Duncan P, McKerral L, Feng S, Tsai P K
Merck Research Laboratories, West Point, PA 19486-0004, USA.
Dev Biol (Basel). 2006;126:283-90; discussion 327.
In this presentation we address the "gold standards" among diagnostic tests used to detect some potential adventitious and endogenous contaminants in human biologics and vaccines, reflecting on the breadth as well as limits of detection of these assays. This perspective may help developers of innovative diagnostics to address the unique needs of this highly regulated industry.
在本报告中，我们探讨了用于检测人类生物制品和疫苗中一些潜在外来和内源性污染物的诊断测试中的“金标准”，同时思考了这些检测方法的检测范围和局限性。这一观点或许有助于创新诊断方法的开发者满足这个高度规范行业的独特需求。
