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：
10491251
负责人：
VAMSEE K. PAMULA
金额：
$ 25.37万
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 2023-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10491251
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 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 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 Disease 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 community transmission 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

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.

摘要 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 正在进行的新型冠状病毒病 (COVID-19) 大流行正在全球范围内迅速蔓延，截至 4 月 29 日，确诊病例已超过 320 万例。 2020 年。大多数 COVID-19 病例有轻微症状（发烧、咳嗽）或无症状，但呼吸急促和双侧肺炎等严重并发症在患者中是致命的。据估计，流感和呼吸道合胞病毒 (RSV) 是最常见的病毒性呼吸道疾病，占确诊病例的 3-5%，通常会出现与 COVID-19 报告的症状类似的症状。秋季和冬季“流感季节”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、儿科医生办公室、零售步入式诊所、驾车通过检测点） ,在非医院环境中进行鉴别诊断将有助于对住院的急性病例进行分类，提供适当的针对性治疗，并减少社区传播。我们概述了一种创新的、易于使用的鉴别诊断组合，该组合将同时检测新冠病毒。 -19、两种甲型流感亚型（H1N1 和 H3N2）、乙型流感和 RSV，使用基于核酸的测试该平台将获得 CLIA 豁免，可在分布式护理环境中使用，并将在采样后 10 分钟内提供诊断结果。测试将在我们的小型数字微流体测试平台上实现自动化，该平台目前已获得 CE 标志，并正在等待 FDA 的 510(k) 许可。我们的系统将提供集成样品处理的独特优势，并将提供易于拟合的快速结果。在典型的紧急护理、初级或儿科医师护理或零售预约诊所预约中，我们正在与杜克人类疫苗研究所合作，以实现该快速通道项目的临床前目标。由于我们公司的使命专注于儿科，因此迫切需要进行 COVID-19 诊断检测来监测疾病的传播，识别轻度受影响的个体和无症状携带者，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。护理方面，我们特别感兴趣的是识别可能出现在儿科初级保健诊所的患有 COVID-19、流感或 RSV 症状的新生儿、婴儿和年龄较大的儿童，我们的创新数字微流体平台将消除繁琐的手册的要求。样本处理协议并在患者等待时提供结果，该技术的未来迭代将扩大呼吸道病毒测试面板，以包括十多种病原体（即副流感病毒），并将血清学测试添加到同一测试盒中以提供过去的数据。病毒暴露。