人肺炎球菌参考血清09CS中11个血清型抗荚膜多糖的抗体IgG含量的定值

对人肺炎球菌参考血清09CS中11个肺炎球菌血清型(2、8、9N、10A、11A、12F、15B、17F、20、22F、33F)的抗荚膜多糖抗体IgG含量进行定值。方法用WHO推荐的标准检测人血清中抗肺炎球菌荚膜多糖抗体IgG定量ELISA方法,以国际标准血清89SF为标准,对此11个血清型抗荚膜多糖抗体IgG含量进行定值;以暂定的09CS的定值为标准检测12份WHO校正血清、16份兰州生物制品研究所有限责任公司(LIBP)质控血清和89SF,对定值的准确性进一步验证。结果以09CS的定值为标准检测的12份WHO校正血清和16份LIBP质控血清的11个血清型抗荚膜多糖抗体结果,与以89SF为标准检测的结果,均具有良好的直线相关关系(r≈1.00,P0.05);以09CS的定值为标准检测的89SF的11个血清型抗荚膜多糖抗体的新值与其原定值比较,各血清型的误差均20%。结论实验完成了人肺炎球菌参考血清09CS中的11个血清型抗荚膜多糖抗体IgG含量的准确定值。

Calibration of IgG levels to capsular polysaccharide for 11 serotypes of the human pneumoccocal reference serum 09 CS

Objective To calibrate IgG levels to capsular polysaccharide for 11 serotypes （2、8、9N、10A、11A、12F、15B、17F、20、22F、33F）in the human pneumoccocal reference serum 09CS.Methods IgG levels to capsular polysaccharide for 11 serotypes in the human pneumoccocal reference serum,known as 09CS, prepared by Lanzhou Institute of Biological Prod-ucts Co., Ltd.（LIBP）, and were calibrated with international reference serum 89SF as a standard by using WHO recom-mended standardized ELISA in LIBP laboratory .Provisional IgG levels of 09CS were intensively validated by testing a panel of 12 WHO calibration sera and a panel of 16 LIBP quality controls （QCs） with 09CS and 89SF as the standard respective-ly, and by testing 89SF as a sample and 09CS as the standard as well.Results Provisional IgG levels of 09CS to capsular polysaccharide was established for 11 serotypes with 89SF as the standard.Furthermore, IgG levels of a panel of 12 WHO calibration sera and a panel of 16 LIBP QCs generated with 09CS as the standard, both were correlated well with those gen-erated with 89SF as the standard （r≈1.00,P〈0.05）.New IgG levels of 89SF generated with 09CS as the standard was correlated well with its previously assigned values （r=0.99,P〈0.05）.Conclusion IgG levels to capsular polysaccharide for 11 serotypes of the human pneumococcal reference serum 09CS was successfully calibrated .