Development of a platform for point-of care testing: Accelerating the Assay Pipeline

开发即时检测平台：加速检测流程

• 批准号: 461032-2013
• 负责人: Raha, Sandeep
• 金额: $ 1.82万
• 依托单位: McMaster University
• 依托单位国家: 加拿大
• 项目类别: Engage Grants Program
• 财政年份: 2013
• 资助国家: 加拿大
• 起止时间: 2013-01-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=542428
• 关键词: Development; platform; point; care; testing

Evik Diagnostics proposes to engage with Dr. Sandeep Raha, McMaster University, to validate and transfer rapid assay development technologies that will help the company to accelerate new diagnostic tests to market. With assistance from IRAP, Evik has developed simple, low cost, disposable cartridge tests, with all reagents enclosed, that are suitable for deployment in Africa and other resource limited settings. They are similar to a home pregnancy test in simplicity and stability. The first market target for this test device is the growing HIV/AIDS pandemic. Despite 30 years of development effort we do not yet have an HIV vaccine. Worldwide, 34 million are living with AIDS, and 2.5 million new cases are reported each year. The demand for this test device is enormous with hundreds of millions needing screening for new infection, and people living with retroviral therapy needing repeated monitoring for viral load. The test device will report viral load by HIV p24 concentration plus p24 antibodies in blood, a combination method which has been validated to be faster and simpler than DNA tests but in sensitivity. Using microarray high throughput screening, Dr. Raha's lab will test a library of antibodies to find the optimal pair for highest HIV detection sensitivity, and will provide labeled antibody conjugates for the test device. Dr. Raha's lab will transfer the microarray and conjugate chemistry technologies to Evik and vest these rapid assy development tools in the company so that Evik can quickly bring followup diagnostic tests to market. This alliance of complementary technologies will also foster the development of additional diagnostic assays in the future and promote the Canadian Biotechnology industry.

艾维克诊断公司建议与麦克马斯特大学的桑迪普·拉哈博士合作，验证和转让快速检测开发技术，这些技术将帮助该公司加快新的诊断测试进入市场。在IRAP的帮助下，evik开发了简单、低成本的一次性试剂盒测试，所有试剂都是封闭的，适合在非洲和其他资源有限的环境中部署。它们在简单性和稳定性上类似于家庭验孕。这种检测设备的第一个市场目标是日益严重的艾滋病毒/艾滋病大流行。尽管经过了30年的发展努力，我们仍然没有艾滋病毒疫苗。全世界有3400万艾滋病患者，每年新增病例250万例。对这种检测设备的需求是巨大的，数亿人需要筛查新感染，接受逆转录病毒治疗的人需要反复监测病毒载量。该检测设备将通过HIV p24浓度加上血液中的p24抗体来报告病毒载量，这是一种组合方法，已被验证比DNA测试更快、更简单，但灵敏度更高。通过使用微阵列高通量筛选，拉哈博士的实验室将测试抗体库，以找到最高艾滋病毒检测灵敏度的最佳抗体对，并将为测试设备提供标记的抗体结合物。Raha博士的实验室将把微阵列和共轭化学技术转让给evik，并将这些快速分析开发工具授予该公司，以便evik能够迅速将后续诊断测试推向市场。这一互补技术的联盟还将促进未来更多诊断分析的发展，并促进加拿大生物技术产业的发展。