We previously developed an ELISA assay for detection of tetanus toxoid antigen in tetanus vaccines for human use. Tetanus vaccines for veterinary use are qualitatively different to those used in humans, often containing a larger number and variety of non-tetanus antigens in the multi-valent products, and adjuvants that are not found in human vaccines. We assessed performance of the capture ELISA with a range of veterinary tetanus vaccines as a first step towards development of an immunoassay as a potential in vivo potency substitute. Nine tetanus vaccines were tested and all produced a good dose response in the ELISA. The shape of the dose response curve for the whole vaccine compared to a matched non-adjuvanted tetanus toxoid antigen was more comparable for vaccines containing a non-aluminium adjuvant than products containing aluminium adjuvants. Elution of the antigen from aluminium adjuvant did not improve the comparability of the dose response curve but did increase the total amount of tetanus antigen available for detection. The ELISA was highly specific for tetanus with no signal obtained for a large number of non-tetanus antigens. These results suggest that a capture ELISA assay can be applied to a control strategy for veterinary tetanus vaccines.

我们先前开发了一种ELISA检测试剂盒，用于检测人类使用的破伤风疫苗中的破伤风类毒素抗原。兽用破伤风疫苗在质量上不同于人类使用的破伤风疫苗，通常在多价产品中包含大量和多种非破伤风抗原，以及在人类疫苗中找不到的佐剂。我们评估了一系列兽用破伤风疫苗的捕获ELISA的性能，这是迈向开发作为潜在体内效价替代品的免疫测定法的第一步。测试了九种破伤风疫苗，并在ELISA中均产生了良好的剂量反应。与包含非铝佐剂的疫苗相比，与匹配的非佐剂破伤风类毒素抗原相比，整个疫苗的剂量反应曲线形状更具有可比性。从铝佐剂中洗脱抗原并不能改善剂量反应曲线的可比性，但是确实增加了可用于检测的破伤风抗原的总量。ELISA对破伤风具有高度特异性，没有获得大量非破伤风抗原的信号。这些结果表明，捕获ELISA测定法可用于兽破伤风疫苗的控制策略。