Quality Control Test for a Carbon Electrode in a Point-of-Care Diagnostic Test Cartridge

即时诊断测试盒中碳电极的质量控制测试

• 批准号: 103719
• 金额: $ 5.61万
• 依托单位: AGPLUS DIAGNOSTICS LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=103719
• 关键词: Quality; Control; Test; Carbon; Electrode

AgPlus Diagnostics produces medical test devices that can be used by a doctor to give patients information on their health in less than 10 minutes during a single doctor’s appointment. Our medical device is used by inserting a test cartridge into a handheld reader that performs the medical test using AgPlus’s unique signal detection chemistry. This is called electrochemical signalling and requires a particular component called a carbon electrode to be built into the test cartridges in order to work. The electrodes are made by another company and we have found that around one third of these electrodes are defective which can lead to a wrong medical test result. At AgPlus, we must screen out these defective electrodes during manufacturing but currently we cannot do that until we have fully made the medical test cartridge. This is very wasteful, so AgPlus needs to better understand what causes this problem with our electrodes. Based on this knowledge, we can determine the best approach for the electrode manufacturer to minimise these losses. Also we will then have a test to check each batch of electrodes at AgPlus when we receive them from the supplier so that the defective ones can to screened out and discarded as early as possible in the manufacturing process. This will help our company reduce manufacturing costs and material wastage significantly. The knock-on effect of this is that it will help AgPlus sell more tests and for the company to grow and employ more skilled people.

AgPlus诊断公司生产的医疗测试设备可供医生使用，在一次医生预约中，在不到10分钟的时间内为患者提供有关其健康状况的信息。我们的医疗设备是通过将测试盒插入手持式阅读器来使用的，该阅读器使用AgPlus独特的信号检测化学进行医疗测试。这被称为电化学信号，需要一个称为碳电极的特殊组件内置到测试盒中才能工作。这些电极是由另一家公司制造的，我们发现大约三分之一的电极有缺陷，这可能导致错误的医疗测试结果。在AgPlus，我们必须在制造过程中筛选出这些有缺陷的电极，但目前我们无法做到这一点，直到我们完全制造出医疗测试盒。这是非常浪费的，因此AgPlus需要更好地了解是什么导致我们的电极出现这种问题。基于这些知识，我们可以为电极制造商确定最佳方法，以最大限度地减少这些损失。此外，当我们从供应商那里收到每批电极时，我们将在AgPlus进行测试，以检查每批电极，以便在制造过程中尽早筛选出有缺陷的电极并将其丢弃。这将帮助我们公司显著降低制造成本和材料浪费。这样做的连锁反应是，它将帮助AgPlus销售更多的测试，并为公司发展和雇用更多的熟练人员。