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| 抗柯萨奇病毒A组10型中和抗体检测用毒株的应用研究 | |
| 引用本文： | 赵丽丽 梁祁 张改梅 樊欢 嵇红 谢学超 陈磊 马廷涛 徐颖之 顾美荣 刘建凯 高帆 朱凤才. 抗柯萨奇病毒A组10型中和抗体检测用毒株的应用研究[J]. 国际生物制品学杂志, 2021, 44(6): 318-322. DOI: 10.3760/cma.j.cn311962-20210901-00049 |
| 作者姓名： | 赵丽丽 梁祁 张改梅 樊欢 嵇红 谢学超 陈磊 马廷涛 徐颖之 顾美荣 刘建凯 高帆 朱凤才 |
| 作者单位： | 北京民海生物科技有限公司研发中心 北京市新型联合疫苗工程技术研究中心 102600;江苏省疾病预防控制中心（江苏省公共卫生研究院），南京 210009;中国食品药品检定研究院肝炎病毒疫苗室，北京 102600 |
| 摘 要： | 目的 研究抗柯萨奇病毒A组10型（Coxsackievirus A10，CV-A10）中和抗体检测用毒株的应用。方法 对CV-A10毒株进行扩增培养，建立3级种子批并进行相关检定。采用3人3次独立测定病毒滴度，对工作种子批进行滴度标定，通过分别与肠道病毒71型（enterovirus A71，EV-A71）、CV-A16、CV-A6免疫血清进行交叉中和反应，评价该毒株的专属性。对CV-A10自然感染人血清和CV-A10小鼠免疫血清样品进行中和抗体效价检测，对其应用进行评价研究。结果 获得一株CV-A10中和抗体检测用毒株，3级种子批的无菌检查、支原体检查等项目均符合中国药典2020年版三部相关要求；经标定，平均病毒滴度为7.903 lg半数细胞培养物感染量（50% cell culture infectious dose，CCID50）/ml（95%置信区间：7.868~7.937 lgCCID50/ml），变异系数为1.10%；与EV-A71、CV-A16、CV-A6免疫血清无交叉反应，专属性良好；检测CV-A10自然感染人血清和CV-A10小鼠免疫血清，中和抗体的最大值与最小值倍数差均小于4，中和抗体检测变异系数分别为6.38%和3.64%。结论 抗CV-A10中和抗体检测用毒株具有较好的专属性可很好的应用于后续抗CV-A10中和抗体的相关检测。 |
| 关 键 词： | 手足口病 抗体，中和 检测毒株 |
Application of the specificity detection strain for anti-Coxsackievirus A10 neutralizing antibody |
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| Affiliation: | 1Beijing Minhai Biotechnology Co., Ltd., R & D Center, Beijing New Combined Vaccine Engineering Research Center, Beijing 102600; 2Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Institute of Public Health), Nanjing 210000; 3Hepatitis Virus Vaccine Laboratory, China Institute of Food and Drug Control, Beijing 102600 |
| Abstract: | Objective To study the application of specificity detection strain for anti-Coxsackievirus A10 (CV-A10) neutralizing antibody. Methods The anti-CV-A10 detection strain was amplified and cultured to prepare 3-level seed batches, on which relevant assays were performed. The work seed was calibrated for viral titers by 3 testers for 3 times and by cross-neutralization test with immune sera against control strains enterovirus A71 (EV-A71), CV-A16 and CV-A6, respectively, to evaluate its specificity. The strain was then applied to determinate neutralizing antibody in human serum samples from CV-A10 naturally infected people and mouse serum samples from CV-A10 immunized animals, and the results were evaluated. Results Anti-CV-A10 detection strain for neutralizing antibody titers was prepared, belonging to C2 subtype. The items of sterility check and mycoplasma check were all in compliance with the relevant requirements of the Chinese Pharmacopoeia (Volume Ⅲ, 2020 edition). The average viral titer by calibration was 7.903 lg 50% cell culture infectious dose (CCID50)/ml (95% confidence interval: 7.868-7.937 lgCCID50/ml), with a coefficient of variation of 1.10%. No cross-reactivity with EV-A71, CV-A16 and CV-A6 immune sera were observed and the specificity was good. In the results of neutralizing antibody titers in CV-A10 naturally infected human sera and CV-A10 immunized mouse sera, the ratios between the maximum and minimum titers were all less than 4, with coefficients of variation of 6.38% and 3.64%, respectively. Conclusion The CV-A10 strain for determination of neutralizing antibody titers has good specificity, and can be used for the detection of anti-CV-A10 neutralizing antibody titers. |
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