CONSENT POLICY

41
consent to test
41.1

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

41.2

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.

41.3

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.

41.4

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.

42
Background
42.1

Covid-19 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.

42.2

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.

43
COVID-19 Antibody Test
43.1

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.

43.2

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.

Important Information

43.3

Results are issued for the Covid-19 antibody test at 10pm each day. However, please note that there's a small possibility that your sample may fail or be inconclusive because of the above and may need to be repeated. Sample failure is rare, but if this happens, the sample needs to be repeated or retaken which will take another 24 hours from the time of your original result release, possibly involving a new sample collection.

43.4

You need to be aware of the above and make an informed decision to proceed.

44
COVID-19 pcr test and covid-19 fit to fly test
44.1

The Covid-19 PCR Test 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.

44.2

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.

44.3

Please note that there's a small possibility that your sample may fail or be inconclusive (such as where your viral load increasing or decreasing leads to an inconclusive result) because of the above and may need to be repeated. If your result is inconclusive, your test will be re-run to ascertain either a positive or negative result which will take another 24-48 hours from the time of your original result release. Sample failure is rare, but if this happens, the sample needs to be repeated or retaken which will take another 24 hours from the time of your original result release, possibly involving a new sample collection.

Important Information

44.4

Do not use any nasal medication, nasal wash or hay fever spray for at least 12 hours prior to testing. This may spoil your sample.

44.5

Do not brush your teeth, use mouthwash, chew gum, eat, drink or smoke for at least 2 hours prior to testing. This may spoil your sample.

44.6

Turnaround times for Covid-19 PCR Tests

44.6.1

Subject to clause 44.6.3, all home testing results will be delivered within 24 hours of receipt of the sample at the Corona Test Centre laboratory. Corona Test Centre bears no liability for any postal delays that may occur.

44.6.2

Subject to clause 44.6.3, the turnaround times for in-clinic tests results are either express (results within 3 hours), same day (results at 23:59), overnight (results the next day at 07:59) or next day (results at 17:59pm).

44.6.3

Please note that there's a small possibility that your sample may fail or be inconclusive (such as where your viral load increasing or decreasing leads to an inconclusive result) because of the above and may need to be repeated. If your result is inconclusive, your test will be re-run to ascertain either a positive or negative result which will take another 24-48 hours from the time of your original result release. Sample failure is rare, but if this happens, the sample needs to be repeated or retaken which will take another 24-48 hours from the time of your original result release, possibly involving a new sample collection

44.7

Save where:

44.7.1

there has been a postal delay in respect of a home testing result; or

44.7.2

clause 44.6.3 applies

and subject always to clause 32 (Our Liability) and clause 35 (Events Outside Our Control), in the event that we do not meet the turnaround times specified in clause 44.6, you will be offered a refund or credit in accordance with clause 44.8.

44.8

In respect of any applicable refund or credit under clause 44.7:

44.8.1

You must complete the following form in full in order to claim your refund or credit; and

44.8.2

the amount of any such refund or credit shall be calculated in accordance with the following table:

How late were your express pcr test results?

Amount of refund or credit

Up to 1 hours late

No refund or credit

1 to 1.5 hours late

25 % refund or credit

1.5 hours to 3 hours late

50% refund or credit

Over 3 hours late

100% refund or credit

How late were your same day, overnight or next day results?

Amount of refund or credit

Up to 3 hours late

No refund or credit

3 to 6 hours late

25 % refund or credit

6 hours to 12 hours late

50% refund or credit

Over 12 hours late

100% refund or credit

44.9

You need to be aware of the above and make an informed decision to proceed.

45
covid-19 day 2 and day 8 travel test package
45.1

The Covid-19 Day 2 & 8 Travel Test Package 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.

45.2

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.

Important Information

45.3

How it Works

Step 1 

Please ensure you fill out the Day 2 & 8 travel declaration form you will receive in the text/email that follows this booking confirmation. This form is mandatory. It enables us to issue you with your Test Result Certificate for Day 2 & 8.

Step 2

48 hours before your arrival in England, enter the unique package booking reference you receive with your Day 2 & 8 test on your passenger locator form.

Step 3

Once you arrive in England go directly to the address where you will be self-isolating.

Step 4

Come for your Day 2 Test on or before day 2 of your self-isolation period at your chosen Corona Test Centre. You will receive your results the next day at 6pm by email/text. Alternatively, a home test can be sent to you, with a turnaround time for results of 24 hours after receipt of your sample at our laboratory. 

Step 5

Come for your day 8 Test on or after day 8 of your self-isolation period at your chosen Corona Test Centre. You will receive your results the next day at 6pm by email/text. Alternatively, a home test can be sent to you, with a turnaround time for results of 24 hours after receipt of your sample at the UKAS certified laboratory.

Step 6

Continue to self-isolate at your address until you receive your Covid-19 test results. Irrespective if your Covid-19 PCR test result is negative then you must continue to self-isolate until day 10 unless you were eligible and took a Test to Release test.

If your Covid-19 PCR test is positive you must continue to self-isolate.

If your Covid-19 PCR test result is indeterminate. It’s not possible to say if you had the virus when the test was done. You must, by law, continue self-isolating for the remainder of your self-isolation period as an international arrival travelling to the UK from a non-exempt country, territory or region. If you want to shorten your self-isolation period you will need to take another test.

If you arrive from a country that is on the Gov.uk banned list during the last 10 days you must follow the UK government’s guidance.

It's your responsibility to ensure that you take your PCR day 2 & 8 test on the right date.

You need to be aware of the above and make an informed decision to proceed.

45.4

Test preparation 

45.4.1

Do not use any nasal medication, nasal wash or hay fever spray for at least 12 hours prior to testing. This may spoil your sample.

45.4.2

Do not brush your teeth, use mouthwash, chew gum, eat, drink or smoke for at least 2 hours prior to testing. This may spoil your sample.

45.5

Turnaround times for the Covid-19 Day 2 & 8 Travel Test Package

45.5.1

The turnaround times for the COVID-19 PCR Test conducted in clinic we offer for the scheme is next day (results at 6pm). For home tests, there is a turnaround time of 24 hours after receipt of your sample at the UKAS certified laboratory. Corona Test Centre bears no liability for any postal delays that may occur.

45.5.2

Please note that there's a small possibility that your sample may fail or be inconclusive because of the above and may need to be repeated (such as where your viral load increasing or decreasing leads to an inconclusive result). If your result is inconclusive, your test will be re-run to ascertain either a positive or negative result which will take another 24-48 hours from the time of your original result release. Sample failure is rare, but if this happens, the sample needs to be repeated or retaken which will take another 24-48 hours from the time of your original result release, possibly involving a new sample collection.

45.6

Save where:

45.6.1

there has been a postal delay in respect of a home testing result; or

45.6.2

clause 45.5.2  applies

and subject always to clause 32 (Our Liability) and clause 35 (Events Outside Our Control), in the event that we do not meet the turnaround times specified in clause 45.5, you will be offered a refund or credit in accordance with clause 45.7.

45.7

In respect of any applicable refund or credit under clause 45.6:

45.7.1

You must complete the following form in full in order to claim your refund or credit; and

45.7.2

the amount of any such refund or credit shall be calculated in accordance with the following table:

How late were your same day, overnight or next day results?

Amount of refund or credit

Up to 3 hours late

No refund or credit

3 to 6 hours late

25 % refund or credit

6 hours to 12 hours late

50% refund or credit

Over 12 hours late

100% refund or credit

45.8

You need to be aware of the above and make an informed decision to proceed.

46
covid-19 pcr test to release test
46.1

The Covid-19 PCR Test to Release Test 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.

46.2

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.

Important Information

46.3

How it works 

Step 1

Please ensure you fill out the Test to Release questionnaire you will receive in the text/email that follows this booking confirmation. This form is mandatory. It enables us to issue you with your Test Result Certificate for Test to Release.

Step 2

48 hours before your arrival in England, enter the Unique Test Reference Number you receive with your Test to Release questionnaire on your passenger locator form.

Step 3

Once you arrive in England go directly to the address where you will be self-isolating.

Step 4

Come to your chosen Corona Test Centre for your Test to Release Test on or after day 5 of your self-isolation period at your chosen Corona Test Centre. You will receive your results the next day at 6pm by email/text. Alternatively, a home test can be sent to you, with a turnaround time for results of 24 hours after receipt of your sample at the UKAS certified laboratory.

Step 5

Continue to self-isolate at your address until you receive your Covid-19 test results. If your Covid-19 PCR test result is negative then you may stop self-isolating but you must keep your test results to show the police if requested.

46.4

If your Covid-19 PCR test is positive you must continue to self-isolate.

46.5

If your Covid-19 PCR test result is indeterminate. It’s not possible to say if you had the virus when the test was done. You must, by law, continue self-isolating for the remainder of your self-isolation period as an international arrival travelling to the UK from a non-exempt country, territory or region. If you want to shorten your self-isolation period you will need to take another test.

46.6

If you take your PCR Test to Release test too early your result will be voided and you will require another test on the appropriate date (on or after day 5 of your self-isolation period).

46.7

If you arrive from a country that is on the Gov.uk banned list during the last 10 days you must complete a passenger locator form and self-isolate along with members of your household. You cannot be released early through the Test to Release Scheme. Please check this list carefully to make sure you aren't arriving from a banned country before booking your test.

46.8

It's your responsibility to ensure that you take your PCR Test to Release test on the right date (on or after day 5 of your self-isolation period) and that you didn't arrive from a country on the Gov.uk banned list during the last 10 days.

46.9

You need to be aware of the above and make an informed decision to proceed.

Test Preparation 

46.10

Do not use any nasal medication, nasal wash or hay fever spray for at least 12 hours prior to testing. This may spoil your sample.

46.11

Do not brush your teeth, use mouthwash, chew gum, eat, drink or smoke for at least 2 hours prior to testing. This may spoil your sample.

46.12

Turnaround times for the Covid-19 PCR Test to Release Test

46.12.1

The turnaround times for the COVID-19 PCR Test we offer for the scheme is next day (results at 17:59). For home tests, there is a turnaround time of 24 hours after receipt of your sample at the UKAS certified laboratory. Corona Test Centre bears no liability for any postal delays that may occur.

46.12.2

However, please note that there's a small possibility that your sample may fail or be inconclusive because of the above and may need to be repeated (such as where your viral load increasing or decreasing leads to an inconclusive result). If your result is inconclusive, your test will be re-run to ascertain either a positive or negative result which will take another 24-48 hours from the time of your original result release. Sample failure is rare, but if this happens, the sample needs to be repeated or retaken which will take another 24-48 hours from the time of your original result release, possibly involving a new sample collection.

46.13

Save where:

46.13.1

there has been a postal delay in respect of a home testing result; or

46.13.2

clause 46.12.2 applies

and subject always to clause 32 (Our Liability) and clause 35 (Events Outside Our Control), in the event that we do not meet the turnaround times specified in clause 46.12, you will be offered a refund or credit in accordance with clause 46.14.

46.14

In respect of any applicable refund or credit under clause 46.13:

44.8.1

You must complete the following form in full in order to claim your refund or credit; and

44.8.2

the amount of any such refund or credit shall be calculated in accordance with the following table:

How late were your same day, overnight or next day results?

Amount of refund or credit

Up to 3 hours late

No refund or credit

3 to 6 hours late

25 % refund or credit

6 hours to 12 hours late

50% refund or credit

Over 12 hours late

100% refund or credit

46.15

You need to be aware of the above and make an informed decision to proceed.

47
covid-19 antigen test 
47.1

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.

47.2

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.

47.3

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.

47.4

Alternatively, a Covid-19 Antigen test can be administered using a home testing kit. 

Important Information

47.5

Do not use any nasal medication, nasal wash or hay fever spray for at least 12 hours prior to testing. This may spoil your sample.

47.6

Subject to clause 47.7:

47.6.1

COVID-19 Antigen tests which are administered at home have a turnaround time for results in 3 hours of the User registering the COVID-19 Antigen test and sending a photo of the result to Corona Test Centre;

47.6.2

results are issued for the COVID-19 antigen swab test within 3 hours of the test being taken in clinic.

47.7

Please note that there's a small possibility that your sample may fail or be inconclusive (such as where your viral load increasing or decreasing leads to an inconclusive result) and may need to be repeated. If your result is inconclusive, the sample needs to be retaken which will involve the need for a new sample collection to be arranged at no additional charge.

47.8

Save where clause 47.7 applies, and subject always to clause 32 (Our Liability) and clause 35 (Events Outside Our Control), in the event that we do not meet the turnaround times specified in clause 47.6, you will be offered a refund or credit in accordance with clauses 47.9 and 47.10.

47.9

In respect of Covid-19 Antigen tests which are administered at home:

47.9.1

You must complete the following form in full in order to claim your refund or credit; and

47.9.2

the amount of any such refund or credit shall be calculated in accordance with the following table:

How late were your same day, overnight or next day results?

Amount of refund or credit

Up to one hour late

No refund or credit

1 to 1.5 hours late

25 % refund or credit

1.5 hours to 3 hours late

50% refund or credit

Over 3 hours late

100% refund or credit

47.10

In respect of COVID-19 antigen swab tests where these were taken in clinic:

45.10.1

You must complete the following form in full in order to claim your refund or credit; and

45.10.2

the amount of any such refund or credit shall be calculated in accordance with the following table:

How late were your same day, overnight or next day results?

Amount of refund or credit

Up to one hour late

No refund or credit

1 to 1.5 hours late

25 % refund or credit

1.5 hours to 3 hours late

50% refund or credit

Over 3 hours late

100% refund or credit

47.11

You need to be aware of the above and make an informed decision to proceed.

47.12

Please note that the Covid-19 antigen test is not suitable for travel to most destinations. If you are travelling please book a PCR Fit to Fly Test.

47.13

COVID-19 antigen tests are suitable for travel for many international destinations. Our tests are CE and UK government-approved and therefore accepted on the EU’s approved list of antigen tests for entry.

47.14

We are a leading UK Government recognised provider of all private COVID-19 tests.

47.15

For destinations that do not accept antigen tests, a PCT fit to fly test may be required. We recommend customers check their specific destination requirements before arranging an antigen test.

47.16

Supporting documents 

47.16.1

Please find below more information on our test:

Schedule of accreditation

Gov.uk Approved Testing Provider List

48
antibody test procedure

Capacity 

48.1

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 

48.2

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.

48.3

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.

48.4

The healthcare professional  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.

48.5

The specimen collected will be labelled with your Name, Date of Birth and Booking Number to identify your sample.

48.6

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.

48.7

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

48.8

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

48.9

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 

48.10

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

48.11

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.

48.12

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.

48.13

There is a chance that this test may give a positive result for the antibody when the virus is not present (false positive).

48.13.1

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.

48.13.2

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.

48.13.3

A false-positive result could lead you to believe that you have had the virus, which may cause psychological distress.

48.13.4

A false-positive result could lead you to make unnecessary changes in your lifestyle or seek costly medical advice or treatment.

48.14

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.

48.15

There is a chance that this test may give a negative result for the antibody when the virus is present (false negative).

48.16

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.

48.16.1

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.

48.16.2

A false-negative result could lead you to believe that you have not had the virus, which may cause psychological distress.

48.16.3

A false-negative result could lead you to make unnecessary changes in your lifestyle or seek costly medical advice or treatment.    

48.17

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

48.18

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

48.19

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.

48.20

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.

48.21

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.

48.22

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.

48.23

Subject to clause 48.23, results are issued for the COVID-19 antibody test at 10pm each day where these are taken in clinic.

48.24

Please note that there's a small possibility that your sample may fail or be inconclusive (such as where your viral load increasing or decreasing leads to an inconclusive result) and may need to be repeated. If your result is inconclusive, your test will be re-run to ascertain either a positive or negative result which will take another 24-48 hours from the time of your original result release Sample failure is rare, but if this happens, the sample needs to be repeated or retaken which will take another 24 hours from the time of your original result release, possibly involving a new sample collection.

48.25

Save where clause 48.24 applies, and subject always to clause 32 (Our Liability) and clause 35 (Events Outside Our Control), in the event that we do not meet the turnaround times specified in this clause 48.23, you will be offered a refund or credit in accordance with clause 48.25.

48.26

In respect of any applicable refund or credit under clause 48.25:

48.26.1

You must complete the following form in full in order to claim your refund or credit; and

48.26.2

the amount of any such refund or credit shall be calculated in accordance with the following table:

How late were your same day, overnight or next day results?

Amount of refund or credit

Up to one hour late

No refund or credit

1 to 1.5 hours late

25 % refund or credit

1.5 hours to 3 hours late

50% refund or credit

Over 3 hours late

100% refund or credit

When do the antibodies appear? 

48.27

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

48.28

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

48.29

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.

48.30

The antibody test provides 4 possible serological outcomes:‍

48.30.1

Positive IgG Antibodies and Positive IgM Antibodies: You've had Covid-19 and are developing IgG antibodies.

48.30.2

Positive IgG Antibodies and Negative IgM Antibodies: You've had Covid-19 and have developed IgG antibodies.

48.30.3

Positive IgM Antibodies and Negative IgG Antibodies: You’re likely to have had Covid-19 and have developed IgM antibodies.

48.30.4

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.

48.31

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

48.32

It's important to note that low-level IgM that is just above the cut-off is likely to be non-specific and should not be regarded to imply that you've had Covid-19.

48.33

Research also 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.

48.34

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.

What if I test positive?

48.35

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.

48.36

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.

48.37

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?

48.38

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).

48.39

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.

48.40

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.

Other Considerations 

48.41

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.

48.42

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.

48.43

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.

48.44

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.

48.45

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

48.46

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.

48.47

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.

49
Privacy
49.1

XMedical Ltd will collect personal data from you for your Covid-19 test results when you register with us and authenticate your results. This personal data will include your name, date of birth, sex, ethnic origin, postal address, email and telephone number (whether your test result is positive, negative, indeterminate or void). 

49.2

It is necessary for XMedical Ltd to process your personal data for the performance of its contract with you in order to provide you with your Covid-19 test results, and XMedical Ltd will share and report this information to Public Health England (PHE) and third party laboratories where there is a legal obligation to do so. There is a legal obligation to do so for PCR tests at this time, and there may be a legal obligation to report antigen test results and antibody test results in the future.

49.3

For more information about how XMedical Ltd uses your personal data, please see our Privacy Policy below. 

49.4

Whom you tell your test results to 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.

50
costs
50.1

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.

51
what happens if you are harmed
51.1

Subject to clause 51.2, 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.

51.2

Notwithstanding any other provision of this agreement neither party limits or excludes its liability for:

51.2.1

fraud or fraudulent misrepresentation;

51.2.2

death or personal injury caused by its negligence (or the negligence of its personnel, agents or subcontractors);

51.2.3

breach of any obligation as to title implied by statute; or

51.2.4

any other liability for which may not be limited under any applicable law.

52
whom to call if you have questions
52.1

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.

53
declaration
53.1

I have read and understood all of the information provided and have sought independent consultation from a verified medical practitioner where necessary.

53.2

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.

53.3

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.

53.4

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.

53.5

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.

54
consent statement
54.1

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.

55
Covid-19 recovery certificates
55.1

By applying to Corona Test Centre for a Covid-19 Recovery Certificate you are confirming the following:

55.1.1

That you are the patient or their parent, legal guardian or representative;

55.1.2

That the details entered onto your application for a Covid-19 Recovery Certificate are true, accurate and correct to the best of your knowledge and belief;

55.1.3

That the test certificate/notification that you are using is an original and has not been edited or altered in any way;

55.1.4

That you have reviewed the guidance of your intended destination, if travelling, or the organisation to which you intend to present any Covid-19 Recovery Certificate issued by us and are satisfied that it will meet the requirements that must be met for you to gain entry or travel, as applicable;

55.1.5

That you understand that you must follow the Covid-19 guidelines, including any specified period of isolation, of the country from which you are travelling;

55.1.6

That if your positive Covid-19 test result was received less than 7 days prior to travel, or if your Covid-19 symptoms began less than 11 days prior to travel, you understand that you must wear a mask at all times whilst travelling;

55.1.7

That you understand that all information provided by you in support of your application for a Covid-19 Recovery Certificate will be reviewed by a healthcare professional, and a Covid-19 Recovery Certificate can be issued by us only if, in their professional opinion, it is deemed appropriate so to do;

55.1.8

That you understand that if any of the information provided in support of your application for a Covid-19 Recovery Certificate changes, or if you become unwell, you will seek a medical opinion, and follow any advice received, on the continued use of any Covid-19 Recovery Certificate issued by us

55.1.9

That any Covid-19 Recovery Certificate issued by us needs to be used in conjunction with a positive test result for Covid-19;

55.2

Any complaint concerning your application for a Covid-19 Recovery Certificate must be raised with us within 14 days of the incident complained of.  We will not be able to consider complaints raised outside of this period.