LOW-COST BIOSENSOR FOR REAL-TIME DIAGNOSIS OF BACTEREMIA

描述(由申请人提供)：BCR诊断公司(BCR)建议研究将其低成本生物传感器技术应用于实时(即不到5分钟)菌血症检测的可行性。应用的前提是菌血症的早期诊断是至关重要的，因为任何治疗的延误都会大大增加败血症综合征的风险。在美国，这种危及生命的疾病每年影响超过25万人，死亡率为20%-50%，具体取决于患者的潜在疾病。目前，菌血症的实验室诊断是通过血培养检测完成的，这是一种传统的方法，需要24到72小时才能完成。 BCR的生物传感器基于LEXSAS(无标签指数信号放大系统)；LEXSAS是一种独特的方法，使用孢子作为超灵敏的纳米检测器，能够在遇到单个细菌细胞时发出荧光信号。 这项研究将由三个主要任务组成：任务1。使用添加了大肠杆菌的人血样本作为分析物，调整和优化LEXSAS的每个成分。任务2：从选择性、分析物回收率和分析重复性方面评价LEXSAS的性能。任务3.通过比较生物传感器的结果和常规培养的结果来建立LEXSAS的精确度。分别添加了六种不同细菌菌株的血液样本将被用作分析对象。 这项拟议的研究将使用LEXSAS的实验室版本启动，该版本目前用于识别打算输血的受细菌污染的血小板。任务2和任务3的实验将使用高灵敏度细菌生物传感器的商业原型进行。细菌生物传感器的其他潜在商业应用包括环境监测、监测用于输血的血液产品、食品和饮料筛选以及无菌测试。

DESCRIPTION (provided by applicant): BCR Diagnostics, Inc. (BCR) proposes to study the feasibility of applying its low-cost biosensor technology to detecting bacteremia in real-time (i.e., less than 5 min). The premise underlying the application is that early diagnosis of bacteremia is crucial because any delay of treatment increases considerably the risk of sepsis syndrome. In the U. S., this life-threatening disease affects more than 250,000 individuals every year with a mortality rate of 20-50% depending on the patient's underlying illness. Currently, laboratory diagnosis of bacteremia is accomplished by blood culture testing, a traditional methodology requiring 24 to 72 hours for completion. BCR's biosensor is based on the LEXSAS (Label-free Exponential Signal-Amplification System); a unique methodology using spores as ultra-sensitive nanodetectors capable of emitting fluorescent light signals when encountering single bacterial cells. The study will consist of three major assignments: Task 1. Adapting and optimizing each of the LEXSAS components using as analyte human blood specimens spiked with Escherichia coli. Task 2. Evaluating performance of the LEXSAS in terms of selectivity, analyte recovery and assay reproducibility. Task 3. Establishing precision of the LEXSAS by comparing the biosensor results with those of conventional culturing. Blood specimens spiked with each of six different bacterial strains will be used as analytes. The proposed study will be initiated using a laboratory version of the LEXSAS that is currently used for identifying bacterially contaminated platelets intended for transfusion. Experiments for Tasks 2 and 3 will be done using a commercial prototype of a highly sensitive bacteriologic biosensor. Other potential commercial applications of the bacteriologic biosensor include environmental surveillance, monitoring blood products intended for transfusion, food and beverage screening, and sterility testing.