Kulpa-Eddy J
USDA - Animal and Plant Health Inspection Service - Veterinary Services, Riverdale, MD 20737, USA.
Dev Biol (Basel). 2012;134:101-6.
The standard requirement for serial release potency testing of Leptospira bacterins in the United States is the hamster vaccination challenge test. It is a test that uses a large number of animals experiencing pain or distress, takes weeks to conduct, can be expensive and requires that laboratory personnel handle a viable zoonotic pathogen. In an effort to address these concerns, the United States Department of Agriculture (USDA) developed an in vitro method for potency testing of four Leptospira serovars. This enzyme-linked immunosorbent assay (ELISA) was subsequently validated in the target species. USDA informed their biologics licensees, permittees and applicants of the availability of reference bacterins and the regulatory acceptance regarding this alternative test method in notices issued in 2007 and 2009. This presentation describes how the initial research and subsequent development and validation work were accomplished.
在美国，钩端螺旋体菌苗的连续释放效力测试的标准要求是仓鼠接种攻击试验。该试验使用大量经历疼痛或痛苦的动物，需要数周时间进行，成本可能很高，并且要求实验室人员处理一种活的人畜共患病原体。为了解决这些问题，美国农业部（USDA）开发了一种用于四种钩端螺旋体血清型效力测试的体外方法。这种酶联免疫吸附测定（ELISA）随后在目标物种中得到验证。美国农业部在2007年和2009年发布的通知中告知其生物制品许可证持有人、许可证持有者和申请人参考菌苗的可用性以及关于这种替代测试方法的监管认可情况。本报告描述了最初的研究以及后续的开发和验证工作是如何完成的。
