Rapid Differential Diagnosis of COVID-19 and Common Respiratory Infections

COVID-19 和常见呼吸道感染的快速鉴别诊断

基本信息

批准号：
10156099
负责人：
VAMSEE K. PAMULA
金额：
$ 27.81万
依托单位：
BAEBIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-02-11 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10156099
关键词：
2019-nCoV Acute Affect Appointment Bilateral Biological Assay COVID-19 COVID-19 diagnosis COVID-19 diagnostic COVID-19 pandemic COVID-19 test COVID-19 testing Caring Child Childhood Clinic Clinical Common Cold Communities Coronavirus Coughing Custom Data Diagnostic Differential Diagnosis Disease Disease Outbreaks Ensure Fever Flu virus Fluorescence Formulation Future Future Generations Hospitalization Human Image Immunoglobulin A Immunoglobulin G Immunoglobulin M Individual Influenza Influenza A Virus, H1N1 Subtype Influenza A Virus, H3N2 Subtype Influenza A virus Influenza B Virus Institutes Location Lung diseases Manuals Measures Methods Microfluidics Mission Monitor Names Newborn Infant Nucleic Acids Oropharyngeal Patients Pattern Performance Phase Physicians Physicians&apos Offices Pneumonia Population Preparation Primary Health Care Process Protocols documentation Quarantine Readiness Reagent Recurrence Reporting Respiratory Tract Infections Respiratory syncytial virus Reverse Transcription Running Sampling Seasons Serology test Shipping Shortness of Breath Site Small Business Innovation Research Grant Specimen Symptoms System Technology Testing Time Triage Universities University Hospitals Vaccines Validation Viral Visit Walking assay development base clinical care commercialization coronavirus disease cost design detection platform diagnostic assay diagnostic panel digital falls flexibility flu improved innovation instrument interest molecular diagnostics nasopharyngeal swab novel coronavirus oropharyngeal swab parainfluenza virus pathogen pathogenic bacteria pathogenic virus point of care point-of-care diagnosis point-of-care diagnostics portability pre-clinical product development research and development research clinical testing respiratory respiratory virus sample collection targeted treatment urgent care

项目摘要

ABSTRACT Rapid Differential Diagnosis of COVID-19 and Common Respiratory Infections Fast Track SBIR NOT-AI-20-031 The ongoing novel coronavirus disease (COVID-19) pandemic is spreading rapidly across the globe with over 3.2 million confirmed cases as of April 29, 2020. Most cases of COVID-19 have mild symptoms (fever, cough) or are asymptomatic, however severe complications including shortness of breath and bilateral pneumonia are lethal in an estimated 3-5% of confirmed cases. Influenza and respiratory syncytial virus (RSV) are the most common viral respiratory diseases and typically present with symptoms similar to those reported for COVID-19. There is no foreseeable eradication of COVID-19, and as the “flu season” arrives in the fall and winter, there will be an acute need to perform differential diagnosis of patients in distributed locations (e.g., urgent care, primary care, pediatric physician offices, retail walk-in clinics, drive through testing sites, etc.). A differential diagnosis in non-hospital settings will allow triaging of acute cases for hospitalization, provide appropriate targeted therapies, and decrease community spread. We outline an innovative, simple-to-use differential diagnostics panel that will simultaneously test for COVID-19, two influenza A subtypes (H1N1 and H3N2), influenza B, and RSV using nucleic acid based tests. The platform will be CLIA-waived for use in a distributed care setting and will provide diagnostic results within 10 minutes of sample collection. The tests will be automated on our small footprint digital microfluidics testing platform, which is currently CE marked and pending 510(k) clearance from the FDA. Our system will provide unique advantages of integrated sample processing and will provide rapid results that easily fit within a typical urgent care, primary or pediatric physician care, or retail walk-in clinic appointment. We are collaborating with the Duke Human Vaccine Institute, who are currently running COVID-19 tests, on the preclinical aims of this Fast Track project. Improved COVID-19 diagnostic assays are desperately needed to monitor the spread of the disease, identify mildly affected individuals and asymptomatic carriers to reduce community spread through appropriate quarantine, and ensure proper protective measures for critical patients requiring hospitalization. As our company mission is focused on pediatric care, we are especially interested in identifying newborns, infants, and older children who may present at pediatric primary care clinics with symptoms indicative of COVID-19, influenza, or RSV. Our innovative digital microfluidics platform will remove the requirements for tedious manual sample processing protocols and deliver the results while the patient is waiting. Future iterations of this technology will expand the respiratory virus test panel to include over a dozen pathogens (i.e. parainfluenza viruses) and add serology testing to the same test cartridge to provide data on past viral exposure.

抽象的 COVID-19 和常见呼吸道感染的快速鉴别诊断快速通道 SBIR NOT-AI-20-031 正在持续的新型冠状病毒病（COVID-19）大流行正在全球范围内迅速蔓延，超过截至 2020 年 4 月 29 日，已有 320 万确诊病例。大多数 COVID-19 病例有轻微症状（发烧、咳嗽）或无症状，但存在呼吸短促和双侧肺炎等严重并发症据估计，流感和呼吸道合胞病毒 (RSV) 占确诊病例的 3-5% 致死率最高。常见的病毒性呼吸道疾病，通常表现出与 COVID-19 报告的症状类似的症状。 COVID-19 无法预见被消灭，随着秋季和冬季“流感季节”的到来，迫切需要对分散地点的患者进行鉴别诊断（例如紧急护理、初级护理鉴别诊断非医院环境将允许对住院的急性病例进行分类，提供适当的有针对性的治疗，并减少社区传播。我们概述了一种创新、易于使用的鉴别诊断面板，可同时测试 COVID-19、使用基于核酸的测试平台检测两种甲型流感亚型（H1N1 和 H3N2）、乙型流感和 RSV。将获得 CLIA 豁免，可用于分布式护理环境，并将在 10 分钟内提供诊断结果样品收集将在我们的小型数字微流体测试平台上实现自动化。目前已获得 CE 标志并正在等待 FDA 的 510(k) 批准我们的系统将提供独特的优势。集成样本处理，将提供快速结果，轻松适合典型的紧急护理、初级护理或儿科医师护理，或零售预约诊所预约。疫苗研究所目前正在针对该快速通道项目的临床前目标进行 COVID-19 测试。迫切需要改进的 COVID-19 诊断检测方法来监测疾病的传播、识别轻度受影响的个人和无症状携带者，通过适当的措施减少社区传播隔离，并确保对需要住院的危重患者采取适当的防护措施。使命专注于儿科护理，我们对识别新生儿、婴儿和老年人特别感兴趣可能出现儿科初级保健诊所出现 COVID-19、流感或其他症状的儿童 RSV。我们创新的数字微流体平台将消除繁琐的手动采样的要求。该技术的未来迭代将在患者等待时处理协议并提供结果。扩大呼吸道病毒检测范围，纳入十多种病原体（即副流感病毒），并添加对同一测试盒进行血清学测试，以提供过去病毒暴露的数据。