Consent to COVID-19 Antibody Testing
This page provides information for the consent to testing for the qualitative determination of IgG/IgM antibodies against COVID-19 (SARS-CoV-2) from a sample of whole blood. It is essential for individuals to give consent for testing prior to the procedure. Testing at London Dental Centre is only available to adults aged 18 years or older who have been asymptomatic of COVID-19 for at least 14 days.
This page explains the testing procedure, as well as the risks, benefits and limitations of testing in order to help you decide whether to proceed with the test. You are requested to please read the following carefully and to seek advice from your doctor if you have any questions about whether or not the test is suitable for you.
You may also contact London Dental Centre if you have any questions. It is imperative to answer any questions you may have about the test before proceeding. If you agree to have the testing done, you should agree to this consent form.
Please note that testing is optional and a personal choice. We will only carry our testing at London Dental Centre with informed consent, including additional verbal consent before performing the test procedure. Additionally, consent is implied by booking and paying for a test online for clinic testing or mobile testing.
What is COVID-19?
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.
Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.
The best way to prevent and slow down transmission is be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol based rub frequently and not touching your face.
The COVID-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that you also practice respiratory etiquette (for example, by coughing into a flexed elbow).
At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments. WHO will continue to provide updated information as soon as clinical findings become available.
When an organism’s immune system encounters a foreign molecule (such as a virus) for the first time, specialised cells in the body recognises the virus as harmful and mount an immune response. This immune response results in the production of antibodies, also known as immunoglobulin. Immunoglobulins are produced, which attach to the virus and activate the rest of the immune system to attack and clear the virus. IgM is the first immunoglobulin to be created. The presence of IgM is an indicator of a recent/present infection. IgG is a more specialised antibody that specifically binds to the virus. The presence of IgG is an indicator of later-stage infection. Antibodies produced in this way are generally specific for the foreign molecule that they are produced in response to infection with COVID-19 elicits an immune response that results in the production of antibodies to the COVID-19 virus. Our test detects these antibodies.
Symptoms of COVID-19:
COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.
Most common symptoms: fever, dry cough, tiredness.
Less common symptoms: aches and pains, sore throat, diarrhoea, conjunctivitis, headache, loss of taste or smell, rash on skin, or discolouration of fingers or toes.
Serious symptoms: difficulty breathing or shortness of breath, chest pain or pressure, loss of speech or movement.
Seek immediate medical attention if you have serious symptoms. Always call before visiting your doctor or health facility.
People with mild symptoms who are otherwise healthy should manage their symptoms at home.
On average it takes 5–6 days from when someone is infected with the virus for symptoms to show, however it can take up to 14 days.
COVID-19 Antibody Test
The COVID-19 Antibody test shows if you have antibodies to COVID-19 in your body using a lateral flow immunoassay for the qualitative determination of IgG/IgM antibodies against COVID-19 in whole human blood. It is intended for use as a tool to assist in the diagnosis of SARS-CoV-2 infections. It is also intended as a tool for carrying out serological epidemiological investigations.
A blood (finger prick) sample will be taken from you and be processed by a qualitative lateral flow immunochromatographic assay for the detection of IgM and IgG antibodies to SARS-CoV-2. You will be provided with a qualitative result for the detection of IgG and IgM antibodies to COVID-19.
Principle
The COVID-19 Rapid Test is a qualitative lateral flow membrane-based immunoassay for the simultaneous detection of IgM and IgG antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens. The test cassette contains recombinant SARS-CoV-2 antigen conjugated to coloured particles. When a specimen is added to the sample well of the cassette, any IgM and IgG present in the specimen will bind to the antigen conjugate, forming coloured coronavirus antigen-antibody complexes. This mixture migrates laterally along the membrane to the test region. In this test region, anti-human IgM and anti-human IgG have been immobilised onto the membrane. These capture any IgM and IgG complexes that have formed, resulting in the appearance of coloured lines.
Therefore, if the specimen contains SARS-CoV-2 IgM antibodies, a coloured line will appear in the IgM test line region. If the specimen contains SARS-CoV-2 IgG antibodies, a coloured line will appear in the IgG test line region. If the specimen does not contain SARS-CoV-2 antibodies, no coloured line will appear in either of the test line regions, indicating a negative result. To serve as an internal control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen and buffer has been added, and correct procedure has been followed.
The test used is CE Marked from a UK based company which develops and manufactures in vitro test kits for clinical laboratories, veterinary practice, environmental protection, and food safety, both locally and globally. This test is for healthcare professional use only.
Conducting the test
Capacity
The healthcare professional administering your test will first assess your capacity to consent to test. If the healthcare professional feels you have the ability to give your consent, your decision will be accepted. If the healthcare professional feels you cannot currently give consent, they reserve the right to decline to test.
Specimen Collection
A sample of whole blood will be collected by finger prick. The finger prick procedure is very similar to the way people with diabetes check their blood sugar, or the heel stick given to all newborns. It is a routine procedure.
One of your fingers will be used for the test and the end of the finger will first be cleaned using a wipe/alcohol swab. Your finger will be stuck once, using a sterile single-use lancet (tiny with a sharp point). The first drop of blood will be wiped away (not used) and gentle pressure may need to be applied to the finger/hand to form a rounded drop of blood over the puncture site. The next few drops will be collected using a capillary tube. If the finger continues to bleed, a plaster may be applied. It will take about five minutes to complete this collection. Occasionally it is necessary to stick the finger more than one time to get enough blood.
The specimen collected will be labelled with your Name and Date of Birth to identify your sample.
The blood will be mixed with a solution for testing by a trained operator using a routine protocol in a test unit which contains recombinant SARS-CoV-2 antigen conjugated to coloured particles. The test cassette uses lateral flow immunoassay to determine whether you have antibodies to SARS-CoV-2.
A final report will be generated with your test results which will be provided to you via email or text. We do not provide any (medical) interpretation of the test results, and we recommend that you follow up with your regular healthcare provider.
If the amount of blood collected from you was not enough to do the tests, you will be informed of this. If your test result was indeterminate (control test failure), you will be notified of this.
Intended Benefits
The benefits of taking the test are to identify, within the limitations of the testing equipment and protocol, whether you have COVID-19 IgG and/or IgM in your blood.
Risks
When the finger prick blood sample is collected, the needle may pinch, sting, or otherwise cause pain. The finger prick may cause excessive bleeding, a bruise or scarring.
You may experience pain at the site of the finger prick test for several days after the test. There is also a risk of infection or tissue death (a long-term effect) at the fingerpick site. There may be skin breakdown from repeated use of adhesive plasters.
There is a chance that this test may give a positive result for the antibody when the virus is not present (false positive).
A false-positive result could lead you to be less compliant to preventative measures to avoid contracting COVID-19, and you could subsequently contract COVID-19, which could result in you becoming seriously unwell or result in death.
If you inform a medical professional that you have had the virus based on the false-positive results, there is a chance that this could influence decisions that they make around any future care that you receive. This result could put you at increased risk.
A false-positive result could lead you to believe that you have had the virus, which may cause psychological distress.
A false-positive result could lead you to make unnecessary changes in your lifestyle or seek costly medical advice or treatment.
The above represents several predictable scenarios. It’s essential to think about any actions that you may take if you receive a positive test result. It is crucial to think about any personal (such as employment) implications of receiving a positive test result. In essence, these are personal to each individual.
There is a chance that this test may give a negative result for the antibody when the virus is present (false negative).
If you inform a medical professional that you have not had the virus based on a false negative result, there is a chance that this could influence the decisions that they make around any future care that you receive. This result could put you at increased risk.
A false-negative result could lead you to (falsely) believe that you have not had the virus when you have had the infection, which could prevent your return to work, require extended isolation or social distancing measures and have other serious implications.
A false-negative result could lead you to believe that you have not had the virus, which may cause psychological distress.
A false-negative result could lead you to make unnecessary changes in your lifestyle or seek costly medical advice or treatment.
The above represents several predictable scenarios. It is crucial to think about any actions you may take if you receive a negative test result. It’s essential to think about any personal (such as employment) implications of receiving a negative test result. In essence, these are personal to each individual.
Results
Immunoglobulin M (IgM) is the body’s most abundant antibody. It’s also the first antibody to appear in response to initial exposure to an antigen (a toxin or other foreign substance), which induces an immune response in the body. The presence of IgM is an indicator of early infection (usually 3-7 days after infection).
It’s widely accepted that the IgM antibody provides the first line of defence during viral infections, followed by the generation of the IgG antibody for longer-term immunity and immunological memory. IgG is a more specialised antibody that specifically binds to the SARS-CoV-2 virus. The presence of IgG is an indicator of a later stage infection (usually 7 days or longer after infection).
As a result, testing for IgM and COVID-19 IgG antibodies is an effective method for the identification of a current or recent COVID-19 infection and an immune response. However, research indicates that not everyone has a good antibody response to the virus, nor is it fully known how long the immunity against COVID-19 will last. Based on data from other kinds of Coronavirus, protection may only last a few months and reinfection may still occur.
Therefore, you should not change your behaviour based solely on your antibody test result. You should continue to protect yourself appropriately against COVID-19 until further data is received about how long immunity lasts.
The antibody test provides 4 possible outcomes:
Positive IgG and Positive IgM: You’re recovering from a recent COVID-19 infection and have a level of immunity.
Positive IgG Negative IgM: You’ve recovered from COVID-19 and have a level of immunity.
Positive IgM Negative IgG: You’re in the early stages of your COVID-19 immune response. You haven't yet made IgG antibodies.
Negative IgM Negative IgG: No IgM or IgG antibodies were detected.
To determine sensitivity, samples were taken from 239 patients who were confirmed positive by PCR. Samples were taken at a range of times from onset of symptoms.
Other Considerations:
The test may yield a false-positive result(s) due to the cross-reactions and/or non-specific adhesion of certain sample components to the capture/detector antibodies.
The test may yield a false negative result(s) due to the non-responsiveness of the antigen to the antibodies which is most common if some unknown components mask the epitope, so therefore not being able to be detected or captured by the antibodies.
The instability or degradation of the antigen with time and/or temperature may also cause the false-negative result as it makes antigen unrecognisable by the antibodies.
Other factors may interfere with the test and cause erroneous results, such as technical/procedural errors, degradation of the test components/reagents or presence of interfering substances in the test samples.
No clinical diagnosis should be solely based on the test result and must be supported by a comprehensive judgment of the concerned physician, including clinical symptoms and other relevant test results.
Choices
This testing is voluntary. It’s your choice to have this testing done on you. You may refuse to have the test performed at any time before the specimen (whole blood sample) is collected.
There are several other tests for COVID-19 Antibody’s available in the UK. We don’t know which tests work the best and cannot comment on their validity. You should consult your doctor for advice on the appropriateness of testing and the validity of available tests.
Privacy
By agreeing to this consent form, you explicitly consent to your personal data being collected and stored by London Dental Centre and to London Dental Centre processing your details for the purposes described.
The Antibody test results are private and may be given only to you. We will keep all information about you private. There is a possibility that the government could request your test results. We would expect this participation to be voluntary but cannot confirm this. If the government makes it a legal requirement for us to disclose your test results we will follow all necessary steps to maintain your privacy, contact you immediately, keep you informed and involve you in any decisions.
Whom you tell is up to you. Something to consider is that some people who have had the test may qualify or be disqualified from current and future government policies around the management of the COVID-19 pandemic, including the UK government’s isolation and social distancing policies and may be treated differently by employers.
Costs
The clinic test will cost £80 and the mobile test will cost £120. You will need to pay for the cost of the test. There may be other costs related to the testing, such as medical consultations to discuss the results or to receive further medical assessment or treatment. You are fully and solely responsible for any future costs incurred directly or indirectly as a result of the test results.
What Happens If You Are Harmed?
If you are harmed as a result of taking the samples, London Dental Centre will NOT pay any costs for hospital and medical care, legal advice or any other expenses incurred directly or indirectly as a result of the test. You or your insurer will need to pay those costs. You do not give up any legal rights that otherwise would be available to you.
Whom to Call If You Have Questions
Please call your doctor if you have any questions about this testing as described. You may also contact London Dental Centre directly. If you have questions about your rights or if you feel you have been harmed or injured by taking part in the program, please contact London Dental Centre.
Declaration
I have read and understood all of the information provided and have sought independent consultation from a verified medical practitioner where necessary.
I understand that the service is a test that detects antibodies to COVID-19 in your body for the qualitative determination of IgG/IgM antibodies against COVID-19 and does not provide any clinical interpretation of the test results.
I have independently assessed or sought independent third-party medical advice on whether the test is suitable to me, and I have read and understood the procedure, intended benefits and risks of testing and the limitations of results.
I agree with the use of personal information relating to me for the purpose described above and the disclosure of this information to the parties involved in the testing and administration process.
I acknowledge that any additional follow up health treatment arising from the screening service is not included in the service, and I am solely responsible for any direct or indirect repercussions of test results.
Consent Statement
I have read and understood consent to test for the qualitative determination of IgG/IgM antibodies against COVID-19 (2019 –nCoV,‘Novel Coronavirus’) in a sample of whole blood and have had any questions answered. I consent to this investigational testing.