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Electrical System for Rapidly Detecting Viable Bacteria in Blood Culture

用于快速检测血培养中活细菌的电气系统

基本信息

批准号：
9067282
负责人：
Eugene David Boland
金额：
$ 93.64万
依托单位：
TECHSHOT, INC.
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-08-01 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9067282
关键词：
Adult Agitation Aliquot Amplifiers Bacteria Blood Blood Volume Carbon Dioxide Cataloging Catalogs Cell membrane Cessation of life Charge Clinical Clinical Research Clinical Trials Computer software Culture Media Custom Data Detection Development Devices Electric Capacitance Electronics Ensure Frequencies Funding Goals Gold Health Hematocrit procedure Hospitals Hour Infection Inflammation Institutional Review Boards Intensive Care Investigation Legal patent Life Malignant neoplasm of lung Manuals Marketing Measurement Measures Mechanics Methods Microbe Organism Outcome Patient-Focused Outcomes Patients Performance Phase Process Proliferating Property Reading Recording of previous events Records Reporting Research Sampling Scanning Sepsis Septicemia Small Business Innovation Research Grant Steam Sterility Suspension substance Suspensions System Technology Testing Time Tissues arm base clinical Diagnosis clinically relevant design electric impedance electrical measurement experience graphical user interface improved improved outcome innovation instrument malignant breast neoplasm meetings microorganism mortality neonate operation product development prototype research study response verification and validation

项目摘要

DESCRIPTION (provided by applicant): Background: Each year in the US, there are over 18 Million Blood Cultures performed to determine the presence/absence of viable microorganisms in the blood of patients suspected of having Blood Steam Infection (BSI or Septicemia). Current technology for Blood Cultures typically takes 1-5 days to provide a result. Our proposed system would enable the user to obtain Blood Culture results in 2-24 hrs. instead which will greatly improve the outcomes for patients with Sepsis. Innovation: At the core of the system lies a patent-pending electrical method, which can detect proliferating microorganisms in suspensions based on charges stored at the intact cell membranes of live microorganisms. This approach was shown (prior to Phase I) to be 4-10X faster than the current methods employed in BACTEC TM (current Gold Std.) However, in order to achieve the desired sensitivity, our method required that aliquots be periodically withdrawn from the broth (blood culture medium + patient blood) into a thin long chamber for an "electrical scan" (impedance measurements are frequencies 1KHz - 100 MHz). The data from this "scan" is then analyzed to calculate the "Bulk Capacitance" (Cb), a parameter that rises with the rise in the number of live microbes. We successfully achieved our Phase I goals by showing that (a) the automated sampling could be repeatedly performed aseptically over 5 days (5x longer than foreseen need); (b) the sophisticated electrical measurements needed could be obtained using a circuit designed and assembled by us; and (c) the threshold concentrations, and hence Times to Detection (TTDs), using our Phase I were much lower than those of BACTEC TM. Approach: In Phase II, we propose to (a) build an 8-unit "research" unit; (b) verify the robustness of our device: its abilit to handle different volumes of blood with different properties such as hematocrit and WBC counts; (c) verify our ability to correctly diagnose clinical samples using the 8-unit system; and (d) design (using "Good Design Principles"& keeping records in a "Device History File") a 64 unit 'market ready' system. By the end of the funded period (3 yrs.), we will be ready to meet with the FDA armed with a Device History File documenting the development of the product (64-unit system) & clinical studies (NB: not clinical trials) showing equivalency to existing devices such as BACTECTM (in terms of being able to correctly identify positives) and also demonstrate improved performance (reduced TTDs) to potential partners and/or investors.

背景：在美国，每年进行超过1800万次血液培养，以确定疑似患有血液蒸汽感染（BSI或败血症）的患者血液中是否存在活微生物。目前的血液培养技术通常需要1-5天才能得出结果。我们提出的系统将使用户能够在2-24小时内获得血培养结果。这将极大地改善脓毒症患者的预后。创新：该系统的核心是一种正在申请专利的电方法，该方法可以根据储存在活微生物完整细胞膜上的电荷来检测悬浮液中增殖的微生物。该方法被证明（在第一阶段之前）比BACTEC TM（目前的Gold Std）中使用的当前方法快4-10倍。然而，为了达到所需的灵敏度，我们的方法需要定期从肉汤（血液培养基+患者血液）中抽取等分液，进入一个细长的腔室进行“电扫描”（阻抗测量频率为1KHz - 100mhz）。然后，通过分析这种“扫描”的数据来计算“体积电容”（Cb），该参数随着活微生物数量的增加而增加。我们通过证明(a)自动化取样可以在5天内无菌重复进行（比预期需要长5倍），成功实现了第一阶段的目标；(b)使用我们设计和组装的电路可获得所需的精密电气测量；(c)与BACTEC TM相比，第一阶段的阈值浓度和检测时间（TTDs）要低得多。方法：在第二阶段，我们建议(a)建立一个8单元的“研究”单元；(b)验证我们设备的稳健性：它能够处理不同体积的血液，具有不同的特性，如血细胞比容和白细胞计数；(c)验证我们使用8单元系统正确诊断临床样本的能力；以及(d)设计（使用“良好设计原则”并在“设备历史文件”中保存记录）64个单元的“市场就绪”系统。在资助期（3年）结束时，我们将准备好与FDA会面，并携带设备历史文件，记录产品（64单元系统）的开发和临床研究（注：不是临床试验），显示与现有设备（如BACTECTM）的等效性（在能够正确识别阳性方面），并向潜在合作伙伴和/或投资者展示改进的性能（减少TTDs）。