A novel, rapid & highly sensitive test device enables multiple tests for e.g. food allergens/gluten; animal species or mycotoxins to be completed in minutes by non-technical staff.

About

Rapid, "on-site" detection of dangerous food allergens, cereal glutens and many other food-related contaminants is limited to single tests with no web connectivity to facilitate data sharing. Our new device is an improvement on an existing (CE-marked, "at home" allergy diagnosis) device which will: 1. Overcome deficiencies in current, rapid food tests 2. Allow for several results to be generated on one test device. 3. Be simple and quick to use, even by non-technical staff. 4. Will detect at lower levels than is currently possible. 5. Be machine- or phone-app readable, allowing results to be stored and shared via the cloud. Previous Innovate_UK projects have allowed the initial computer-aided design work to be competed - see attached image of the proposed device; this now needs to proceed to: 1. "Final device design" and preparation of 3D-printed prototypes that will enable fluidics to be evaluated and test biochemistries developed. 2. "Design for manufacturing", which will produce detailed injection moulding tools to be produced and the final plastic parts produced in small numbers for final test validation. As an example of how the device will work, here is an outline of a multi-allergen test: 1. A food sample (raw material; part- or fully-processed food) is mixed thoroughly with an extraction solution. 2. The food extract is allowed to settle for a few minutes. 3. A small sample of the crude, liquid food extract is removed with a self-measuring pipette. 4. The pipette contents are added to a sample well on the test device, which separates solids from liquid extract. 5. A small volume of liquid buffer is added to a second well to start the test running. 6. Initially the diluted extract flows into the device and allergens bind to a series of different "Test" lines for each allergen. 7. Importantly, the reaction continues and the Test lines are "washed" to remove contaminants. 8. After 5-10 minutes the device is partially pulled apart, allowing a highly-coloured detection reagent to flow across the Test lines. 9. If allergens are present, detection reagent binds to allergen on the Test lines,developing readable responses. 10. The test device can then be read by eye and/or in a device reader/using a phone app whereby the results are captured. The existing test detects remarkably low levels of (IgE) antibodies in human blood samples as markers of allergy (see www.https://www.imutest.com/pages/how-imutest-works). Unfortunately the current device tricky to use and both difficult and expensive to manufacture, which make it impossible to scale up for cost-effective food testing use. The new design is smaller, easier to manufacture and both simple and foolproof to run.

Key Benefits

Multiple test results using a single device. Reduced cost per test result for users due to multiplexing. Test results within minutes - less than 30 minutes from sample preparation to multiple results. No additional labour cost - same effort as single tests. No propensity for False Negative results at very high analyte levels. Greater sensitivity (lower limits of detection) improves data/product quality. Simple Yes/No visual readouts. Can also be read electronically to give semi-quantitative data. Test results can be uploaded to the cloud for record-keeping; sharing with clients. Can also be applied to e.g. mycotoxins; species detection in food factories/labs. And to human and veterinary diagnostics.

Applications

On-site testing of a wide variety of proteins, antibodies, small molecules etc across multiple market sectors.

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