Portable Raman Analyzer for point-of-care rapid analysis of COVID-19 antibody

新冠肺炎感染的快速诊断对防止疾病传播至关重要。我们的研究团队开发了一种护理点试剂盒QT100DxTM，该试剂盒在样品准备2分钟后提供测试结果，可供非技术人员在非实验室环境中使用，特别适用于聚集环境下的大规模筛查。该试剂盒分析未经处理的生唾液和血浆。QT100Dx同时检测构建绝对病毒和免疫反应信号(抗体)所涉及的多个关键关键生物标记物，这些信号和免疫反应信号(抗体)从非常微量的10 ul唾液样本中上升。该试剂盒检测灵敏度高达每毫升唾液中20个病毒颗粒和每毫升血浆20 ng抗体，远远优于流行的聚合酶链式反应检测方法。机器学习算法实现了计算机化诊断。对患者样本的临床前分析显示，诊断的敏感性和特异性接近100%。交叉反应试验表明，该试剂盒能够区分新冠肺炎与人类冠状病毒229E、人类冠状病毒OC43、流感和呼吸道合胞病毒，准确率接近100%。QT100Dx诊断新冠肺炎病毒的能力已经通过临床前验证得到验证，并已与我们的工业合作伙伴合作构建了原型。本项目的目的是开发一种新的功能，即唾液和血浆中抗体的定量分析。抗体Ig G的定量用于评估既往感染和疫苗效果，抗体Ig M的定量分析在辅助新冠肺炎感染的早期诊断方面具有潜在的潜力。本研究的成功将扩大QT100Dx的临床应用范围，使该试剂盒具有更高的附加值和市场竞争力。

Rapid diagnosis of COVID-19 infection is critical for the prevention of disease spread. Our research team developed a point-of-care kit, QT100DxTM, which provides test result 2 minutes after sample preparation and can be used by non-technical personal in a non-lab setting, particularly suitable for mass screening at congregated settings. The kit analyzes both unprocessed raw saliva and blood plasma. The QT100Dx simultaneously detects multiple key essential biomarkers involved in constructing the absolute virus and immune response signals (antibodies) rising in patients due to COVID-19 infection from a very minimal salivary sample of 10 ul. The kit detection sensitivity up to 20 viral particles in 1 ml of saliva and 20 ng antibody per mL of blood plasma, far superior to popular PCR assays. Machine learning algorithm enabled computerized diagnosis. Pre-clinical analysis with patient samples showed diagnosis sensitivity and specificity near 100%. Cross reactivity test showed that the kit is capable of differentiation of COVID-19 from Human Coronavirus 229E, Human Coronavirus OC43, Influenza, and Respiratory Syncytial Virus with near 100% accuracy. The ability of QT100Dx diagnosis COVID-19 virus has been demonstrated with preclinical validation and a prototype has been built in collaboration with our industrial partner. The object of this project is to develop a new function, namely, antibody quantitative analysis from saliva and blood plasma. While quantitation of antibody IgG is used to assess past infections and vaccine effectiveness, quantitative analysis of antibody IgM finds potentials in assisting early diagnosis of COVID-19 infection. The success of this research will expand the clinical utility of QT100Dx and make the kit value-added and market competitive.