人细小病毒B19 IgG抗体检测试剂国家参考品的建立及应用  

Establishment and Application of the Reference Panel for Human Parvovirus B19 IgG Detection Kits

作　　者：周海卫[1] 田亚宾[1] 郭世富[2] 黄颖[2] 张春涛[1] 

机构地区：[1]中国食品药品检定研究院体外诊断试剂检定所传染病诊断试剂二室,北京100050 [2]中国食品药品检定研究院医疗器械标准管理研究所,北京100050

出　　处：《标记免疫分析与临床》2018年第2期282-285,292,共5页Labeled Immunoassays and Clinical Medicine

基　　金：战略性新兴医疗器械产业关键技术标准研究(2015BAI44H01)

摘　　要：目的建立人细小病毒B19 IgG抗体检测试剂国家参考品并对试剂质量进行评价。方法收集并筛选B19 IgG抗体阳性和阴性样本,建立人细小病毒B19 IgG抗体检测试剂国家参考品,包括:阳性参考品10份、阴性参考品10份、重复性参考品1份和最低检测限参考品5份,以WHO第二代B19抗体(IgG)参考品进行溯源和标定,并进行稳定性考察。使用建立的参考品对人细小病毒B19 IgG抗体检测试剂盒进行质量评价。结果重复性参考品的标定结果为16 IU/m L,最低检测限参考品(S1~S4)的标定结果分别为29、14、7、4 IU/m L,S5为阴性基质血浆;室温(25℃)放置3d、4℃放置5d及反复冻融5次均不影响参考品的稳定性;试剂质量评价结果显示,阴性符合率1家为9/10,其余均为10/10,阳性符合率均为10/10,重复性均符合要求,最低检测限结果 1家为14 IU/m L、2家为7 IU/m L、3家为4 IU/m L。结论建立的参考品能够用于人细小病毒B19 IgG抗体检测试剂盒的质量控制。Objective To developthe reference panel for Human Parvovirus B19 IgG detection kits, and assess detection kits quality with the reference panel. Methods The positive and negative plasma samples were collected and screened,which were used to prepare 10 positive references, 10 negative references, 1 precision reference and 5 detection limit references. The precision and detection limit references were traceable to 2nd International Standard for Anti-Parvovirus B19 plasma, human. Evaluation of the stability of the reference panel was performed. The assessment of the diagnostic consistence between six commercial kits was performed. Results The calibration results for precision reference was 16 IU/mL, and the calibration results for detection limit references （ S1 - S4 ） were 29,14,7 and 4 IU/mL, respectively. The process of storing at room temperature（25℃）for 3 days, at 4℃ for five daysor five times freeze-thawing did not affect the stability of the reference panel. The evaluation results of the diagnostic consistence between different commercial kits displayed that the negative reference coincidence rate was between 9/10 - 10/10, the positive reference coincidence rate was 10/10, the precision met the requirement, and the limit of detection was between 4 IU/mL and 14 IU/mL. Conclusion The established reference panel could be used for quality control of Human Parvovirus B19 IgG detection kits.

关 键 词：人细小病毒B19 IGG抗体 参考品 质量评价 

分 类 号：R446.6[医药卫生—诊断学]