甲型肝炎病毒IgM抗体快速检测试剂国家参考品的建立  

Development of national reference panel for rapid detection of hepatitis A virus IgM antibody

作　　者：段欣欣 于洋[1] 周诚[1] DUAN Xin-xin;YU Yang;ZHOU Cheng(Division I of Diagnostic for Infectious Diseases,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院传染病诊断试剂一室,北京100050

出　　处：《中国医药生物技术》2023年第2期136-140,共5页Chinese Medicinal Biotechnology

摘　　要：目的建立甲型肝炎病毒IgM抗体快速检测试剂国家参考品,制订其质量标准,用于该类试剂的质量评价。方法通过对200多份单采浆站收集到的血浆进行初筛,筛选出16份备选样本。经多家实验室协助标定,分析标定结果,确定参考品的组成及其质量标准,并对参考品稳定性进行评估。结果本参考品由10份阴性参考品、1份最低检出限参考品和重复性参考品组成。质量标准为10份阴性参考品符合率(-/-)应为10/10,最低检出限参考品要求1:40稀释时检测阳性,重复性参考品要求1:15稀释时连续检测10次,结果应均为阳性,且显色度均一。稀释血浆应均为HCV、HBV和HIV标志物阴性。参考品在4℃放置3、7 d和反复冻融2次条件下相对比较稳定。结论成功建立甲型肝炎病毒IgM抗体快速检测试剂国家参考品,可用于该类试剂的质量控制及评价。Objective To establish a national reference for rapid detection of hepatitis A virus IgM(HAV IgM)antibody and formulate its quality standards for quality evaluation of the reagents.Methods Through preliminary screening of more than 200 samples of plasma collected from a single plasma collection station,16 candidate samples were selected.The composition and quality standards of the reference were determined by cooperative calibration of several laboratories through analyzing the calibration results,and the stability of the national reference panel was evaluated.Results The national reference panel for rapid detection of HAV IgM antibody consisted of 10 negative,1 minimum detection limit and repetitive samples.The quality standard was that the coincidence rate(-/-)of 10 negative reference samples should be 10/10.The minimum detection limit reference sample requires a 1:40 dilution to detect positive results,and the repetitive reference sample requires a 1:15 dilution to test 10 consecutive times.The results should be all positive,and the color development should be uniform.The dilution plasma should be all negative.The reference panel was relatively stable after storage at room temperature for 3 and 7 days,or after freezing twice.Conclusion The national reference panel for rapid detection reagents of hepatitis A virus IgM antibody is successfully established,which may be used for quality control and evaluation of such reagents.

关 键 词：甲型肝炎病毒IgM抗体 快速检测试剂 国家参考品 质量评价 

分 类 号：TH77[机械工程—仪器科学与技术]