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

用于即时快速分析 COVID-19 抗体的便携式拉曼分析仪

• 批准号: 563655-2021
• 负责人: Venkatakrishnan, Krishnan
• 金额: $ 2.19万
• 依托单位: Ryerson University
• 依托单位国家: 加拿大
• 项目类别: Alliance Grants
• 财政年份: 2021
• 资助国家: 加拿大
• 起止时间: 2021-01-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=722139
• 关键词: Portable; Raman; Analyzer; point; care

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.

快速诊断COVID-19感染对预防疾病传播至关重要。我们的研究团队开发了一种即时检测试剂盒QT 100DxTM，该试剂盒在样品制备后2分钟提供检测结果，可由非技术人员在非实验室环境中使用，特别适用于聚集环境中的大规模筛查。该试剂盒分析未经处理的原始唾液和血浆。QT 100Dx可同时检测多个关键的基本生物标志物，这些生物标志物参与构建绝对病毒和患者因COVID-19感染而产生的免疫反应信号（抗体），这些信号来自10 ul的极少量唾液样本。该试剂盒检测灵敏度高达20个病毒颗粒在1毫升唾液和20 ng抗体每毫升血浆，远远优于流行的PCR检测上级。 机器学习算法使计算机化诊断成为可能。患者样本的临床前分析显示诊断灵敏度和特异性接近100%。交叉反应性测试显示，该试剂盒能够将COVID-19与人类冠状病毒229 E、人类冠状病毒OC 43、流感和呼吸道合胞病毒区分开来，准确率接近100%。QT 100Dx诊断COVID-19病毒的能力已通过临床前验证得到证明，并与我们的工业合作伙伴合作建立了原型。 本项目的目标是开发一种新的功能，即唾液和血浆中的抗体定量分析。虽然抗体IgG的定量用于评估过去的感染和疫苗有效性，但抗体IgM的定量分析在协助COVID-19感染的早期诊断方面具有潜力。 该研究的成功将扩大QT 100Dx的临床应用，使该试剂盒具有附加值和市场竞争力。