A COVID-19 Point of Care Serological Assay for Rapid Quantification of Antibody Titer.

用于快速定量抗体滴度的 COVID-19 护理点血清学测定。

• 批准号: 10157509
• 负责人: Alberto Gandini
• 金额: $ 24.04万
• 依托单位: ACCEL DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-03 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10157509
• 关键词: 2019-nCoV; Age; Antibodies; Antibody titer measurement; Biological Assay; Blood; Blood Tests; COVID-19; COVID-19 monitoring; COVID-19 pandemic; COVID-19 vaccine; Calibration; Chickenpox; Clinical; Clinical Data; Collaborations; Companions; Development; Devices; Diagnosis; Diagnostic; Disease; Disease Progression; Drops; Emergency Situation; Enrollment; Ensure; Fetal Development; Fingers; Funding; Funding Mechanisms; Gender; Hand; Health Personnel; Health Sciences; Hearing; Hepatitis B; Herd Immunity; Immune system; Immunity; Immunocompetence; Immunoglobulin G; Immunoglobulin M; Immunologics; Individual; Infection; Institutional Review Boards; Lateral; Legal patent; Licensing; Measles; Medicine; Molecular; Monitor; Mothers; Nucleic Acid Amplification Tests; Outcome; Patients; Phase; Physicians; Play; Population; Pregnancy; Process; Protocols documentation; Readiness; Reagent; Reproducibility; Rubella; SARS-CoV-2 antibody; SARS-CoV-2 infection; SARS-CoV-2 positive; Sample Size; Sampling; Secondary Immunization; Secure; Self Administration; Serology; Serology test; Severities; Societies; Specificity; Statistical Data Interpretation; Symptoms; Technology; Test Result; Testing; Texas; Thinness; Time; Time trend; Translating; Universities; Vaccination; Validation; Viral Proteins; Virus; Virus Diseases; acquired immunity; antibody test; cost; design; expectation; health management; mHealth; microfluidic technology; mobile application; novel; pandemic disease; point of care; pre-clinical; prototype; rapid test; response; scale up; tool; trend; vaccination strategy

Summary In response to the COVID-19 pandemic and the increasing need of serological testing we propose the development and clinical validation of a novel serological blood test, RapidQCT™, to aid in the diagnosis and management of the COVID-19 pandemic. As the case for other viral infections, the immune system responds to the COVID-19 infection by developing antibodies (IgG and IgM, among others) against the virus (SARS-COV-2). Antibody titer tests have been a valuable tool to determined individual immunity to several infection diseases, from rubella, to measles. More importantly, as COVID-19 vaccines become available, and a large-scale vaccination strategy will take place, the RapidQCT will help stratify potentially hundred of millions of people and identify who is most likely to benefit, and sparing those who will not. Because the test can be self-administered by patients, it will also promote mobile health management of the pandemic, expanding the breadth of testing, and protecting health care workers from exposure. Current serological tests are binary test, which only provide a yes/no answer, and therefore unable to provide a full picture of the development the immunity across the population. On the other hand, the RapidQCT is an easy to use and rapid test and the first quantitative Point-of-Care (POC) anti-COVID-19 antibody titer test. The size of credit card, it requires only one drop of blood from finger prick to asses the presence and titer level of anti- COVID-19 antibodies. The test companion mobile app enables the tracking of the disease spreading, progression, as well as development of the immunity throughout the population. This project will be completed in two Phases: Phase I - Aim 1: Fabrication Streamline, Scale-Up, and Assay Calibration. In this Aim, we will translate from the current lean development phase to the manufacturing phase. Phase I - Aim 2: Assay Calibration: Here we will determined the assay titer curve calibration. Phase II - Aim 1: Longitudinal monitoring of COVID-19 specific antibody titers. The RapidQCT tests will use to follow longitudinally to three groups: Symptomatic Infected (SI), Asymptomatic Infected (AI), and Not Infected (NI) (control). The trend of the antibody titer for each group will be stratified by gender, age, pre-conditions, and severity of infection. Phase II - Aim 2: Longitudinal monitoring of antibody titers in pregnancy. Immunological changes occurring in COVID-19 positive pregnancy versus the non-pregnant population will be monitored. This project is the result of an ongoing collaboration between Accel Diagnostics and The University of Texas Health Science Center at Houston (Houston, TX), and it is expected to deliver a clinically validated and novel tool to manage the COVID-19 pandemic.

概括 为了应对19日的大流行和血清学检测的需求，我们提出了 新型血清学血液测试RapidQct™的开发和临床验证，以帮助 COVID-19大流行的诊断和管理。作为其他病毒感染的情况， 免疫系统通过开发抗体（IgG和IgM，在 其他）反对病毒（SARS-COV-2）。抗体滴度测试已成为确定的宝贵工具 从风疹到麻疹的几种感染疾病的个人免疫。更重要的是，如 COVID-19疫苗可用，将发生大规模的疫苗策略， RapidQct将有助于分层潜在的数亿人，并确定谁最有可能 受益，并保留那些不会的人。因为该测试可以由患者自我管理，所以它将 还可以促进大流行的移动健康管理，扩大测试的广度和 保护卫生保健工作者免于暴露。当前的血清学测试是二进制测试，仅 提供是/否答案，因此无法提供有关开发的完整图片 人群的免疫力。另一方面，RapidQCT是一种易于使用和快速测试 以及第一个定量的护理（POC）抗COVID-19抗体滴度测试。信用的规模 卡，它只需要一滴血液中的血液来刺激抗抗的存在和滴度水平 covid-19抗体。测试伴侣移动应用程序可以跟踪疾病扩散， 在整个人群中的进展以及免疫力的发展。这个项目将是 分为两个阶段完成：第一阶段 - 目标1：制造精简，扩展和测定 校准。在此目标中，我们将从当前的精益发展阶段转化为 制造阶段。第一阶段 - 目标2：测定校准：在这里我们将确定测定滴度 曲线校准。 II阶段 - 目标1：COVID -19特定抗体滴度的纵向监测。 RapidQCT测试将用于纵向跟踪三组：有症状感染（SI），， 不对称感染（AI），未感染（Ni）（对照）。每种抗体滴度的趋势 组将按性别，年龄，前提和感染的严重程度进行分层。第二阶段 - 目标2： 怀孕中抗体滴度的纵向监测。免疫变化发生在 COVID-19将受到监测与非妊娠人群的阳性妊娠。 该项目是Accel Diagnostics与大学之间持续合作的结果 德克萨斯州休斯顿（德克萨斯州休斯顿）的德克萨斯健康科学中心，预计将在临床上提供 经过验证和新颖的工具来管理COVID-19大流行。