Evaluating Detection of SARS-CoV-2 antibodies using home test kits [COVID-19]
Research type
Research Study
Full title
Evaluating Detection of SARS-CoV-2 antibodies using home test kits (EDSAB-HOME)\n
IRAS ID
284980
Contact name
Isabel Oliver
Contact email
Sponsor organisation
Public Health England
ISRCTN Number
ISRCTN56609224
Duration of Study in the UK
1 years, 6 months, 6 days
Research summary
Purpose and design \n\nIt is likely, although not certain, that prior infection with SARS-CoV-2 will confer some protection from severe disease on re-exposure. Therefore, developing validated means of identifying individuals with such protection is a pressing public health priority.\n\nOne method of assuring wide accessibility of ‘immunity’ or ‘protection’ tests for SARS-CoV-2 would be the availability of home testing systems – either in the form of ‘bleed at home, test in the lab’ formats, or as ‘completely at home’ home testing kits (HTKs) delivered in ‘pregnancy test’ type format. EDSAB-HOME is primarily designed to address the performance and acceptability of the latter system, although other key issues of interpretation (such the correlates of immune protection to SARS-CoV-2) may also be discernible from the study design.\n\nThe rapid, high quality assessment of a novel coronavirus antibody HTK is challenging.\n•\tMultiple HTKs are under development, and timelines for manufacture keep shifting: we still have little idea when viable products will be available for testing. Timelines between July and September 2020 seem quite possible at present, with at least two candidate products in development.\n•\tIt is well recognised that test performance (measured for example by positive predictive value) may differ markedly in low vs. high prevalence populations, however\n•\tthe seroprevalence (proportion of people positive) remains quite low in parts of the population who might be targeted, such as (for example) Police. By contrast, higher seroprevalence in health care workers is recognised.\n•\tThe acceptability of such a test may differ by target population. For example, a test involving self-bleeding may be accepted by healthcare professionals but not by other groups.\n•\tLaboratory based enzyme immunoassays for coronavirus antibodies are being deployed for patient screening soon.\n\nIn consequence, if we wish to determine with narrow confidence limits the performance of a novel HTK in target populations a very short timeframe (which is the UK Government requirement):\no\tWe need a well characterised, volunteer population which is rapidly accessible.\no\tThe volunteer population must reflect a range of backgrounds and seroprevalences\no\tIt must also reflect the UK Government priority groups for testing, which are at present key workers (Police, etc) and Health Care workers.\no\tWe are likely to need to be able to do stratified as well as random sampling from the volunteer population both to study sufficient positive individuals and to represent the demographics of the target population.\n\nThese considerations have led us a design featuring a “Volunteer bank”. Building this we refer to as “Phase 1”. The volunteer bank will be characterised by questionnaire and serological assays, allowing us to sample it to ensure sufficient positive individuals in a second “Phase 2” in which the Home Testing Kits will be evaluated.\n\nRecruitment \nOur approach is workplace-based recruitment: we will recruit people who are actually at work in key worker workplaces (not self isolating, furloughed, working from home). This is because\n- these individuals are our target key worker population, and \n- we do not wish to cause population admixture (i.e. bringing in home workers) unnecessarily.\nHaving decided this, we engaged with the HRA’s PPI panel to review recruitment strategies. The advice was for\n- Poster and web site based recruitment in the workplace\n- Mass staff email using non-coercive, neutral language while at the same time stressing the importance of the project. These emails will cover (a) all staff (b) subsets of staff who have had previous coronavirus infection. Template emails are provided for ethical review.\n\nInclusion / exclusion \nWe will recruit healthcare workers and public service workers (such as police officers) who\n•\tare aged 18 or over; \n•\tare currently working in their place of work, not self-isolating at home;\n•\tdo not currently have symptoms suggestive of COVID-19;\n•\thave not have COVID-19 compatible symptoms in the last seven days; \n•\thave not been diagnosed with COVID-19 in the last seven days; \n•\tproficient in written and spoken English;\n•\tCan read normal sized print e.g. a newspaper (with glasses if necessary) (because they have to be able to read a home testing kit);\n•\tAre not taking part in trials of COVID-19 vaccines.\nThese criteria reflect a need to (i) understand the study (ii) be able to read the HTK (iii) be safe to come to a testing centre (iv) be at minimal additional risk of disease acquisition by attending a testing centre.\nConsent \n\nCapacity: Our workplace based recruitment will involve responsible individuals (hospital worker, police, fire) and will be supported by a detailed patient information sheet, by opportunity to contact the study team, initially by email and then on the phone.\n\nWe believe the groups recruitment are likely to be well informed about the background, and to have capacity to assess the importance of the work, as well as to decline.\n\nCoercion: As has been heavily publicised by the Chief Medical Officers and others, high performance antibody detection systems are being deployed by the NHS imminently (days) and will be used by patients and then staff. These tests have therefore become a standard of care even before analysis of the extent to which they predict protection becomes clear. We are going to be using some of these high performance antibody tests on our subjects to assess their immunity.\n\nWe have had a detailed discussion about whether we should offer these test results, obtained using the same technology used by the NHS to issue results to staff and patients, to our research subjects. Minutes are available on request. Our view is that we have to offer the participants the current standard of care, which is releasing result of validated assays deployed by the NHS, along the NHS’ guidance on what these mean, if they wish to do so. We accept, however, that access to such test results may represent an inducement to take part.\n\nRisks, burdens and benefits \n\nThe main risks from venesection and from unnecessary social mixing in the testing centre. We assess both a minor, given the subject selection, social distancing and use of protective equipment in the testing centre. The precise protective equipment used will follow the guidance of the hospital/public service at the time, but is likely to involve use of masks and gloves.\n\nThe burden as mainly in terms of staff time. \n\n\nConfidentiality \n\nWe follow Caldicott principles of justifiable purpose, minimal use of personal data, and will hold personal data within PHE. Subjects have the right to withdraw from the study and to have their personal data deleted. Statutory rights (Data Protection Act, GDPR) are described in the patient information leaflet. Informed consent applies throughout.\n\nConflict of interest \nThere are no conflicts of interest we are aware of.\n\nUse of tissue samples in future research \nWe follow the principles that samples are gifts, to be used fairly. We offer the subjects the opportunity to have their blood cells, which are present in the blood taken for antibody testing, disposed of if they wish. This material contains their DNA potentially useful for developing new types of coronavirus immunity tests – but we recognise that some people may not wish to have this retained. \n\n\n\n\n
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0166
Date of REC Opinion
2 Jun 2020
REC opinion
Further Information Favourable Opinion