监管与法律 · 1998/10/161 分钟阅读
National Institute of Child Health and Human Development; Availability of a Panel of HIV-1 Subtypes for Commercial Production and Distribution
本地自动翻译 · 来源原始语言
摘要
The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), in cooperation with the Department of Defense (DoD) and the European Network for Viral Assessment, would like to make available to a qualified recipient a panel of HIV-1 subtypes for commercial production. The panel will consist of approximately 10-12 virus seed stocks representing clades A,B,C,D,E,F,G,H, and O. These isolates are an invaluable resource to the HIV-1 research community for development of assays for the detection of various subtypes of HIV-1 and for use as standards in quality assuring the performance of these assays. A qualified manufacturer must demonstrate a well-established history in the acquisition, production and provision of quality assurance reagents. The manufacturer must be willing to provide the commercially produced reagents at cost to non-profit representatives and under specific stipulations which will be set forth in a Transfer Agreement with the collaborating groups. These materials will be transferred to the qualified manufacturer at no cost other than the costs associated with the packaging and shipping of the materials from the current reposi