Microfluidic Platform for Multiplexed Diagnostics

用于多重诊断的微流控平台

• 批准号: 8269155
• 负责人: Anup K. Singh
• 金额: $ 84.95万
• 依托单位: SANDIA CORP-SANDIA NATIONAL LABORATORIES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8269155
• 关键词: Ally; Animal Model; Animals; Anthrax disease; Antibodies; Beds; Benchmarking; Biological; Biological Assay; Biotechnology; Blood; Botulinum Toxins; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinic; Clinical; Consumption; Contracts; Detection; Development; Development Plans; Devices; Diagnosis; Diagnostic; Disease; Disease Marker; Disease Outbreaks; Enterotoxins; FDA approved; Face; Goals; Gold; Health; Heart Diseases; Hospitals; Human; Immunoassay; Individual; Infection; Institution; Intoxication; Laboratories; Laboratory Personnel; Legal patent; Liquid substance; Malignant Neoplasms; Measures; Medical; Methods; Microfluidics; Military Personnel; Mucous body substance; Mus; National Institute of Allergy and Infectious Disease; National Security; Nose; Performance; Plastics; Population; Preparation; Primary Health Care; Production; Public Health; Reagent; Research; Ricin; Saliva; Sampling; Satellite Hospitals; Screening procedure; Serotyping; Serum; Shiga-Like Toxins; Site; Swab; System; Systemic disease; Testing; Texas; Therapeutic Intervention; Time; Toxin; Transportation; United States Department of Agriculture; Universities; Urine; Whole Blood; Work; assay development; base; blind; cost; cross reactivity; design; driving force; instrument; mouse model; multidisciplinary; next generation; novel marker; pathogen; point of care; product development; prototype

DESCRIPTION (provided by applicant): Urgent need exists for developing next-generation clinical diagnostics devices for screening individuals exposed to and/or intoxicated with biological threat agents. These devices need to be capable of rapid, sensitive, and specific diagnosis to enable effective countermeasures including therapeutic intervention. Such systems must also be easy-to-use, automated and self-contained, and preferably have a small footprint to allow use in point-of-care and point-of-incident settings. Our goal is to develop, with our commercial partners Invetech and Bio-Rad, a manufacturable and commercializable device (SpinDx) in preparation for 510(k) submission to the FDA. The device is intended for use in primary care facilities, public health labs, and military clinics overseas for detection of NIAID priority pathogens and toxins Botulinum, Anthrax, Ricin, Shiga-like toxin, and Staphyloccocus enterotoxin B (SEB) in clinical samples. Invetech will design and develop Beta prototypes ready for field-testing at Sandia and two independent laboratories using spiked human samples as well as serum and nasal swabs from intoxicated/infected mice. A test-bed version of the device has already been demonstrated with ultra-sensitive detection of a number of analytes including biotoxins (e.g., our assay for Botulinum toxin A is ~100-fold more sensitive than the gold-standard mouse bioassay). The device uses centrifugal force-driven flow to implement bead-based sandwich immunoassays and activity assays in a plastic disk, and can rapidly (<10 min) and sensitively (~ fM) detect multiple analytes using a few ?L of clinical sample. The diagnostic device, owing to its bead-based assay format, is readily adaptable to detection of other pathogens and disease markers. The device requires no off-device sample preparation and is compatible with multiple bodily fluids including whole blood, serum, saliva, and urine. We have assembled a multidisciplinary team for development, manufacturing and testing of SpinDx which includes, in addition to Sandia, Invetech and Bio-Rad, two institutions for developing animal models for intoxication/infection - United States Department of Agriculture's Western Regional Research Center (USDA-WRRC) in Albany, CA and University of Texas Medical Branch (UTMB) at Galveston, TX; and two sites for independent, blind testing of the device at UTMB Allied Health hospital lab and USDA-WRRC. PUBLIC HEALTH RELEVANCE: The proposed device will be a multi-purpose medical diagnostic device that can be used to diagnose people potentially exposed to a biotoxin or pathogen. It can also be used to diagnose many other systemic diseases and conditions such as cancer and heart disease.

描述（由申请人提供）：迫切需要开发下一代临床诊断设备，以筛查暴露于生物威胁药物和/或陶醉的个体。这些设备需要能够快速，敏感和特定的诊断，以实现包括治疗干预在内的有效对策。这样的系统还必须易于使用，自动化和独立，并且最好具有较小的占地面积，以允许在即将到期的设置中使用。我们的目标是与我们的商业合作伙伴Invetech和Bio-Rad一起开发一种可制造且可商业化的设备（SPINDX），以准备向FDA提交510（k）。该设备旨在用于海外初级保健机构，公共卫生实验室和军事诊所，以检测NIAID优先病原体和作毒素的肉毒杆菌，炭疽，ricin，shiga样毒素和葡萄球菌肠毒素B（SEB）（SEB）。 Invetech将设计和开发使用尖刺的人类样品以及来自醉酒/感染小鼠的血清和鼻拭子，准备在Sandia和两个独立实验室进行现场测试的Beta原型。 该设备的测试版本已经证明了对包括生物毒素在内的许多分析物的超敏感性检测（例如，我们对肉毒杆菌毒素A的测定法比金标准的小鼠生物测定量高约100倍）。该设备使用离心力驱动的流量来在塑料盘中实现基于珠的三明治免疫测定和活动测定，并且可以使用几个临床样本迅速（<10分钟），敏感（〜fm）检测多个分析物。由于其基于珠的测定格式，该诊断装置很容易适应其他病原体和疾病标志物的检测。该设备不需要偏离样品样品制备，并且与多种体液兼容，包括全血，血清，唾液和尿液。 我们已经组建了一个多学科团队，用于开发，制造和测试Spindx，其中包括桑迪亚，Invetech和Bio-Rad，这是两个用于开发中毒/感染动物模型的机构 - 美国农业部西部地区区域研究中心（USDA-WRRC）在Albany，CA和Texas Medical Branch（USDA-WRRC）以及在UTMB Allied Health Hospital Lab和USDA-WRC上对该设备进行独立，盲目测试的两个站点。 公共卫生相关性：拟议的设备将是一种多用途的医疗诊断装置，可用于诊断潜在暴露于生物毒素或病原体的人。它也可以用来诊断许多其他全身性疾病和疾病，例如癌症和心脏病。