Objective
Our objective is to complete the design and testing required for a finger-prick lateral flow test that can be used to screen for T1D in the community.
Background Rationale
We have already proven that it is possible to make the lateral flow assay and to detect all the four key aAb that are found in T1D. We now want to improve the test and ensure that it can be taken forward at scale in manufacturing processes and used in patients.
Our application is to take our LFA tests and develop them so that they meet the requirements of regulatory bodies in the US, Europe and UK that oversee the use of tests in routine clinical practice.
Description of Project
This project aims to take our 4 lateral flow Type 1 Diabetes (T1D) autoantibody tests, which we have already shown are possible, through the development steps required to allow their submission to appropriate regulatory bodies and use in patients as a single point of care test. This tests will help global efforts to accelerate both screening and early detection of T1D.
Autoantibodies (aAb) are proteins produced by the immune system that recognize a person’s own tissues. This is what happens in T1D where an individual produces aAb against their own pancreas (the organ that makes insulin which in turn controls sugar levels in the body). In T1D, these aAb are present in people before they need to start taking insulin and tells us the immune system has already started targeting the pancreas. Knowing there are these markers in the blood is very useful as we now have new medicines which can suppress the immune system and slow the onset of T1D. As a result, there has been huge global interest in developing screening programs to detect these aAb. Screening and widespread testing involves testing very high numbers of people and to make this possible we need new types of tests.
A lateral flow assay (LFA), like a pregnancy test or a COVID test, is easy to use, low cost, stable and detects all four of the key aAbs found in T1D. The test requires the user to prick their finger and add a drop of blood onto the device and a marker line will let the user know whether T1D aAbs are present at the time of testing. This is simple and relatively painless to do and so can be used at home or in the community and would be very well suited to screening programs.
Anticipated Outcome
At the end of the two years of this project, the LFA will be ready to progress through the final stages required to make them suitable for regulatory approval, allowing them to be used in patients. The project will be undertaken in the laboratory that is undertaking the testing and sample storage for the ELSA study. The ELSA study is currently screening 20,000 children in the UK for T1D. The combination of the expertise in the UoB and M2M teams and access to these ELSA samples to make sure the test is performing how we expect, will help create an attractive proposition for further investment to take the LFA into the market and be used to benefit patients.
Relevance to T1D
Research is finding increasingly successful medicines that can delay or hopefully even prevent T1D and the need for insulin or severe life-threatening complications such as diabetic ketoacidosis. The psychological and medical impact of T1D on individuals, and the associated health care costs, is significant. The ability to intervene, to prevent this disease before insulin is required, would provide significant health improvements for a disease which affects 15 in every 100,000 people globally. We know that positivity to one or more aAb increases the risk of a person going to develop T1D in the future and that the risk increases depending on the number of aAb they are positive for. If we look for autoantibodies in the general population, only about 6 in 1,000 people will be positive and so a testing solution must be easy and cheap to perform because the majority of tests will be negative. A significant proportion of the cost of a test is taking the blood from a patient and transporting the sample to a laboratory. A test that can be performed and give a result without posting back to the laboratory would significantly reduce the cost of screening and enable interventions that prevent or delay T1D.