Rapid Clinical Surge-Testing for Biothreat Agents

生物威胁制剂的快速临床浪涌测试

• 批准号: 7691597
• 负责人: Don Straus
• 金额: $ 29.87万
• 依托单位: FIRST LIGHT DIAGNOSTICS , INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-04-15 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7691597
• 关键词: Address; Animals; Anthrax Attack; Anthrax disease; Antibiotics; Antigens; Bacillus anthracis; Bacteria; Bacterial Proteins; Biological; Biological Assay; Biological Markers; Biological Warfare; Biosensor; Bioterrorism; Blood; Blood Tests; Blood Volume; Blood specimen; Cardiovascular Diseases; Cells; Cities; Clinic; Clinical; Communicable Diseases; Complex; Data; Detection; Development; Device or Instrument Development; Diagnosis; Diagnostic; Disease; Disease Marker; Disease Progression; Early Diagnosis; End Point; Event; Exposure to; Food and Beverages; Future; Goals; Government; Hand; Healthcare; Human; Image; Immunoassay; Individual; Industrial Microbiology; Infection; Infectious Agent; Intellectual Property; Knowledge; Laboratories; Life; Link; Malignant Neoplasms; Marketing; Modeling; Nucleic Acid Amplification Tests; Numbers; Patients; Pharmacologic Substance; Phase; Phase I Clinical Trials; Pregnancy Tests; Preparation; Printing; Process; Proteins; Public Health; Readiness; Reporting; Research Infrastructure; Running; Sampling; Scanning; Sentinel; Serum; Signal Transduction; Site; Speed; Staging; Standards of Weights and Measures; System; Test Result; Testing; Time; Toxin; Viral; Viral Proteins; Virus; Whole Blood; Work; base; biodefense; biothreat; commercialization; concept; cost; cost effectiveness; day; detector; flu; improved; instrument; microbial; next generation; novel therapeutics; particle; programs; prototype; research clinical testing; response; size; tool; user-friendly

DESCRIPTION (provided by applicant): Following a bioterrorist attack, hundreds of thousands of potential victims may require testing and treatment. The critical need to test large numbers of people for exposure to a biothreat agent may overwhelm the capacity of the clinical and public health infrastructure. The approximately 25,000 sentinel laboratories in the Laboratory Response Network, which coordinates preparedness and response, need diagnostic tools to enable accurate decentralized testing. The goal of the proposed project is to develop a surge-testing platform for this network. The 2001 anthrax attacks showed that administering aggressive therapy to victims who have early diagnostic evidence of blood infections saves lives. Specifically, we will address the need for identifying patients that require aggressive life-saving therapy by developing a blood test for B. anthracis infection that tests for multiple-toxin and cellular antigens using the MultiPath(tm) testing system which we demonstrated in Phase I. The MultiPath system is an ideal surge-testing platform, being ultra-sensitive, quantitative, accurate, cost-effective, user-friendly, portable, and automated. The test rapidly detects multiple targets with sensitivities approaching nucleic acid amplification tests but with the cost-effectiveness and user-friendliness of over-the-counter immunoassay "strip" tests. In Phase I we showed that the MultiPath test detects protein, bacterial, and viral targets at levels up to thousands of times lower than commercial strip tests. This sensitivity comes from using a proprietary imaging approach which detects individual microparticles rather than the millions of particles required to detect a signal in standard strip tests. The system will comprise kits that acquire and automatically test blood samples rapidly (target assay time = 5 min) for sub-picogram levels of multiple B. anthracis antigens (to minimize false positives); an identification system to link patients to the test results; and a portable standalone near-patient test analyzer that will automatically process batch-loaded samples (<10 seconds per sample) and that will print and wirelessly post the results. The Specific Aims of the application are to (1) develop a prototype consumable kit containing an integrated consumable for collecting the sample and automatically running the assay; (2) develop the cost-effective batch-loadable near-patient analyzer; (3) integrate the system components; and (4) demonstrate the efficacy of the system to detect B. anthracis sensitively and specifically in whole blood samples. The Phase 2 project results and deliverables will support the Phase 3 commercialization goals for implementing the MultiPath B. anthracis test in the public health preparedness system. Follow-on products will include clinical tests for other potential biothreat and infectious agents and an instrument-free platform for detection of biothreat agents outside of the clinic. Competitive advantages of the MultiPath test include the intellectual property covering key features of the test, an unprecedented feature list of high-end results and customer-friendly attributes, and straightforward commercialization path. Besides addressing the large and growing bioterrorism market, the MultiPath test addresses significant unmet testing needs in healthcare (infectious disease, cancer, cardiovascular disease) and in industrial microbiology (food, beverage, pharmaceutical manufacturing). The value that the MultiPath test will bring to both the primary and secondary markets should attract large corporations as partners to support commercial development, marketing, and distribution.

描述（申请人提供）：生物恐怖袭击发生后，成千上万的潜在受害者可能需要检测和治疗。对大量人进行生物威胁剂暴露测试的迫切需要可能会超出临床和公共卫生基础设施的能力。实验室应对网络负责协调备灾和应对工作，其中约有25 000个哨点实验室需要诊断工具，以便能够进行准确的分散检测。拟议项目的目标是为该网络开发一个浪涌测试平台。2001年的炭疽袭击表明，对有血液感染早期诊断证据的受害者进行积极治疗可以挽救生命。具体而言，我们将通过开发B的血液检测来解决识别需要积极挽救生命治疗的患者的需求。炭疽感染，使用我们在第一阶段中展示的MultiPathTM测试系统测试多种毒素和细胞抗原。MultiPath系统是一个理想的浪涌测试平台，具有超灵敏、定量、准确、成本效益高、用户友好、便携和自动化等特点。该测试快速检测多个目标，灵敏度接近核酸扩增测试，但具有非处方免疫分析“条”测试的成本效益和用户友好性。在第一阶段，我们表明MultiPath测试检测蛋白质、细菌和病毒目标的水平比商业条带测试低数千倍。这种灵敏度来自于使用专有的成像方法，该方法检测单个微粒，而不是标准试纸测试中检测信号所需的数百万个颗粒。该系统将包括快速采集和自动检测血液样本（目标检测时间= 5分钟）的多个B亚皮克水平的试剂盒。炭疽抗原（以最大限度地减少假阳性）;一个将患者与检测结果联系起来的识别系统;一个便携式独立近患者检测分析仪，该分析仪将自动处理批量加载的样本（每个样本<10秒），并将打印和无线发布结果。本申请的具体目标是：（1）开发一种原型耗材套件，其中包含用于收集样本和自动运行检测的集成耗材;（2）开发具有成本效益的批量检测近患者分析仪;（3）集成系统组件;以及（4）证明系统检测B的有效性。炭疽敏感和特异性的全血样品。第2阶段项目结果和可交付成果将支持第3阶段实现MultiPath B的商业化目标。公共卫生准备系统中的炭疽病测试。后续产品将包括对其他潜在生物威胁和传染性病原体的临床测试，以及用于在诊所外检测生物威胁病原体的无仪器平台。MultiPath测试的竞争优势包括涵盖测试关键功能的知识产权、前所未有的高端结果和客户友好属性的功能列表以及直接的商业化路径。除了解决庞大且不断增长的生物恐怖主义市场外，MultiPath测试还解决了医疗保健领域尚未满足的重大测试需求（传染病、癌症、心血管疾病）和工业微生物学（食品、饮料、制药）。多路径测试将为一级和二级市场带来的价值应该会吸引大公司作为合作伙伴，支持商业开发、营销和分销。