Nucleic acid detection techniques for adventitious agent testing
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Abstract
The availability of safe and effective animal vaccines is critical for the prevention of animal disease. Adventitious agent testing is done on master seed viruses prior to vaccine licensure to ensure that no biological contaminants were introduced during manufacture. Traditional adventitious agent testing is performed using a variety of cell culture lines and a panel of polymerase chain reaction tests. The purpose of this research was to determine if new technologies like DNA microarray and next-generation sequencing (NGS) could be of any benefit for adventitious agent testing. A literature review describes the state of the field and the challenges that will have to be addressed to use these technologies in a regulatory environment. Both techniques were tested on a panel of mammalian and avian viruses, and each virus was tested individually and in combination with other viruses. NGS was found to be a more reliable method of screening for adventitious agents than microarray.