IPSOS MORI/Imperial REACT II Antibody Study additional Rounds

Department of Health and Social Care · Ministerial Department

Expired The latest version ended on 22 March 2022. The September 2026 register still lists the agreement, but its term has passed.

Reference: DARS-NIC-389914-N9R8R
Latest version: v4.3
Term of latest version: 1 April 2021 to 22 March 2022
Start date: 7 July 2020
Data controller: Joint Data Controller
Commercial purposes: No
Sublicensing: No
Files released to date: 0

Data controllers

Why the data was released

Objective for processing

***This amendment (v4) is to provide Ipsos MORI with four additional drops of Demographics data for Rounds 6 and 7 (April 2021 and May 2021) of this study. It supersedes amendment (v3.0) which covered Round 5 (January 2021) of this study.***

This agreement is to support Study 5, one element of the REal-time Assessment of Community Transmission 2 (REACT 2): Usability and feasibility study of widespread home self-testing for SARS-CoV-2 antibodies, being conducted by Imperial College London (sponsor) on behalf of the Department of Health and Social Care (funder).

- Study 1: Usability, acceptability and performance of LFTs (Lateral flow immune-assay test) in individuals with COVID

- Study 2: Usability, acceptability and design of LFT self-testing in public volunteers

- Study 3: Usability and feasibility of LFT self-testing in the community

- Study 4: Usability and validity of LFT self-testing in key workers

- Study 5: A nationally representative sero-prevalence study through self-administered lateral flow tests

This research is being carried out to help the Government establish the cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic. This is based on analysis of LFT self-test results obtained from a random sample of the population ages 18 and above using the NHS register as sampling frame. The lawful basis for processing is Article 6 (1)(e) – ‘processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller and Article 9 (2)(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes’. The processing of data for this study is a task of public interest as it will provide a measure of the national seroprevalence both nationally and across regional and local authority levels.

The legal basis for identifiable data to flow is under Regulation 3(4) of the National Health Service (Control of Patient Information Regulations) 2002 (COPI).

The survey will involve processing special category data in relation to the health and ethnicity of individuals taking part. The results will be used for processing relevant information to support the current efforts of the UK government authorities for understanding the prevalence and spread of COVID-19, informing the public health response to the ongoing pandemic.

While the legal basis is public interest the research has had ethical approval from the South Central Berkshire B Research Ethics Committee (REC) and Health Regulator Authority (HRA).

There will also be two brief online or telephone questionnaires to complete. There are no invasive procedures, although finger prick may cause some short-lived discomfort. There is minimal risk from completing a Lateral flow immune-assay test (LFT) but those with a medical condition that might increase bleeding risk from a self-delivered finger prick test with a lancet are excluded.

In addition, as part of Studies 1-3 the process of home testing with the device that will be used has been extensively evaluated. The choice of testing kits and materials provided have been optimised based on feedback from healthcare professionals and public representatives to support their safe and effective use in home settings.

There is a risk that individuals may change their behaviour based on the belief that a positive test offers them protection if they put themselves at greater risk of infection or adhere less closely to public health protection advice. In all materials it will be made clear that these are research tests and that participants should not change their behaviour based on the results.

The research aims to contact a representative sample of adults (aged 18+) in England in order to meet the five study aims (see above). This sample will be selected from the PDS (Patient Demographics Service) – considered an almost complete sample frame of adults in England, allowing stratification by gender, age and local authority.

It is currently unclear how many people in the UK population have been infected by SARS-CoV-2. One way to explore this question is to measure antibodies in blood of a large number of people, to perform sero-epidemiology. Lateral flow immune-assay test (LFTs) are point of care tests to measure specific antibody in blood. A number have been developed by commercial entities and attained CE mark. However, before widescale use of any LFT for self-testing can be introduced to assess seroprevalence of SARS CoV-2 antibody in the UK population there should be pilot work on the acceptability, usability and reliability of the use of self-tests in real world settings. For example, whether such tests can be used in the home and what degree of confidence could be placed in the results self-reported by the user. These should be conducted at the same time as laboratory-based assessments are being conducted of the performance and validity of the tests in comparison with a gold standard.

The overall objective of REACT 2 is to assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community.

The data extracts requested from NHS Digital's Patient Demographic Service (PDS) will be used in order to select a nationally representative sample of adults to take part in the testing. The study needs to provide reliable estimates of infection point seroprevalence at the level of local authority, as this is the administrative level responsible for local government and will feed into the local public health response. This will be particularly important to inform disease control measures such as contact tracing at local level. It is also powered to explore differences by key sociodemographic variables (age, gender, ethnicity and socio-economic status (SES)).

This research was originally planned for three waves. The first round was in April 2020 (under an IG email of release) and Round 2 was in July 2020 (under version 1 of this agreement) which was for 375,00 randomly selected records, aiming to produce 100,000 completed tests.

There were two further Rounds in August and September 2020 (under amendment v1.2 of this agreement). The test sample size was then increased for August and September 2020 to c200,000 completed tests. This was because, based on assumptions and the time, Ipsos MORI will need to send out c560,000 invitations to achieve the complete test target. However, the registration window for August fell over the bank holiday weekend which impacted response rates, and because the identifiable population was provided in April 2020, more of the requested sample was removed each wave (deaths, changes to address etc). As a result, Ipsos MORI requested 615,000 records to provide some buffer). The August sample was required for mid-August 2020. The September identifiable Demographic (PDS) cohort sample size from the NHS Demographics Team was subsequently increased to 700,000 in order to address the lower than expected response rate.

A further iteration of the agreement (v2.2) was processed to extend the expiry date of the agreement to 31/12/2020 to allow for any delays to fieldwork starting.

A further amendment of the agreement (v3), requested a further extraction of Demographic data by a further extension of Ipsos MORI's contract by DHSC, for Round 5 in early January 2021. The take-up rate from invitation to registration has fallen from 40% to 36% between Round 1 and Round 4 and the registration window for Round 5 (in January 2021) had been reduced by three days. Based on profile of registration response Ipsos MORI anticipated a registration rate of c34% (33.6% was achieved). To account for this and allowing for removal of sample (to account for deaths, changes to address etc), Ipsos MORI requested ~700,000 individuals aged 18 years and above to provide some buffer.

*** This amendment to the agreement (v4) asks for two further extracts of Demographic data by a further extension of Ipsos MORI’s contract by DHSC for Round 6 (in April) and Round 7 (in May/ June). Reflecting progress with the roll out of the vaccination programme, Round 6 will include an additional booster sample of people aged between 55 and 74 in order to estimate the potential impact of antibody positivity on hospital admission rates in the period after 28 days following the first dose (of a two-dose vaccine) but before the second dose. Round 6 will aim to achieve 100,000 completed tests from a nationally representative sample of adults across England and an additional booster sample of 140,000 adults aged between 55 and 74, bringing the total test sample size for Round 6 to 240,000. Round 7 will not include the additional booster sample and will aim to achieve 100,000 completed tests from a nationally representative sample of adults. Based on analysis of responses to previous rounds, it is evident that response rates among the booster group are consistently higher than among the population as a whole. Taking the larger sample size, higher response levels among the booster group and the downward trend seen in response levels across the general population we anticipate needing to send out ~780,000 invitations to achieve the complete test target for Round 6 and ~385,000 invitations to achieve the complete test target for Round 7. This will mean the April identifiable Demographic (PDS) cohort sample size requested from the NHS Demographics Team will increase to ~917,000 individuals aged 18 years and above for Round 6 and ~392,000 individuals aged 18 years and above for Round 7, allowing some buffer for deaths, changes to address and other exclusions . ***

The research aims to contact a representative sample of adults (aged 18+) in England in order to meet the study aims:

1. To estimate the cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to March 2021.

2. To characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to March 2021

3. To investigate the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES).

4. To establish a baseline prevalence at a level reached soon after the end of the initial lockdown and hence provide crucial reference data for future (repeated) surveys.

The data required is demographic information from the Personal Demographics Service, to allow individuals aged 18+ to be contacted for the purpose of undertaking a survey of seroprevalence using self-administered lateral flow assays from an age-stratified representative population sample. Month and year of birth is sufficient for processing, rather than full date of birth.

The data is requested in two stages

- 1 – identifiable record-level population (including NHS ID, patient postcode, gender and age band) in order to allow selection of a representative sample

- 2 – identifiable record-level demographic data request for selected sample only (including NHS ID, patient address, gender, Month and Year of Birth, telephone number and email – where available)

Current data held on the system only. The identifiable contact information will be securely destroyed by Ipsos MORI once the analysis has been completed.

The cohort covers Individuals in England, in all local authorities, since this is the administrative level responsible for local government and the data will feed into the public health response.

There is no other national register of the population that would allow contact with a named and representative sample of adults.

Data controllers:

• Department of Health and Social Care (funder)

• Imperial College London (sponsor) who also processes data

Data processor:

• Ipsos MORI – who are working with the following suppliers to deliver the project

• Imperial College London (as stated above)

• Formara Limited – Print and despatch

• Adare SEC Ltd – Print and despatch

• Txtlocal Ltd - Text message reminders

• Questback GmbH - Online front-end data collection platform accessed by Ipsos Germany.

LEGAL BASIS for DATA PROCESSING

The lawful basis for processing data under GDPR has been reviewed against the guidance and been assessed as acceptable. The Department of Health and Social Care and Imperial College London process data under the legal basis of Article 6(1)(e) ‘processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller’ as the Department of Health and Social Care is a public authority and government department, and Imperial College London is a Public Authority as it has a Royal Charter.

Both Data Controllers process special category data under Article 9(2)(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes …’ as the data are required for research purposes in the public interest and judged subject to the appropriate safeguards. This means that DHSC and Imperial College London (the Data Controllers) can use the personal data they hold about individuals for research with appropriate safeguards in place. Health and care research should serve the public interest, and the Data Controllers have demonstrated in this Purpose section that their research serves the interests of society as a whole. They also do this by following the UK Policy Framework for Health and Social Care Research.

Processing activities

**** AMENDMENT REQUEST:

This amendment (v4.0) is to provide Ipsos MORI with additional drops of Demographics GPES data for Rounds 6 and 7 ). ****

ADDITIONAL DATA REQUESTED UNDER THIS AMENDMENT (v4) & PROPOSED METHODOLOGY

The data will be requested in two drops:

- Drop 1 – Early April 2021 - NHS Digital's Spine Team provide the identifiable data extract (approx. 917,000), including demographic and contact details, for Round 6 to Ipsos MORI via MESH.

- Drop 2 – late May/ early June 2021 - NHS Digital's Spine Team provide the identifiable data extract (approx. 392,000), including demographic and contact details, for Round 7 to Ipsos MORI via MESH.

A refreshed record level data drop derived from PDS (including NHS Number, gender, age band, postcode and local authority to Ipsos MORI via MESH (Message Exchange for Social Care and Health - a secure file transfer system) may be requested from NHS Digital’s Spine Team ahead of Drop 2 for Round 7. Ipsos MORI use this to review the survey individuals to ensure the sample frame is an up-to-date reflection of the population aged 18 years and upwards. In addition it will reflect recent address changes, ensuring the survey invitations reach the intended recipient. Ipsos MORI will then select from the refreshed sample with NHS Number. Ipsos MORI will then supply these NHS Numbers to NHS Digital's Spine Team via MESH .

Age Bands requested for Demographic data:

• Age Band C 18 - 22

• Age Band D 23 - 27

• Age Band E 28 - 32

• ….(5-year bands)….

• Age Band U 108 - 112

• Age Band V 113+

- Starting Age - Anyone 18 and over on age calculation date.

- Age Calculation Date: Date the Extract is run

NOTE: Any records marked as Invalid or Sensitive are excluded from the data extract. If a patient is no longer eligible for the survey due to not meeting one of the criteria below when an initial sample is requested then we just return the NHS Number:

• Registered at a GP Practice in England, the sample is not to include those registered at practices in Wales and the Isle of Man.

• Not Registered at a military practice starting with A91*

• Registered with the GP Practice since ‘Patient Age Calculation Date’

• Aged 18+ (Age as calculated using the ‘Patient Age Calculation Date’

• Any Gender

• Not deceased (informal or formal) i.e. no Date of Death

• Record not superseded

• Record not marked as Sensitive or Invalid

****

The contact details will be used to contact a sample of people to ask them to register to complete the test. In order to do this each person will be sent a letter by an approved print supplier (Adare SEC Ltd). If they agree they will register online which will then trigger a test being sent to their address by a second approved print supplier (Formara Limited). The test is then self-administered and the participant is asked to take part in a short online or telephone survey including information on demographic variables, household composition and recent symptoms.

Questback GmbH is the responsible for the technical implementation of the online registration/ survey and data collection platform for the REACT studies. While Ipsos Germany programme the questionnaires using the Questback GmbH platform and therefore have access to sample data, Questback GmbH actually hold the sample data on their servers, which are hosted by Amazon Web Services inc. All suppliers are GDPR compliant.

***Amazon Web Services inc supply IT infrastructure for Questback GmbH and are therefore listed as data processors. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.***

Name and address information is held securely and separately from the survey data, for example, there is controlled and restricted access to the computer system where this information is stored at Ipsos MORI.

The personal data is only used for the purpose of inviting people to take part in the research. No identifiable data is shared outside the research team (unless they consent to data linkage) and it is not possible to identify individuals in the published results.

If participants consent to further data linkage - Imperial College London may link the results to other health information held by the NHS. This linkage would be done by the NHS and any identifying information would be removed from the data after linkage. Any subsequent data linkage is still to be agreed – should this situation arise – a further iteration to this agreement would be needed to detail this linkage and be subsequently approved. This agreement (v3) does not currently permit subsequent linkage of NHS Digital data to other health information.

The data supplied by NHS Digital is being used to select a representative sample of patients to be invited to take part in the testing. This involves using identifiable information in order to make the initial selection (NHS Number, postcode, age band, gender) and then identifiable patient level data is supplied for this selected sample (contact information gender, age (month, year of birth)). The identifiable patient level data is used to invite patients to register to take part in the research.

No linkage will be done without consent from patients.

All employees involved in the processing are appropriately trained in data protection and confidentiality. Ipsos MORI is certified to ISO 27001 the international standard for Information Security and ISO 20252 the international standard for market research, as well as an MRS Company partner. All employees sign contracts that include appropriate confidentiality clauses, requiring them to comply with relevant data protection policies and procedures. Information Security and acceptable use policies and procedures include clauses that clearly define unauthorised use and/or deliberate misuse, disclosure, loss or destruction as misconduct, with appropriate links to disciplinary procedures. Policies and procedures also include clear warnings that such actions may also lead to legal action against those involved.

All suppliers (for printing and online survey delivery) are approved suppliers (also certified to ISO 9001 and ISO 27001) and an Article 28 compliant agreements are in place.

All personal data held in delivering this survey will be subject to appropriate security measures to ensure it is kept secure from accidental or deliberate loss, destruction or disclosure. All organisations handling personal data are accredited to the international standard for information security (ISO 27001), which requires an information security policy documenting their approach.

In terms of technical measures, all users have their own login and password, and access controls are based on user accounts with rights automatically controlled by ‘Active Directory’ group security policy objects.

Access to patient identifiable data will be restricted to the minimum number of personnel; all of whom have undergone training in data protection law, their duty of confidentiality under contract and in the care and handling of personal data. Any locations containing patient identifiable information would have restricted access to a limited number of project team members, with access rights regularly reviewed. A similar approach is used by suppliers.

Where data needs to be transferred, this will be done via via MESH. Controls extend to data destruction policies, with electronic data destroyed using Blancco Eraser shredding software, to agreed timescales, and evidenced by destruction certificates stored in the project folder.

Data extract shared with Imperial College London, for the purposes of further analysis:

This data extract will include all survey responses, as well as some sample information (postcode, gender, age (derived from Demographics data) with additional variables mapped (including IMD, local authority name). Photographic images of test results may also be shared where participants have uploaded these.

All individuals accessing the NHS Digital data extract are substantive employees of Imperial College London or on an honorary contract and additionally sign a confidentiality form for accessing REACT data. Honorary staff will not have transfer rights and will be limited to screen view only.

NHS Digital data will be processed on Imperial College London statistical servers at Slough (that are backed up at South Kensington and Hammersmith Campus). Servers holding REACT data can only be accessed by REACT approved users. Specified users do have the ability to transfer files, but this is for the upload of scripts and the download of anonymised data (such as graphs and aggregated tables). By default, users have “screen view” only. Dedicated hardware firewalls surround all servers that hold the REACT data (known as the REACT enclave), this blocks outgoing traffic as well as incoming. All user network traffic is via “gateways” that are controlled by the Imperial College London Security Manager. Once connected to a REACT server users cannot “browse the web”, send/receive emails, connect to Imperial College London network drives etc. Everything must be through the gateways.

Users access the gateways via Pulse secure VPN software. Before connections are allowed the software checks that the users operating system is patched and has an up to date virus checker is installed and operating. The authentication is multi-factor with users also needing a smartphone as well as username and password. All VPN connections are monitored, and the Security Manager receives alerts if non-UK connections are detected. Once authenticated the gateway determines if the user has appropriate rights at access the react servers. The gateways are used to determine which enclave and services the users have access to.

Network traffic between Slough and South Kensington / Hammersmith campus is encrypted and is via dedicated “dark fiber”. All network infrastructure at Virtus Holdco Ltd (Slough) is owned and managed by Imperial College London staff in space dedicated to Imperial College London, with separate rack space. Access into the Imperial College London area is via swipe cards, CCTV covers the area and is monitored by Imperial College London and Virtus Holdco Ltd staff (24 hour).

Virtus (Infinity SDC Limited) do not access data held under this agreement as they only supply the building for Imperial College London's servers. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.

The NHS Digital data will not be used for any other purposes or combined with any other datasets other than those detailed in this Agreement.

Expected output

This study is part of a wider study of understanding COVID-19 and determining the government’s public health response to the pandemic, and it's overall aim is to assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community.

Data will not be made available to any third parties, other than those specified in this agreement, except in the form of aggregated outputs with small numbers suppressed in line with the suppression rules stated in the HES analysis guide.

Expected measurable benefits

There is a direct public health benefit in understanding the infection point seroprevalence of COVID-19 at regional and local authority level.

To achieve the overall study aim, this study (Study 5) is a nationally representative sero-prevalence study through self-administered lateral flow tests. The objectives of the study overall are to understand current diagnostic tests and will inform testing and the public health response to the COVID-19 pandemic.

The testing programme will allow estimates of cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to March 2021. It will help characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to March 2021.

It will also help establish the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES). It also provides a crucial reference data for future (repeated) surveys.

Benefits reported so far

The REACT2 survey data has provided deep and valuable insights to help understand the nature of COVID-19 antibodies over time, and improve our understanding about the virus itself. It has enabled accurate and timely measurement of the prevalence of an immune response to COVID-19 across England since the start of the pandemic, helping to identify parts of the country and particular groups within society who have been most vulnerable to catching the virus.

The survey data continues to provide robust evidence to help assess if having antibodies gives someone long-lasting protection from the virus, helping to inform and guide public health policy. Furthermore as the vaccine roll out programme progresses, the study will continue to play an important role in helping to assess the impact of the vaccines on levels of immune response across the country.

Results from the REACT2 study rounds have been extensively reported through mainstream and digital media platforms and the latest findings from the REACT studies are published via the REACT findings webpage - https://www.imperial.ac.uk/medicine/research-and-impact/groups/react-study/real-time-assessment-of-community-transmission-findings/

Datasets on the latest version

Legal basis for provision: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261(5)(d); Other-COPI Legislation

Datasets approved under DARS-NIC-389914-N9R8R-v4.3
Dataset	Type of data	Sensitivity	Frequency	Confidential data
Demographics	Identifiable	Sensitive	One-Off	Statutory exemption to flow confidential data without consent

Files released

Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.

No files recorded as released under this agreement.

Version history

The register lists each renewal of this agreement as a separate row. This site has 5 versions.

DARS-NIC-389914-N9R8R-v4.3 1 April 2021 to 22 March 2022

Title: IPSOS MORI/Imperial REACT II Antibody Study additional Rounds
Commercial: No
Sublicensing: No
Datasets: 1
Files released: 0

Datasets: Demographics

What changed from DARS-NIC-389914-N9R8R-v3.2

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-389914-N9R8R-v3.2
Field	Was	Became
Title	~~IPSOS MORI/Imperial REACT II Antibody Study~~	IPSOS MORI/Imperial REACT II Antibody Study additional Rounds
Start date	~~2020-12-11~~	2021-04-01
End date	~~2021-03-31~~	2022-03-22
Demographics: legal basis	~~CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261(5)(d)~~	CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261(5)(d); Other-COPI Legislation

Objective for processing

****This ***This amendment ~~(v3.0)~~ (v4) is to provide Ipsos MORI with ~~two~~ four additional drops of Demographics data for Rounds 6 and 7 (April 2021 and May 2021) of this study. It supersedes amendment (v3.0) which covered Round 5 (January 2021) of this study. **** study.*** [20 paragraphs unchanged] *** This A further amendment of the agreement (v3), ~~requests two~~ requested a further ~~extractions~~ extraction of Demographic data by a further extension of Ipsos MORI's contract by [25 words unchanged] Round 4 and the registration window for Round 5 (in January 2021) ~~has~~ had been reduced by three days. Based on profile of registration response Ipsos MORI ~~anticipate~~ anticipated a registration rate of ~~c34%.~~ c34% (33.6% was achieved). To account for this and allowing for removal of sample (to account for deaths, changes to address etc), Ipsos MORI ~~have~~ requested ~700,000 individuals aged 18 years and above to provide some buffer. ~~***~~ *** This amendment to the agreement (v4) asks for two further extracts of Demographic data by a further extension of Ipsos MORI’s contract by DHSC for Round 6 (in April) and Round 7 (in May/ June). Reflecting progress with the roll out of the vaccination programme, Round 6 will include an additional booster sample of people aged between 55 and 74 in order to estimate the potential impact of antibody positivity on hospital admission rates in the period after 28 days following the first dose (of a two-dose vaccine) but before the second dose. Round 6 will aim to achieve 100,000 completed tests from a nationally representative sample of adults across England and an additional booster sample of 140,000 adults aged between 55 and 74, bringing the total test sample size for Round 6 to 240,000. Round 7 will not include the additional booster sample and will aim to achieve 100,000 completed tests from a nationally representative sample of adults. Based on analysis of responses to previous rounds, it is evident that response rates among the booster group are consistently higher than among the population as a whole. Taking the larger sample size, higher response levels among the booster group and the downward trend seen in response levels across the general population we anticipate needing to send out ~780,000 invitations to achieve the complete test target for Round 6 and ~385,000 invitations to achieve the complete test target for Round 7. This will mean the April identifiable Demographic (PDS) cohort sample size requested from the NHS Demographics Team will increase to ~917,000 individuals aged 18 years and above for Round 6 and ~392,000 individuals aged 18 years and above for Round 7, allowing some buffer for deaths, changes to address and other exclusions . *** [17 paragraphs unchanged] ~~***~~ [8 paragraphs unchanged]

Processing activities

[1 paragraph unchanged] This amendment ~~(v3.0)~~ (v4.0) is to provide Ipsos MORI with additional drops of Demographics GPES data for ~~one round of data (round 5).~~ Rounds 6 and 7 ). **** ADDITIONAL DATA REQUESTED UNDER THIS AMENDMENT ~~(v3)~~ (v4) & PROPOSED METHODOLOGY [1 paragraph unchanged] - Drop 1 - Mid December 2020 - NHS Digital's Spine Team provide a refreshed identifiable population derived from PDS (including NHS Number, gender, age band, postcode and local authority to Ipsos MORI via MESH (Message Exchange for Social Care and Health - a secure file transfer system). Ipsos MORI use this to review the survey individuals to ensure the sample frame is an up-to-date reflection of the population aged 18 years and upwards. In addition it will reflect recent address changes, ensuring the survey invitations reach the intended recipient. Ipsos MORI will then select the refreshed sample with NHS Number. Ipsos MORI will then supply these NHS Numbers to NHS Digital's Spine Team via MESH. - Drop 1 – Early April 2021 - NHS Digital's Spine Team provide the identifiable data extract (approx. 917,000), including demographic and contact details, for Round 6 to Ipsos MORI via MESH. - Drop 2 ~~- Early January~~ – late May/ early June 2021 - NHS Digital's Spine Team provide the identifiable data extract (approx. ~~700,000),~~ 392,000), including demographic and contact details, for Round 5 7 to Ipsos MORI via MESH. A refreshed record level data drop derived from PDS (including NHS Number, gender, age band, postcode and local authority to Ipsos MORI via MESH (Message Exchange for Social Care and Health - a secure file transfer system) may be requested from NHS Digital’s Spine Team ahead of Drop 2 for Round 7. Ipsos MORI use this to review the survey individuals to ensure the sample frame is an up-to-date reflection of the population aged 18 years and upwards. In addition it will reflect recent address changes, ensuring the survey invitations reach the intended recipient. Ipsos MORI will then select from the refreshed sample with NHS Number. Ipsos MORI will then supply these NHS Numbers to NHS Digital's Spine Team via MESH . [20 paragraphs unchanged] ~~***~~ Questback GmbH is the responsible for the technical implementation of the online registration/ survey and data [21 words unchanged] to sample data, Questback GmbH actually hold the sample data on their ~~servers.~~ servers, which are hosted by Amazon Web Services inc. All suppliers are GDPR compliant. ~~***~~ ***Amazon Web Services inc supply IT infrastructure for Questback GmbH and are therefore listed as data processors. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.*** [10 paragraphs unchanged] Where data needs to be transferred, this will be done via ~~MESH (with NHS Digital) or using a secure transfer service encrypted to minimum standard AES256.~~ via MESH. Controls extend to data destruction policies, with electronic data destroyed using Blancco Eraser shredding software, to agreed timescales, and evidenced by destruction certificates stored in the project folder. [5 paragraphs unchanged] Network traffic between Slough and South Kensington / Hammersmith campus is encrypted [51 words unchanged] monitored by Imperial College London and Virtus Holdco Ltd staff (24 hour). ~~***~~ Virtus (Infinity SDC Limited) do not access data held under this agreement as they only supply the building for Imperial College London's servers. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data. [1 paragraph unchanged]

Benefits reported

Not stated in the previous version; added here.

Unchanged: Expected output, Expected measurable benefits.

DARS-NIC-389914-N9R8R-v3.2 11 December 2020 to 31 March 2021

Title: IPSOS MORI/Imperial REACT II Antibody Study
Commercial: No
Sublicensing: No
Datasets: 1
Files released: 0

Datasets: Demographics

What changed from DARS-NIC-389914-N9R8R-v2.2

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-389914-N9R8R-v2.2
Field	Was	Became
Start date	~~2020-10-29~~	2020-12-11
End date	~~2020-12-31~~	2021-03-31

Objective for processing

****This amendment (v3.0) is to provide Ipsos MORI with two additional drops of Demographics data for Round 5 (January 2021) of this study. **** [1 paragraph unchanged] - Study 1: Usability, acceptability and performance of LFTs (Lateral flow immune-assay test) in individuals with COVID [4 paragraphs unchanged] ~~This research is being carried out to help the Government develop its approach to COVID-19 testing.~~ This research is being carried out to help the Government establish the cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic. This is based on analysis of LFT self-test results obtained from a random sample of the population ages 18 and above using the NHS register as sampling frame. The lawful basis for processing is Article 6 (1)(e) – ‘processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller and Article 9 (2)(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes’. The processing of data for this study is a task of public interest as it will provide a measure of the national seroprevalence both nationally and across regional and local authority levels. The legal basis for identifiable data to flow is under Regulation 3(4) of the National Health Service (Control of Patient Information Regulations) 2002 (COPI). [2 paragraphs unchanged] There will also be two brief online or telephone questionnaires to complete. [12 words unchanged] discomfort. There is minimal risk from completing a Lateral flow immune-assay test ~~(LTF)~~ (LFT) but those with a medical condition that might increase bleeding risk from a self-delivered finger prick test with a lancet are excluded. [1 paragraph unchanged] There is a risk that individuals may change their behaviour based on [27 words unchanged] In all materials it will be made clear that these are research ~~test~~ tests and that participants should not change their behaviour based on the results. The research aims to contact a representative sample of adults (aged 18+) in England in order to meet the five study aims (see above). This sample will be selected from the PDS (Patient Demographics Service) – considered an almost complete sample frame of adults in England, allowing stratification by gender, age and local authority. It is currently unclear how many people in the UK population have been infected by SARS-CoV-2. One way to explore this question is to measure antibodies in blood of a large number of people, to perform sero-epidemiology. Lateral flow immune-assay test (LFTs) are point of care tests to measure specific antibody in blood. A number have been developed by commercial entities and attained CE mark. However, before widescale use of any LFT for self-testing can be introduced to assess seroprevalence of SARS CoV-2 antibody in the UK population there should be pilot work on the acceptability, usability and reliability of the use of self-tests in real world settings. For example, whether such tests can be used in the home and what degree of confidence could be placed in the results self-reported by the user. These should be conducted at the same time as laboratory-based assessments are being conducted of the performance and validity of the tests in comparison with a gold standard. The overall objective of REACT 2 is to assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community. The data extracts requested from NHS Digital's Patient Demographic Service (PDS) will be used in order to select a nationally representative sample of adults to take part in the testing. The study needs to provide reliable estimates of infection point seroprevalence at the level of local authority, as this is the administrative level responsible for local government and will feed into the local public health response. This will be particularly important to inform disease control measures such as contact tracing at local level. It is also powered to explore differences by key sociodemographic variables (age, gender, ethnicity and socio-economic status (SES)). This research was originally planned for three waves. The first round was in April 2020 (under an IG email of release) and Round 2 was in July 2020 (under version 1 of this agreement) which was for 375,00 randomly selected records, aiming to produce 100,000 completed tests. There were two further Rounds in August and September 2020 (under amendment v1.2 of this agreement). The test sample size was then increased for August and September 2020 to c200,000 completed tests. This was because, based on assumptions and the time, Ipsos MORI will need to send out c560,000 invitations to achieve the complete test target. However, the registration window for August fell over the bank holiday weekend which impacted response rates, and because the identifiable population was provided in April 2020, more of the requested sample was removed each wave (deaths, changes to address etc). As a result, Ipsos MORI requested 615,000 records to provide some buffer). The August sample was required for mid-August 2020. The September identifiable Demographic (PDS) cohort sample size from the NHS Demographics Team was subsequently increased to 700,000 in order to address the lower than expected response rate. A further iteration of the agreement (v2.2) was processed to extend the expiry date of the agreement to 31/12/2020 to allow for any delays to fieldwork starting. *** This amendment of the agreement (v3), requests two further extractions of Demographic data by a further extension of Ipsos MORI's contract by DHSC, for Round 5 in early January 2021. The take-up rate from invitation to registration has fallen from 40% to 36% between Round 1 and Round 4 and the registration window for Round 5 (in January 2021) has been reduced by three days. Based on profile of registration response Ipsos MORI anticipate a registration rate of c34%. To account for this and allowing for removal of sample (to account for deaths, changes to address etc), Ipsos MORI have requested ~700,000 individuals aged 18 years and above to provide some buffer. *** [1 paragraph unchanged] 1. To estimate the cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to ~~June 2020.~~ March 2021. 2. To characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to ~~June 2020~~ March 2021 [2 paragraphs unchanged] ~~This sample will be selected from the PDS – considered an almost complete sample frame of adults in England, allowing stratification by gender, age and local authority.~~ The data required is demographic information from the Personal Demographics Service, to allow individuals aged 18+ to be contacted for the purpose of undertaking a survey of seroprevalence using self-administered lateral flow assays from an age-stratified representative population sample. Month and year of birth is sufficient for processing, rather than full date of birth. This study is one element of the REal-time Assessment of Community Transmission 2 (REACT 2): Usability and feasibility study of widespread home self-testing for SARS-CoV-2 antibodies, being conducted by Imperial College London (sponsor) on behalf of the Department of Health and Social Care (funder). It is currently unclear how many people in the UK population have been infected by SARS-CoV-2. One way to explore this question is to measure antibodies in blood of a large number of people, to perform sero-epidemiology. Lateral flow immune-assay test (LFTs) are point of care tests to measure specific antibody in blood. A number have been developed by commercial entities and attained CE mark. However, before widescale use of any LFT for self-testing can be introduced to assess seroprevalence of SARS CoV-2 antibody in the UK population there should be pilot work on the acceptability, usability and reliability of the use of self-tests in real world settings. For example, whether such tests can be used in the home and what degree of confidence could be placed in the results self-reported by the user. These should be conducted at the same time as laboratory-based assessments are being conducted of the performance and validity of the tests in comparison with a gold standard. The overall objective of REACT 2 is to assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community. ~~The work proposed under this application is part of the REACT 2 programme – there are 5 linked sub studies and this is study 5.~~ ~~- Study 1: Usability, acceptability and performance of LFTs in individuals with COVID~~ ~~- Study 2: Usability, acceptability and design of LFT self-testing in public volunteers~~ ~~- Study 3: Usability and feasibility of LFT self-testing in the community~~ ~~- Study 4: Usability and validity of LFT self-testing in key workers~~ ~~- Study 5: A nationally representative sero-prevalence study through self-administered lateral flow tests~~ The data requested from the Patient Demographic Service (PDS) will be used in order to select a nationally representative sample of adults to take part in the testing. The study needs to provide reliable estimates of infection point seroprevalence at the level of local authority, as this is the administrative level responsible for local government and will feed into the local public health response. This will be particularly important to inform disease control measures such as contact tracing at local level. It is also powered to explore differences by key sociodemographic variables (age, gender, ethnicity and socio-economic status (SES)). This agreement is for three waves of research among the general public. The first was in July 2020 (for which data has now been provided) – this request was for 375,00 randomly selected records, aiming to produce 100,000 completed tests. There will be two further waves in August and September 2020. The test sample size has been increased for August and September to c200,000 completed tests. To achieve this, based on current assumptions, Ipsos MORI will need to send out c560,000 invitations. However, the registration window for August 2020 falls over the bank holiday weekend which may impact response rates, and because the pseudonymised population was provided in April, more of the requested sample is removed each wave (deaths, changes to address etc). As a result, Ipsos MORI would like to request 615,000 records to provide some buffer. The August sample is required for Monday 17 August. Timings are to be confirmed for Sept but likely +4 weeks. The September sample size may vary slightly based on a review of response rate assumptions. This study is one component of a larger programme: the REal-time Assessment of Community Transmission 2 (REACT 2): Usability and feasibility study of widespread home self-testing for SARS-CoV-2 antibodies. ~~The research aims to contact a representative sample of adults (aged 18+) in England in order to meet the study aims:~~ ~~1. To estimate the cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to June 2020.~~ ~~2. To characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to June 2020~~ ~~3. To investigate the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES).~~ ~~4. To establish a baseline prevalence at a level reached soon after the end of the initial lockdown and hence provide crucial reference data for future (repeated) surveys.~~ The data required is demographic information from the Personal Demographics Service, to allow individuals aged 18+ to be contacted for the purpose of undertaking a survey of seroprevalence using self-administered lateral flow assays from an age-stratified representative population sample. [3 paragraphs unchanged] Current data held on the system only. The identifiable contact information will be securely destroyed by Ipsos MORI once the analysis has been completed. ~~This has been communicated to participants in the privacy notice as December 2020.~~ The cohort covers Individuals in England, in all local authorities, since this is the administrative level responsible for local government and the data will feed into the public health response. [1 paragraph unchanged] ~~The data request is in two stages to ensure that only pseudonymised data is requested at the population level. Identifiable data is only requested for the selected sample.~~ ~~Month and year of birth is sufficient for processing, rather than full date of birth).~~ [1 paragraph unchanged] • Department of Health and Social Care (funder) • Imperial College London (sponsor) who also processes data [1 paragraph unchanged] ~~• Ipsos MORI~~ • Ipsos MORI – who are working with the following suppliers to deliver the project ~~SUBCONTRACTORS~~ *** ~~Ipsos MORI are working with the following suppliers to deliver the project:~~ • Imperial College London (as stated above) • Formara Limited – Print and despatch ~~(Formara and Adare)~~ ~~• Mail service (Royal Mail)~~ • Adare SEC Ltd – Print and despatch • Txtlocal Ltd - Text message reminders ~~(TextLocal)~~ • Questback GmbH - Online front-end data collection ~~(Ipsos Germany)~~ platform accessed by Ipsos Germany. ~~• Courier services (co-ordinated by The Delivery Group)~~ ~~• Laboratory Services (Eurofins)~~ Formara, Adare, Eurofins, The Delivery Group and TextLocal are all approved Ipsos MORI suppliers (subcontractors) which means that they are also certified to ISO 9001 and ISO 27001 and an Article 28 compliant data sharing agreements are in place. They are not considered Data Processors in this application as they each have a Data Sharing agreement with Ipsos MORI for the services performed. These suppliers are approved and compliant with the General Data Protection Regulations. [1 paragraph unchanged] The lawful basis for processing data under GDPR has been reviewed against the guidance ~~provided by IGARD~~ and been assessed as acceptable. The Department of Health and Social Care [54 words unchanged] College London is a Public Authority as it has a Royal Charter. [1 paragraph unchanged]

Processing activities

~~METHOD:~~ **** AMENDMENT REQUEST: ~~17 August 2020 - The data will be requested in two drops:~~ This amendment (v3.0) is to provide Ipsos MORI with additional drops of Demographics GPES data for one round of data (round 5). **** - Drop 1 - NHS Digital's Spine Team provide a refreshed identifiable population derived from PDS (including NHS Number, gender, age band, postcode and local authority to Ipsos MORI via MESH. Ipsos MORI use this to review the survey individuals to ensure the sample frame is an up-to-date reflection of the population aged 18 years and upwards. This will enable Ipsos Mori to include those who have turned 18 years since the original population was supplied in July 2020 and to increase the sample size to 615,000 invitations. In addition it will reflect recent address changes, ensuring the survey invitations reach the intended recipient. Ipsos MORI will then select the refreshed sample with NHS Number. Ipsos MORI will then supply these NHS Numbers to NHS Digital's Spine Team via MESH. ADDITIONAL DATA REQUESTED UNDER THIS AMENDMENT (v3) & PROPOSED METHODOLOGY ~~- Drop 2 - NHS Digital's Spine Team provide the identifiable data extract, including demographic and contact details, for wave 2 to Ipsos MORI via MESH.~~ The data will be requested in two drops: ~~Mid September 2020 - The data will be requested in two drops:~~ - Drop 1 - Mid December 2020 - NHS Digital's Spine Team provide a refreshed identifiable population derived from PDS (including NHS Number, gender, age band, postcode and local authority to Ipsos MORI via MESH (Message Exchange for Social Care and Health - a secure file transfer system). Ipsos MORI use this to review the survey individuals to ensure the sample frame is an up-to-date reflection of the population aged 18 years and upwards. In addition it will reflect recent address changes, ensuring the survey invitations reach the intended recipient. Ipsos MORI will then select the refreshed sample with NHS Number. Ipsos MORI will then supply these NHS Numbers to NHS Digital's Spine Team via MESH. - Drop 3 - NHS Digital's Spine Team provide a refreshed identifiable population derived from PDS (including NHS Number, gender, age band, postcode and local authority to Ipsos MORI via MESH. Ipsos MORI use this to review the survey individuals to ensure the sample frame is an up-to-date reflection of the population aged 18 years and upwards. This will enable Ipsos Mori to include those who have turned 18 years since the original population was supplied in August 2020 and to increase the sample size further if necessary. In addition it will reflect recent address changes, ensuring the survey invitations reach the intended recipient. Ipsos MORI will then select the refreshed sample with NHS Number. Ipsos MORI will then supply these NHS Numbers to NHS Digital's Spine Team via MESH. - Drop 2 - Early January 2021 - NHS Digital's Spine Team provide the identifiable data extract (approx. 700,000), including demographic and contact details, for Round 5 to Ipsos MORI via MESH. ~~- Drop 4 - NHS Digital's Spine Team provide the identifiable data extract, including demographic and contact details, for wave 3 to Ipsos MORI via MESH.~~ Age Bands requested for Demographic data: The contact details will be used to contact a sample of people to ask them to register to complete the test. In order to do this each person will be sent a letter by an approved print supplier (Adare). If they agree they will register online which will then trigger a test being sent to their address by a second approved print supplier (Formara). The test is then self-administered and the participant is asked to enter the results into an online survey. This online survey data platform is managed by an approved supplier (Ipsos MORI Germany). All suppliers are GDPR compliant. • Age Band C 18 - 22 • Age Band D 23 - 27 • Age Band E 28 - 32 • ….(5-year bands)…. • Age Band U 108 - 112 • Age Band V 113+ - Starting Age - Anyone 18 and over on age calculation date. - Age Calculation Date: Date the Extract is run NOTE: Any records marked as Invalid or Sensitive are excluded from the data extract. If a patient is no longer eligible for the survey due to not meeting one of the criteria below when an initial sample is requested then we just return the NHS Number: • Registered at a GP Practice in England, the sample is not to include those registered at practices in Wales and the Isle of Man. • Not Registered at a military practice starting with A91* • Registered with the GP Practice since ‘Patient Age Calculation Date’ • Aged 18+ (Age as calculated using the ‘Patient Age Calculation Date’ • Any Gender • Not deceased (informal or formal) i.e. no Date of Death • Record not superseded • Record not marked as Sensitive or Invalid **** The contact details will be used to contact a sample of people to ask them to register to complete the test. In order to do this each person will be sent a letter by an approved print supplier (Adare SEC Ltd). If they agree they will register online which will then trigger a test being sent to their address by a second approved print supplier (Formara Limited). The test is then self-administered and the participant is asked to take part in a short online or telephone survey including information on demographic variables, household composition and recent symptoms. *** Questback GmbH is responsible for the technical implementation of the online registration/ survey and data collection platform for the REACT studies. While Ipsos Germany programme the questionnaires using the Questback GmbH platform and therefore have access to sample data, Questback GmbH actually hold the sample data on their servers. All suppliers are GDPR compliant. *** [2 paragraphs unchanged] If participants consent to further data linkage - Imperial College London may link the results to other health information held [11 words unchanged] and any identifying information would be removed from the data after linkage. Any subsequent data linkage is still to be agreed – should this situation arise – a further iteration to this agreement would be needed to detail this linkage and be subsequently approved. This agreement (v3) does not currently permit subsequent linkage of NHS Digital data to other health information. [3 paragraphs unchanged] All suppliers (for printing and online survey delivery) are approved suppliers (also certified to ISO 9001 and ISO 27001) and an Article 28 compliant agreements are in place. ~~Print and dispatch service suppliers are under sub-contract with Ipsos MORI and thus the print and dispatch services are not considered Data Processors under this agreement.~~ [4 paragraphs unchanged] Data extract shared with Imperial College London, for the purposes of further analysis: This data extract will include all survey responses, as well as some sample information (postcode, gender, age (derived from Demographics data) with additional variables mapped (including IMD, local authority name). Photographic images of test results may also be shared where participants have uploaded these. All individuals accessing the NHS Digital data extract are substantive employees of Imperial College London or on an honorary contract and additionally sign a confidentiality form for accessing REACT data. Honorary staff will not have transfer rights and will be limited to screen view only. NHS Digital data will be processed on Imperial College London statistical servers at Slough (that are backed up at South Kensington and Hammersmith Campus). Servers holding REACT data can only be accessed by REACT approved users. Specified users do have the ability to transfer files, but this is for the upload of scripts and the download of anonymised data (such as graphs and aggregated tables). By default, users have “screen view” only. Dedicated hardware firewalls surround all servers that hold the REACT data (known as the REACT enclave), this blocks outgoing traffic as well as incoming. All user network traffic is via “gateways” that are controlled by the Imperial College London Security Manager. Once connected to a REACT server users cannot “browse the web”, send/receive emails, connect to Imperial College London network drives etc. Everything must be through the gateways. Users access the gateways via Pulse secure VPN software. Before connections are allowed the software checks that the users operating system is patched and has an up to date virus checker is installed and operating. The authentication is multi-factor with users also needing a smartphone as well as username and password. All VPN connections are monitored, and the Security Manager receives alerts if non-UK connections are detected. Once authenticated the gateway determines if the user has appropriate rights at access the react servers. The gateways are used to determine which enclave and services the users have access to. Network traffic between Slough and South Kensington / Hammersmith campus is encrypted and is via dedicated “dark fiber”. All network infrastructure at Virtus Holdco Ltd (Slough) is owned and managed by Imperial College London staff in space dedicated to Imperial College London, with separate rack space. Access into the Imperial College London area is via swipe cards, CCTV covers the area and is monitored by Imperial College London and Virtus Holdco Ltd staff (24 hour). *** [1 paragraph unchanged]

Expected output

Data file shared with Imperial College London, for the purposes of further analysis. This file will include all survey responses, some sample information (postcode, gender, age) with additional variables mapped (including IMD, local authority name). Photographic images of test results may also be shared where participants have uploaded these. The data extracts requested from NHS Digital's Patient Demographic Service (PDS) will be used in order to select a nationally representative sample of adults to take part in the testing. The study needs to provide reliable estimates of infection point seroprevalence at the level of local authority, as this is the administrative level responsible for local government and will feed into the local public health response. This will be particularly important to inform disease control measures such as contact tracing at local level. It is also powered to explore differences by key sociodemographic variables (age, gender, ethnicity and socio-economic status (SES)). This study is part of a wider study of understanding COVID-19 and determining the government’s public health response to the pandemic, and it's overall aim is to assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community. Data will not be made available to any third parties, other than those specified in this agreement, except in the form of aggregated outputs with small numbers suppressed in line with the suppression rules stated in the HES analysis guide.

Expected measurable benefits

There is a direct public health benefit in understanding the infection point seroprevalence of COVID-19 at ~~the level of~~ regional and local ~~authority.~~ authority level. The testing programme will allow estimates of cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to June 2020. It will help characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to June 2020. To achieve the overall study aim, this study (Study 5) is a nationally representative sero-prevalence study through self-administered lateral flow tests. The objectives of the study overall are to understand current diagnostic tests and will inform testing and the public health response to the COVID-19 pandemic. It will also help establish the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES). It also provides a crucial reference data for future (repeated) surveys – happening at the end of the initial lockdown. The testing programme will allow estimates of cumulative community seroprevalence since the beginning of the SARS-CoV-2 epidemic up to March 2021. It will help characterise the geographical variation in SARS-CoV-2 seroprevalence across local authorities up to March 2021. ~~This study is part of a wider study of understanding COVID-19 and determining the government’s public health response to the pandemic.~~ It will also help establish the variation in cumulative prevalence of infection by sociodemographic characteristics including age, gender, ethnicity and socio-economic status (SES). It also provides a crucial reference data for future (repeated) surveys. Overall study aim: To assess the acceptability and usability of a self-sampling and self-testing kit for SARS-CoV-2, (starting with the Wondfo SARS-CoV-2 Antibody Test, Guangzhou Wondfo Biotech Co Ltd) and the feasibility of using such a kit at home as part of a large study in the community. ~~To achieve the overall study aim, this study (Study 5) is a nationally representative sero-prevalence study through self-administered lateral flow tests.~~ ~~The objectives of the study overall are to understand current diagnostic tests and will inform testing and the public health response to the COVID-19 pandemic.~~

Objective for processing

****This amendment (v3.0) is to provide Ipsos MORI with two additional drops of Demographics data for Round 5 (January 2021) of this study. ****