摘要
目的验证国产全自动核酸检测系统的分析性能、操作性能及过程控制措施,确保血液筛查工作高效有序。方法分析性能评估采用含HIV-1、HCV、HBV国际标准株的血清盘验证WanTag-Vortex Plus系统的符合率和分析灵敏度,采用HIV-1、HCV、HBV弱阳性标本验证其精密度;操作性能评估采用HIV-1、HCV、HBV强阳性标本验证其抗交叉污染能力,采用阴性血浆标本验证其通量和压力测试,采用HIV-1、HCV、HBV弱阳性标本验证其试剂稳定性,采用性能验证血清盘验证其系统间性能一致性。另外,采用实验室质量控制需求量表验证其过程控制措施。结果1)符合率验证:对HIV-1、HCV、HBV阴性和阳性标本的检测结果均与预期一致,符合率为100%;2)精密度验证:重复性及中间精密度极高,变异系数均5%;3)分析灵敏度验证:对HIV-1、HCV、HBV标准株的95%检出限与试剂厂家提供的分析灵敏度一致;4)抗交叉污染能力验证:5支强阳性标本、87支阴性标本按照实际工作情况和设备操作设计摆放,检测结果均与预期一致,检测系统内部不存在交叉污染现象;5)通量和压力测试:每套系统在12 h内均完成了3个批次276份标本的单人份检测;4套系统在连续3 d的大通量压力测试期间均无故障发生;6)试剂稳定性验证:采用开封后保存1周且经过4次冻融的保存极限组试剂对弱阳性标本进行检测时,其核酸检测检出率均为100%,检测结果与对照组差异无统计学意义(Kappa=1);7)系统间性能一致性验证:系统操作性能稳定,4套系统的性能比对结果均与血清盘一致(Kappa=1);8)过程控制措施:系统软件能够对设备运行过程进行精确控制,质量控制措施完备,检测结果能够正确判读并安全报告。结论WanTag-Vortex Plus系统分析性能、操作性能能够达到厂商设计要求和实验室业务运行基本要求。系统控制软件与实验室LIS相结合,过程控制功能满足实验室基本需求,但仍有需要改进之处。
Objective To validate the analytical performance,operational performance,and process control measures of a domestic fully automatic nucleic acid testing(NAT)system,thereby ensuring an efficient and orderly blood screening workflow.Methods The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1,HCV and HBV,while precision was assessed using weak positive samples of HIV-1,HCV and HBV.As for its operational performance evaluation,cross-contamination resistance was assessed using strong positive samples,and throughput and stress testing were conducted using negative samples.Reagent stability was verified using weak positive samples,and inter-system performance consistency was assessed using verification panels.In addition,the process control measures were verified using the laboratory quality control demand scale.Results 1)Verification of concordance rate:The detection results of negative and positive samples of HIV-1,HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations,and the concordance rate was 100%.2)Precision verification:the repeatability and intermediate precision were extremely high,and the coefficient of variation was less than 5%.3)Verification of analytical sensitivity:The detection limit of 95%for standard strains of HIV-1,HCV and HBV by WanTag-Vortex Plus system in our labo-ratory was consistent with the analytical sensitivity provided by reagent manufacturers.4)Verification of cross-contamination resistance:Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design,and the test results were consistent with expectations,with no cross-contamination in the testing system.5)Throughput and stress testing:Each system completed the individual donor-nucleic acid amplification testing(ID-NAT)of 276 samples in three batches within 12 hours,and successfully completed the ID-NAT test of 828 samples in three consecutive days.6)Verification of reagent stability:After extreme storage(unsealed storage for 1 week with 4 freeze-thaw cycles),the reagents maintained 100%detection rate in the weak positive samples of HIV-1,HCV,and HBV,showing no significant differences from the control group(Kappa=1).7)Verification of inter-system performance consistency:The system has stable operation performance,and the performance comparison results across the four devices were consistent(Kappa=1).8)Process control measures:WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures,and correctly interpreted and safely reported the test results.Conclusion The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements.Integrated with laboratory information system(LIS),the system’s control software meets standard process control requirements,yet requires further improvement.
作者
姚凤兰
王瑞
胡京辉
葛红卫
冷婵
查祎
赵子复
刘正敏
YAO Fenglan;WANG Rui;HU Jinghui;GE Hongwei;LENG Chan;ZHA Yi;ZHAO Zifu;LIU Zhengmin(Beijing Red Cross Blood Center,Beijing 100088,China)
出处
《中国输血杂志》
2025年第7期941-949,共9页
Chinese Journal of Blood Transfusion
