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

摘要 为了应对新冠肺炎大流行和日益增长的血清学检测需求，我们建议 一种新的血清学血液检测方法RapidQCT™的开发和临床验证 新冠肺炎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(免疫球蛋白和免疫球蛋白M，其中包括 其他)抗病毒(SARS-COV-2)。抗体滴度测试一直是确定 个人对几种传染病的免疫力，从风疹到麻疹。更重要的是，因为 新冠肺炎疫苗问世，大规模的疫苗接种战略将会发生 RapidQCT将帮助对潜在的数亿人进行分层，并确定谁最有可能 受益，宽恕那些不愿受益的人。由于这项测试可以由患者自行进行，因此它将 还促进对大流行的流动卫生管理，扩大检测的范围，以及 保护医护人员免受接触。目前的血清学检测是二元检测，这只是 提供是/否的答案，因此无法提供发展的全面情况 在整个人口中享有豁免权。另一方面，RapidQCT是一种易于使用和快速测试的工具 以及第一个定量的护理点(POC)抗新冠肺炎抗体效价测试。信贷规模 卡，只需要从手指刺伤处取一滴血就可以判断抗-HBs的存在和滴度水平 新冠肺炎抗体。与测试配套的移动应用程序能够跟踪疾病的传播， 进展，以及整个人群的免疫力发展。这个项目将是 分两个阶段完成：第一阶段-目标1：制造流水线、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换到 制造阶段。阶段I-目标2：化验校准：这里我们将测定化验效价 曲线校准。第二阶段-目标1：新冠肺炎特异性抗体效价的纵向监测。 快速QCT测试将用于纵向跟踪三组：症状性感染(SI)， 无症状感染组(AI)和非感染组(NI)(对照组)。各抗体效价的变化趋势 将按性别、年龄、前提条件和感染严重程度对患者进行分层。第二阶段-目标2： 孕期抗体效价的纵向监测。发生在中国的免疫学变化 对新冠肺炎阳性妊娠与非妊娠人群进行监测。 该项目是Accel Diagnostics和华盛顿大学之间持续合作的结果 位于休斯顿(德克萨斯州休斯顿)的德克萨斯健康科学中心，预计将提供临床 经过验证的新工具来管理新冠肺炎大流行。

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.