Bleed Tips

Frequently Asked Questions

Can the BioCard detect if my Vaccine worked?

Yes. The successful vaccines all produce immunity by mimicking infection to trigger the immune system to produce spike antibodies.

Because the  COVID-19 BioCard works differently from other technologies, it has been proven to be able to detect when a vaccine has worked, and will provide a positive result if it has.

We recommend waiting until after the 3rd week after the vaccination, however is it possible to detect a successful response after 14 days, and the BioCard has done so many times.

A positive result on a BioCard will tell you that you have generated spike antibodies which have been proven to provide immunity to the virus. It is not yet established if this is sterilising immunity.

The vaccine does not result in the generation of spike antibodies in everyone, and may fail to more commonly in specific age groups. A negative results strongly suggests no antibodies have been generated in response to the vaccination, providing no evidence of immunity. If a vaccine fails, alternative strategies should be discussed with your doctor, who may recommend an alternative vaccine be tried which has showed greater success in certain age groups, or recommend a booster. In either case, waiting at least 3 weeks before another test is recommended.

How accurate was the BioCard™ in validation studies?

In order to CE mark a test such as the COVID-19 BioCard™, many months of research and repeat testing is required. A total of 258 diverse samples from different people from Europe and the USA were collected and analysed in our laboratories. Of these, 72 were found to be true positives, and 186 were found to be true negatives. These were cross-referenced with other laboratory test results (some of which utilised Public Health England (PHE) accredited systems where available), as well as other data such as PCR test results and clinical data.

The 1st and 2nd generations of the device were never released as validation data was less than 98%. Having identified why we made further changes which resulted in the third generation BioCard™.

The current, 3rd generation of the COVID-19 BioCard™ matched all positive samples 100% correctly and identified 99.5% of negative samples correctly.

We have therefore concluded that in operation >99% sensitivity and >99% specificity may be attained when administered correctly and all instructions are correctly followed. No test can guarantee perfect results 100% of the time, as there is always the possibility for error for a variety of reasons.

Be sure to use a test that is both sensitive (meaning it will detect the antibodies) and specific (meaning it will detect only antibodies to SARS-CoV-2).

How long do spike antibodies last from natural exposure or vaccination?

Our own data based on the highly sensitive BioCard, has found most people maintain spike antibodies from natural exposure for over a year, and often at moderate levels in younger people.

Because vaccines haven’t been in use for as long, we cant be sure they will last this long. Where very weak levels are attained, we have seen spike antibodies appear in circulation and fall away in cases where a second vaccine has not been then given to boost the outcome at 3 weeks.

Stronger results will most likely last longer than weak ones.

How long can the BioCard detect spike antibodies from natural exposure?

In our own validation studies, where we have been able to take subsequent blood samples, in all cases the spike antibodies persisted. No one repeat tested has been found to have ceased producing the spike antibodies that the BioCard detects.

The earliest patients reported to have clinical symptoms and subsequently found to have specific antibodies, are from February 2020. One year on, (and counting), we are still detecting circulating spike antibodies from patients with clinical symptoms of COVID-19. It is therefore not too late to establish if symptoms consistent with COVID-19 were from SARS-CoV-2, and record a history of immunity before the antibodies fade and become undetectable. 

To confirm the continued presence of any antibodies, retesting at regular intervals will confirm the ongoing presence of the SARS-CoV-2 virus spike antibodies detected by this test.

What’s included in the service?

When you use the service, you will receive:

The bleed kit which contains everything you will need and will be sent to your nominated address. Purchasing the service includes the cost of P&P to you and contains a special return pack with prepaid postage for each person using the service. (please only return one sample per return pack).

Once you return your sample, we will process your blood, and then run the serum we obtain on the Covid-19 BioCard. Once our professional laboratory has finished testing your sample, we will upload your results for you to view in your account online. We will also email your results to your registered email address.

To help guide you every step of the way, we will also provide you with instructions so you know what to do in a simple, clear way.

Is this the “have I got it now” test?

No. To find out if you are likely to currently be infected with the virus, you would need to utilise a PCR or equivalent test.

Please do not use this service if you think you may currently be infectious.

The COVID-19 BioCard will not give a positive result until after you have developed immunity.

Is this the “have I had it” test?

Yes and No.

More accurately, this is the “have I developed specific immunity” test.

There has been some confusion over what antibody tests can prove.

The majority of other tests use non-specific proteins which may also indicate a positive result – not to a past infection to COVID-19, but to a virus from the same Beta group of the coronavirus family, of which SARS-CoV-2 is a member.

Using non-specific proteins raises the possibility of a positive result, not for COVID-19, but for past exposure to a common cold.

The COVID-19 BioCard works differently.

It was designed very specifically to use edited proteins which bind only to SARS-CoV-2 and not produce a positive result to the common cold.

Therefore, a positive result on a BioCard will tell you that you have had COVID-19, rather than a common cold, but a negative result cannot (or does not) guarantee you have not had it. This is because a fraction of people don’t appear to produce specific antibodies to SARS-CoV-2, possibly due to fighting off the infection with a generic one prior to needing to.

When should I test for Antibodies?

If you have not had a PCR test but believe you may have had symptoms of COVID-19, wait at least 14 days prior to taking an antibody test.

Day zero is defined as the first day of suspected symptoms and day 14 is two weeks after that.

If you have had a positive PCR result, then wait at least 14 days before using an Antibody test.

As not all PCR positive results are correct, if you have had a false positive result you will not get any antibodies to COVID-19 because you have not been exposed to the virus.

If the PCR positive result was accurate, you may not generate a specific antibody to SARS-CoV-2, because your body was able to utilise a generic one from a previous infection to neutralise the virus prior to your cells generating the specific ones.

For efficient use of the test, as not everyone will necessarily develop antibodies on day 14 specifically, waiting until day 21-28 is recommended. After this, the BioCard™ will detect any specific antibodies present, for as long as they remain.

What does the COVID-19 Antibody BioCard™ test for?

Simply put this is the test, that if positive, tells you that you already had COVID-19 and developed immunity to it.

We know this because the COVID-19 BioCard™ specifically detects antibodies which our research shows only bind to the SARS-CoV-2 virus. Results should not be compared to non-specific tests which may also detect similar Coronaviruses, which may also, for example, include some forms of the common cold.

The BioCard™ was developed to only detect IgG specific to the SARS-CoV-2 virus which causes COVID-19.

Is the COVID-19 Antibody BioCard™ Approved?

The COVID-19 BioCard™ was researched, developed, optimised and manufactured in our laboratories in the Midlands, UK. We are ISO13485 accredited and both the device and the home bleed kits have been validated as part of our development.

Both devices are CE marked, which allows its sale to any country in Europe, including the UK.

I think I had COVID-19, but couldn’t get a PCR test. Can I use the COVID-19 BioCard to see if I’m right?

Yes. If you couldn’t get a PCR test but would like to use the COVID-19 BioCard™ to find out if you might have had COVID-19, you can do so 14 days after you first had symptoms. If you get a positive result, you almost certainly had COVID-19 and have already developed an immune response to fight it off.

Do I need to pay extra for a nurse to come and take my blood at home?

No. The COVID-19 BioCard™  was specifically developed to work with both venous and finger prick blood.

You can still therefore use a nurse if you prefer, but for convenience, you can also take a small amount of blood from your finger tip in the comfort of your own home without needing anyone to visit.

Why test for Antibodies?

Testing of your sample will help find out if you have specific antibodies to the virus that causes COVID-19.

TheBioCard™ tests for antibodies the majority of other tests aren’t designed to look for and therefore fail to detect.

The antibodies the BioCard™ detects are likely to be missed at many NHS testing laboratories and are a more appropriate and specific target to the virus that causes the infection.

If you have been tested for antibodies and not attained a positive result, when wider clinical history suggests COVID-19 exposure, it is possible that you may attain a positive result using this service.

This is because a significant number of laboratory analysers, and all rapid tests, are unable to specifically detect the same COVID-19 specific antibodies the BioCard is designed to.

Consequently, it is entirely possible we could detect antibodies overlooked by a large proportion of NHS testing laboratories.

Do specific antibodies provide immunity?

Our immune systems have evolved to produce antibodies from immune cells in response to infections, such as when we are infected with a virus.

Some antibodies will bind to more than one virus and others are unique to only one specific form of a virus within a group. When these specific antibodies bind to the virus, they are known to resist subsequent infection providing immunity.

It is important to note that SARS-CoV-2 is a new virus, so there has not been enough time for scientifically peer-reviewed papers to retrospectively confirm if the presence of specific antibodies provide “complete immunity”, although specific antibodies have been retrospectively proven to for many other viruses.

Whilst a number of anecdotal stories have appeared, given the global incidence of the disease, it is interesting to note that at the time of writing, very few peer-reviewed papers have suggested patients have been proven to have had a correct positive diagnosis initially, and later been re-infected with the same form of SAR-CoV-2

In part, detection of dead viral particles on PCR which cannot illicit infection, and inaccurate false-positive test results may explain the lack of clarity concerning immunity.

Critically widely used antibody tests failing to detect the “right” antibodies may also be to blame. Therefore, it is also important to note that studies have relied on more generic antibody tests.

To date, no study has been carried out on a large scale which establishes if the specific antibodies detected by the BioCard™ prevent either active reinfection or provide complete immunity.

Similarly, no one is known to have been tested on a BioCard™ and subsequently been found to be positive for specific antibodies and been infected twice. Studies are urgently needed as the outcome may result in a solution to the pandemic in the longer term, as well as clarifying results from studies into vaccination development, which may rely on accurate specific antibody tests to confirm an immune response has been elicited.

In absence of such research, rational insights can be gleaned from the overall data from the pandemic. Given the many millions of infections, if reinfection was common in the presence of specific antibodies, the logical questions are; Why are there so few examples of (possible) reinfection? and; How would RNA vaccines and monoclonal antibodies work, if specific antibodies do not resist the virus?

What does a positive (antibodies detected) test result mean?

This service does not test for active infection. As the antibodies this test detects develop beyond 14 days from symptom onset, it is very unlikely that you would still be actively infected, as you are positive for antibodies that do not appear during the infective phase of the disease.

If you have a positive test result, it is very likely that you previously had exposure to SARS-CoV-2. The presence of the type of antibodies detected by this test, strongly suggests that you have developed an immune response to the virus, and definitively have immunity.

This differs from expressly stating (in the commonly assumed meaning of immunity), that a person has full or complete immunity to SARS-CoV-2, either seasonally, or longer, as this is yet to be proven in peer-reviewed literature.

If you have had a positive BioCard™ result from a previous test and have chosen to retest,  and are still positive, it shows that the antibodies you made have persisted. There is no guarantee of antibodies persisting after the day of testing, but that said, levels will not suddenly fall to zero either. The time antibodies persist will differ from person to person.

When retesting over time, ensure the same BioCard™ test is used again to enable comparative results.

The longer the time between tests, the less likelihood of another positive result following the previous one. Re-testing daily is not recommended. The frequency of testing is up to individual choice, but a sensible guide for retesting could be between 14 days to 2 months after the initial result.

Note; There is always a small chance that this test can give a positive result that is wrong (a false positive result). Always seek advice from a healthcare professional before acting on any test result and if they need further information, guide them to this website.

Who can access the home service at the moment?

Anyone can use the service and have access to the BioCard via a fingertip bleed and return service. Unlike some other laboratory standard tests, we specifically validated the test, and the CE marked bleed kit in combination with it, for this purpose.

To enable our testing service to maintain our high standards, initially we are using these two CE marked products together, with samples processed within our own laboratories to provide access to accurate testing to anyone who wants it. The bleed kit, BioCard and processing of the test, performed by the same company that invented it, are uniquely available here.

Who can buy the test itself at the moment?

We also validated a laboratory version of the COVID-19 BioCard which is CE marked for professional use. Any healthcare professional can purchase the COVID-19 BioCard from us, and use it in an appropriate testing location anywhere throughout Europe.

Healthcare professionals in the UK and Europe who would like access to the test should contact us.

Can antibody tests help take the pressure off PCR testing centres?

Yes. Whereas the result of a PCR test, which tests for the active infection, may only apply to the day the swab was taken (and can produce a negative one day, and a positive the next) results from an antibody test can be relied upon for much longer.

If you have already developed IgG specific antibodies to SARS-CoV-2 then it is very unlikely that live virus will exist, and be therefore result in a negative PCR test result.

This is because the type of antibodies the BioCard™ detects are produced after the window for PCR testing is long gone, are specifically produced after COVID-19 infection, and they do not exist in response to any other virus.

This differs to nucleoprotein antibodies that may pre-exist in response to a common cold and therefore COVID-19 antibody tests that also generate positive results from more generic antibodies are not suitable for this approach.

A positive result on a BioCard™ will therefore confirm that a past infection was COVID-19, and if governments use the technology to mass screen local populations, they can focus on prioritising those people found not to already have antibodies, with one test.

What is the difference between SARS-CoV-2 and COVID-19?

SARS-CoV-2 describes the virus, whereas COVID-19 describes the disease the virus causes.

Antibody Testing, what do we know, and where has it gone wrong?

Some studies have incorrectly inferred test inaccuracy if a patient isn’t found to have detectable antibodies by a certain date.

In reality, when people develop antibodies is a study in itself, but certainly not a test of how accurate an antibody test is.

If a patient has definitely had COVID-19 but hasn’t developed specific antibodies by day 14, the test should show a negative. That is not a fault with the test. The patient has nothing to detect.

Similarly if a vaccine has failed to elicit spike antibodies by a certain time, the test should show a negative result, and the test repeated later or after an additional vaccine has been administered.

Additionally, the majority of tests use blunt proteins that might also detect antibodies to the common cold, inferring an immune response to SAR-CoV-2, which they may have never actually been exposed to, and for which “full” immunity doesn’t actually exist.

New studies, which take into account the relatively high levels of inaccurate PCR results, in combination with antibody specific tests, such as the COVID-19 BioCard, will likely shed new light on the answers to the following questions:

How many people develop specific immunity?

Do people with specific immunity demonstrated on a BioCard™ also have a T-Cell response, and if so, is it the majority of the time?

Has anyone who has developed specific immunity ever been later found to have been re-exposed, but not reinfected?

Many of the answers to these and more questions are already known, or can logically be deduced.  Nonetheless, further research is essential to definitively conclude the facts, so that immunity passports and positive actions can be taken to mitigate the next waves of the pandemic.