Frequently asked questions

FREQUENTLY ASKED QUESTIONS (COVID19 TEST)

1. What is the COVID19 antibody test actually testing for?

The COVID19 rapid antibody test is a finger prick test which identifies if the body has developed an antibody response to a COVID19 infection. Antibody tests tell you if you have had the infection in the past, whereas antigen tests tell you if you have current infection.

2. Does the test tell you if you have an active COVID19 infection?

No. The test is not a viral test to identify if you currently have COVID19. The test is a highly sensitive and a very reliable marker of past infection but will not show up a current infection. DO NOT come and see us if you think you currently have the virus – this puts others at risk but also the test we use will not work whilst you have the infection.

3. How accurate is this test?

We only use antibody tests which are CE approved and can be adminstered by a halthcare professional.

4. Is the test specific to COVID19 or will antibodies to other coronaviruses show a positive result?

The test is highly specific for COVID19. Evaluation found it had a 99.2% specificity which means that 8 in 1000  (that’s less than 1 in a 100) positive tests might be false positives due to other reasons such as other coronaviruses. 99 out of 100 people will correctly test as NOT having antibodies.

5. What is the difference between IgM and IgG (these are the antibodies that might be picked up on the test)?

• IgM antibodies are the body’s initial immune response that help the body fight off infection
• IgG antibodies are the body’s secondary immune response that remain in the blood to fight off infection

Our distributor’s (PharmaDoctor) terms state that the requirement for the tests on the public are that they must only be carried out after at least 21 days after symptoms have subsided. By leaving 21 days the more accurate IgG can be used to identify a patient’s antibody response.

6. How accurate is the test’s IgG response?

No test can be 100% accurate however, the ROCHE finger prick test is highly accurate. The manufacturer quotes the following accuracy data:

• IgG Specificity 99.2%
• IgG Sensitivity @ 21 days+ 99.9%*
• Specificity = % of people who will test correctly negative for COVID-19 antibodies
• Sensitivity = % of people who will test correctly positive for COVID-19 antibodies

7. What is the incidence of false results?

At 21 days post symptoms, the test is >99.9%* accurate at detecting IgG antibodies and has 99.2% specificity in producing a correct negative test result.

8. If the test gives a positive result does this mean that I can catch COVID19 again?

There is currently no evidence that the presence of antibodies protects you from being infected by the virus again or possibly passing on the infection again. All individuals being tested will be told that the presence of antibodies does not infer immunity and to continue following Government guidelines in maintaining vigilance, practicing social distancing and isolating when appropriate.

9. If antibodies don’t mean I am immune, why have the test?

It is up to the individual if they want to be tested. Some people may want to have the test to find out if it was coronavirus when they experienced symptoms which could have been COVID19.  Knowing you have had the virus before may give peace of mind that your body managed to successfully fight off the virus.

10. What is the benefit of having the test?

For now, it is for no other reason than a confirmation that you have had or not had COVID19. Feedback is that people simply want peace of mind that they have had COVID19 and recovered. Or that they are curious as to whether the symptoms they had earlier in the year, were or were not COVID19.

A positive test does not mean that you will have immunity, or any improved resistance should you catch the virus again. We are waiting on the research regarding ongoing immunity. However, if positive, it does confirm that you have most likely been through a coronavirus infection and built up antibodies for COVID19.

Additionally, the NHS is asking for volunteers who have had the virus to donate some of their blood plasma to help others by contributing to a clinical trial. More information can be found here.

11. If a patient is positive for IgM antibodies does that mean the patient is infectious?

Presence of IgM antibodies can be detected for some time after the infection has been fought off. IgM is usually only detected once the patient has built up enough antibodies and this is usually in the post-infectious stage. We request patients to be tested at least 21 days after the onset of symptoms and at least 28 days after contact with a symptomatic individual, in order to ensure that they are no longer infectious. Although a test result detecting IgM only, can potentially be a marker of the patient fighting the virus and may be infectious if they are 21 days post infection, this is very unlikely.

If IgM only is presented, we would question the patient on when they first felt ill, their symptoms and when they stopped. The Government advises a 7-day quarantine for coronavirus. However, the individual should continue isolation if they are still presenting the following symptoms:

• a high temperature or feeling hot and shivery
• a cough and/or breathlessness
• loss of smell and/or taste
• a runny nose or sneezing
• feeling or being sick
• diarrhoea
• loss of appetite

https://www.nhs.uk/conditions/coronavirus-covid-19/self-isolation-and- treatment/how-long-to-self-isolate/

12. Can pregnant or breast-feeding women be tested?

Yes, there is no harm to the mother or baby when performing a test.

13. Can babies and children be tested?

The tests have not been validated for use in babies and children and so we cannot determine their accuracy in under 18’s . We will advise people that this this evidence is currently not available.

14. Is there anyone that shouldn’t be tested?

Anyone with symptoms should not come to the clinic as they may be infectious nor will the antibodies be detectable. In fact, any one with symptoms should be self-isolating in line with Government guidelines, so please stay at home.

As the test requires a blood sample, anyone with a blood-related health condition (such as haemophilia) or who is on blood-thinning medication should discuss this with us before performing a test.

15. Is the test CE approved for testing?

Yes. The test we use has a CE mark for point-of-care finger-prick use by a healthcare professional. The test can only be performed and evaluated by a healthcare professional such as a pharmacist, nurse, paramedic or doctor and cannot be sold directly to the public to self-test. Deborah Evans is a registered healthcare professional with the General Pharmaceutical Council (GPhC number: 2032997).

16. The Government say that there is no accurate antibody test that is approved to use other than the NHS testing programme. Why is this test ok?

The Government has requested that Public Health England (PHE) evaluate tests for their national testing programme. PHE has conducted some evaluation of antibody tests but have only identified the ROCHE and ABBOTT tests to be suitable for any national program. Both PharmaDoctor and BIOPANDA have submitted requests for the test to be evaluated by PHE. To date, PHE has not evaluated the BIOPANDA test and not asked for the test to be submitted for evaluation.

17. How does the evaluation of the BIOPANDA test compare to the ROCHE and ABBOTT tests?

There has not been any published study that has compared the ABBOTT and ROCHE lab-based test or the BIOPANDA finger prick point of care test. However, we can look at the separate evaluations that have been made of each test and how many COVID19 samples were used in each evaluation:

• The PHE evaluation of the ROCHE test used a total of 93 samples of COVID19 positive serum samples.
• The PHE evaluation of the ABBOT test used a total of 96 samples of COVID19 positive serum samples.
• PHE has not evaluated BIOPANDA’s test.
• BIOPANDA’s own evaluation used 239 samples each from unique patients, both symptomatic and asymptomatic but with a PCR-confirmed COVID19 infection, to review the tests specificity.
• BIOPANDA’s own evaluation also used 60 extra unique blood samples without
• COVID19 infection, to review the tests sensitivity.
• ROCHES own evaluation used a total of 204 samples from 69 symptomatic patients with a PCR-confirmed COVID19 infection, to review the ROCHE test for specificity.

https://www.biopanda.co.uk/php/products/rapid/infectious_diseases/covid19.php https://diagnostics.roche.com/content/dam/diagnostics/Blueprint/en/pdf/cps/Elecsys

-Anti-SARS-CoV-2-factsheet.pdf

https://www.sciencemediacentre.org/expert-reaction-to-phe-laboratory-evaluations- of-roche-and-abbott-antibody-tests/

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attach ment_data/file/890566/Evaluation_of_Abbott_SARS_CoV_2_IgG_PHE.pdf

https://www.gov.uk/government/publications/covid-19-laboratory-evaluations-of- serological-assays

https://www.cebm.net/covid-19/covid-19-roche-antibody-test-14th-may/

18. How does the BIOPANDA test compare to the ROCHE and ABBOTT tests?

The ROCHE and ABBOTT tests have various different published data available whereas the BIOPANDA test only has the manufacturer’s own published evaluation.

Taking the Eurofins County Pathology evaluations published on the Babylon Health website: https://www.babylonhealth.com/coronavirus/covid-19-antibody-test

All evaluations below are from the IgG antibody marker and relate to tests like the ROCHE and ABBOT tests:

• 98.5% sensitivity  – this means that among 1000 people who have had COVID19, 985 of them will correctly test positive. For 15 of these 1000 people who have had COVID19, the result will come back negative – this is called a false negative. This means that 15 out of 1000 people will think they do not have antibodies to COVID-19, but in fact they do.
• 99.5% specificity – this means that among 1000 people who have not had COVID19, 995 of them will correctly test negative. For 5 of these 1000 people who have not had COVID-19, the result will come back positive – this is called a false positive. This means that 5 out of 1000 people will think they have antibodies to COVID-19, but in fact they don’t.

So how does this compare with the Pharmadoctor HCP antibody tests e.g. the BIOPANDA tests?

• >99.9%* sensitivity – this means that among 1000 people who have had COVID-19, almost 100% of them will correctly test positive. For less than 1 of these 1000 people who have had COVID-19, the result will come back negative – this is called a false negative. This means that less than 1 person out of 1000 people will think they don’t have antibodies to COVID-19, but in fact they do.
• 99.2% Specificity – this means that among 1000 people who have not had COVID-19, 983 of them will correctly test negative. For 8 of these 1000 people who have not had COVID-19, the result will come back positive – this is called a false positive. This means that 8 out of 1000 people will think they have antibodies to COVID-19, but in fact they don’t.

It should be noted that regardless of the test result (+ve or -ve), people should continue following the Government’s advice, practice social distancing wherever possible and isolate when appropriate.

19. Does PHE evaluate tests?

Public Health England is not a regulator and so does not have any role in approvals for tests for use in the UK. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the national regulator for medical tests. The MHRA only accredit manufacturer’s CE certification however, the MHRA do not evaluate or approve the actual tests or devices themselves.

Any test can legally be marketed and deployed in the UK once it receives a CE mark. CE marking is a certification mark that indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area. A CE mark is applied by manufacturers to devices which meet the requirements of medical device regulations.

20. What is the law with regards approving tests and how they can be used?

It is a common misconception that PHE need to evaluate COVID19 tests before they can be used. PHE is not a regulator and so does not have any role in approvals for tests for use in the UK private market. The Government has asked PHE to evaluate tests for use in the UK’s national program, but this does not mean that tests must be evaluated by PHE in order to be used.

21. What is the regulatory requirement to use a test?

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the national regulator for medical tests. The MHRA only accredits the manufacturer’s CE certification however, they do not evaluate or approve the actual tests or devices themselves.

Any test can legally be marketed and deployed in the UK once it receives a CE mark. CE marking is a certification mark that indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area. A CE mark is applied by manufacturers to devices which meet the requirements of medical device regulations.

The BIOPANDA tests are CE certified by the manufacturer. The CE certificate and documentation have been reviewed by the MHRA who have authorised the test for sale to Health Care Professionals only.

22. Did the MHRA stop companies from supplying finger prick tests?

This relates to the ROCHE and ABBOTT tests which are CE certified for intravenous blood collection by healthcare professionals and for lab evaluation only. The MHRA confirmed that capillary blood samples are not to be used for these types of tests. The BIOPANDA test differs from these ROCHE and ABBOTT tests as it has been CE certified as a point of care finger prick blood test to be performed and evaluated by healthcare professionals only (capillary blood sample is allowed, and no lab evaluation is required).

The MHRA guidance clearly states: “Some UK providers such as high street pharmacies and private healthcare providers offer COVID19 antibody testing for members of the public…collecting a finger prick blood sample into a small container following a set of instructions.

https://www.gov.uk/government/publications/how-tests-and-testing-kits-for- coronavirus-covid-19-work/for-patients-the-public-and-professional-users-a-guide-to- covid-19-tests-and-testing-kits

23. Does Public Health England (PHE) not advise against the use of tests?

Public Health England (PHE) advice does not rule out antibody testing services provided in a clinical setting by healthcare professionals who can provide suitable assistance to patients to ensure they are fully informed.

The PHE Statement: “COVID19: rapid point of care tests for use in community pharmacies or at home” – first published 25th March, advises against the use of rapid point of care antibody tests. https://www.gov.uk/government/publications/covid-19- rapid-tests-for-use-in-community-pharmacies-or-at-home/covid-19-rapid-tests-for- use-in-community-pharmacies-or-at-home

Despite developments since the published date, the advice has not changed since and may not be up to date. In part, the advice conflates different types of tests and is not specific to any test:

• Their first bullet point states that there are different types of tests – this is not advice but simply a statement
• Their second point raises concerns, due to the lack of, “information on the accuracy of these rapid point of care tests, or on how a patient’s antibody response develops or changes during COVID-19 infection. It is not known whether either a positive or negative result is reliable.” Since the first publication, there is now published information on the accuracy of the BIOPANDA rapid point of care tests. There are also statistics of regional rates of infection which allow for a clearer understanding of probable reliability for positive and negative rates.
• Their third point does not even relate to antibody testing, instead questions the evidence of the suitability of tests to diagnose COVID-19 infection. Antibody tests such as the BIOPANDA test are not designed to ‘diagnose COVID-19 infection (that is what an antigen test is designed to do) but are designed to test if someone has previously had a COVID-19 infection. For this reason, this statement is not relevant to the BIOPANDA antibody tests.

Underlying the above points is a concern that the general public may not understand the full implications of testing and subsequently change their behaviour after testing. PHE is against the use of the tests “at home” by the public, and indeed the MHRA has indicated that no test that has yet been authorised for home use. Trained professionals can legally perform and evaluate tests and are suitably trained to deliver the relevant information relating to testing and COVID19. It is important that the public are suitably informed about immunity and infection advice, test accuracy and the importance of following Government advice and regulations relating to the Coronavirus pandemic.

24. Why does the Government require a highly sensitive test?

It is problematic to evaluate the immunity levels of a population using a national program as the numbers being tested are so large. If you had a test with a specificity rate of 99.0% you may think it is very accurate. However, this would mean that the test would produce 10 false positives for every 1000 and if you tested a population with a true infection rate of just 2 in every 1000 within, then you would have 5 false positives for every real positive. It is for these reasons that highly specificity accurate tests are required for any national program.

* Current BIOPANDA 99.9% accuracy evaluation was for 21 days post infection. Evaluations conducted by all manufacturers are based on samples taken in hospital. When tested within the community on patients with mild or no symptoms, the sensitivity may vary and likely be lower.