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

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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.