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。
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 007 sp 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.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第13期1551-1555,共5页
Chinese Journal of New Drugs
基金
国家高技术研究发展计划(863计划资助项目)(2012AA02A402)