风疹病毒(RV)IgM抗体质控盘的建立

目的: 建立风疹病毒(RV)IgM抗体质控盘,质控盘包括风疹病毒抗体阳性血清P1～P5,抗体阴性血清N1～N10,以及用于评价试剂盒灵敏度的血清L1～L3。此质控盘为以酶联免疫法和化学发光法为原理的风疹病毒(RV)IgM诊断试剂盒的性能评价提供了可靠的质控物质。方法: 通过试剂盒筛选出风疹病毒IgM的阳性和阴性血清,将5份不同来源的阳性血清作为质控盘的P1～P5,将10份不同来源的阴性血清作为质控盘的N1～N10,将5份阳性血清混合制成质控盘的L1～L3,之后,将建立的质控盘用不同的试剂盒进行验证。结果: 不同的试剂盒对质控盘的验证表明成功地建立了风疹病毒(RV)IgM抗体质控盘。结论: 本研究建立的质控盘,可用于以酶联免疫法和化学发光法等原理的风疹病毒(RV)IgM诊断试剂盒的性能评价。

Objective: To establish the control panel for rubella virus (RV) IgM antibody detection which involves the positive serum P1-P5, the negative serum N1-N10, and the L1-L3 used to evaluate the sensitivity of kits and is designed to provide a reliable quality control substance for performance evaluation of the RV IgM diagnosis kit based on euzymelinked immunosorbent assay (ELISA) and chemiluminescence (CLIA). Methods: The positive and negative sera were selected by kits, of which five positive serum of different sources were taken as control plate P1-P5, 10 different sources of negative serum as control plate N1-N10, the L1-L3 was produced by the mixture of 5 positive serum of different sources.Then, the established panel was verified with different kits. Results: The control panel for RV IgM antibody was proved to be successfully established through the verification of the different kits. Conclusion: The quality control panel can be used for the performance evaluation of most RV IgM diagnosis kits which are based on principles of enzyme-linked immunosorbent assay and chemiluminescence, etc.

1 Goodson JL,Masresha B,Dosseh A,et al.Rubella epidemiology in Africa in the prevaccine era,2002-2009.J Infect Dis,2011,204(Suppl):S215
2 Duszak R.Congenital rubella syndromes-major review.Optometry,2009,80(1):36
3 Miller E,Cradock-Waston JE,Pollock TM.Consequences of confirmed maternal rubella at successive stages of pregnancy.Lancet,1982,2(8302):781
4 CHEN Chao-qun(陈超群),HU Si-hai(胡四海),LI Zhong-yu(李忠玉).Detection and analysis of the RV-IgM specific antibody in sera of pregnant women(孕妇血清风疹病毒抗体IgM的检测与分析).J Nantong Univ Med Coll(南通大学学报医学版),2001,29(1):8
5 Dimech W,Panagiotopoulos L,Marler J,et al.Evaluation of three immunoassays used for detection of anti-rubella virus immunoglobulin M antibodies.Clin Diagn Lab Immunol,2005,12(9):1104
6 Sullivan EM,Burgess MA,Forrest JM.The epidemiology of rubella and congenital rubella in Australia,1992 to 1997.Commun Dis Intell,1999,23(8):209
7 ZHAN Si-en(战思恩).Examination of rubella virus antibody in women of childbearing age(育龄妇女风疹病毒抗体检测结果分析).Label Immun Clin Med(标记免疫分析与临床),2012,19(4):218
8 Davidkin I,Jokinen S,Paananen A,et al.Etiology of mumps-like illnesses in children and adolescents vaccinated for measles,mumps,and rubella.J Infect Dis,2005,191(5):719
9 PEI Ling-zhi(裴灵芝),CHEN Dao-zhen(陈道桢),GAO Jing-sheng(高锦声),et al.Establishment of reverse-transcription-loop-mediated isothermal amplify-cation method for detection of rubella virus(逆转录环介导等温扩增检测风疹病毒RNA方法的建立).Chin J Birth Health Hered(中国优生与遗传杂志),2011,19(11):14
10 Cooray S,Warrener L,Jin L.Improved RT-PCR for diagnosis and epidemiological surveillance of rubella.J Clin Virol,2006,35(1):73
11 ZHUO Fei(卓菲),YANG Gui-qing(杨贵清),LIU Wei-min(刘卫民),et al.Study on application of real-time PCR in detection of rubella virus(实时荧光PCR检测风疹病毒的应用研究).Pract Prev Med(实用预防医学),2012,19(3):352
12 Gravell M.Detection of antibody to rubella virus by ELISA.J Inf Dis,1977,136:s300