Feasibility and development of an automated HIV self-testing system

HIV自动化自检系统的可行性与开发

• 批准号: 10004563
• 负责人: HELEN H LEE
• 金额: $ 41.66万
• 依托单位: DIAGNOSTICS FOR THE REAL WORLD, LTD
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-31 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004563
• 关键词: Automation; Bedside Testings; Biological Assay; Blood Glucose; Blood specimen; California; Car Phone; Chemistry; Clinical; Databases; Detection; Development; Device Designs; Devices; Diagnostic; Europe; Evaluation; Fingers; HIV; Heating; Home environment; Human Resources; Human immunodeficiency virus test; Investigation; Knowledge; Liquid substance; Methods; Monitor; Nucleic Acids; Performance; Phase; Pregnancy Tests; Process; Production; Reading; Reagent; Sampling; Secure; Sensitivity and Specificity; Ships; Silicon Dioxide; Source; System; Systems Development; Temperature; Testing; Time; Vial device; Weight; Whole Blood; Work; acute infection; amplification detection; cloud based; cost; design; experience; improved; innovation; instrument; manufacturing process; performance tests; point of care; prototype; research and development; seal

PAR-17-471: Detection of HIV for Self-testing (R61/R33) Feasibility and development of an automated HIV self-testing system Abstract Diagnostics for the Real World Ltd (DRW) has developed and CE-marked its SAMBA II platform for sample-in result-out point of care (PoC) testing, with tests for HIV acute infection and vial load monitoring. SAMBA II uses pre-loaded, ready-to-use cartridges containing all required reagents, which can be shipped and stored at room temperature. SAMBA II is a fully automated, PoC testing system incorporating sample extraction, nucleic acid amplification, detection and interpretation of results. Results are automatically read and can be printed and sent via SMS messaging to a mobile phone or any cloud–based or secure database. DRW will exploit development and field experience from SAMBA II to develop an innovative system for HIV self-testing: SAMBA III. It will aim to be as easy to use as a pregnancy test or blood glucose test: a user will only need to collect a whole blood sample from a finger prick, add it to a device or cartridge to automatically process the sample and return a result. Development will involve chemistry and a device. The main aims of the chemistry development during the R61 phase will focus on reducing the assay time and simplifying the chemistry for automation with the current SAMBA chemistry as a starting point. Chemistry development will focus mainly on (1) improving the detection of Group O subtype; (2) simplification of nucleic acid extraction from whole blood; (3) simplification and reduction in time of the amplification/detection method. The chemistry will be processed in a new SAMBA III cartridge and device, the latter to supply temperature control, fluid handling and results reading. The project will be challenging and DRW will also pursue an alternative strategy of reductions of size, weight and cost to the current SAMBA II system to allow it to be used for self- testing. Overall direction and project management will be done by DRW in California along with the main chemistry development, quality, system testing, sample testing and regulatory management, including field performance evaluation. The current SAMBA II chemistry, cartridge and instrument were originally developed by personnel at DRW’s subsidiary in the UK, Diagnostics for the Real World (Europe) Limited, therefore a portion of the work proposed in this application will be done by DRW Europe in the UK. If the R61 Phase succeeds, DRW will continue with an R33 phase. The work for this phase will involve finalizing and optimizing the cartridge and device design, further develop manufacturing capabilities for the new system, evaluate test performance, including sensitivity, specificity and testing actual clinical samples and useability.

PAR-17-471：用于自我检测的HIV检测（R61/R33） 艾滋病病毒自动自我检测系统的可行性和开发 摘要 Diagnostics for the真实的World Ltd（DRW）开发了桑巴舞II平台， 样本输入结果输出护理点（PoC）检测，包括艾滋病毒急性感染检测和小瓶负载监测。 桑巴舞II使用预装的即用型试剂盒，其中包含所有必需的试剂，可以运输， 在室温下储存。桑巴舞II是一个全自动的，可重复使用的测试系统，包括样品提取， 核酸扩增、检测和结果解释。结果会自动读取， 打印并通过SMS消息发送到移动的电话或任何基于云的或安全的数据库。 DRW将利用桑巴舞II的开发和现场经验，开发一种创新系统， 艾滋病毒自我检测：桑巴舞III。它的目标是像怀孕测试或血糖测试一样容易使用：用户将 只需要从手指穿刺处采集全血样本，将其添加到设备或检测盒中， 处理样本并返回结果。开发将涉及化学和设备。 R61阶段化学开发的主要目标将集中于缩短测定时间 并以当前的桑巴舞化学为起点，简化自动化化学。化学 发展将主要集中在（1）改善O组亚型的检测;（2）简化核酸检测， 从全血的酸提取;（3）简化和减少扩增/检测方法的时间。 化学物质将在新的桑巴舞III盒和设备中处理，后者提供温度 控制、液体处理和结果阅读。该项目将具有挑战性，DRW也将寻求替代方案 减少目前桑巴舞II系统的尺寸、重量和成本的战略，使其能够用于自 试验. 总体方向和项目管理将由加州州的DRW沿着主要的 化学开发、质量、系统测试、样品测试和法规管理，包括现场 业绩评价目前的桑巴舞II化学、测试卡片和仪器最初是由 由DRW在英国的子公司Diagnostics for the真实的World（Europe）Limited的人员进行，因此， 本申请中提出的工作将由英国的DRW Europe完成。 如果R61阶段成功，DRW将继续R33阶段。这一阶段的工作将涉及 最终确定并优化药筒和器械设计，进一步发展新产品的制造能力 系统，评价测试性能，包括灵敏度、特异性和测试实际临床样本， 可用性