全自动化学发光平台检测系统性能评价  

Performance Evaluation of Fully Automated Chemiluminescent Platform Detection System

作　　者：陈静 张金蕊 刘利晶 李佳霖 韩文斌 杨旭 CHEN Jing;ZHANG Jin-ru;LIU Li-jing;LI Jia-lin;HAN Wen-bin;YANG Xu(Autobio Diagnostics Co.,Ltd.Zhengzhou,Henan Zhengzhou 450016)

机构地区：[1]郑州安图生物工程股份有限公司,河南郑州450016

出　　处：《中国医疗器械信息》2024年第17期41-44,共4页China Medical Device Information

摘　　要：目的:应用化学发光测定仪对化学发光平台的检测系统进行性能评价。方法:根据实验室认可准则和体外诊断检验系统性能评价文件,使用AutoLumo A2000 Plus型全自动化学发光测定仪从精密度、正确度、回收试验、检出限、线性区间及分析特异性等进行性能评价。结果:重复性变异(CV)均<1/4TEa,精密度变异(CV)均<1/3TEa,均达到规定要求;11个肿瘤标志物项目用该设备参加上海临床检验质量控制中心近5次的室间质评的检测结果均在允许范围内,并且用患者样本的正确度评价中95%置信区间(93.91~100.35ng/mL)包含指定值100ng/mL验证通过;回收试验、检出限、线性范围及分析特异性等检验结果均在厂家声明的范围内。结论:全自动化学发光平台检测系统从精密度、正确度、回收试验、检出限、线性区间及分析特异性等性能评价结果均与厂家声明的各项指标要求相符,检测系统的分析性能满足检测及临床要求。Objective:Application of chemiluminescence assay to performance evaluation of detection systems for chemiluminescence platforms.Methods:The performance of the fully automated chemiluminescent assay using AutoLumo A2000 Plus was evaluated in terms of precision,correctness,recovery experiments,detection limits,linearity intervals and analytical specificity in accordance with the guidelines for laboratory accreditation and the document performance evaluation of in vitro diagnostic testing systems.Results:Repeatability variation(CV)is<1/4TEa and precision variation(CV)is<1/3TEa,which meet the specified requirements;The test results of 11 tumour marker items using this device to participate in the last 5 inter-room quality assessment by Shanghai Clinical Laboratory Quality Control Centre were all within the permitted range,and the 95%confidence interval(93.91-100.35ng/mL)including the specified value of 100ng/mL in the correctness evaluation with patient samples was verified and passed;The results of the recovery test,detection limit,linear range and analytical specificity were all within the limits stated by the manufacturer.Conclusion:The performance evaluation results of the fully automated chemiluminescence platform detection system in terms of precision,correctness,recovery test,detection limit,linearity interval and analytical specificity are all in line with the manufacturer’s declaration of the requirements of the indicators,and the analytical performance of the detection system meets the detection and clinical requirements.

关 键 词：全自动化学发光平台 精密度 正确度 性能评价 

分 类 号：TP216[自动化与计算机技术—检测技术与自动化装置]