Coronavirus infection study: Information sheet

This research study builds on the recent UK Biobank coronavirus self-test antibody study, which identified UK Biobank participants who had antibodies to the SARS-CoV-2 coronavirus that causes COVID-19. This additional study aims to determine whether the antibodies detected in those study participants resulted from SARS-CoV-2 infection.

You have been invited to take part because the results you returned in our coronavirus self-test antibody study indicated that you had antibodies to the SARS-CoV-2 coronavirus and you told us that you had been vaccinated at the time you took the test.

No; whilst we are keen for every invited participant to contribute, your participation is entirely voluntary. We do understand that you may not be able or wish to help, and this would not affect your future relationship with UK Biobank.

If you consent to join this study then we will provide your name and address in confidence to Thriva Limited who manufacture the blood sampling kits and who will send you your kit. (Note: They will not use your contact details for any other purpose and will remove them from their files after the study has been completed).

Instructions will be included explaining how to provide a sample of blood, as follows:

• Use the lancet provided to prick your finger and produce about 10 drops of blood (which is only about 1/10^th of a teaspoon);
• Guide the blood drops into the tube provided, and then seal and label it;
• Return your blood sample to the laboratory in the Tracked 24 pre-paid plastic mailing envelope;
• Wait to receive your test result, which UK Biobank will send to you by email.

Please note that the result will be sent to the email address that UK Biobank currently holds for you. If you are using a shared email address and would like it to be sent to a different email address, please change it by logging into the UK Biobank participant website.

When a person is infected with SARS-CoV-2, several antibodies are produced in response to viral proteins, including nucleocapsid and spike proteins. The vaccines currently approved for use in the UK only trigger antibodies against the spike protein, not the nucleocapsid protein.

Because the test we used in the self-test antibody study detected antibodies to the spike protein, it cannot distinguish between antibodies that are a consequence of infection or of vaccination. This additional study will use a laboratory-based blood test that can detect antibodies to the nucleocapsid protein. A positive test result will tell us that you have previously been infected with SARS-CoV-2.

All UK Biobank participants who took part in the self-test antibody study and reported both the presence of antibodies and that they had been vaccinated prior to taking the test are eligible to participate.

We advise people with certain conditions not to take a blood sample. These are:

• participants with untreated clotting or bleeding disorders
• participants who have had a mastectomy and there is swelling of the arm

If you would like to take part, please log into the UK Biobank participant website using your Participant ID (PID) and personal details, where you can amend your postal address if required and complete our online consent form by clicking on the “Join study” button.

If you do not want to take part, please log into the UK Biobank participant website using your Participant ID (PID) and personal details, click on the “Join study” button and indicate that you do not wish to participate.

It may be a few weeks before a kit is sent to you, so we will email you before your kit is despatched to let you know when to expect it. 

Please collect the sample as soon as possible after you receive your kit. You can take the blood sample at any time of the day (but please avoid taking it on a Saturday to avoid weekend mail delaying its receipt at the laboratory).

We may send you an email reminder if you have not returned your blood sample within 4-6 weeks of the kit having been sent to you.

The kit will contain full instructions about how to take the blood sample safely and easily. These instructions can also be found on our website, along with a video showing how to collect the sample.

If you consent to take part and then decide that you do not wish to provide the blood sample, you do not need to do anything. Dispose of the kit in your usual household waste and ignore any reminders to return your sample. Please do not return the kit to the laboratory.

For the study findings to be useful, and so that we can incorporate the findings into the UK Biobank resource, it is important that the blood sample is not supplied by anyone else.

If there is a problem with your kit that prevents you from obtaining a blood sample, a replacement kit can be requested by logging into the UK Biobank participant website, clicking on “Request new kit” and providing details about any problems encountered with your sample collection kit. You can only request one replacement kit using this form so if there is a problem with your new kit, please call us on 0800 0 276 276.

If you have an adverse reaction, are harmed as a result of taking the sample, or had any other problems that did not require you to request a replacement kit, please contact our Participant Resource Centre on 0800 0 276 276.

Please complete the label supplied with your kit (on the return form), attach it to the sample tube and put this and your used and unused finger-prick devices into the specimen transport bag. Put the bag in the box your kit arrived in and put the box in the Tracked 24 pre-paid plastic mailing envelope provided. Post the envelope as soon as possible after having taken your sample.

Your blood sample will be tested for antibodies to the nucleocapsid (N) protein that is produced following infection with SARS-CoV-2. You will receive the result of this test from UK Biobank via email within about two weeks of sending your sample to the laboratory.

Your test result will be incorporated into the UK Biobank resource and made available (in a de-identified form so that you cannot be identified) to approved researchers for research.

In accordance with the Health Protection (Notification) Regulations 2010, the results of COVID-19 antibody test conducted in laboratories in England are required to be notified to Public Health England^[1] (PHE). For more information, click here. This enables greater understanding of the spread of the virus, and the impact that vaccines are having on the ongoing pandemic, which will support future public health decisions. If you live in Scotland or Wales, your result will be returned to PHE who carry out this analysis on behalf of Public Health Scotland and Public Health Wales.

In order for UK Biobank to notify PHE of your antibody result, personal details including name, NHS number, gender, date of birth, postcode, and the result of your antibody test, will be transferred to PHE at the end of the study. You do not need to do anything and this will have no direct implications for you; you should continue to follow government guidelines and advice.

[1] Public Health England is an executive agency of the Department of Health and Social Care (DHSC). It fulfils the Secretary of State’s statutory duties to protect health and address health inequalities and executes the Secretary of State’s power to promote the health and wellbeing of the nation.

Yes. You will receive an email with the result of this test from UK Biobank within about two weeks of sending your sample to the laboratory.

The tests carried out as part of this study are for research purposes only. We do not currently know if these antibodies will protect you from getting COVID-19 again. Therefore, whatever your test result, please do not make any medical or personal safety decisions based on the result of this test.

A positive antibody test will not confer any privileges, certifications or exemptions from existing HM Government or Devolved Administration COVID-19 guidelines. You should continue to follow government legislation and guidelines and self-isolate if you come into contact with somebody who has COVID-19.

You will receive information about whether you are likely to have been previously infected with the SARS-CoV-2 coronavirus in the last six months (and possibly longer), which may be of interest to you.  

Your involvement will enable researchers to carry out crucial research into the long-term health effects of coronavirus (‘long COVID’).

Participation in the study involves collecting a blood sample using a finger-prick device called a lancet. This produces a small (less than 2mm) hole in the skin.

You may experience slight discomfort when using the lancet (people have described the feeling as a slight sting, much less than you would experience in a typical blood collection with a needle and syringe). As with any cut, there is a small risk of infection and/or bruising. However, the equipment is sterile and following the instructions provided in the kit (in particular, cleaning the skin before and afterwards) will minimise any risk of infection.

The process and products in the kit are similar to those used routinely for collecting blood samples for a wide range of healthcare purposes, including for home measurement of blood glucose levels in the management of diabetes.

Yes, this study has received ethics approval from the North West – Haydock Research Ethics Committee, 16/NW/0274.

The information obtained in this study will be treated in exactly the same way as all of the other data that we have collected about you.  It will be stored securely by UK Biobank for many years, and provided only in a de-identified form (such that no participant can be identified from their data or samples) to approved researchers for medical and other health-related research (including scientists in other countries and in commercial companies).

We will put the results from all of these studies back into our database for other researchers to use. Scientists must make public the results of all research based on the resource so that everyone can benefit from it. You can find details of research that is being conducted using the UK Biobank resource and related publications on our website.

We have strict measures in place to protect your confidentiality, which should prevent identifiable information from being used – inadvertently or deliberately – for any purpose other than to support this study:

• We do not include any details that will identify you in any information or samples we provide to researchers.
• We keep any information that might identify you (such as your name and address) separately from other information about you in our database.
• We use advanced computer security technologies to prevent unauthorised access to the computers that hold personal information.
• Our procedures comply with international standards (ISO/IEC 27001) for information security and management. We are externally audited and we comply with the guidance contained in the UK Government’s ten cyber security steps.
• We restrict access to personal information as much as possible, and all research staff working for us sign confidentiality agreements as part of their employment contracts.

The way in which UK Biobank collects, shares and uses your information is explained on our website.  This includes an explanation of the way in which we protect your data and remove any personal identifiers before making any data available to researchers. 

For the purposes of the coronavirus infection follow-up study, we have appointed Thriva Limited as a third party data processor. Thriva will only use your personal data for the purpose of this study and only as instructed by UK Biobank.  At the end of the coronavirus infection follow-up study, Thriva will delete any personal data that they have processed about you. 

As explained above, in accordance with the Health Protection (Notifications) Regulations 2010, UK Biobank has a statutory duty to notify Public Health England (PHE) of antibody test results obtained from this study.

If you would like further information or have any concerns about anything to do with UK Biobank, please refer to our frequently asked questions, or email us at ukbiobank@ukbiobank.ac.uk, or telephone our Participant Resource Centre free of charge on 0800 0 276 276 (Monday to Friday 9am to 5pm).

Alternatively, if you would like to write to the person in charge, please send your letter to:

Professor Sir Rory Collins

Principal Investigator, UK Biobank

1-2 Spectrum Way

Adswood

Stockport

Cheshire

SK3 0SA

We shall reply to your letter in writing, unless you enclose your telephone number so that we can call you to discuss your concerns.

UK Biobank Limited (company no. 4978912) is a registered charity in England & Wales (1101332) and in Scotland (SC039230).