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

• 批准号: 10449549
• 负责人: VAMSEE K. PAMULA
• 金额: $ 100万
• 依托单位: BAEBIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-11 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10449549
• 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' 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; public health relevance; research and development; research clinical testing; respiratory; respiratory virus; sample collection; targeted treatment; urgent care

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.

摘要新冠肺炎和常见呼吸道感染的快速鉴别诊断快速追踪SBIR NOT-AI-20-031持续的新型冠状病毒病(新冠肺炎)大流行正在全球迅速传播，截至2020年4月29日已有320多万确诊病例。大多数新冠肺炎患者有轻微症状(发烧、咳嗽)或没有症状，但在约3%-5%的确诊病例中，包括呼吸急促和双侧肺炎在内的严重并发症是致命的。流感和呼吸道合胞病毒是最常见的病毒性呼吸道疾病，通常表现出与新冠肺炎报告的症状相似的症状。新冠肺炎无法被消灭，随着秋季和冬季的“流感季节”到来，将迫切需要对分布在不同地点的患者进行鉴别诊断(例如紧急护理、初级保健、儿科医生诊所、零售无预约诊所、驾车通过检测地点等)。在非医院环境中进行鉴别诊断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。我们概述了一个创新的、易于使用的鉴别诊断小组，它将使用基于核酸的测试同时测试新冠肺炎、两个甲型流感亚型(H1N1和H3N2)、B型流感和呼吸道合胞病毒。该平台将被CLIA豁免用于分布式护理环境，并将在样本收集后10分钟内提供诊断结果。测试将在我们的小型占地面积数字微流控测试平台上自动进行，该平台目前已获得CE认证，并正在等待FDA的510(K)批准。我们的系统将提供集成样品处理的独特优势，并将提供快速结果，轻松适用于典型的紧急护理、初级或儿科医生护理，或零售无预约诊所。我们正在与杜克人类疫苗研究所合作，后者目前正在进行新冠肺炎测试，以实现这个快速通道项目的临床前目标。迫切需要改进的新冠肺炎诊断检测方法来监测疾病的传播，识别受轻微影响的个人和无症状的携带者，以通过适当的隔离减少社区传播，并确保对需要住院的危重患者采取适当的保护措施。由于我们公司的使命是专注于儿科护理，因此我们对识别可能出现新冠肺炎、流感或呼吸道合胞病毒症状的新生儿、婴儿和年龄较大的儿童特别感兴趣。我们创新的数字微流控平台将消除繁琐的手动样品处理方案的要求，并在患者等待的同时提供结果。这项技术的未来迭代将扩大呼吸道病毒测试小组，将十几种病原体(即副流感病毒)包括在内，并在同一测试盒中增加血清学测试，以提供有关过去病毒暴露的数据。