COVID-19 home antibody testing study
| ISRCTN | ISRCTN53701620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53701620 |
| Secondary identifying numbers | B3566, CPMS 46980 |
- Submission date
- 26/07/2023
- Registration date
- 08/08/2023
- Last edited
- 05/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The COVID-19 home antibody testing study will invite Avon Longitudinal Study of Parents and Children (ALSPAC) participants who previously completed the COVID-19 questionnaire to complete a home antibody test. This is part of a collaborative effort across UK cohorts to collect serological data on past infection status. In particular, cohorts have been selected to provide information on prevalence across important areas of variation – ethnicity, age, socioeconomic status and geography.
Who can participate?
Volunteers aged 28 to 50 years old of the ALSPAC longitudinal study
What does the study involve?
This is an antibody research study. In this study, the results of antibody tests that participants have taken at home are used to help understand how many people in Children of the 90s may have been infected with the virus which causes COVID-19.
What are the possible benefits and risks of participating?
The aim of the study was to have results that inform public policy/public health in the time of a pandemic. Risks include potential bruising associated with the test kit.
Note, this was an antibody research study rather than a medical device study. Covid19 test kits had not been licensed when this study ran. Because of this, the study was run as a device study.
Where is the study run from?
ALSPAC (Children of the 90s), University of Bristol (UK)
When is the study starting and how long is it expected to run for?
April 2020 to January 2021
Who is funding the study?
1. Medical Research Council (UK)
2. Wellcome Trust (UK)
3. University of Bristol (UK)
Who is the main contact?
Nicolas Timpson, N.J.Timpson@bristol.ac.uk (UK)
Contact information
Principal Investigator
Oakfield House
Oakfield Grove
Bristol
BS8 2BN
United Kingdom
 ORCID ID |
0000-0002-7141-9189 |
|---|---|
| Phone | +44 (0)1173310131 |
| N.J.Timpson@bristol.ac.uk |
Public
Deputy Chief Operating Officer
ALSPAC (Children of the 90s)
Population Health Sciences
Bristol Medical School
University of Bristol
Oakfield House
Bristol
BS8 2BN
United Kingdom
| Phone | +44 (0)117 4553686 |
|---|---|
| Paul.hazell@bristol.ac.uk |
Study information
| Study design | Case-control across within a longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | 44008_PIS_v0.1.pdf |
| Scientific title | Serological testing for COVID-19 in ALSPAC (G0/G1) |
| Study hypothesis | Serological testing for COVID-19 in ALSPAC (G0/G1) (Lay title: COVID-19 home antibody testing study) will invite ALSPAC participants who have previously completed a COVID-19 questionnaire to complete a home antibody test. This is part of a collaborative effort across UK cohorts to collect serological data on past infection status. In particular, a set of cohorts have been selected to provide information on prevalence across 4 important areas of variation – ethnicity, age, socio-economic status and geography. (Please note each cohort is running its studies separately and are have its own protocol and route to ethics approval). |
| Ethics approval(s) |
Approved 21/07/2020, ALEC - ALSPAC ethics and Law committee (ALSPAC (Children of the 90s), Bristol, BS8 2BN, United Kingdom; +44 (0)117 455 3687; lynn.molloy@bristol.ac.uk), ref: 110264 |
| Condition | COVID-19 home antibody testing study |
| Intervention | Our outcome measure is lateral flow test derived evidence of positive antibody response to COVID-19 given knowledge of the sensitivity and specificity of the Fortress Home Test kit. This is relevant given our objectives in this work. The broad objective of this work (and contribution to the work already underway by REACT and UKBiobank) is the collection of epidemiological-grade biological test data for COVID-19 infection across a series of select studies across the UK which provide information on prevalence across 4 main axes of variation important for developing mitigation strategy relevant evidence (age, geography, socio-economic position, ethnicity/ancestry) and with the ability to assess this against information on existing comorbidities. The study's aim is to have results that are policy useful in a short period reflecting the burden of COVID-19 retrospectively across these important gradients but also to allow for the effective planning of research into the nature of the events before, during and after infection. This can only be done in longitudinal studies with retrospective data that are continuing (and part of funded examinations into COVID-19 studies) in the future. The Avon Longitudinal Study of Parents and Children (ALSPAC) is the first of 5 studies to have DHSC procured Fortress lateral flow tests available to do this. This approach will use the same testing approach as the existing REACT-2 study (https://www.reactstudy.org) and consequently, methods are based directly on this successful investigation which has recruited and tested over 100,000 participants. Participants are invited to read the instructions of the antibody kit and do the test themselves at home. The test uses a drop of blood taken from your finger. An instruction booklet is provided with the test for detailed guidance on taking the test. Participants are also asked to go online to complete a short questionnaire that will ask them to: 1. Record any COVID-19 symptoms you may have had in recent months 2. Record your test result 3. Upload a photograph of your test result (this step is optional) In total, this should all take around 45 minutes. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | COVID-19 home antibody test |
| Primary outcome measure | Covid 19 infection status measured using a COVID-19 home antibody test at one timepoint |
| Secondary outcome measures | The are no secondary outcome measures |
| Overall study start date | 20/04/2020 |
| Overall study end date | 20/01/2021 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 28 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 7000 |
| Participant inclusion criteria | Eligible participants in ALSPAC, a longitudinal study |
| Participant exclusion criteria | 1. Any participant who responded ‘No’ to the question that asked if they would be happy for the study team to send information about research involving testing for COVID-19 in the ‘Learning more about COVID-19’ questionnaire 2. Increased risk of bleeding (participants will be asked at the consenting stage to self-declare any issues related to bleeding disorders) 3. Participants outside the UK. Costs and timescales for postage outside the UK make this impractical. 4. Participants who are flagged as deceased, withdrawn, no to questionnaires and no to contact. |
| Recruitment start date | 16/09/2020 |
| Recruitment end date | 14/10/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Population Health Sciences
Oakfield House
Bristol
BS8 2BN
United Kingdom
Sponsor information
University/education
Avon Longitudinal Study of Parents and Children (ALSPAC) (Children of the 90s) Core funding
Population Health Sciences
Oakfield House
Bristol
BS8 2BN
England
United Kingdom
| Phone | +44 (0)1173310131 |
|---|---|
| N.J.Timpson@bristol.ac.uk | |
| Website | https://www.bristol.ac.uk/alspac/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Government organisation / Universities (academic only)
- Alternative name(s)
- Universitas Bristolliensis, bristoluniversity, bristoluni
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Wellcome, WT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 22/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Through numerous media types, the ALSPAC communications team continue to summarise and describe the footprint of ALSPAC research (http://www.bristol.ac.uk/alspac/covid-19/). This includes usual social media routes and looks to acknowledge the diversity of the study. This is an essential addition for a volunteer participant group like ALSPAC as it provides an important route to disseminate results aimed specifically at population-based or epidemiological findings. Please find a link to ALSPAC’s Access Policy - ALSPAC_Access_Policy.pdf (bristol.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Funder report results | 24/01/2022 | 07/08/2023 | No | No | |
| Participant information sheet | version 0.1 | 07/08/2023 | No | Yes | |
| Preprint results | 22/05/2022 | 07/08/2023 | No | No | |
| Protocol file | version 2.1 | 01/08/2020 | 07/08/2023 | No | No |
| Results article | results | 24/01/2023 | 07/08/2023 | Yes | No |
Additional files
Editorial Notes
05/09/2023: Internal review.
07/08/2023: Trial's existence confirmed by the ALSPAC Law and Ethics Committee (ALEC).
