COVID-19 Diagnostics: University of Exeter’s New Next-Generation Triple Antibody Test for COVID-19 Secures UK Regulatory Approval
: Researchers from the University of Exeter have developed a revolutionary new device that could allow health professionals to accurately test patients' antibody response to COVID-19 in as little as seven minutes.
The new pioneering COVID-19 Triple Antibody Test has been produced by the University of Exeter spin-out company Attomarker Ltd and is set to spearhead the next-generation of rapid and accurate antibody testing.
With successful trials from an initial patient study at St. Thomas' Hospital in London conducted earlier this year, the test device has received approval by the Medicines and Healthcare Regulatory Agency (MHRA).
The research findings are published in the journal: Analyst https://pubs.rsc.org/en/Content/ArticleLanding/2020/AN/D0AN01066A#!divAbstract
The Attomarker technology is being developed into a miniaturized hand-held "pocket laboratory" that can be docked to a smartphone to provide accurate testing at point-of-care, including care homes and pharmacies.
Many of the currently available tests only measure antibodies for one nucleocapsid protein (N) of the SARS-CoV-2 virus. However the Attomarker device can simultaneously test for multiple, clinically relevant, biomarkers against the SARS-CoV-2 virus.
The medical device can test for three virus proteins (Spike 1, Spike 2 & N) and three classes of antibodies (IgM, IgG and IgA), giving a more powerful profile of the patient's immune response to COVID19.
In late March, an extensive pilot study for the device was conducted at St. Thomas' Hospital, in London. It was fully funded by University of Exeter alumni and friends, more than 1,300 of whom gave a total of £120,000 through the COVID-19 Emergency Appeal.
Researchers carried out 119 tests over an initial five-day period, investigating the performance of the antibody test on 74 admitted patients from an early stage of the COVID-19 outbreak.
Detailed and further analysis with an additional 200 patients shows that Attomarker's Triple Antibody test delivers a sensitivity of up to 96% in detecting COVID-19 antibodies including in patients who previously presented negative swab tests.
In order to deliver the technology to the front line, Smiths Detection, part of Smiths Group, is working with Attomarker and has manufactured 10 pre-production devices, with the ability to ramp up volume according to demand. Together with Scienion, the array manufacturer, this gives Attomarker the capacity to provide a testing service in volume from early Autumn.
Additionally Attomarker has also begun further testing at the Royal Devon and Exeter Hospital in Exeter for a combined COVID-19/Flu antibody test in order for healthcare professionals to differentiate between patients with the two infections.
CEO & Founder of Attomarker and Associate Professor of Physical Chemistry at the University of Exeter, Professor Dr Andrew Shaw told Thailand Medical News, "The Attomarker team are excited with the high sensitivity and specificity results of our patented n
ew triple-antibody testing technology. We are proud to be working alongside the St Thomas' Hospital and Royal Devon and Exeter Hospital to test our technology including the combination COVID19-Flu test ahead of the winter season, and we look forward to sharing results from this crucial study in due course."
The study published in the Analyst
was developed with methodological support from Professor Chris Hyde, Director of the Exeter Test Group at the University of Exeter's College for Medicine and Health. He said: "I'm delighted to see this exciting research progress to the next phase, towards speeding up COVID-19 testing and having significant benefits for patients and healthcare workers."
Dr Neil Gow, DVC Research at the University of Exeter, said: "It is exciting to see the painstaking development of this technology by the Attomarker team led by Andrew Shaw at Exeter delivering a vital tool to address the health challenge of Covoid-19. The collaboration with colleagues at St. Thomas' Hospital fully validates the considerable potential of this novel diagnostic platform in simultaneously detecting three separate anti-COVID antibodies."
Dr Sean Fielding, Director of Innovation, Impact and Business at the University of Exeter said: "We have been supporting the development of Attomarker technology for several years and we are delighted to see such an effective test for the fight against COVID-19 emerging from this spin-out."
Professor Sir Robert Lechler, Senior Vice President/Provost (Health) Kings College London, said "This technology tests for antibodies against three viral proteins, two spikes and the nucleocapsid, as well as three classes of antibody, showing quantitative results. These differentiators will be key to beginning the next phase of COVID-19 testing urgently needed in the UK, and around the world, equipping healthcare professionals initially with the data they need to better manage the epidemic."
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