REAL-TIME DETECTION OF BACTERIA IN PLATELET CONCENTRATES

描述(由申请人提供)：BCR诊断公司(BCR)建议 论证采用其LEXSAS(无标签指数)的可行性 信号放大系统)技术用于实时细菌学分析 供输血用的血液制品。LEXSAS技术在以下方面独一无二 它使用孢子作为能够发射的超灵敏纳米设备 遇到单个细菌细胞时发出荧光信号。这 非凡的能力归功于集成的孢子机制 在环境中感应/转换/放大离散的生物分子信号。 基于理论考虑和初步研究，BCR预计 该生物传感器将具有以下规格：能够检测 单个细菌；能够在不到60%的时间内产生定量结果 分钟；最少的样品制备；没有标记试剂(如荧光， 放射性同位素或酶报告分子)；线性检测 对每毫升1至10E6细菌的大动态范围内的响应；一次性使用 (一次性)、低制造成本；以及自动化的适用性 高吞吐量操作。 实时细菌生物传感器应该会产生重大影响，不仅是在 使输血对患者更安全，但也在经济方面 血库。 拟议的商业应用：BCR的实时细菌生物传感器将对公共卫生和其他主要行业产生关键影响，目前依赖于通常需要16-48小时才能完成的基于培养的检测。该技术的潜在商业应用包括：(1)临床诊断；(2)生物恐怖主义防御；(3)筛选食品和饮料；(4)环境监测(空气和水)；(5)无菌测试；(6)筛查用于输血的血液产品。

DESCRIPTION (Provided by applicant): BCR Diagnostics, Inc. (BCR) proposes to demonstrate the feasibility of adapting its LEXSAS (Label-free Exponential Signal-Amplification System) technology for real-time bacteriologic analysis of blood products intended for transfusion. The LEXSAS technology is unique in that it uses spores as ultrasensitive nanodevices capable of emitting fluorescent light signals when encountering single bacterial cells. This extraordinary ability is due to integrated spore mechanisms for sensing/transducing/amplifying discrete biomolecular signals in the milieu. Based on theoretical considerations and preliminary studies, BCR expects that the biosensor will have the following specifications: ability to detect a single bacterium; ability to yield quantitative results in less than 60 minutes; minimal sample preparation; no labeling reagents (such as fluorescent, radioisotopic or enzymatic reporter molecules) are required; linear detection response over a wide dynamic range of one to 10E6 bacteria per ml; single use (disposable), low manufacturing cost; and applicability to automated high-throughput operations. A real-time bacteriological biosensor should have a major impact not only in making transfusions safer for patients, but also in the financial aspects of blood banking. PROPOSED COMMERCIAL APPLICATION: BCR's real-time bacteriologic biosaensor would have a critical impact in public health and other major industries now relying on culture-based testing that usually requires 16-48 hours for completion. Potential commercial applications of the technology include: (1) clinical diagnostics; (2) bioterrorism defense; (3) screening food and beverages; (4) environmental monitoring (air and water); (5) sterility testing; and (6) screening blood products intended for transfusion.