人肺炎链球菌参考血清BW09的制备及其24个血清型IgG抗体浓度的赋值  

Preparation of human pneumococcal reference serum BW09 and assignment of IgG antibody concentrations for 24 serotypes

作　　者：陈娟[1] 陈秋璟 张建华[1] 刘威[2] 陈祥 朱小广 舒成林 张锐[1] 何建琴 兰芳[1] Chen Juan;Chen Qiujing;Zhang Jianhua;Liu Wei;Chen Xiang;Zhu Xiaoguang;Shu Chenglin;Zhang Rui;He Jianqin;Lan Fang(Department of Bacterial Vaccine, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China;Department of Bacterial Vaccine Research and Development, Chengdu Institute of Biological Products Co., Ltd., Chengdu 610041, China;Chengdu Rongsheng Pharmaceutical Co., Ltd., Chengdu 610041, China)

机构地区：[1]成都生物制品研究所有限责任公司细菌性疫苗二室,610023 [2]成都生物制品研究所有限责任公司细菌性疫苗研究室,610023 [3]成都蓉生药业有限责任公司,610041

出　　处：《中华微生物学和免疫学杂志》2019年第6期466-471,共6页Chinese Journal of Microbiology and Immunology

摘　　要：目的制备成都生物制品研究所有限责任公司人肺炎链球菌参考血清,并对24个血清型的抗荚膜多糖抗体IgG浓度进行赋值。方法用23价肺炎链球菌多糖疫苗免疫50名健康成人,采集免疫后血浆,制备人肺炎链球菌参考血清BW09。采用世界卫生组织推荐的人血清肺炎链球菌荚膜多糖抗体IgG定量酶联免疫吸附测定方法,以兰州生物制品研究所有限责任公司的09CS为参考血清,对24个血清型别(1、2、3、4、5、6A、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F、33F)抗体的IgG浓度进行赋值;以赋值后的BW09为参考血清,检测09CS,比较09CS新值与原赋值之间的差异;分别以BW09和09CS为参考血清,检测质控血清QC02、QC03和8个血清样品,比较两种参考品测定抗体浓度的差异,对新制参考血清赋值的准确性进一步验证。结果制备了人肺炎链球菌参考血清BW09;确定了BW09中24个血清型IgG抗体浓度。以BW09为参考血清检测09CS的新值与原赋值比较,各血清型的误差百分率绝对值均在10%以内。分别以BW09和09CS为参考血清检测质控血清QC02、QC03和8个血清样品的24个血清型IgG抗体,测得的检测值间呈线性相关。结论成功制备了人肺炎链球菌参考血清BW09,并对其中的24个血清型抗体IgG浓度进行了准确赋值。Objective To prepare human pneumococcal reference serum and assign IgG antibody concentrations for its 24 serotypes. Methods Fifty healthy male and non-pregnant female volunteers were vaccinated once with 23-valent pneumococcal polysaccharide vaccine. Plasma samples were collected following immunization and used to prepare reference serum BW09. IgG antibody concentrations of BW09 against the capsular polysaccharides of 24 serotypes(1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F)were assigned by WHO recommended standardized Pn PS ELISA using 09CS(supplied by Lanzhou Institute of Biological Products Co., Ltd)as a reference serum. Finally, 09CS, two quality control sera and eight serum samples had concentrations reassigned for 24 pneumococcal serotypes using BW09 as the reference, and the results were compared with those using 09CS as the reference serum. Results Glycerol-contained human pneumococcal reference serum BW09 was prepared and the IgG antibody concentrations for its 24 serotypes were assigned. 09CS had concentrations reassigned for 24 pneumococcal serotypes using BW09 as the reference, and the newly assigned concentrations were similar to the original values(with percentage error less than 10% in all serotypes). IgG antibodies against capsular polysaccharides of 24 serotypes of two quality control sera and eight serum samples were assigned by BW09 and 09CS, and the results showed a linear correlation. Conclusions The human pneumococcal reference serum BW09 was successfully prepared and IgG antibody concentrations for its 24 serotypes were accurately assigned.

关 键 词：肺炎链球菌 参考血清 IGG 酶联免疫吸附试验 

分 类 号：R392[医药卫生—免疫学]