s批间)分别为3.82％、2.20％,正确度符合要求.线性分析通过验证实验,最低检出限为2.0 × 103 copies/mL.结论 ABI7500+BKV-DNA检测系统的正确度、精密度、线性范围、最低检出限、特异性等性能参数均符合相关标准的要求,是临床检测BKV的首选方法.
Abstract
Objective To verify the performance of the ABI7500+BKV-DNA detection system and evaluate whether it meets the requirements.Methods According to the requirements of the China National Accreditation Service for Conform-ity Assessment(CNAS)series of documents,verify the accuracy,precision,linear range,minimum detection limit,spe-cificity and other performance parameters of the ABI7500+BKV-DNA detection system.Results The accuracy of the ABI7500+BKV-DNA detection system meets the requirements,with intra batch precision of 3.11％and 1.93％,and inter batch precision of 3.82％and 2.20％,respectively.The accuracy meets the requirements.Linear analysis through validation experiments,with a minimum detection limit of 2.0 x 103 copies/mL.Conclusion The accuracy,precision,linear range,minimum detection limit,specificity,and other performance parameters of the ABI7500+BKV-DNA detec-tion system meet the requirements of relevant standards,making it the preferred method for clinical detection of BKV.
关键词
BKV相关肾病/BK病毒/BKV感染/正确度/精密度/线性/BKV-DNAKey words
BKV related nephropathy/BK virus/BKV infection/Accuracy/Precision/Linear/BKV-DNA引用本文复制引用
基金项目
河南省医学科技攻关计划联合共建项目(LHGJ20210042)
出版年
2024
NETL
NSTL
万方数据