BioSURE COVID-19 ANTIBODY SELF TEST
Understanding your antibody status can help you make more informed decisions about your well-being and health risk.
The BioSURE COVID-19 IgG Neutralising Antibody Self Test is Europe’s first CE marked true self test that detects protective neutralising antibodies made as a consequence from SARS-CoV-2 (COVID-19) natural infection and as an immune response to vaccination.
The BioSURE COVID-19 IgG Antibody Self Test is supplied as a complete kit, with all components.
- Requires only a fraction of a drop of blood (2.5μL finger prick)
- Result in just 20 minutes
- In-built true sample control line that will only appear if sufficient blood is applied to the test.
- 98.2% sensitivity and 99.7% specificity
- CE Marked by independent Notified Body specifically for self-testing
- Developed and manufactured in the UK
It is now accepted that antibody levels decline over a period of about 6 months, whether your immune system has created these in response to either natural infection or vaccination.
The number of cases is now back on the rise, with the number of infections in fully vaccinated people rising steadily, currently at about 30% of all cases.
Knowing whether you have protective antibodies is more important than ever. The strength of the positive line on your test can vary and some can be quite faint, but the strength of your line does correlate to the amount of antibodies in your blood and even a faint line means there are detectable levels of neutralising antibodies, giving you a 50% reduced risk of suffering severe symptoms.
Why test for Antibodies?
When a person has recovered from COVID-19 infection and/or has received COVID-19 vaccination, their body produces antibodies. IgG antibodies are retained and ‘neutralising antibodies’ are created. These neutralising antibodies offer protection from COVID-19 infection as they block the spike on the outside of the virus from being able to enter and infect cells.
- Suitable for testing for neutralising IgG antibodies from 14 days post infection/vaccination.
- It is confirmed that Covid-19 IgG antibodies decline over a period of time.
- The only way to know your status is to regularly test.
- Knowledge is power and understanding your status can help you make better informed choices.
- Routine testing is recommended to regularly monitor your levels of protection.
How does it work?
The BioSure Covid-19 IgG Antibody Self Test is incredibly simple to use.
- Prick your finger.
- Collect just a drop of blood collected using a novel barrel design that collects the correct blood sample size.
- Poke the testing device into the pre-filled buffer pot.
- Then wait 20 minutes for the results.
Detailed instructions on the testing process and how to read the results are all available in the uniquely designed box.
Still not sure how it works? Why not watch the video on how to perform the test below.
Clinical sensitivity means how reliably your test will give you a true positive result if you have detectable levels of neutralising antibodies to SARS-CoV-2 in your blood.
Your BioSURE COVID-19 IgG Antibody Self Test has a proven sensitivity of 98.3%. This means that, on average, 983 in every one thousand people who have neutralising antibodies will be correctly identified and get a positive test result.
Clinical specificity means how reliably your test will give you a true negative result if you do not have detectable levels of neutralising antibodies to SARS-CoV-2) in your blood
Your BioSURE COVID-19 IgG Antibody Self Test has a proven specificity of at least 99.7%, meaning on average only three in every one thousand people who test but do not have neutralising antibodies in their blood will be incorrectly identified and get a false positive test result.
Frequently Asked Antibody Test Questions
What is the antibody test for?
Does this test tell me if I currently have Coronavirus infection?
No – this is not a test to measure whether you currently have an infection. This is solely to test whether you have neutralising antibodies or not.
How long does it take for the results to show?
The process of taking a finger-prick blood sample and performing the test will take just under 20 mins (the test takes 15 minutes before it can be read)
What does the antibody test involve?
You will need to produce a small blood sample using a sterile lancet that is enclosed within the test kit. The lancet pricks the side of your finger and you massage a small amount of blood into the collection well. Full instructions are supplied with the test kit
Should the test be supervised?
No, they are licenced for self-use and the instructions come with the test (with a video to help). If you need help with the test from one of our online specialist nurses please arrange a nurse only appointment on the website, and wait to do the test with them.
What are the benefits to taking the antibody test?
The test may provide you with information that could provide peace of mind. Should the test provide a positive result it’ll give you the knowledge that you have antibodies in your system. However, presently the test is for personal information only, and the result would not change what you can do. You are still required to follow all government guidelines.
Can someone do the test for me?
No. Someone cannot complete the test on your behalf. However, you could ask someone to help you with the finger-prick should you not be comfortable doing this yourself.
Does the test have a CE Mark?
Yes, the test is CE marked for self-test for use in the United Kingdom and the European Union (EU).
What are neutralising antibodies?
Neutralising IgG antibodies are the antibodies that target the spike of the SARS-CoV-2 virus so that it cannot enter the cell it is trying to infect and therefore the virus cannot replicate. They can also help stop the virus from changing, which are known as conformational changes that help it improve how it enters and replicates within a cell. They are different from binding antibodies which they work alongside with, which bind to the virus and then alert your immune system so it can produce white blood cells to fight the virus off. Neutralising antibodies are made by B-cells which are made in your bone marrow
Why should I wait until 2 weeks after my symptoms started for my negative test result to be reliable?
People produce antibodies at different rates and at different times after becoming infected. Most people have made these antibodies within 10 days and around 95% of people in 17 days, some people produce them much later. It is thought that around 5% of people will not create detectable levels of antibodies.
Do you always get antibodies after infection or vaccination?
No, not everyone will get an immune response, and some will not develop antibodies.
Does it tell me the number of antibodies I have?
No, the test just detects the presence of antibodies
Can I be infectious if I have antibodies?
We are presently unsure if this is the case. We know that re-infection with COVID can occur.
How long do antibodies remain in your system?
Presently we are not sure how long antibodies remain in the body, research is ongoing and we will keep our FAQs updated
Is this a government approved test?
Presently there are no Government approved tests, but these tests fulfil the Government’s target Product Profile for Neutralising Antibody Tests for Coronavirus. It has a CE mark for self-use in the UK
Do I still need to follow the government guidelines if I have antibodies?
Yes, whatever the result of the test, you have to continue to follow all government guidelines
Can I still catch COVID if I have antibodies?
This is still unknown but thought unlikely to cause serious infection, however, you could still be at risk of spreading the disease
Does it mean I am immune?
The test will only tell you if you have neutralising antibodies. The test does NOT tell you if you are immune or if you can or cannot spread the virus to other people
How does my neutralising antibody test work?
The technology we use is very similar to a pregnancy test and is commonly called ‘lateral flow’ (because the solution of buffer and sample flow laterally along the test strip), but our self-test detects specific neutralising antibodies to SARS-CoV-2 in your blood sample. When your body detects something harmful (like a bacteria or a virus) your immune system begins to produce antibodies to try and defend your body. Each type of antibody is unique, and everybody makes them at different rates.
Do I develop antibodies after asymptomatic infection?
Yes, up to 30% of people can have COVID and be asymptomatic, and this test would demonstrate you have been previously exposed, and your body has mounted an immune response
Does the test always work?
No, there is a small chance (less than 1% with all the lateral flow devices) that the test will not work. If this is the case, please contact Customer Service and we will send you a new test free of charge.
How accurate is the test?
Compared to lab-based tests (ELISA – the current gold standard). The sensitivity is 99.48% and specificity is 98.85%.
How long after infection or vaccination before I develop antibodies?
The average time to develop antibodies after the onset of infection, or vaccination, is roughly 2 weeks. We recommend a minimum of 2 weeks before taking the test, and the majority would have antibodies by 3 weeks.
Does it prove I have had the infection or vaccination?
It would suggest you have either been previously exposed to the virus or had a vaccine, which has enabled your body to mount an antibody response.
The test will not differentiate between immune response mounted in response to infection or vaccination, just your body has mounted a response
Does it tell me whether I currently have antibodies?
Yes, it does show whether you have neutralising antibodies to SARS-CoV-2 but not the concentration of antibodies in your system
Why do antibodies decline over time?
It is quite natural for antibody levels to decline after a person has recovered from a disease, as there is no longer a pathogen (because it has been defeated) to keep them stimulated, but your immune system does have a memory. These are called T-cells and B-cells which are the cells that learn about the pathogen so that they can protect you in the future by producing the appropriate, specific antibodies.
What is the antibody ‘window period’?
This is the time between infection and when your test can correctly give a positive result. During this period someone who has been infected with COVID-19 could get a negative test result if they have not produced enough antibodies to the virus.
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.
How does the Covid-19 vaccine work?
Most of the approved COVID-19 vaccines are currently mRNA vaccines https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html, which are a new (but not unknown) type of vaccine. mRNA vaccines do not use live virus so it cannot give you COVID-19 and messenger RNA (orMRNA) is genetic material that tells your body how to make protein that will trigger an immune response. When you are vaccinated with COVID-19 mRNA it teaches your immune system how to make copies of the spike protein, so that if your body is exposed to the actual virus it will recognise it and know how to fight it off.
What is the difference between a Covid-19 antigen (Swab) test and a Covid-19 antibody test?
A COVID-19 antigen test tells you if you have the virus at the particular time of testing (that is why you need to use it for things like travel and event entry) Generally these types of test need a throat or nasal swab sample and there are two main types of antigen test – a PCR test which is performed in a lab and a rapid test (now commonly known as a lateral flow test or LFD) that gives you your result in about 30 minutes. An antibody test tells you if you have antibodies.
What are the 2 different lateral flow tests for antibodies?
Sandwich assays – A positive test is represented by the presence of a coloured line at the test line position. This is the BIOSURE self-test
Competitive assays – A positive test is represented by the absence of a coloured line at the test line position.
Still have Questions?
Should you require any additional assistance or information you can contact us on 0203 677 0009 or send us an email using our Contact Form.