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

新冠肺炎令人震惊的发病率和死亡率表明，没有有效地进行疾病的早期发现，导致易感人群被未发现的病例感染。虽然基于聚合酶链式反应的标准护理检测方法对于检测活跃的上呼吸道新冠肺炎感染是关键，但对于从感染后一周内的常规鼻腔或喉咙样本中检测病毒并不有用。抗体侧向流动免疫分析(LFA)是一种低成本、终端用户友好的快速检测方法，通过检测机体对新冠肺炎疾病的免疫反应，可以为基于聚合酶链式反应的检测提供补充和额外信息。虽然这些LFA可以在整个人群中迅速使用，但它们的敏感性和准确性在疾病的早期阶段是有限的。因此，由于缺乏良好的免疫学检测方法，无法在早期阶段以高灵敏度检测免疫反应，这就排除了许多宝贵的临床干预和阻断疾病传播的机会。在这个项目中，我们与加拿大BTNX公司合作，将热光子解译引入他们现有的新冠肺炎LFA，以获得一种不仅低成本和快速，而且敏感和定量的新的分析方法。预计该项目将产生的创新1)在发病第一周内可靠地检测到新冠肺炎抗体；2)准确量化新冠肺炎抗体的浓度(抗体效价)。拟议的新检测系统将成为一种快速、低成本的工具，供1)卫生网络和最终用户使用，以便在大规模疾病的早期阶段对新冠肺炎抗体进行快速和现场检测；2)公共卫生当局用于估计人口的脆弱程度；3)献血诊所用于识别抗体效价丰富的恢复期血浆4)加拿大各地的雇主用于更客观的重返工作岗位筛查。对于加拿大研究人员来说，建议的化验方法是一种有价值的定量和便携工具，可以快速、低成本地定量检测新冠肺炎免疫球蛋白M和免疫球蛋白抗体，这对疫苗和治疗策略的开发至关重要。

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.