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: 10223133
• 负责人: HELEN H LEE
• 金额: $ 41.15万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10223133
• 关键词: Automation; Biological Assay; Blood Glucose; Blood specimen; California; Car Phone; Chemistry; Clinical; Databases; Detection; Development; Device Designs; Devices; Diagnostic; Europe; Evaluation; Fingers; HIV; Heating; 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; detection method; experience; home test; improved; innovation; instrument; manufacturing process; performance tests; point of care; point of care testing; prototype; research and development; seal; self testing

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：用于自我检测的艾滋病毒检测(R61/R33) 艾滋病病毒自动自检系统的可行性及开发 摘要 现实世界诊断有限公司(DRW)已经开发了其Samba II平台，并将其CE标记为 抽样结果-护理点(PoC)测试，包括艾滋病毒急性感染测试和药瓶负载监测。 Samba II使用预装的、即用即用的墨盒，其中包含所有所需的试剂，可以运输和 在室温下储存。Samba II是一个全自动化的PoC测试系统，包含了样品提取， 核酸扩增、检测和结果解释。结果是自动读取的，并且可以 打印并通过短信发送到移动电话或任何基于云的或安全的数据库。 DRW将利用Samba II的开发和现场经验来开发一个创新的系统 HIV自我检测：Samba 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 只需从手指刺伤处采集完整的血液样本，将其添加到设备或墨盒中即可自动 处理样本并返回结果。研发将涉及化学和一种设备。 R61阶段的化学开发的主要目标将集中在减少分析时间上 以当前的Samba化学为起点，简化化学以实现自动化。化学 发展将主要集中在(1)改进O群亚型的检测；(2)核简化 从全血中酸提取；(3)简化和缩短了扩增/检测方法的时间。 化学作用将在新的Samba III试剂盒和装置中进行处理，后者提供温度 控制、流体处理和结果读取。该项目将是具有挑战性的，DRW还将寻求替代方案 减少目前Samba II系统的尺寸、重量和成本的战略，使其能够用于自我 测试。 总体指导和项目管理将由加州的DRW与主要 化学开发、质量、系统测试、样品测试和监管管理，包括外地 绩效评估。目前的Samba II化学、试剂盒和仪器最初是开发出来的 DRW在英国的子公司，现实世界诊断(欧洲)有限公司的人员，因此是一部分 这项申请中提议的工作将由DRW欧洲公司在英国完成。 如果R61阶段成功，则DRW将继续进行R33阶段。这一阶段的工作将包括 最终确定和优化墨盒和设备设计，进一步发展新的制造能力 系统，评估测试性能，包括敏感性、特异性和测试实际临床样本和 可用性。