Regional collaboration delivers quality focused 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.

With the focus on mild non-hospitalized patient blood samples, the SARS-CoV-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, utilizing its world-renowned knowledge of 35-years in developing highly precise, accurate blood tests that affect the immune system. The 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 this 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.

Professor Adam Cunningham, Professor of Functional Immunity at the University of Birmingham explains: “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.”

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 test in a non-hospitalized population that had mild symptoms – which is the largest target population for COVID-19 testing - and 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.

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.”

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 recognizing? 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.”

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 Pediatric 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.

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