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: 10574627
• 负责人: Alberto Gandini
• 金额: $ 9.73万
• 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 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10574627
• 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 point of care; COVID-19 vaccine; Calibration; Chickenpox; Clinical; Collaborations; Companions; Data; Development; Devices; Diagnosis; Diagnostic; Disease; Disease Progression; Drops; Emergency Situation; Enrollment; Ensure; Fetal Development; Fingers; Funding; Funding Mechanisms; Gender; Hand; Health Personnel; Health Sciences; Health protection; Hearing; Hepatitis B; Herd Immunity; Immune system; Immunity; Immunocompetence; Immunoglobulin G; Immunoglobulin M; Immunologics; Individual; Infection; Institutional Review Boards; Lateral; Legal patent; Licensing; Marketing; Measles; Medicine; Molecular; Monitor; Nucleic Acid Amplification Tests; Outcome; Patients; Persons; Phase; Physicians; Play; Population; Pregnancy; Process; Protocols documentation; Readiness; Reagent; Recommendation; 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; fabrication; health management; mHealth; manufacture; maternal immune system; 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.

总结 为应对COVID-19大流行和血清学检测需求的增加，我们建议 开发和临床验证一种新的血清学血液测试，RapidQCT™，以帮助 诊断和管理COVID-19大流行。与其他病毒感染一样， 免疫系统通过产生抗体（IgG和IgM， 其他）对抗病毒（SARS-COV-2）。抗体滴度测试是一种有价值的工具， 个体对从风疹到麻疹等几种传染病的免疫力。更重要的是作为 COVID-19疫苗上市，大规模疫苗接种战略将实施， RapidQCT将帮助潜在的数亿人分层，并确定谁最有可能 而那些不愿付出的人，也会得到回报。因为测试可以由患者自行管理，它将 还促进大流行的移动的健康管理，扩大检测的广度，以及 保护医护人员免受辐射。目前的血清学检测是二元检测， 答：是/否，因此无法全面介绍 免疫力在人群中。另一方面，RapidQCT是一种易于使用和快速的测试。 以及第一个定量的床旁（POC）抗COVID-19抗体滴度测试。信贷规模 卡，它只需要一滴血从手指刺破，以评估存在和滴度水平的抗- COVID-19抗体测试伴侣移动的应用程序可以跟踪疾病的传播， 发展，以及整个人群的免疫力的发展。该项目将 分两个阶段完成：第一阶段-目标1：生产流水线、规模扩大和试验 校准。在本目标中，我们将从当前的精益开发阶段转变为 制造阶段。阶段I -目标2：测定校准：在此，我们将测定测定滴度 曲线校正第二阶段-目标1：COVID-19特异性抗体滴度的纵向监测。 RapidQCT测试将用于纵向跟踪三组：症状感染（SI）， 无症状感染（AI）和未感染（NI）（对照）。每种抗体滴度的趋势 组将按性别、年龄、先决条件和感染严重程度分层。第二阶段-目标2： 妊娠期抗体滴度的纵向监测。免疫学变化发生在 将对COVID-19阳性妊娠与非妊娠人群进行监测。 该项目是Accel Diagnostics和The University of 德克萨斯州休斯顿健康科学中心（休斯顿，德克萨斯州），预计将提供临床 管理COVID-19疫情的有效和新颖工具。