Clinical Need
Collaboration delivers COVID-19 test kit in record time The Binding Site has launched a new test to detect COVID-19 antibodies in people with recent exposure who are asymptomatic or have mild symptoms. the test in a non-hospitalised population that had mild symptoms, which is the largest target population for COVID-19 testing. We designed the testing kit so it can be used by any laboratory in the world.” The test was developed using over 800 blood samples taken from people who had mild to moderate disease, including over 100 samples from healthcare workers in Birmingham. The test is already being used in many of the clinical studies conducted at Birmingham hospitals, and is expected to be rapidly adopted by surveillance teams seeking to understand the distribution of infection in the population, as well as vaccine researchers who need to assess antibody responses in clinical trials.
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ith the focus on mild non-hospitalised patient blood samples, the SARSCoV-2 Antibody ELISA assay was developed in partnership with the University of Birmingham’s Clinical Immunology Service, with the initial antigen being provided by the University of Southampton. This latest development is a natural progression for The Binding Site, utilising its knowledge of 35 years in developing highly precise, accurate blood tests that affect the immune system. The Birminghambased company already produces over 35 million IVD tests per year for sale globally and expects this UK manufactured product to be in high demand.
The new test specifically detects antibodies (IgG, IgA, and IgM) to the SARS-CoV-2 trimeric spike protein, which is an important protein for the virus infectivity. Targeting IgG, IgA and IgM, the assay will cover all the immunoglobulins which are vital in the body’s fight against the virus. These three antibodies appear at different times after infection. The test was
designed to detect all three, to increase detection at the earliest possible stage after exposure to the virus.
Charles de Rohan, CEO of The Binding Site, commented: “The long-standing partnership with the University of Birmingham has brought together unrivalled academic, clinical and commercial expertise, and the combined team worked together seamlessly and quickly to deliver this unique and forward thinking test in record time.”
“Humans make three types of antibodies – Anti-IgM, IgG and IgA. IgM tends to appear first, and IgG and lgA tend to appear later. By combining all three, The Binding Site test is able to detect COVID-19 infection in people who have only recently been exposed, or who have mild symptoms.”
Professor Alex Richter, Professor of Clinical Immunology at the University of Birmingham, who led the team that identified the antibodies to the spike protein, added: “There are two things to get right in an antibody test – which antibodies are we looking for, and what are they recognising? Testing for IgM, IgG and IgA antibodies to the spike protein should give an advantage in terms of early and accurate detection of people with recent exposure who are not showing symptoms.”
Professor Adam Cunningham University of Birmingham
The CE-marked ELISA test is simple to use and provides up to 93 test results in 60-90 minutes. Dr Stephen Harding, Chief Scientific Officer at The Binding Site, said: “We set out to develop a test with the University of Birmingham that would detect COVID-19 early, and validated
The Binding Site has provided free kits to support work in developing countries where the disease continues to spread quickly and is impacting on children through Paediatric Multisystem Inflammatory Syndrome (PIMS). The test has been submitted for rapid FDA approval and is expected to be available in quantities of over 2 million tests per month. www.bindingsite.com
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