Scottish Health Innovations Ltd (SHIL) works in partnership with NHS Scotland to identify, protect, develop and commercialise new innovations from healthcare professionals. Registered Number: SC 236303. Registered address: The Golden Jubliee National Hospital, Fourth Floor East, Agmemmon St, Clydebank, G81 4DY
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SHIL is collaborating with NHS Greater Glasgow & Clyde and a range of partners on the development of an accurate and reliable antibody test in the fight against COVID-19.
With the involvement of clinicians, the biorepository team and coordinated through Scottish Health Innovations Ltd (SHIL); a UK based consortium is accelerating the development of a unique lateral flow test, supporting the requirement for reliable antibody testing at scale.
Based on existing prototypes developed for Zika virus and Dengue fever and work on the herpes simplex virus; this innovative solution will be tested and validated using blood samples from previously infected COVID-19 patients.
Using a finger-prick blood sample, the test will establish if a person has acquired antibodies to the COVID-19 virus. The presence of antibodies as markers of viral immunity is widely used in clinical practice to indicate exposure to a virus and a degree of immunity.
Using a novel and highly sensitive lateral flow (pregnancy-test-like) design, the diagnostic will use capillary blood samples, which can be extracted by a lancet from a fingertip in any point of care location. It will take around 20 minutes to complete, providing a reliable and accurate result.
Dr John Goodfellow – Consultant Neuroimmunologist and Clinical Director of the Neuroimmunology Laboratory at the Queen Elizabeth University Hospital, Glasgow explains: “There are two contexts in which testing is required - diagnosis of active infection, and diagnosis of likely immunity to infection. We are specifically looking at immunity to infection and our unique lateral flow design has several innovative features that will produce a more accurate test than traditional designs, and can be rapidly adapted to viral mutations. Our approach also, reduces the development time and manufacturing cost of the product.”
The project is being developed through a new company, Coronex Limited, that brings together the collaboration of NHS Greater Glasgow and Clyde, Scottish Health Innovations Ltd, UK based biotechnology industry partners and Glasgow based investment partner Axon Healthcare.
The test will be developed and manufactured in the UK, ensuring secure, cost effective supply to the NHS. It addresses the urgent need for a diagnostic which demonstrates high sensitivity and accuracy, and at speed, whether a person has acquired immunity to the COVID-19 virus.
Professor Julie Brittenden, Research and Development Director at NHS Greater Glasgow and Clyde comments: “I am so proud of our team of clinicians, research nurses, biorepository specialists and patients who have made it possible to kick-start the development of a brand new antibody test for COVID-19. This is part of our wider research and development efforts to improve the diagnosis and treatment of the virus which includes clinical trials and innovative projects and the wider R&D Team.”
Graham Watson, Executive Chairman at SHIL adds: “Testing is a nuanced and technical area. However, an expert team has been mobilised at speed and we are now supporting a rapid, robust process to create a prototype, test against clinical samples; and if successful, progress through regulatory approval to manufacture. We are hoping to roll out the test within 12-15 weeks; but must remain cognisant that we are innovating at speed within a healthcare setting and with evolving scientific evidence.”
Accurate and reliable testing is a key pillar of the COVID-19 response strategy around the world and a key component of the safe and managed easing of current lockdown restrictions.
The ability to test vast numbers of the population on a regular basis is critical to managing the disease and supporting economic recovery.
Notes to editor
- Antibody tests for COVID-19 diagnosis fall into 2 groups: Antibody tests for diagnosis performed in laboratory on specialist equipment; and point of care antibody tests using a “lateral flow” mechanism
- Lateral flow antibody tests require no specialist equipment and can be done anywhere, producing results in between 10 – 20minutes
- Lateral flow antibody tests fall within the specification criteria for serology point of care tests and self-tests set out by Medicines and Healthcare products Regulatory Agency (MHRA). Target Product Profiles (TPP) have been developed to assist manufacturers to design and deliver tests that might be useful in support of Pillar 3 of the UK testing strategy. How closely a product matches the TPP will be helpful in procurement and regulatory decision making
- To date, no such test has been validated and experts have urged people against purchasing unvalidated antibody (lateral flow) tests
- The project brings together experts in the development of large scale test and antigen manufacture, clinicians, a major Scottish health board and an innovation development company
- Project partners are: Scottish Health Innovations Limited (SHIL); NHS Greater Glasgow & Clyde, Excivion Limited, Lateral Dx Limited, Activotec Limited, The Antibody Company Limited, Axon Healthcare Investments Limited
- The NHSGGC Biorepository is an invaluable resource for clinical research, providing access to a wide range of fully-consented human tissue samples including surplus materials from diagnostic and surgical procedures