Riches-Duit Rebecca, Hassall Laura, Rigsby Peter, Stickings Paul
National Institute for Biological Standards and Control, Division of Bacteriology, South Mimms, Potters Bar, EN6 3QG, United Kingdom.
National Institute for Biological Standards and Control, Biostatistics Group, South Mimms, Potters Bar, EN6 3QG, United Kingdom.
Biologicals. 2019 Sep;61:8-14. doi: 10.1016/j.biologicals.2019.08.003. Epub 2019 Aug 27.
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.
我们之前开发了一种酶联免疫吸附测定（ELISA）方法，用于检测人用破伤风疫苗中的破伤风类毒素抗原。兽用破伤风疫苗在性质上与人类使用的疫苗不同，在多价产品中通常含有更多数量和种类的非破伤风抗原，以及人用疫苗中未发现的佐剂。作为开发一种免疫测定法以作为潜在的体内效力替代方法的第一步，我们评估了捕获ELISA法对一系列兽用破伤风疫苗的性能。测试了九种破伤风疫苗，所有疫苗在ELISA中均产生了良好的剂量反应。与匹配的无佐剂破伤风类毒素抗原相比，含非铝佐剂的疫苗的全疫苗剂量反应曲线形状比含铝佐剂的产品更具可比性。从铝佐剂中洗脱抗原则并未改善剂量反应曲线的可比性，但确实增加了可用于检测的破伤风抗原总量。该ELISA对破伤风具有高度特异性，对大量非破伤风抗原未获得信号。这些结果表明，捕获ELISA测定法可应用于兽用破伤风疫苗的控制策略。
