Frequently Asked Questions - COVID-19

A COVID-19 Antibody self-test must be specifically CE marked by a Notified Body as a self-test for use by people who are not trained. Keep an eye out on the packaging, as the Notified Body number must be stated under the CE mark log. The BioSURE COVID-19 IgG Antibody Self Test is specifically designed and CE marked for self-testing, and is designed to detect neutralising antibodies to SARS-CoV-2 (the virus that causes COVID-19) at home or wherever is convenient for you.

 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 

Firstly, other antibody rapid tests that are available are not CE marked for self-testing. Secondly, there are two main different types of antibodies – nucleocapsid antibodies (which appear after an infection) and spike antibodies (which appear after an infection or vaccination) which are the neutralising IgG antibodies – the ones that are important for you to know your status about. Most antibody rapid tests, especially those manufactures in China, only detect the nucleocapsid antibodies which you do not produce from vaccination. Our BioSURE IgG Antibody Self Test detects the IgG spike antibodies that bind to the SARS-CoV-2 spike protein, which is the part that the virus uses to infect human cells. This is why they are called neutralising antibodies. The BioSURE COVID-19 IgG Antibody Self Test  holds more significance owing to the neutralising capabilities of IgG antibodies (as opposed to detecting antibodies to the Nucleocapsid protein).

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.

Extensive research has proven that our test is extremely accurate when performed correctly.
  • Clinical sensitivity (how reliably the test will give a true positive result for people who have detectable levels of antibodies to SARS-CoV-2) 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 (how reliably the test will give a negative result for people who do not have not neutralising antibodies to SARS-CoV-2) of at least 99.7%. This means that on average only three in every one thousand people who test but do not have neutralising antibodies will be incorrectly identified and get a false positive test result.

Because our test is specifically CE marked for self-use and is proven to be easy to use, accurate and effective. Very importantly, it also has a special in-built feature called a sample control line, which means that the negative (control) line can only appear if you have performed your test correctly, including adding enough blood. Most other lateral flow tests do not have this special in-built feature, so you have no way of knowing. If you get one line (the control line) on your BioSURE self-test you will know that you have performed your test correctly and applied enough blood – so you can be confident in trusting your result.

Self-sampling entails taking quite a large volume of your own sample of blood (400-500 microlitres) from finger pricks into a blood collection tube and sending the sample off to a lab for analysis. Your result is then sent to you a few days later. A self-test means you will perform your own test and you will get your own result while you wait. The BioSURE COVID-19 IgG Antibody Self Test requires only 2.5 microlitres of blood and the test come complete with a very fine, paediatric gauge, single use lancet. 

With the BioSURE COVID-19 IgG Antibody Self Test, you will get your own result after 20 minutes.

Your test can be ordered on-line here (insert link to buy page) and delivered directly to an address of your choice. Standard postage and packing is included in the price of your test. Alternatively, there are many independent pharmacies that may stock on shelf.

COVID-19 antibody testing is becoming increasingly relevant for COVID passports, entry to venues etc. but is also important to know especially in intergenerational meetings and for people at higher risk. Knowing your antibody status can help you make more informed choices and decisions, whether you have a positive or negative test result – you are always better to know.

We are still learning about COVID-19 and especially how long antibodies can last whether through natural infection or immunisation. We do not that antibody levels decline over a period of time and current evidence suggests that neutralising antibodies should remain detectable for at least 6 months

If you would like to know whether your body has produced neutralising antibodies to COVID-19 due to a previous infection or post vaccine and get your results while you wait from a fraction of a drop of blood, then self-testing is a good choice for you. There are some people who don’t like the idea of self-testing and laboratory tests are available. At BioSure we are passionate about giving you choice – so you can choose what is suitable for you.

All BioSURE Self-Test devices have an inbuilt sample control line, which means your negative (control) line can only appear if you have put enough blood onto the test.  This means you can know that you have performed your test correctly. If there are no lines on your test and you have pushed the tip right down to the bottom, then either you haven’t added enough blood or something hasn't worked properly. You will know that something has not worked and you will need to test again with a new test device.

You may see a faint red mark at the very bottom of the test strip – this is simply where the solution of the buffer and your blood sample has migrated up the strip. It is not a line and is nothing to worry about. The lines can only appear in the exact positions where they are sprayed onto the strip.

A positive test result shows you have detectable levels of neutralising antibodies in your blood, that your body has generated due to either a previous infection or from vaccination, or from both.

  • You may test positive for antibodies even if you have never had symptoms of COVID-19 or have not yet received your COVID-19 vaccine. This can happen if you had an infection without symptoms, which is called an asymptomatic infection. It is recommended that you get your vaccination even if you have already had COVID-19, as it can help your body make even more of these antibodies.
  • Sometimes a person can test positive for SARS-CoV-2 antibodies when they do not actually have detectable levels of neutralising  antibodies. This is called a false positive and our data suggests that this may happen for up to 3 in every 1000 people who use our test.

A negative test result means you do not have detectable levels of neutralising antibodies. This could be because you have not had COVID-19 infection or yet received full vaccination. It could also be because you are still in the window period (link to other FAQ) and have not yet produced antibodies.

Not everyone who is infected with COVID-19 develops IgG antibodies and it can depend on your viral load (how much of the virus you had when you were infected) and the strength of your primary immune response. It is estimated that about 5% needs link to data( GC)  of people do not develop antibodies following infection. Most people do produce detectable antibodies after full vaccination, however there are some people do not

Your test has been validated to prove you’re your result will remain stable for one hour, however because your test uses whole blood, there are lots of particles that can cause staining and blocking in your test strip over time, so you should not read your result after more than one hour.

Even though there is still not enough knowledge to claim that COVID-19 IgG neutralising antibodies provide immunity, we do know that they can provide protection against severity of symptoms. Even if they do provide immunity, it is not clear how long this immunity will last. Knowing your status, means you will know whether or not your have detectable levels of neutralising antibodies so you can make better informed choices and decisions. We have had many people in contact with us and one chap wanted to volunteer in a vaccine centre but when he found out he did not have detectable levels of neutralising antibodies, decided to wait until he had had his second vaccination. Another older lady, who had had both vaccinations, was still too nervous to see her family, but when she knew she had detectable levels of neutralising antibodies felt far more comfortable in seeing her grandchildren. Either way you are better to know.

To protect your privacy a sealable, opaque polythene bag is included with your test. Place all the components back into the box, place this into the bag and seal. You can throw the bag away discreetly with your usual rubbish.

BioSure has partnered with PocDoc to create an app as a companion to the BioSURE COVID-19 IgG Antibody Self Test so that you are able to keep a record of your result and also get a time-stamped pdf certificate. The app is fully certified, GDPR compliant and available on IoS and Android. All data is held securely by PocDoc for one month and any reports are generated in an anonymised and aggregated format. Finally, the app also gathers feedback from users about their BioSURE test so that we can continue to learn and deliver the best possible test with the best possible user experience and customer service. Post-market surveillance is a vital point of concern for regulators who are especially worried about people performing their own tests. 

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.

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.

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

Most of the approved COVID-19 vaccines are currently mRNA vaccines, 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.  

Not all vaccines require two shots, however the COVID-19 vaccines approved in the UK and Europe (Oxford-AstraZeneca, Pfizer-BioNTech and Moderna) do all require two doses. Basically, the first dose starts the process of triggering your immune system to start the process of building up protection by introducing it to the spike protein and then the second dose reinforces the protection. There is a gap in the middle of the two doses as some time is needed to allow your body to process the vaccines  properly. 

We are still learning about COVID-19, antibodies and immunity and there is a lot of ongoing research. We do know that antibody levels decline over a period of time, so it may be that if you had a COVID-19 infection some time ago then you may not still have detectable levels of neutralising antibodies. Evidence generally points to about 6 months, but this can vary quite widely between people and is dependent upon a number of factors including age and general levels of health. Generally the B cells that are made in your bone marrow and which go on to produce neutralising antibodies have a memory. There is also ongoing research to see how B cells are responding to historical infection, vaccination and mutations in the virus.

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.

The answer is we can’t be absolutely sure yet, but the general answer is yes (insert European CDC link) B-cells and T-cells are the cells are able to recognise a pathogen that has been presented to them before and they start to replicate millions of times to defend your body.  Quite cleverly, B-cells swallow the virus and start producing the correct antibodies and T-cells help them by seeking and destroying the pathogen and also sticking to the B-cells to help them ramp up antibody production.

Clinical sensitivity means how reliably the test will give you a true positive result, ie you have detectable levels of antibodies to SARS-CoV-2 and you will correctly get a positive test result – how sensitive the test is at finding the thing it is looking for, if it is there. Your BioSURE COVID-19 IgG Antibody Self Test has been independently evaluated and has a sensitivity of 98.2%  which means that, on average, 982 in every one thousand people who have neutralising antibodies will be correctly identified and get a positive test result.

Clinical specificity means how reliably the test will give you a true negative result when you do not have neutralising antibodies to SARS-CoV-2 and will not be triggered to give you a false positive result by wrongly identifying another different type of antibody, such as flu. – ie how specific the test is. Your BioSURE COVID-19 IgG Antibody Self Test has been independently evaluated and has a specificity of at least 99.7% (CI: 99.1-99.99). This means that on average only three in every one thousand people who test but do not have neutralising antibodies will be incorrectly identified and get a false positive test result. This is the highest risk incorrect result as a person would wrongly assume that they had neutralising antibodies when in fact they didn’t.

You will find it at the top of your test device, at the other end from the tip. Remove it and place it in the tray.

It needs to be foil side up to fit in the hole and is a snug fit. 

The lancet is designed to only work once. You may have already clicked the lancet by mistake.

Not really. It is best to take the sample from the side of the tip of your finger as there are less nerve endings there.

No, the blood will be the same from whichever finger you take it from.

The device automatically sucks 2.5μL of blood into the tip by capillary action. You can see when the tip has filled with blood.

The test is designed to run standing upright. The test may not run properly if it is left laying down.

You will get your test result in 20 minutes. You should not read your test result more than one hour after running your test. This could give you an incorrect result.

The test is designed to run standing upright. The test may not run properly if it is left laying down.

Stand it up as soon as possible. Your test should still work. You will know that your test has run correctly by the appearance of the Control Line after 20 minutes.

You will get your test result in 20 minutes. You should not read your test result more than one hour after running your test. This could give you an incorrect result.

Sometimes the solution can migrate above the absorbent pad on the test and is nothing to worry about. The lines can only appear in the exact place they are shown in the packaging.

The BioSURE COVID-19 IgG Antibody Self-Test has an inbuilt Sample Control Line to show that the test has run correctly. If the Control Line does not appear, your test has not worked. This is known as an “invalid” result. Please discard your test and retest with a new device. If the control line appears, you know that the test has run correctly.

Make sure the green wording is facing towards you when you place the test device into the cut-out shape in the box. 

The lines on your test can vary in strength and intensity and any line should be read as a line, regardless of how faint it is. Two lines is a positive test result.

To dispose of your BioSURE COVID-19 IgG Antibody Self-Test, place all components back into the box and throw away with your normal household rubbish. Not suitable for recycling.

There is nothing harmful in the test that can cause infection or injury to the user and others, including pets. The buffer solution contains an antimicrobial agent that means that any microbes in the blood sample will be neutralised and is why the test can be disposed of in household waste.

The expiration date of the test can be found on the bottom of the white tray or on the back of the white sleeve. The batch code can also be found here.

Research shows that antibodies decline over a period, so really it is up to you. Evidence generally suggest that detectable antibodies should last for about 6 months, however this varies between people and depends upon lots of things including the strength of your original immune response, age and your general level of wellbeing. We have subscription packages available and so you can buy discounted tests sent to you as regularly as you choose. (needs link BB/GC)

The tip of the device must be fully inserted into the buffer pot for the test to run. Make sure the tip has been pushed right to the bottom of the buffer pot. You may need to push quite hard until it won’t go in any further.

Coronaviruses are a family of common viruses that can cause an infection in the nose, sinuses and throat in animals and humans. They usually cause mild colds in humans, but SARS (severe acute respiratory syndrome China 2002-2003), MERS (Middle East respiratory syndrome 2012) and SARS-CoV-2 (serious acute respiratory syndrome 2) can cause severe disease.

SARS-CoV-2 (severe acute respiratory syndrome 2) is the name given to the virus leading to the disease called COVID-19. As the name suggest, SARS=CoV-2 is genetically connected to SARS-CoV which is the virus that caused the outbreak of SARS in 2002-2003. ‘CO’ stands for ‘corona’, ‘VI’ stands for ‘virus’, and ‘D’ is for disease. The 19 stands for the year it was discovered – 2019.

SARS-CoV-2 enters the body when people breathe in contaminated droplets in the air, often produced by coughing or sneezing. A spike (S) protein on the outside of the coronavirus membrane binds to receptors on cells in your body called ACE2, which are most commonly found on cells in your nose, throat and lungs, hence the respiratory infection.

There are a number of things you can do to reduce your risk of catching COVID-19 or spreading it to other people. Vaccination is one way but meeting people outdoors if possible and wearing a mask when it is hard to stay away from other people in crowd can also help. Washing your hands with soap and water regularly throughout the day is a really good method of infection control and if you can, avoid touching your eyes, nose and mouth, especially if your hands are not clean

The main symptoms of COVID-19 are generally stated as having a high temperature, a new and continuous cough and a loss of your sense of taste and smell, but many other symptoms are listed including for some, shortness of breath or trouble breathing, tiredness, headaches and muscle aches and a sore throat. If you have any symptoms, you should get tested. We do know that up to one third of people infected with  COVID-19 may not get any symptoms. 

The SARS-CoV-2 virus is covered in spikes and by using the protein that is on the surface (the spike protein or SP) it binds to a special place (called the receptor binding domain or RBD) in cells in your body called ACE2 cells. These ACE2 cells are generally found in your nose, throat and lungs which is why the infection is spread through coughing and sneezing.

An antigen test tells you if you have current infection and requires a swab from your throat and nose (nasopharyngeal or anterior nasal) You need this type of sample because this is where the antigen (virus) will be found. An antibody test will tell you if you have antibodies, which your immune system will have produced from either being infected or from vaccination. There are different types of antibodies, and the BioSURE COVID-19 IgG Antibody Self Test only detects neutralising antibodies, which are the type of antibody that give you protection. You need to use blood for an antibody test as this where antibodies are found.

You should use an antigen test if you are showing symptoms of COVID-19 or you think you may have been exposed to the virus. An antigen test, or a lateral flow test as the government are currently calling them, will only give you a positive test in the first week or so after infection. You should use an antibody test to see if you have had an immune response either from infection or vaccination, or if you want to see if you still have detectable antibody levels from an immune response some time ago

Most professional use antibody tests look for 2 different types of antibodies – IgM and IgG. IgM are the type that fight the current infection, so they are present towards the end of infection and then drop off quite quickly, because there is no virus left for them to fight. IgG antibodies are the type that stay in your body after infection, but they do wane over time and the amount of them can vary depending on your immune system and things like how severe your infection was. There are also different types IgG antibodies and the neutralising type are the ones that target the spike protein of the virus, as these stop it from being able to enter cells. These are the type of antibodies detected by your BioSURE test.

The spike protein is the basis of the current COVID-19 vaccines as they make your body have an immune response to it, so that your body recognises it again in the future. It generally takes a couple of weeks after your second vaccination. Some people do have an immune response after their first vaccine, but from the samples we have been working with, these tend to be people who had already had COVID-19 infection before their vaccination.

The SARS-CoV-2 virus is covered in spikes and it uses these spikes to attach to and infect cells. In simplified terms. a neutralising antibody works by targeting the spike protein and acting almost like a shower cap by blocking the spike from entering the cell. 

The new mutations, or variants as they are sometimes called, of the virus have shown some changes in the spike protein, which can affect how transmissible they are. The spike protein is also the basis of the current COVID-19 vaccinations, which is why there are such high levels of concern and they are being studied so closely.