| 肺炎链球菌荚膜多糖特异性IgG抗体定量ELISA检测及质量控制要求 |
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| 引用本文： | 王欣茹,;赵志强,;谢贵林. 肺炎链球菌荚膜多糖特异性IgG抗体定量ELISA检测及质量控制要求[J]. 微生物学免疫学进展, 2014, 0(4): 61-67 |
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| 作者姓名： | 王欣茹, 赵志强, 谢贵林 |
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| 作者单位： | [1]国药中生兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心,甘肃兰州730046; [2]中国生物技术股份有限公司,北京100029 |
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| 基金项目： | 国家科技支撑计划（2008BAI66B01） |
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| 摘 要： | 检测肺炎链球菌荚膜多糖(PPS)特异性抗体的酶联免疫吸附试验多年来经历了两次主要改进。介绍了WHO推荐的人血清抗肺炎链球菌(Streptococcus pneumoniae)荚膜多糖抗体IgG定量ELISA(Pn PS ELISA)检测方法、关键试剂、局限性以及方法验证等内容。ELISA定量检测法,为预防肺炎链球菌的婴幼儿侵袭性疾病提供准确的抗体水平,并对肺炎链球菌疫苗的临床评价提供血清学证据。人血清中肺炎链球菌荚膜多糖抗体IgG是判断肺炎链球菌疫苗效力的重要指标。
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| 关 键 词： | 肺炎链球菌 抗荚膜多糖IgG抗体含量 酶联免疫吸附试验 检测质量控制要求 |
ELISA for quantitation of human antibodies to pneumococcal polysaccharides and requirements in quality control of determination |
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| Affiliation: | WANG Xin-ru , ZHAO Zhi-qiang, XIE Gui-lin ( Lanzhou Institute of Biological Products Co. , Ltd. , Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, Gansu province, China) |
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| Abstract: | Over the years, the specific ELISA for detection antibody to capsular polysaccharide （ PPS ） of Streptococcus pneumoniae has experienced two major improvements. The paper introduces the WHO recommended quantitative ELISA （ Pn PS ELISA） in determination of human serum IgG antibody to pneumococcal capsular polysaccharide with the key reagents, limitations in its application, and its verification, etc. If the value of IgG antibody level in sera determinated by Pn PS ELISA is above protective threshold, the sera can prevent of invasive disease in infants. The protective threshold provides serological data in the registration and serves as the primary endpoint of the protective efficacy for pneumococcal vaccine. |
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| Keywords: | Streptococus pneumonia Anticapsular polysaccharide IgG level ELISA Requirements in quality control of determination |
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