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: 10542478
• 负责人: Alberto Gandini
• 金额: $ 96.36万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10542478
• 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; 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; Persons; 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 COVID-19 大流行和血清学检测日益增长的需求，我们建议 新型血清学血液检测 RapidQCT™ 的开发和临床验证，以帮助 COVID-19 大流行的诊断和管理。与其他病毒感染的情况一样， 免疫系统通过产生抗体（IgG 和 IgM，其中包括 其他）对抗病毒（SARS-COV-2）。抗体滴度测试已成为确定抗体滴度的重要工具 个体对多种感染性疾病（从风疹到麻疹）具有免疫力。更重要的是，作为 COVID-19 疫苗已上市，大规模疫苗接种策略将会实施， RapidQCT 将帮助对数亿潜在人群进行分层，并确定谁最有可能 受益，并饶恕那些不愿受益的人。由于该测试可以由患者自行进行，因此 还促进疫情的移动健康管理，扩大检测范围， 保护医护人员免受暴露。目前的血清学检测均为二元检测，仅 提供是/否答案，因此无法提供发展的全貌 全民免疫力。另一方面，RapidQCT 是一种易于使用且快速的测试 以及首个定量护理点 (POC) 抗 COVID-19 抗体滴度测试。信贷规模 卡，只需从手指刺破一滴血即可评估抗-抗体的存在和滴度水平 COVID-19 抗体。测试配套移动应用程序可以跟踪疾病传播， 进展以及整个人群免疫力的发展。该项目将 分两个阶段完成：第一阶段 - 目标 1：制造流程、放大和分析 校准。在这个目标中，我们将从当前的精益开发阶段转变为 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。第二阶段 - 目标 1：纵向监测 COVID-19 特异性抗体滴度。 RapidQCT 测试将用于纵向跟踪三组：有症状的感染者 (SI)、 无症状感染者 (AI) 和未感染者 (NI)（对照）。各抗体滴度变化趋势 小组将按性别、年龄、先决条件和感染严重程度进行分层。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 将监测 COVID-19 阳性妊娠人群与非妊娠人群的情况。 该项目是 Accel Diagnostics 和英国大学持续合作的成果 休斯顿德克萨斯健康科学中心（德克萨斯州休斯顿），预计将提供临床 用于管理 COVID-19 大流行的经过验证的新颖工具。