Thermo-Photonic Reader for Accurate and Sensitive Interpretation and Quantification of BTNX Inc COVID-19 Antibody Rapid Tests

COVID-19的发病率和死亡率令人震惊，这表明疾病的早期发现没有得到有效执行，导致未被发现的病例感染弱势群体。虽然基于聚合酶链反应（PCR）的标准护理检测方法是检测活动性上呼吸道COVID-19感染的关键，但对于在感染后一周内从常规鼻腔或喉咙样本中检测病毒并不有用。抗体侧流免疫测定法（LFAs）是一种低成本且对终端用户友好的快速检测方法，可以通过检测人体对COVID-19疾病的免疫反应，为基于pcr的检测提供补充和额外的信息。虽然这些lfa可以在人群中快速施用，但其敏感性和准确性在疾病的早期阶段受到限制。因此，缺乏在早期阶段检测免疫反应的高灵敏度的良好免疫学检测方法，排除了许多临床干预和阻断疾病传播的宝贵机会。在该项目中，我们与加拿大快速即时诊断领域的全球领导者BTNX Inc.合作，将热光子解释引入其现有的COVID-19 LFAs，以获得一种新的检测方法，不仅成本低、快速，而且敏感且定量。该项目预计将产生的创新是：1)在发病的第一周内可靠地检测COVID-19抗体；2)准确定量COVID-19抗体浓度（抗体滴度）。拟议的新检测系统将是一种快速和低成本的工具，供1)卫生网络和最终用户用于快速和现场检测COVID-19抗体，即使在疾病的早期阶段也是如此；2)公共卫生当局用于估计人口的脆弱性程度；3)在献血者诊所鉴定抗体滴度高的恢复期血浆；4)加拿大各地的雇主进行更客观的复工筛查。对于加拿大研究人员来说，拟议的检测方法是一种有价值的定量便携式工具，可以快速、低成本地定量检测COVID-19 IgM和IgG抗体，这是开发疫苗和治疗策略的关键。

The alarming rate of COVID-19 morbidity and mortality is an indicator that early detection of the disease is not being executed effectively, resulting in infection of vulnerable individuals by undetected cases. While the standard-of-care testing method based on PCR (polymerase chain reaction) is key for detecting active upper airway COVID-19 infections, it is not useful for detecting the virus from the routine nasal or throat samples ~one-week post-infection. Antibody lateral flow immunoassays (LFAs) are low-cost and end-user friendly rapid tests that could provide complementary and additional information to PCR-based assays by detecting immune response of the body to COVID-19 disease. While these LFAs can rapidly be administered across the population, their sensitivity and accuracy are limited at the early stages of the disease. Therefore, unavailability of good immunological assays to detect the immune response at early stages with high sensitivity preclude many valuable opportunities for clinical intervention and interruption of disease transmission. In this project we have partnered with BTNX Inc., a Canadian world leader in rapid point-of-care diagnostics, to introduce thermo-photonic interpretation to their existing COVID-19 LFAs to obtain a new assay that is not only low cost and rapid but also sensitive and quantitative. The innovation to be produced in this project is expected to 1) reliably detect COVID-19 antibodies within the first week of illness onset; 2) accurately quantify the concentrations of COVID-19 antibodies (antibody titer). The proposed new assay system will be a rapid and low-cost tool for use by 1) the health network and end-users for rapid and on-site detection of COVID-19 antibodies even at early stages of disease at large scale; 2) public health authorities for estimating the degree of vulnerability in population; 3) blood donor clinics for identifying convalescent plasma with abundant antibody titers 4) employers across Canada for more objective return-to-work screening. For Canadian researchers, the proposed assay is a valuable quantitative and portable tool for rapid, yet low-cost, quantification of COVID-19 IgM and IgG antibodies which is key for the development of vaccine and therapeutic strategies.