目的　对自制的兔源5型肺炎球菌特异性血清参考品进行质量控制检测，用于23价肺炎球菌多糖疫苗生产过程中的过程样品检测。方法　采用双光径速率浊度免疫分析系统非竞争性浊度模式进行检测，依次考察5型血清的工作浓度及线性、交叉情况、与市售血清的可比性、室间室内检测差异以及工作浓度下的稳定性。结果　4批自制5型血清工作浓度最大稀释倍数分别为75、20、30、8倍，对应工作浓度下，多糖浓度在0.625~4.000 μg/ml范围内与响应值呈现良好线性关系，线性相关系数均＞0.985；4批5型血清参考品与其余22个型别均无交叉现象，特异性良好；与市售血清的可比性考察中，5批血清（包括市售血清）同时检测3个不同厂家上市疫苗中的5型多糖含量的变异系数均小于5%，4批自制5型血清与市售血清重均分子量降低后的检测结果无明显差异；室间、室内检测结果变异系数均＜10%；工作浓度的4批5型血清在2~8 ℃均可在至少1个月内保持良好稳定性。结论　自制的兔源5型肺炎特异性血清效价高、线性良好、无交叉，与市售血清具有可比性，工作浓度下稳定性良好，可用于肺炎5型多糖疫苗的多糖含量检测。

Objective　To benchmark the quality control indicators of the homemade rabbit derived type 5 pneumococcal specific serum by comparing with the commercial reference products, in order to detect the process samples in the production of 23-valent pneumococcus polysaccharide vaccine.Methods　The non-competitive turbidity mode of the dual path rate turbidity immunoassay system was used for detection. The working concentration, linearity, crossover, comparability with commercially available serum, detection difference both between and within laboratories， stability under working concentration of type 5 sera were investigated in turn.Results　The maximum dilution multiples of the working concentrations for the 4 batches of home made type 5 sera were 75, 20, 30 and 8 times, respectively. Under the corresponding working concentrations, the polysaccharide concentration showed a good linear relationship with the response value in the range of 0.625-4.000 μg/ml, and the linear correlation coefficients were all > 0.985. There was no crossover between 4 batches of type 5 sera reference samples and the other 22 types, and the specificity was good. In the comparability test with commercially available serum, the coefficient of variation (CV) of type 5 polysaccharide content in 3 different manufacturers' marketed vaccines was less than 5% for all 5 batches of sera including commercially available serum. There was no apparent difference in the detection results between the 4 batches of type 5 sera and commercially available serum as the weight-average molecular weight decreased. The CV values of between- and within-department outdoor testing results were less than 10%. Four batches of type 5 sera with working concentration maintained good stability for at least one month under 2—8 ℃.Conclusion　The homemade rabbit derived type 5 pneumococcal specific serum has high potency, good linearity,no crossover, comparability to commercially available serum， and good stability at working concentrations， and can be used for polysaccharide content detection of type 5 pneumococcus polysaccharide vaccine.