The results of validation.

Swine atrophic rhinitis is a disease caused by Pasteurella multocida and Bordetella bronchiseptica that affects pigs. Inactivated vaccines containing the toxins produced by Pasteurella multocida and Bordetella bronchiseptica have been widely used for the prevention of swine atrophic rhinitis. The efficacy of a vaccine is correlated with the amount of antigen present; however, the protective toxin of P. multocida bound to aluminum hydroxide, which is used as an adjuvant, can hinder the monitoring of the antigen concentration in the vaccine. This study assessed the applicability of a dot immunoassay as an antigen quantification method using monoclonal antibodies. This quantification method was able to detect the antigen with high specificity and sensitivity even when the antigen was bound to the adjuvant, and its application to vaccine products revealed a correlation between the amount of antigen present in the vaccine and the neutralizing antibody titers induced in pigs. The antigen quantification method presented in this study is a simple and sensitive assay capable of quantifying the amount of antigen present in a vaccine that can be used as an alternative quality control measure.猪萎缩性鼻炎（Swine atrophic rhinitis）是一种由多杀性巴氏杆菌（Pasteurella multocida）与支气管败血波氏杆菌（Bordetella bronchiseptica）共同引发的猪类传染病。以这两种病原菌所产毒素为抗原制备的灭活疫苗，已被广泛应用于猪萎缩性鼻炎的预防。疫苗的效力与其所含抗原剂量呈正相关；但作为佐剂使用的氢氧化铝会结合多杀性巴氏杆菌的保护性毒素，进而干扰疫苗中抗原浓度的检测工作。本研究以单克隆抗体为检测试剂，评估了斑点免疫测定法（dot immunoassay）作为抗原定量方法的适用性。该定量方法即便在抗原与佐剂结合的情况下，仍可实现高特异性与高灵敏度的抗原检测；将其应用于疫苗制品后，结果表明疫苗中的抗原含量与免疫仔猪后诱导产生的中和抗体效价存在显著相关性。本研究提出的抗原定量方法操作简便、灵敏度优异，可精准定量结合佐剂的疫苗抗原，可作为替代方案用于疫苗的质量控制环节。