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1,3,5和7F型肺炎球菌荚膜多糖抗体IgG定量
1,3,5和7F型肺炎球菌荚膜多糖抗体IgG定量
李 红,李亚南,李茂光,陈 琼,王春娥,陈翠萍,叶 强

中国食品药品检定研究院呼吸道细菌疫苗室 卫生部生物技术产品检定方法 及其标准化重点实验室,北京 100050
Validation of the ELISA quantitative determination method for the 1,3,5 and 7F pneumococcal capsular polysaccharide antibody IgG
(National Institutes for Food and Drug Control, Key Laboratory of the Method and Standardization for Quality Control of Biotechnical Products, Ministry of Public Health, Beijing 100050, China)

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起始页:1551

摘要:[摘要] 目的:验证1,3,5和7F型肺炎链球菌荚膜多糖血清IgG抗体定量ELISA检测方法。方法:以国际参考血清007sp为标准,分别测定肺炎国际质控血清盘(12/278)共12份血清中的1,3,5和7F型IgG抗体含量,计算线性、检测限及检测范围;同时测定准确性;连续测定3份质控血清,计算精密度。利用1份质控血清进行抑制试验,绘制抑制曲线,计算特异性。结果:该方法的相关性、检测范围、检测限均可达到可接受标准,准确性较高,精密度良好,特异性较好。结论:该定量检测方法经过验证可用于肺炎球菌疫苗临床血清抗体检测。

关键词:[关键词] 肺炎链球菌;临床血清;抗体; ELISA; 验证

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Abstract:[Abstract] Objective: To validate the quantitative ELISA method for the serotype specific IgG antibody concentrations of 1, 3, 5 and 7F. Methods: Pneumococcal ELISA calibration sera (panel B 12/278)were assayed with pneumococcal international reference serum (007sp) for the linear range, R2, detection limit and accuracy. Another 3 serum quality control samples were tested constantly with 007sp to get the precision, and the inhibition assay was tested with one serum quality control sample with different polysaccharide concentration. Results: The linear range, R2 and detection limit reached the acceptable criteria, andthe accuracy, the precision, and the specificity are satisfactory. Conclusion: Validation results showed that the ELISA method was appropriate for the determination of penumococcal clinical serum antibody concentrations.

Key words:[Key words] Strepcoccus pneumonia;clinical sera;antibody;ELISA;validation

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