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Tell me more about my test...

The BioSURE COVID-19 IgG Antibody Self Test was developed and is manufactured in the UK. It is the first home test to gain independent Notified Body CE marking, specifically for self-testing.

We have data for our test performance against all the main variants and also the main vaccines used in the UK and Europe.

We have a proven specificity (how many times you will get a true negative, ie you will not get a false positive) of more than 99.7% and a proven sensitivity (how many times you will get a trues positive, ie not get a false negative) of 98.2%

We have also evidenced that our test is super simple to use as it only requires 2.5 microlitres of blood (literally a fraction of a drop) and it gives you your own result in 20 minutes.

What's not to like!


What does the BioSURE COVID-19 IgG Antibody Self Test detect?

Our test does not detect the SARS-CoV-2 virus directly, it detects neutralising IgG antibodies specific to the virus that are made by your body as part of your immune response, from either recovery from infection or vaccination.

IgG antibodies can take up to 14 days to appear and stay in your body for some time. Because the virus and the vaccine are so new, we are still learning about what levels of IgG antibodies are needed to give you immunity.

Nobody is sure yet how long these neutralising antibodies last for, but we do know that they decline over a period of months, which is why it is so helpful to test regularly and know what your antibody status is over time.

What is an antibody?

Antibodies are specialised proteins that your immune system produces in response to a foreign substance.

They work like a lock and key and in the case of the coronavirus, the neutralising antibodies blocking the spike on the outside of the virus, to prevent it being able to enter and infect your cells.

It takes your body a little while to make these, so we recommend you do not test until 14 days after your infection or second
vaccination.

SARS-CoV-2 Infectivity and variants

Since the reporting of several cases of pneumonia in Wuhan City, China to the World Health Organization (WHO) in December 2019, the novel coronavirus, known as SARS-CoV-2 which causes the infection now known as COVID-19, has infected hundreds of millions of people, causing a global pandemic.


COVID-19 is primarily spread via respiratory droplets, when an infected person coughs or sneezes. Most infected people experience some flu-like symptoms such as fever, coughing, loss of taste or smell, muscle pains and fatigue. The new Delta variant also includes a runny nose and sneezing, especially in those fully vaccinated.


More than 5 billion doses of vaccine have been administered, but the rapid development of new strains of the virus mean we are are continually developing our understanding of how symptoms and transmission are changing. We do know that those who have been vaccinated do experience less severe and sometimes different symptoms.




Knowing anything that is going on in your own body is important as it helps you to make informed choices that are right for you.

No vaccine is 100% effective. AstraZeneca state their own vaccine demonstrates a 70.4% efficacy at preventing symptomatic COVID-19 after a second dose and the UK government state an effectiveness of around 85-90% after the second dose of Pfizer-BioNTech vaccine.

It is now known that antibody levels decline over time, with them declining rapidly by about 6 months.

Knowing whether or not you currently have neutralising antibodies can help you make decisions with confidence, be that socialising, travelling, going back to work or seeing loved ones.

Why BioSure?

The BioSURE COVID-19 IgG Antibody Self Test uses the same novel barrel testing device that automatically collects the correct blood volume as our BioSURE HIV Self Test - the world's first approved HIV self-test to use blood.

Our test also has a special inbuilt sample control mechanism that means your control line can only become visible if you have applied enough blood. This is the only way you can know you have performed your test correctly and trust your result.

With over 6 years of unique infectious disease self-testing experience, you can trust BioSure.

Vaccines

We've explained above what an antibody is. The first time you get infected it takes a while for your body to recognise the infection and produce the antibodies needed to fight it. Once you have had an infection, your body remembers what it learned the first time that it had to protect your body.

The vaccines that are currently approved in the UK are called mRNA vaccines and they contain a small piece of the SARS-CoV-2 stimulates your body to think it has been infected and produce neutralising antibodies. Then when your body is exposed to it again, it knows what it has to do.

The reason you might have a fever or feel a bit unwell after a vaccine is because your body is starting to build the antibodies by having an immune response.

Mutations

Your body produces different types of antibodies that perform different jobs. The protective IgG antibodies our test detects are the ones that target the spike protein (this is how the virus gets into your cells and infects them)

Although there are many mutations of the SARS-CoV-2 virus happening globally, similarly as happens with flu every year, fundamentally the spike cannot mutate into something else or the virus would no longer be SARS-CoV-2, it would be a different virus. Our BioSURE self-test detects IgG antibodies to the full trimeric spike protein. These are your protective antibodies.

The BioSURE COVID-19 IgG Antibody Self Test has been evaluated to make sure it detects the antibodies from each of the main variants identified so far and we will continue this validation as new strains are identified.