The People’s Test – world first CE marked COVID-19 antibody self-test from award winning UK manufacturer launches today
LONDON, UNITED KINGDOM: The first approved, CE marked COVID-19 antibody self-test is now on sale in the UK. The long-awaited BioSURE COVID-19 IgG Antibody Self Test detects neutralising antibodies that your body creates from either previous COVID-19 infection or vaccination and gives people the choice of being able to know their own antibody status in just 20 minutes, on their own terms, at a time and a place of their choosing.
The BioSURE COVID-19 IgG Antibody Self Test uses the same innovative test format as their BioSURE HIV Self Test, which was another world-first and has successfully allowed individuals across the globe to know their HIV status for over 6 years. It uses only a tiny drop of blood from a finger prick, comes with everything you need to perform the test and is proven to be extremely straightforward to perform. It also has a special inbuilt feature, where the test must have enough blood applied to generate a result so that the user knows they have performed their test correctly.
The test has gone through a rigorous independent process to gain the first CE marking specifically for self-testing for COVID-19 IgG antibodies, a legal requirement for selling in the UK and Europe and has an overall accuracy of over 99%.
Designed, developed and manufactured in the UK, BioSure has worked with members of the public following a high-profile social media campaign last year asking for people to help. The company have come across numerous case studies, including one man who wanted to volunteer at a vaccination centre but then discovered he did not have his own protective antibodies and another lady who was double vaccinated but too anxious to see her grandchildren. Once she knew her positive antibody status, she felt confident in seeing her family again. Until today, that would have meant sending a large blood sample to a lab and waiting days for the result, a test unaffordable for most people.
Neutralising IgG antibodies are the antibodies that give a person protection against infection. For SARS-CoV-2 these antibodies target the spike protein of the virus which prevents it from entering cells, thereby stopping infection. Vaccines stimulate your immune system to produce these antibodies and is breaking the link between infection and severe illness. The more neutralising antibodies a person has, the higher the level of protection and the less severe possible future infection is likely to be.
There’s varying data around the efficacy of vaccines and research estimates that 5% of people do not produce detectable antibodies following infection, especially when they only have mild or no symptoms. It is now accepted that the amount of antibodies a person increases with each vaccine dose but also naturally decreases over time. The current understanding is that after about 6 months antibody levels fall and fall quickly. Some people’s immune systems unfortunately don’t create antibodies to SARS-CoV-2 or to the vaccine.
Data released from the government this week estimates that 93% of the UK adult population should now test positive for antibodies, which leaves over 2.65 million adults testing negative. The prevalence of these antibodies is 30% lower in men. The newly launched BioSURE self-test differs from the government’s recently announced study, which involves people who have just tested positive for the current COVID-19 infection sending a blood sample away to a laboratory.
Unlocking is an important step for the UK to get back on its feet and return to some form of ‘normal’. European travel and many hospitality and nightlife events are requesting double vaccination or evidence of infection within the past 180 days, both of which imply that the person should have protective levels of antibodies. It’s only possible to know a person’s antibody status by testing their blood and it is important information to know and understand.
Brigette Bard, BioSure founder and CEO said, “Understanding your body and ‘Knowing Your Status’ is so important when it comes to making decisions. We are privileged that we have been able to test ourselves throughout the pandemic and it has made such a difference to how we can plan and operate safely as a business. BioSure is proud, as a British company, to once again be launching a first-in-world, gold-standard product that empowers people to test confidently on their own terms.”
