With the government confirming the importance of understanding antibody levels, knowing your status has never been easier.
The first approved, CE marked COVID-19 antibody self-test is now on sale in the UK. The longawaited 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. Neutralising IgG antibodies are the antibodies that give a person protection against infection.
The BioSURE COVID-19 IgG Antibody Self Test 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%.
The recently announced UK government antibody testing study has confirmed the importance of people understanding if they have antibodies. However unlike the newly announced scheme which involves laboratory testing, the new and unique BioSURE home test uses 1/240th of the blood sample and gives the user their own result in minutes.
Designed, developed and manufactured in the UK, BioSure have 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.
Data released from the government last week estimates that 93% of the UK adult population should now test positive for antibodies1, which leaves over 2.65 million adults testing negative. Current understanding is that after about 6 months antibody levels fall and fall quickly, which is why the autumn booster vaccines are being rolled out. Some people’s immune systems unfortunately don’t create antibodies to SARS-CoV-2 or to the vaccine and these are generally older people or those who are more clinically vulnerable.
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 from BioSure 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. BioSure is proud, as a British company, to be launching a first-in-world, gold-standard product that empowers people to test confidently on their own terms.”
The BioSURE COVID-19 Antibody Self Test is now available on-line at www.biosuretest.com for £32.95 which includes free delivery to any UK address. It is also available in a range of community pharmacies.
For more information on BioSure or interviews with Brigette Bard of BioSure, please contact
Suzanne Hobday 07940 534306
Shobday@biosure.co.uk or 0845 222 0012
Notes to Editor
All self-tests require a CE Mark specifically for self-testing use to be legally sold, and COVID-19 self tests are no different. The process of obtaining a CE mark is far more rigorous than for professional use tests and requires evidence that an untrained user can perform the test and read their own result with the same level of accuracy as a trained healthcare professional. The current antigen lateral flow tests distributed by the government are not CE marked for self-testing but have been given derogation for self-use by the MHRA.
The BioSURE COVID-19 IgG Antibody Self Test is proven to have specificity of 99.7% (how many times it will correctly give a true negative result) and sensitivity of 98.2% (how many times it will correctly give true positive result). It will detect neutralising antibodies post 14 days of an infection or 2nd dose of the vaccine.