REAL TIME DETECTION OF BACTERIA IN PLATELET CONCENTRATES

描述（由申请人提供）：血液制品的细菌污染目前是输血医学中的一个主要问题，也是输血相关死亡的主要原因。血小板特别容易受到污染，因为它们在室温下储存。 BCR诊断公司(BCR)已经开发了一种用于真实的检测低水平细菌的新型生物传感器平台（即，约2分钟）。在第一阶段，BCR已经证明了将其技术用于开发低成本生物传感器的可行性，该生物传感器用于在输血前不久检测血小板浓缩物中的细菌。BCR的生物传感器基于LEXSAS（无标记指数信号放大系统），这是一种独特的方法，使用孢子作为超灵敏的纳米检测器，当遇到单个细菌细胞时能够发出荧光信号。 对于第二阶段，巴塞尔公约责任委员会建议：构建一个可销售的生物传感器原型，将系统的灵敏度扩展到单个细菌细胞。2.使用原型进行研究，旨在获得符合美国食品药品监督管理局（FDA）生物传感器上市前批准要求的实验数据。 研究将包括三个主要任务：1。在灵敏度、完成时间、分析再现性和动态范围方面测试、优化和标准化生物传感器原型。2.使用原型进行实验，以获得提交给FDA的“数据包”。这项任务包括实验，将显示生物传感器的准确性（灵敏度和特异性），用于识别掺有来自FDA提供的列表中的约13种不同细菌菌株的血小板浓缩物。3.进行双盲研究以验证生物传感器的商业实用性。 细菌生物传感器的其他潜在应用包括：诊断、环境监测、食品和饮料监测以及无菌测试。

DESCRIPTION (provided by applicant): Bacterial contamination of blood products is currently a major problem in transfusion medicine and a leading cause of transfusion-related deaths. Platelets are particularly susceptible to contamination because they are stored at room temperature. BCR Diagnostics, Inc. (BCR) has developed a novel biosensor platform for detecting low levels of bacteria in real time (i.e., about 2 minutes). During Phase I, BCR has demonstrated the feasibility of adapting its technology to developing a low-cost biosensor for detecting bacteria in platelet concentrates shortly before transfusions. BCR's biosensor is based on the LEXSAS (Label-free Exponential Signal-Amplification System), a unique methodology using spores as ultrasensitive nanodetectors capable of emitting fluorescent light signals when encountering single bacterial cells. For Phase II, BCR proposes: 1. To construct a marketable biosensor prototype that will extend the system's sensitivity to single bacterial cells. 2. To use the prototype for a study designed to obtain experimental data that will meet the Food and Drug Administration (FDA) requirements for premarket approval of the biosensor. The study will consist of three major tasks: 1. To test, optimize, and standardize the biosensor prototype in terms of sensitivity, completion time, analysis reproducibility, and dynamic range. 2. To use the prototype for experiments designed to obtain a "Data Package" to be submitted to the FDA. This task includes experiments that will show the accuracy (sensitivity and specificity) of the biosensor for identifying platelet concentrates spiked with a panel of about 13 different bacterial strains from a list provided by the FDA. 3. To do a double-blind study to validate the commercial usefulness of the biosensor. Other potential applications of the bacteriologic biosensor include: diagnostics, environmental surveillance, food and beverage monitoring, and sterility testing.