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来消除血凝分析中耗时的手动平板读数，该读取器能够在全自动系统中准确和快速地测定血凝(+/-)和相关的滴定值。美国国立卫生研究院、BARDA、FDA和美国疾病控制与预防中心共同发起了一项旨在改进流感疫苗生产的强有力的跨机构倡议：流感疫苗制造优化计划，这证明了改进疫苗开发和生产的分析工具的必要性。流感疫苗开发中一个公认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)试验。目前，HA/HAI检测是在96孔板上进行的，这些板的读数是“用眼睛”。用户必须对每口井进行评估，并手动记录血凝(+)和无血凝(-)。虽然化验准备的许多液体处理步骤都可以自动化，但平板读数完全是手动的，因为没有商业上可用的平板阅读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良好的记录。InDevR是一家私人持股的生物技术公司，位于科罗拉多州博尔德市，开发和商业化微生物分析的突破性检测和量化技术。该公司由科罗拉多大学化学系的3名成员于2003年创立，目前有25名员工，并已将两种产品推向市场，目前正在世界各地销售。InDevR在内部进行所有的研究、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.