Instituto de Virología, CICVyA, INTA-Castelar, 1686 Buenos Aires, Argentina.
J Virol Methods. 2009 Dec;162(1-2):170-8. doi: 10.1016/j.jviromet.2009.07.031. Epub 2009 Aug 7.
Bovine Viral Diarrhea Virus (BVDV) is the causative agent of a worldwide disease. The virus infects bovines of all ages, causing reproductive problems and contaminating biological products of high commercial value. The large-scale production of BVDV vaccines presents the challenge of processing antigenic proteins that are highly susceptible to the processing environment. Potency testing requires the immunization of cattle in order to determine the neutralizing antibodies titers induced by the vaccine. An alternative to the in vivo test is an in vitro measurement of key viral antigens. This paper describes the development and validation of a sandwich-type indirect ELISA that is able to detect and quantify BVDV E2 glycoprotein in live and inactivated BVDV. Validation parameters such as repeatability, intermediate precision, and reproducibility indicated that the developed ELISA constitutes an advanced tool for evaluating the BVDV antigen throughout manufacturing and vaccine release testing.
牛病毒性腹泻病毒（BVDV）是一种全球性疾病的病原体。该病毒感染所有年龄段的牛，导致生殖问题，并污染具有高商业价值的生物制品。BVDV 疫苗的大规模生产带来了处理对加工环境高度敏感的抗原蛋白的挑战。效力测试需要对牛进行免疫接种，以确定疫苗诱导的中和抗体效价。替代体内测试的方法是测量关键病毒抗原的体外方法。本文描述了夹心型间接 ELISA 的开发和验证，该 ELISA 能够检测和定量活的和灭活的 BVDV 中的 E2 糖蛋白。验证参数，如重复性、中间精密度和重现性表明，所开发的 ELISA 构成了一种用于评估整个制造过程和疫苗放行测试中 BVDV 抗原的先进工具。
