Challenge: Creating a Disposable Point-of-Care System to Collect and Test Whole Blood Samples.
Whole Blood Point-of-Care Test systems must be precise as the results gathered could negatively affect patient diagnoses and treatment. For our clients, we need to design and manufacture a device that can successfully achieve the desired test results using a 2 uL -10 uL sample of whole blood.
There are several challenges that the ALine Team needs to overcome to meet this goal. The first is to ensure that the once the blood sample enters the system, it must be thoroughly mixed with diluent. This mixing has to be done without active pumping as the additional movement could damage the sample. Secondly, the sensor used in the device is wire bonded and mounted on a circuit board, creating an irregular surface around the perimeter of the sensing surface. If not addressed the irregularity could negatively affect the sample process and the results.
Solution: Metering and Stability
With these challenges in mind, the ALine Engineers designs an innovative product that contains a whole blood metering system that draws the sample with +/- 2% variability. This allows mixing of the sample with the diluent without harming the sample and, after mixing, the subsequent delivery to the cartridge for measuring.
To address the second issue facing the team, a three-component cartridge, the size of a USB stick is utilized. This device includes a leak-proof seal to enclose the sensing surface, and provides for air-bubble trapping and sample overflow.
The device designed by our ALine team allows our clients to collect quality data. Based on what they learned and from the data collected, our client was able move towards the commercialization of their product! We are so excited for them!
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