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COVID-19 antibody home test is now available

COVID-19 antibody home test is now available

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, 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. 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.”

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 UK Ltd or interviews with Brigette Bard CEO of BioSure, please contact

Suzanne Hobday   07940 534306

Shobday@biosure.co.uk or 0845 222 0012

User video - https://www.youtube.com/watch?v=FlkVOUHOzFY

Notes to Editor 

All self-tests require a CE Mark specifically for self-testing use to be legally sold, and COVID-19 selftests 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. 

 

BioSure (UK) Limited is an award winning UK diagnostic company, specialised in developing and manufacturing high-risk self-tests. The BioSURE HIV Self Test was the first CE marked HIV Self Test and launched in 2015.It is now sold across 4 continents, letting people across the world know their own HIV status in minutes, on their own terms. This year they received the Queens Award for Innovation.

BioSure – “Our success has been built on our consumer responsive approach - everything we do is designed and refined with the unique needs of our customers in mind. We truly believe that selftesting will revolutionise disease diagnoses in our lifetime and we are committed to playing a significant role in both ending the HIV epidemic and the COVID-19 pandemic with this power and  knowledge.”

 

Brigette Bard – Founder & CEO 

Brigette has carved a successful, entrepreneurial career in the FMCG sector. Based on her experience with pregnancy testing, she founded BioSure in 2011 and launched the world’s first blood-based HIV Self Test six years ago; carving out a space with end users, utilising ground-breaking technology. She is passionate about the role HIV self-testing has to play in allowing people to make informed choices and assume responsibility for their own healthcare. She is actively and dynamically involved in normalising the conversation around HIV, changing the way people think about the virus, breaking down stigma, but also nurturing understanding around confident sex and sexual health in the fight to end the HIV/AIDS epidemic by 2030. 

Brigette’s ability to communicate with multiple stakeholders, ranging from governments through to the individual consumers, demonstrates her dedication to making self-testing accessible to everyone

and to ensure everybody has the option to know their status, on their own terms. It is through the on-going growth and learnings of self-testing, in such a challenging arena, that Brigette and the BioSure team turned their joint expertise and pivoted their knowledge to COVID-19 testing. BioSure has developed a range of world class in-vitro diagnostic products, including the BioSURE COVID-19 IgG Antibody Self Test. 

https://www.youtube.com/watch?v=OGu4X_Omfw8

 

 

Gary Carpenter – Director & Clinical Director 

Gary Carpenter is BioSure’s Clinical and Regulatory Affairs Director. His wide-ranging design, medical and business experience have given him the skills to lead development of BioSure’s innovative products, that provide dynamic, cost-effective, robust and reliable testing solutions to countries and governments across the world.

Gary’s unparalleled knowledge and understanding of the global regulatory landscape, has supported millions of people across the world know their HIV status in minutes, meaning people have been able to access treatment sooner and reduce transmission, providing a cost-effective method for healthcare everywhere. This unique knowledge and experience has resulted in BioSure’s unrivalled global expertise in self testing for the past 6 years continuously delivering real results in real time.

Pivoting his expertise, Gary has been responsible in leading the development of BioSure’s latest world-first product - the BioSURE COVID-19 IgG Antibody Self Test, which will help people to know their COVID-19 neutralising antibody status from a previous infection or vaccine response in just 20 minutes, so they can make better informed choices on their own terms and restore confidence by understanding their current protection to the virus.