MRC LHA & NSHD > Data collection > COVID-19 Antibody testing > Participant Information Sheet

Search this site

Antibody Test - Participant Information Sheet

We would like to invite you to take part in a research project called ‘COVID-19 home antibody testing’.  Before you decide it is important for you to understand why the research is being done and what it will involve.  Please take time to read the following information carefully. Talk to others about the study if you wish.

What is the purpose of the research?

This is an antibody research study. Antibodies are made by the immune system to fight infection. In this study, we will use the results of antibody tests that you do yourself at home to help us understand how many people in MRC National Survey of Health and Development (NSHD) may have already been infected with the virus which causes COVID-19.

This is part of a national initiative where other population based research studies in the UK are also asking their participants to complete the same antibody test. Analysing the information from NSHD alongside these other studies will allow a greater understanding of the impact of COVID-19 on people’s health and other aspects of life.  We would like you to take part, even if you have been vaccinated.

Why have I been invited to participate?

You have been invited to participate in this study because you completed our COVID-19 questionnaire.

What is involved?

We recommend that you both watch the video and read the instructions carefully before beginning the home test. This will help ensure that the test is successful.

We will ask you to provide a finger-prick of blood (approximately 10 drops, which is about 0.5ml or one tenth of a teaspoon) for the testing of the coronavirus antibodies and storage for use in future health research. 

You can see what is in the kit and what it involves by watching the video here:

Do I have to take part?

No. Whether you take part in the study is entirely up to you. Even if you do decide to take part, you can change your mind at any time without giving a reason. If you decide not to participate, this decision will not in any way affect your ability to continue to participate in future NSHD data collections.  It will not affect any NHS treatment you receive if you do not take part.  If you decide you do not want to take part, please throw away the testing kit as set out in the test instructions which come with the kit.

How do I take part?

If you would like to take part, please click on the unique link in your email to access an online form to confirm your willingness to take part and give consent to provide blood samples.  It also asks you to confirm your contact details so that we are able to send you the blood sampling kit.  Once you receive your kit, please follow the instructions in the kit. 

With your permission we may also invite you to participate in similar studies in the future.  You do not have to take part in these studies.

Confidentiality and use of information

All the information you give us and the results from the antibody test will be treated in the strictest confidence. They will be stored securely and will be the responsibility of the MRC Unit for Lifelong Health and Ageing at UCL.  Research data will be coded and kept in an anonymous form, which are stored separately from personal data (such as name and address).  The use of the blood samples beyond the antibody testing will be reserved for future studies of health research.

Only members of the NSHD research and the clinical team at the MRC Unit for Lifelong Health and Ageing at UCL, who have been given permission by the Director of the Study (the Data Custodian), will have access to identifiable information.  Your personal details will not be shared with third parties except for certain service providers working on our behalf, for example Thriva who will be mailing out the test kits.

We shall keep the information for 20 years after the end of the study. We will protect your personal information in accordance with UCL sponsored study Information Governance policy; the handling, processing, storage and destruction of data will be conducted in accordance with the General Data Protection Regulation (GDPR) and UK Data Protection Act (2018) to ensure that confidential information is safeguarded.

The use of the information and biological samples are managed by the NSHD data sharing committee.  Anonymised data and samples may be shared with other bona fide scientists running other research studies from this organisation and in other organisations.  These organisations may be universities in the UK, Europe, USA and Australia; NHS organisations; the Department of Health and Social Care (DHSC); Health Protection Team (e.g. Public Health England (PHE) and Public Health Scotland) and secure data platforms (e.g UK Data Service and UK Longitudinal Linkage Collaboration).

How will this research help others?

The study aims to estimate how many people in NHSD have been infected with the virus that causes COVID-19. We don’t know yet if having antibodies gives someone long-lasting protection from the virus. The results of this study may help guide public health policy and the government’s plan for its antibody testing strategy.

What do the antibody test results mean?

Antibodies are made by the immune system to fight infection. This test looks for two types of antibodies, IgM, which are often short-lasting, and IgG, which are usually longer lasting. By looking for antibodies in blood, we may be able to understand whether someone has previously been infected with the virus that causes COVID-19.

However, whilst the results themselves are very specific to a COVID-19 response, they have limited sensitivity and do not guarantee a perfect result for individual diagnosis. This is a level of error we are able to correct for in analyses of whole populations, but which make the individual relevance of results limited.

Please be aware that the antibody test is not reliable at an individual level.

Whatever your test result, you must continue to follow current Government advice on self-isolation and social distancing and should be vaccinated when you are able.

It is very important, despite what the results of this test shows, that you do not change your behaviour. There is no strong evidence yet to suggest that those who have had the virus develop long-lasting immunity that would prevent them from getting the virus again. It is important that you continue to follow the current Government advice based on symptoms and possible exposures.

What are the possible risks or side-effects of taking part?

Collecting the blood sample for the self-test requires a finger prick which can feel like a little pinch and which may cause some people a small amount of discomfort. As with any cut, there is a small risk of infection and/or bruising. However, the process and products in the kit are used routinely in a wide range of healthcare applications, including measurement of blood glucose levels in the management of diabetes. The equipment is sterile and following the instructions provided in the kit will minimise risk of infection (such as cleaning the area before and after).You should not take part if you are at increased risk of bleeding.  If you continue to bleed after the finger prick, apply pressure to the puncture site until the bleeding stops.

Who is organising and funding the research?

This research is organised by the study team of the MRC Unit for Lifelong Health and Ageing at UCL, who is responsible for the NSHD.  This data collection is funded by UK Research and Innovation (UKRI).  The Department of Health and Social Care (DHSC) have provided the antibody kits for free and have had no involvement in the planning of this study.

Who has reviewed this research?

This research project was given a favourable ethical review by the Queen Square Research Ethics Committee, London (REF: 19/LO/1774).

What will happen to the samples I give?

With your permission, we will store your samples in UCL approved laboratories for as long as scientifically justified.  The sample will be anonymised so that you will not be identifiable from it and will be used in health-related research studies in the future.  Samples may also be sent to other research groups, including those outside the UK. Some of these research groups may work with pharmaceutical companies. These transfers of samples will be strictly governed by the relevant Tissue Bank to ensure your privacy and that appropriate research is being performed.  Should you wish to do so, you can request that your samples be destroyed at any time.

Contacts for further information and complaints:

If you wish to know more about the study:

Dr Andrew Wong
National Survey of Health and Development
MRC Unit for Lifelong Health and Ageing at UCL
1-19 Torrington Place
London
WC1E 7HB

Telephone:    020 7670 5709
Facsimile:      020 7580 1501
E-mail:          MRCLHA.Enquiries@ucl.ac.uk

 

Name and Contact Details of the Principal Investigator

Prof Nish Chaturvedi
National Survey of Health and Development
MRC Unit for Lifelong Health and Ageing at UCL
1-19 Torrington Place
London
WC1E 7HB

Telephone:    020 7670 5700
E-mail:          n.chaturvedi@ucl.ac.uk

 

If you wish to complain, or have any concerns about any aspect of the way you have been approached, please contact Andrew Wong.

 

Thank you for reading this document and for your ongoing support of NSHD.

If you wish to download a copy of this information sheet:

 

Participant_information_booklet. IRAS: 254776. Version 1.2 date (15/03/2021).