火箭免疫电泳法定量检测4价脑膜炎球菌多糖疫苗中C群脑膜炎球菌多糖含量的方法学验证

摘要

目的 验证用火箭免疫电泳法(rocket immunoelectrophoresis,RIE)检测4价脑膜炎球菌多糖疫苗(tetravalent serogroup A/C/W135/Y meningococcal polysaccharide vaccine,MPV4)中C群多糖含量的可靠性.方法以系列浓度的C群多糖溶液为标准,采用RIE对MPV4中C群多糖含量进行重复测定.结果最佳线性范围为30～86 mg/L,相关系数(r)均大于0.985;MPV4与C群多糖参比品的剂量反应曲线之间具有良好的平行性;在精密度试验中,试验内CV为6.08%～8.07%,试验间CV为7.24%～9.19%;A、W135和Y群多糖及乳糖不引起非特异性免疫反应.结论本法的线性、精密度和专属性均符合验证要求,可作为定量检测MPV4中C群多糖含量的方法.%Objective To validate the reliability of RIE for determination of serogroup C meningo-coccal polysaccharide(MenC PS)content in the tetravalent serogroup A/C/W135/Y meningococcal poly-saccharide vaccine(MPV4). Methods A series of concentrations of MenC PS as standards, MenC PS content in MPV4 was determined by RIE repeatly to validate linearity, precision and specificity. Results The optimal linear range was 30-86 mg/L and the coefficients of correlation(r)were>0.985. There was parallelism between the dose response curve of MenC PS and MPV4. The coefficients of variation for in-tra-assay and inter-assay precision were 6.08 %-8.07% and 7.24%-9.19%, respectively. No cross reac-tions were observed with serogroup A, W135 and Y meningococcal polysaccharide, as well as lactose. Conclusions The linearity, precision and specificity of this method are good. It is suitable for quantitative determination of MenC PS content in MPV4.