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: 7625385
• 负责人: Don Straus
• 金额: $ 20.6万
• 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 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7625385
• 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（由申请人提供）：在生物恐怖袭击之后，成千上万的潜在受害者可能需要检测和治疗。对大量人群进行生物威胁剂暴露测试的迫切需要可能超出临床和公共卫生基础设施的能力。协调准备和应对工作的实验室反应网络中的大约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，对有早期血液感染诊断证据的受害者进行积极治疗可以挽救生命。具体来说，我们将通过开发一种针对炭疽杆菌感染的血液检测方法来满足识别需要积极挽救生命治疗的患者的需求，该方法使用我们在i期试验中展示的MultiPath（tm）检测系统来检测多种毒素和细胞抗原。MultiPath系统是一种理想的波浪检测平台，具有超灵敏、定量、准确、经济高效、用户友好、便携和自动化的特点。该测试快速检测多个靶点，灵敏度接近核酸扩增测试，但具有非处方免疫测定“试纸”测试的成本效益和用户友好性。在第一阶段，我们发现MultiPath测试检测蛋白质、细菌和病毒目标的水平比商业试纸测试低数千倍。这种灵敏度来自于使用专有的成像方法，该方法检测单个微颗粒，而不是在标准条带测试中检测信号所需的数百万个颗粒。该系统将包括快速获取并自动检测血液样本（目标检测时间= 5分钟）多种炭疽芽胞杆菌抗原亚图水平的试剂盒（以尽量减少假阳性）；将患者与检测结果联系起来的识别系统；还有一个便携式独立的近病人测试分析仪，它将自动处理批量装载的样品（每个样品<10秒），并将打印和无线发布结果。该申请的具体目的是：(1)开发一个原型消耗品套件，其中包含用于收集样品和自动运行分析的集成消耗品；(2)开发具有成本效益的可批量装载的近病人分析仪；(3)整合系统组件；(4)验证了该系统在全血样本中检测炭疽芽胞杆菌的敏感性和特异性。第二阶段的项目成果和交付成果将支持第三阶段的商业化目标，即在公共卫生准备系统中实施MultiPath炭疽杆菌测试。后续产品将包括其他潜在生物威胁和感染剂的临床测试，以及一个用于在诊所外检测生物威胁剂的无仪器平台。MultiPath测试的竞争优势包括涵盖测试关键特征的知识产权，前所未有的高端结果和客户友好属性特征列表，以及直截了当的商业化路径。除了应对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（传染病、癌症、心血管疾病）和工业微生物学（食品、饮料、制药制造）中大量未满足的测试需求。MultiPath测试将为一级和二级市场带来的价值应该会吸引大型公司作为合作伙伴来支持商业开发、营销和分销。