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：自我测试的HIV检测（R61/R33） 自动艾滋病毒自我测试系统的可行性和开发 抽象的 现实世界有限公司（DRW）的诊断已经开发并标记了其Samba II平台 样品中的结果护理点（POC）测试，并进行了HIV急性感染和小瓶负荷监测的测试。 Samba II使用预装的，即使用的墨盒，其中包含所有必需的试剂，可以发货，并且 存放在室温下。 Samba II是一个完全自动化的POC测试系统，编码样品提取， 结果的核酸扩增，检测和解释。结果自动读取，可以是 通过SMS消息打印并发送到手机或任何基于云或安全的数据库。 DRW将利用桑巴二世的开发和现场经验来开发一种创新系统 艾滋病毒自我测试：桑巴三世。它的目的是像怀孕测试或血糖测试一样易于使用：用户将 只需要从手指刺中收集全血样品，将其添加到设备或墨盒中以自动 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的将集中于减少测定时间 并简化化学以自动化为起点。化学 开发将主要集中在（1）改善O组亚型的检测； （2）简化核 从全血中提取酸； （3）简化和减少放大/检测方法的时间。 该化学物质将在新的Samba III墨盒和设备中处理，后者供应温度 控制，流体处理和结果阅读。该项目将受到挑战，DRW也将寻求替代方案 当前Samba II系统的尺寸，重量和成本减少的策略允许其用于自我 测试。 总体方向和项目管理将由DRW在加利福尼亚州以及主要的 化学开发，质量，系统测试，样品测试和监管管理，包括领域 绩效评估。当前的Samba II化学，墨盒和仪器最初是开发的 由英国DRW子公司的人员，现实世界（欧洲）有限公司的诊断，因此 在本申请中提出的工作中，将由欧洲DRW欧洲在英国完成。 如果R61阶段成功，DRW将继续使用R33阶段。此阶段的工作将涉及 最终确定和优化墨盒和设备设计，进一步开发新的制造能力 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。