INNOVATIVE OPTICAL SYSTEM FOR HEMAGGLUTINATION ASSAYS

描述（由申请人提供）：我们建议通过开发一种创新的96孔板和相关的光学读取器，能够在全自动系统中准确快速地测定血凝（+/-）和相关滴度值，从而消除用于血凝试验的耗时的手动平板读数。改进流感疫苗生产的强大跨机构倡议证明了改进疫苗开发和生产分析工具的必要性：流感疫苗生产优化计划，该计划是NIH、巴尔达、FDA和CDC之间的合作努力。流感疫苗开发中一个确定的有问题的步骤是用于表征流感病毒的血凝（HA）和血凝抑制（HAI）测定。目前，HA/HAI测定在96孔板中进行，其“通过眼睛”读取。用户必须评价每个孔，并手动记录血凝（+）和无血凝（-）。虽然测定制备的许多液体处理步骤可以自动化，但平板阅读完全是手动的，因为没有市售的平板读取器可以区分阳性和阴性血凝。InDevR在将创新概念转化为有影响力的产品方面有着出色的记录。InDevR是一家位于科罗拉多博尔德的私营生物技术公司，开发并商业化用于微生物分析的突破性检测和定量技术。该公司由科罗拉多大学化学系的3名成员于2003年创立，目前拥有25名员工，并已将两种产品推向市场，目前正在全球范围内销售。InDevR在内部进行所有研究、开发和制造活动。

DESCRIPTION (provided by applicant): We propose to eliminate the time-consuming manual plate readout for hemagglutination assays by developing an innovative 96-well plate and associated optical reader capable of accurately and rapidly determining hemagglutination (+/-) and associated titer values in a fully automated system. The need for improved analytical tools for vaccine development and production is evidenced by the robust, cross-agency initiative to improve influenza vaccine manufacturing: Influenza Vaccine Manufacturing Optimization Program, which is a collaborative effort between NIH, BARDA, FDA, and the CDC. One identified problematic step in influenza vaccine development is the hemagglutination (HA) and hemagglutination inhibition (HAI) assays used to characterize influenza viruses. Currently, HA/HAI assays are conducted in 96-well plates which are read "by eye". The user must evaluate each well and manually record a (+) for hemagglutination and a (-) for no hemagglutination. While many of the liquid handling steps of assay preparation can be automated, plate reading is exclusively manual since no commercially available plate readers can differentiate positive and negative hemagglutination. InDevR has an excellent track record in translating innovative concepts into impactful products. InDevR is a privately-held biotechnology company located in Boulder, Colorado that develops and commercializes breakthrough detection and quantification technologies for microbiological analysis. Founded in 2003 by 3 members of the Chemistry Department at the University of Colorado, the company today has 25 employees and has taken two products to market that are now being sold world-wide. InDevR conducts all research, development, and manufacturing activities in-house.