Consent to Test

Consent to testing for the qualitative determination of COVID-19 or IgG/IgM antibodies against COVID-19 (2019 –nCoV,‘Novel Coronavirus’) in a sample of whole blood.

Before you receive a test, you must give your consent for testing. This form explains the procedure, the risks and benefits of having the test done. It also explains the limitations of the test results. It should help you decide whether you want to take the test. Please read it carefully. Please read all this information before you choose to be tested. You should seek advice from your doctor as to whether or not the test is suitable for you.

Please take the time to discuss the test with your doctor, or contact us with any questions, and make sure you understand the answers before you decide to be tested. 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. Testing will only be carried out with informed consent. The tester will also obtain verbal consent before performing the test procedure. Additionally, by attending the test centre to be tested consent is implied.

Background

COVID-19 (2019 –nCoV, ‘Novel Coronavirus’) is an infectious disease caused by a newly discovered coronavirus, SARS-CoV-2. The virus has now been declared a pandemic by the World Health Organization. The most common symptoms associated with COVID-19 are fever, tiredness and a dry cough. A small number of people may be infected with COVID-19 and not develop symptoms. Most people affected with COVID-19 will experience mild to moderate respiratory illness. Older people and those with underlying medical problems are more likely to develop severe illness. At this time, there are no vaccines or treatments for COVID-19. 

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. 

COVID-19 Antibody Test

The COVID-19 Antibody test shows if you have antibodies to COVID-19 in your body using a Fluorescence Immunoassay (FIA) for the qualitative determination of IgG/IgM antibodies against COVID-19 in whole human blood.

A blood (finger prick) sample will be taken from you and be processed using the Boditech ichroma™ COVID-19 Antibody testing device for the detection of IgG/IgM antibodies against COVID-19. You will be provided with a qualitative(yes/no) result for the detection of IgG and IgM antibodies to COVID-19.

COVID-19 PCR Test for Travel

The COVID-19 PCR Test for Travel shows if you have an active infection of COVID-19 in your body using DNA/RNA extraction which is carried out in a UKAS certified laboratory.

A throat and nasopharyngeal swab sample will be taken from you and be processed in a UKAS certified lab for the detection of an active COVID-19 infection. You will be provided with a qualitative (positive/negative) result for the detection of COVID-19.

Sensitivity: 100%

Specificity: 100%

Overall Accuracy: 100%

COVID-19 Antigen Test

The COVID-19 Antigen test shows if you have an active infection of COVID-19 in your body using a Fluorescence Immunoassay (FIA) and provides a positive or negative result.

It does this by looking for antigens: pieces of virus that the immune system recognises. It's helpful in screening for early mild, asymptomatic, or acute patients for the identification of a COVID-19 infection.

A nasopharyngeal swab sample will be taken from you and be processed using the Boditech ichroma™ COVID-19 Antigen testing device for the detection of COVID-19. You will be provided with a qualitative (positive/negative) result for the detection of COVID-19.

Sensitivity: 87.5%

Specificity: 96.5%

Overall Accuracy: 93.8%

Supporting Documents

Please find below more information on our test:

Our tests are CE Marked and from a TUV certified manufacturer in South Korea. This test is for professional use only.

Antibody Test Procedure

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’s a routine procedure. 

One of your fingers will be selected. The end of your finger will be cleaned. 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). The next 3 or 5 drops will be collected using a pipette and will be used for the tests.

The interviewer will collect droplets of your blood from a finger stick, and put the drops into a test tube. If the finger continues to bleed, a plaster may be applied. It will take about five (5) 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, Date of Birth and Booking Number to identify your sample.

The blood will be mixed with a processing solution. It will be tested on-site using the ichroma™ COVID-19 Antibody testing device, by a trained operator using a routine protocol.

A final report will be generated with your test results which will be provided to you. 

We do not provide any (medical) interpretation of the test results, and we recommend that you follow up with a health care 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, 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

An antibody test looks for antibodies in your blood. Your body makes these when it fights an infection, like COVID-19.

Antibodies are one of the strategies used by the body to build immunity to a virus like SARS-CoV-2, the virus that causes COVID-19. The antibody test isn't checking for the virus itself. Instead, it looks to see whether your immune system - your body's defence against illness - has responded with antibodies to the infection.

Immunoglobulin M (IgM) is the body's most abundant antibody. It's 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 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.

As a result, testing for IgM and IgG antibodies is an effective method to determine if you've had COVID-19 and developed an immune response.

When do the antibodies appear?

IgM antibodies rise to detectable levels, 5-7 days after infection.

IgG antibodies rise to detectable levels, 7-21 days after infection.

Antibodies usually stay detectable in your blood long after an infection goes away, but we don't know precisely how long that is for the new coronavirus.

The antibody test provides 4 possible serological outcomes:‍

  • Positive IgG Antibodies and Positive IgM Antibodies: You've had COVID-19 and are developing IgG antibodies.
  • Positive IgG Antibodies and Negative IgM Antibodies: You've had COVID-19 and have developed IgG antibodies.
  • Positive IgM Antibodies and Negative IgG Antibodies: You’ve had COVID-19 and have developed IgM antibodies.
  • Negative IgM Antibodies and Negative IgG Antibodies: There's no serological evidence that you've had COVID-19. No IgM or IgG antibodies were detected.

If you're currently symptomatic with COVID-19 symptoms regardless of your test results, you should follow government guidance.

A positive test result for IgM or IgG is: > 1.1 - 200

A negative test result for IgM or IgG is: < 0.9

An indeterminate test result for IgM or IgG is: 0.9 - 1.1

The test uses a Cut-Off Index (COI) to determine if you have positive, negative or indeterminate results. The index value (0-200) relates to the concentration of antibodies found in your blood sample. So, the higher the number, the higher the level of antibodies that were found.

Research indicates that not everyone has an antibody response to the virus, nor is it fully known how long the immunity against COVID-19 will last at this time. 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 results. You should continue to protect yourself appropriately against COVID-19 in line with government guidance until further data is received about how long immunity lasts.

We will give you a certificate of your test results at 9pm on the day of your test. If you have any questions about your results or would like an interpretation of them by a doctor, you can book a follow-up appointment with Dr Alexander Barber for £60 or redeem your package code if you booked a COVID-19 antibody test and follow-up consultation.

What If I Test Positive?

You should not take any actions or make any decisions based solely on the outcome of your test results. You must continue to follow the government’s advice on the COVID-19 infection. This includes all self-isolation and social distancing measures. It's important to remember that the test is limited by the positive and negative predictive values of the analysis, the validity and reliability of the trial data and the scope for human error in the testing protocol and there is a possibility that your test results are inaccurate.

SARS-CoV-2 is a new coronavirus so there's insufficient evidence about the body’s immune response to the virus and you may still be at risk of contracting COVID-19. A positive test does not mean that you cannot go on to develop the infection.

You should seek professional medical advice for interpretation of your test results and should only act on the independent information received from a verified medical doctor. If you would like us to refer you to one please get in touch.

What If I Test Negative?

A negative result means the biomarkers are not present in your blood or that the antibody titre levels are not high enough to be detected. Regardless you should still exercise caution, as you may still be in the early stages of infection (before IgM levels rise to a detectable level).

If symptoms develop, follow the same protocols as if you test positive for COVID-19 and retest as necessary. If symptoms do not appear, it's unlikely you have COVID-19, but you should still follow strict hygiene procedures.

Ensure you wash your hands regularly, avoid social gatherings and work from home if possible. There’s no need to retest unless you suspect you have contracted the infection and are displaying symptoms.

Limitations

The device manufacturer (Boditech Med Inc.) has provided data on the validity of the test results from their own in-house trials. The study was conducted to evaluate the clinical sensitivity & clinical specificity of the ichroma™ COVID-19 Ab Test.

 You should review the below data and be independently satisfied with the validity of the testing. You should seek an independent third-party opinion from a doctor or other verified professional on your suitability to being tested and for an interpretation of the validity of the ichroma™ COVID-19 Ab Test before consenting to testing.

The device manufacturer (Boditech Med Inc.) has provided data on the validity of the test results from their own in-house trials using definite diagnosis reagent, reference reagent and ichroma™ COVID-19 Ab.

 Materials

  • Test Cartridge: 1 lot of ichroma™ COVID-19 Ab
  • Test Analyser: ichroma™ II
  • Reference Reagent: Indirect ELISA (in-house)
  • Definite diagnosis Analyser: CFX96™ Dx System
  • Definite diagnosis Reagent (Coronavirus Disease 2019 real-time reverse transcriptionPCR)

The trial used a small sample size of 49 samples, 45 of which were negative for COVID-19 by definite diagnosis, 4 of which were positive for COVID-19 by definite diagnosis.

Findings:

Positive Percent Agreement (PPA): 100%

Negative Percent Agreement (NPA): 97.8%

Overall Percent Agreement: 98%

PPA: Positive Percent Agreement is the proportion of samples with COVID-19 Antibody by definite diagnosis who test positive (True positives). This PPA is the probability that following a positive test result, that individual will have COVID-19 antibodies. In a laboratory setting, this is calculated as the ‘Sensitivity’.

NPA: Negative Percent Agreement is the proportion of samples free of COVID-19 by definite diagnosis who test negative (True negatives). This NPA is the probability that following a negative test result, that individual will genuinely not have COVID-19 antibodies. In a laboratory setting, this is calculated as the ‘Specificity’.

A larger in-house trial conducted by Boditech MedInc used 147 samples including samples of plasma (49), serum (49) and whole blood samples (49).

Findings:

Positive Percent Agreement (PPA): 100%

Negative Percent Agreement (NPA): 97.8%

Overall Percent Agreement: 98%

Analytical Sensitivity and Specificity:

Analytical Sensitivity

  • Cut-off: The ichroma™ COVID-19 Ab test result indicates ‘positive’ or ‘negative’ of a sample defined by the algorithm of ichroma™ reader based on COI (cut-off index).

Analytical Specificity

  • Cross-reactivity

Biomolecules such as those in the table below were added to the test sample(s) at concentrations much higher than their normal physiological levels in the blood. ichroma™ COVID-19 Ab test results did not show any significant cross-reactivity with these biomolecules.

 

Precision:

One person tested three different lots of ichroma™ COVID-19 Ab, ten times at each concentration of the control standard.

  • Between lots
  • Between persons
  • Between days
  • Between sites

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 (swab or whole blood sample) is collected.

There are several other COVID-19 PCR, Antigen and Antibody tests 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 XMedical Ltd and to XMedical Ltd processing your details for the purposes described.

Positive PCR test results must be reported to the local health protection team. We have a legal obligation to do so.

Positive antigen test results may be reported to the local health protection team in order to request/obtain a confirmatory PCR test to confirm the original result.

Antibody test results are private and may be given only to you. 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 COVID-19 Antibody Test will cost: £125

The COVID-19 PCR Test for Travel will cost: £175

The COVID-19 Antigen Test will cost: £135

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, XMedical Ltd 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 XMedical Ltd. 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 XMedical Ltd.

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 I must not attend the test centre if I currently display any symptoms of COVID-19 or have been exposed to anyone (including in my household) that has displayed symptoms of COVID-19 in the last 14 days.

I understand that the service offers testing relating to the detection of COVID-19 and antibodies against COVID-19 and that it 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 COVID-19 (2019 –nCoV,‘Novel Coronavirus’) from a throat and nasopharyngeal swab sample and the qualitative determination of IgG/IgM antibodies against COVID-19 (2019 –nCoV,‘Novel Coronavirus’) in a sample of whole blood. I have had any questions answered. I consent to this investigational testing.