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目的建立AC群脑膜炎球菌与b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)联合疫苗(Men AC-Hib)多糖含量免疫速率比浊检测方法,并进行验证。方法采用免疫速率比浊法测定联合疫苗中A群、C群脑膜炎球菌及Hib多糖含量,绘制不同多糖抗原含量的标准曲线,并对方法的检测低限、精密度、准确度和特异性进行验证。结果 3种不同多糖抗原浓度在2~8μg/ml之间具有良好的线性关系,相关系数均大于0.98;建立的方法检测A群、C群脑膜炎球菌和Hib多糖的检测低限分别为0.847、0.043和0.507μg/ml;检测各组分多糖抗原含量的批内和批间变异系数均小于5%,平均回收率在88.30~104.40%之间;各组分特异性多糖抗体仅与各自多糖抗原反应,且各组分多糖抗原共同存在时无相互干扰。结论成功建立了准确、特异的AC群脑膜炎球菌与Hib联合疫苗的多糖含量检测方法。
Objective To establish and validate the immunoturbidimetric method for detecting the immunosuppression of polysaccharides of meningococcal group (AC) and Haemophilus influenzae type b (Hib) combined vaccine (Men AC-Hib). Methods The immunoturbidimetric method was used to determine the content of meningococcal group A and group C meningococci and Hib polysaccharide in the combination vaccine. The standard curve of different polysaccharide antigen content was drawn, and the detection limit, precision, accuracy and specificity of the method were determined verification. Results The three polysaccharide antigen concentrations were in the range of 2 ~ 8μg / ml. The correlation coefficients were all greater than 0.98. The established methods for detection of group A, group C meningococci and Hib polysaccharide were 0.847, 0.043 and 0.507 μg / ml, respectively. The variation coefficients of intra-and inter-assay were all less than 5%, and the average recoveries were between 88.30 and 104.40%. The specific polysaccharide antibodies of each component only reacted with the polysaccharide antigen Reaction, and the polysaccharide antigen components co-exist without mutual interference. Conclusion The accurate and specific method for detecting polysaccharide content of combined vaccine of meningococcus and Hib was established successfully.