质控血清09CS中13个肺炎球菌荚膜多糖抗体IgG含量检测范围的确定

Calibration and analysis of contents for IgG antibodies 09CS as quality control serum to pneumococcus capsular polysaccharide

目的 建立09CS作为质控血清用于13价肺炎球菌多糖蛋白结合疫苗(13PCV)临床血清样本检测中的检测值范围。方法 用WHO推荐的检测人血清中抗肺炎球菌荚膜多糖抗体IgG的定量ELISA,以国际人肺炎球菌标准血清007sp为标准,将09CS作为待测血清,检测其在13个血清型(1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、23F型)中抗荚膜多糖抗体IgG含量的值。连续检测09CS血清100余次,计算99%置信区间的各血清型几何平均抗体浓度、标准偏差(SD)和变异系数(CV)。结果 检测得到09C中13个血清型抗荚膜多糖IgG抗体含量以及在99%置信区间(CI)下±2.58倍SD的检测值范围;13个血清型检测结果的CV分别为10.86%、12.52%、13.96%、14.98%、28.77%、11.16%、14.96%、9.31%、10.43%、7.28%、10.86%、12.52%、13.96%,除6A型外,各型CV均低于15%,表明试验间精密度良好;检测次数异常率低于10%。结论 09CS可作为质控血清,用于13价肺炎球菌结合疫苗临床血清中抗荚膜多糖抗体IgG含量的ELISA检测。

Objective With the aim of using 09CS serum as a quality control (QC) agent, so as to determine the range of IgG antibodies specific against streptococcus pneumonia capsular polysaccharide for 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in related samples from clinical trails. Methods 09CS serum was tested more than 100 times by standardized ELISA recommended by WHO with international reference serum 007sp, the GMC, SD and CV (%) were calculated. Results The concentrations of IgG antibodies for 13-serotypes of 09CS serum were determined, the concentration range for each serotype was determined as ± 2.58 SD under the 99% confidence interval. The CV for 13 serotypes were 10.86%, 12.52%, 13.96%, 14.98%, 28.77%, 11.16%, 14.96%, 9.31%, 10.43%, 7.28%, 10.86%, 12.52%, 13.96% respectively, which were all under 15.00% except for 6A. The abnormal rate of calibration times for each serotype was within 10%. Conclusion 09CS could be used as QC serum in ELISA detection of IgG antibodies contained in samples from clinical trails by immunization of 13-valent pneumococcal conjugate vaccine.