ABI7500+BKV-DNA检测系统的性能评价  

Performance evaluation of ABI7500+BKV-DNA detection system

作　　者：刘德军[1] 田向永 LIU De-jun;TIAN Xiang-yong(Department of Clinical Laboratory,Henan Provincial Peoples Hospital,Henan Provincial Peoples Hospital Affiliated to Zhengzhou University,Zhengzhou 450003,China)

机构地区：[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

出　　处：《医药论坛杂志》2024年第7期715-718,共4页Journal of Medical Forum

基　　金：河南省医学科技攻关计划联合共建项目(LHGJ20210042)。

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2.0×10^(3)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。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 Conformity Assessment(CNAS)series of documents,verify the accuracy,precision,linear range,minimum detection limit,specificity 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 2.0×10^(3) copies/mL.Conclusion The accuracy,precision,linear range,minimum detection limit,specificity,and other performance parameters of the ABI7500+BKV-DNA detection 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-DNA 

分 类 号：R446.5[医药卫生—诊断学]