Rapid, disposable, nucleic acid diagnostic device for multiplexed point of care f

用于多重护理点的快速、一次性核酸诊断装置

• 批准号: 8862353
• 负责人: HONG CAI
• 金额: $ 100万
• 依托单位: MESA TECH INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-15 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8862353
• 关键词: Amendment; Bedside Testings; Bioinformatics; Biological Assay; Buffers; Caring; Cellular Phone; Chemistry; Clinic; Clinical; Clinical Research; Communicable Diseases; Comparative Study; Complex; Cryopreservation; Detection; Development; Device Designs; Devices; Diagnostic; Diagnostic tests; Disease; Disease Outbreaks; Early Diagnosis; Electronics; Engineering; Ensure; Environment; Epidemic; Evaluation; FDA approved; Feasibility Studies; Freeze Drying; Goals; Health; Housing; Human; Influenza; Influenza A virus; Influenza B Virus; Injection of therapeutic agent; International; Intervention; Laboratories; Lateral; Life; Liquid substance; Marketing; Medical; Methods; Molds; Nose; Nucleic Acid Amplification Tests; Nucleic Acids; Performance; Phase; Physicians; Physicians' Offices; Process; Product Approvals; Production; Protocols documentation; Provider; RNase P; Reagent; Resources; Respiratory syncytial virus; Risk; Sampling; Scientist; Sensitivity and Specificity; Solutions; Swab; System; Techniques; Technology; Test Result; Testing; Time; Transportation; Treatment Efficacy; Validation; Work; accurate diagnosis; amplification detection; base; cost; cost effective; cross reactivity; design; flu; follow-up; influenza outbreak; innovation; instrument; instrumentation; internal control; meetings; pandemic disease; point of care; point-of-care diagnostics; prototype; research and development; sample collection; seal; stability testing

DESCRIPTION (provided by applicant): Rapid and accurate identification of highly infectious and pathogenic disease is extremely important for the early forecast of outbreak risk and the effective deployment of medical and administrative countermeasures. Unfortunately, current diagnostics for use at the point-of-care (POC) are largely immunological assays that often lack adequate sensitivity, specificity, and multiplex capacity for an accurate early diagnosis. Nucleic acid- based diagnostic products developed or under development requires a relatively expensive dedicated instrument that is often prohibitive to small clinics and resource-limited settings and unsuitable for pandemic high capacity demand. We propose to develop an instrumentation-free, self-contained, low cost (<$20/unit), disposable, rapid (<30 minute, sample-to-answer), nucleic acid POC diagnostic device (MTIDx) capable of detecting influenza A, influenza B, RSV and RNaseP internal control (4-plex). The final MTIDx product is designed to be a FDA approved, CLIA-waived (Clinical Laboratory Improvement Amendments of 1988) nucleic acid (NA)-based diagnostic device for analyzing human nasal swab samples. MTIDx (Multiple Target Identification Diagnostic) will be a pocket-sized, device that is easy to operate with minimal user-intervention and also has an option to be powered by a 9V battery for use in resource-limited/field settings. It will be suitable for high volume manufacturing allowing rapid production of millions of units to meet surge capacity during an epidemic outbreak. The diagnostic system is based on the integration of Mesa Tech's proprietary technologies of nucleic acid extraction, rapid amplification, lateral flow-based (LF-based) colorimetric detection components with simple fluid control and microheater solutions into one easily used, low cost, disposable device. In Phase 1 project, we have successfully developed of integrated device through a rapid prototyping approach. Work in this Phase II project will focus on the optimization of Phase I design to include more refined design for a low complexity, CLIA-waved product as well as cost effective and environment friendly reusable electronic circuit component concept that allows the wide and rapid adaption at POC. We will further optimize the development of lyophilized reagents to confer ambient storage compatibility, development of stable buffer reagents and capsulation methods, design for manufacturing optimizations and conduct performance evaluation on clinical samples. The primary Phase II deliverable is the design of MTIDx ready for manufacturing (Design For Manufacturing) that offers a sample-to-answer 4-plex diagnostic test (Flu A, FluB, RSV, and RNase P control) under 30 minutes prior to the follow up manufacturing, FDA and marking effort.

描述（由申请人提供）：快速准确地识别高传染性和致病性疾病对于早期预测爆发风险以及有效部署医疗和行政对策至关重要。不幸的是，目前用于护理点（POC）的诊断主要是免疫测定，其通常缺乏足够的灵敏度、特异性和用于准确早期诊断的多重能力。已开发或正在开发的基于核酸的诊断产品需要相对昂贵的专用仪器，这通常对小诊所和资源有限的环境是禁止的，并且不适合大流行的高容量需求。我们建议开发一种免仪器、独立、低成本（<$20/单位）、一次性、快速（<30分钟，采样到应答）的核酸POC诊断装置（MTIDx），其能够检测甲型流感、乙型流感B、RSV和RNaseP内部对照（4重）。最终MTIDx产品设计为FDA批准的CLIA豁免（1988年临床实验室改进修正案）基于核酸（NA）的诊断器械，用于分析人鼻拭子样本。MTIDx（多目标识别诊断）将是一个袖珍型设备，易于操作，用户干预最少，还可以选择由9V电池供电，用于资源有限/现场设置。它将适合大批量生产，允许快速生产数百万个单位，以满足疫情爆发期间的激增产能。该诊断系统基于梅萨科技公司的专有技术核酸提取，快速扩增，基于侧流（LF）的比色检测组件与简单的流体控制和微加热器解决方案集成到一个易于使用，低成本，一次性设备。在第一阶段的项目中，我们成功地通过快速原型方法开发了集成器件。第二阶段项目的工作将集中在第一阶段设计的优化上，包括更精细的设计，以实现低复杂性、CLIA波形产品以及具有成本效益和环境友好的可重复使用电子电路元件概念，从而实现POC的广泛和快速适应。我们将进一步优化冻干试剂的开发以赋予环境储存相容性，开发稳定的缓冲试剂和封装方法，设计生产优化并对临床样本进行性能评估。主要的II期交付成果是准备生产的MTIDx设计（生产设计），在后续生产、FDA和标记工作之前30分钟内提供样品到答案的4重诊断检测（Flu A、FluB、RSV和RNase P质控品）。