key: cord-282526-b8tky324 authors: Berger Gillam, T.; Cole, J.; Gharbi, K.; Hitchcock, M.; Edwards, D.; Brabbs, T.; Lipscombe, J.; Davidson, R.; Rushworth, S. A.; Steel, N. title: Norwich COVID-19 Testing Initiative: feasibility project evaluation date: 2020-09-23 journal: nan DOI: 10.1101/2020.09.22.20199455 sha: doc_id: 282526 cord_uid: b8tky324 Background There is a high prevalence of COVID-19 in university-age students, who are returning to university campuses. There is little evidence regarding the feasibility of universal, asymptomatic testing to control outbreaks in this population. This study aimed to pilot mass COVID-19 testing on a university research park, to assess the feasibility and acceptability of scaling up to all staff and students. Methods This was a cross-sectional feasibility study on a university research park in the East of England. Staff and students (5,625) on the research park were eligible to participate. Polymerase chain reaction (PCR) testing was offered to all participants. Participants were offered 4 swabs, which they self-administered over a two-week period. Outcome measures included: uptake; drop-out rate; positivity rates; participant acceptability measures; laboratory processing measures. Results 798/1053 (76%) of those who registered provided at least one swab and of these, 687 (86%) provided all four. 681/687 (99%) had all negative results. 6 participants had one inconclusive result. There were no positive results. 458/798 (57%) participants responded to a post-testing questionnaire. 446/458 (97.5%) of those who responded agreed that they would be interested in repeat testing in the future. Conclusions Repeated self-testing is feasible and acceptable to a university population. Universities are considering methods of dealing with the transmission of COVID-19 when students return to campus. Students are likely to have a higher than average prevalence of infection (1) and in particular, a high rate of asymptomatic infection (2) . This population is also highly mobile and more likely to have a large number of social contacts (3) . It remains unclear how an outbreak might evolve on a university campus, but modelling studies suggest that students are highly interconnected, indicating significant potential for infectious disease transmission (4, 5) . Colleges in the USA have already reported outbreaks among the student population, necessitating closure in some cases (6) . The UK government is exploring community-wide testing for asymptomatic COVID-19 infection as a potential health protection tool, to enable outbreaks to be identified and controlled early (7) . A SAGE consensus statement has suggested that such a strategy might be useful in "well-defined higher risk settings", such as universities (8) . This method is largely untested within a university setting, however. This pilot study was based in the Norwich Research Park (NRP), which includes the University of East Anglia (UEA) and a range of business and research institutions. The study offered four COVID-19 PCR swabs to all staff and students on the site over a twoweek period, with the aim of piloting communications, logistics and laboratory processes, and assessing participant acceptability in preparation for larger-scale testing. All participants living or working on the NRP were eligible to participate and were invited to join the study via an email cascade to staff and students. Ethics approval (no. 2019/20-140) was obtained from the UEA research ethics committee. A secure web application was developed and hosted by the School of Computer Science at the UEA. Participants registered on the web application and were invited to verify their email accounts. All those who verified their accounts were considered to have enrolled in the study. 180 people participated in a pre-trial, in which they returned two swabs. For the main study, participants were offered four swab tests over two weeks. They collected swab kits, self-administered the swab and returned the test in pre-booked return slots. For the purposes of this report the pre-trial and main trial are considered as a single trial. Swabs were processed in dedicated laboratory facilities at the Earlham Institute (EI) from Monday to Friday. Copan Liquid Amies Elution Swabs (Eswabs) were used for all participants. Participant samples were tested for the presence of SARS-COV-2 using a quantitative polymerase chain reaction (qPCR) assay. Briefly, nasopharyngeal swab samples were pre-treated with a lysis buffer (Cytiva) that disrupts human cells and viral particles to release nucleic acid into solution. Following inactivation, RNA was extracted using Sera-Xtracta Virus/Pathogen Kit (Cytiva) on a liquid handling platform (Beckman NXp). RNA extracts were amplified for detection of the target genes using a set of optimised primers and probes (2019-nCoV CDC EUA Kit, IDT), and enzymes (qPCRBIO Probe 1-Step Go No-ROX, PCRBioystems) in a real-time PCR system (Quantstudio5, Thermofisher). The assay is qualitative with results assessed based on a threshold cycle (Ct value) to determine outcome (positive, negative, insufficient) using a combination of Ct value for the viral target (N1) and human internal control gene (RPP30) genes. Positive and negative controls were included in every RNA extraction and qPCR run for quality control. Negative or inconclusive results were posted on participants' online accounts. A protocol for managing positive results was developed, including notifying participants and NHS Track and Trace by telephone, and advising participants to share their results with their GP. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medRxiv preprint 3 After the completion of the feasibility project, participants who had returned at least one swab were emailed a link to complete a short online participant feedback questionnaire, including questions on demographics and their experience of the project. Groups were compared with Chi-squared tests and free text responses were analysed by extraction of key themes. Results are summarised in Figures 1 and 2 and Tables 1 and 2. Table 1 includes all participants from the pretrial (n= 180) and main trial (n=873). Figure 2 relates to the post-study participant survey (n=458). 19% of the eligible population enrolled in the study and 24% of these dropped out of the study prior to returning any samples. 86% (687/798) of participants who received at least one result returned all four swabs. 6 participants received 1 inconclusive result. All other results were negative (see Figure 1 ). All participants received at least one negative swab. Participants had free choice over the method of returning swabs: pedestrian access sites were favoured over vehicle access sites. The post-trial survey found that the overall acceptability rating was 4.5 stars and 97% of participants would take up repeat testing if available. Self-swabbing received the lowest score for participant acceptability (71% agree or strongly agree that taking the swabs was easy to do). 81% of responders to the post-trial survey were staff and 16% were students. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. There was no significant demographic difference between those enrolled but did not participate and those who did participate. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medRxiv preprint An analysis of guidance documents provided for participants, including an instruction leaflet, standard emails and website text found an average Flesch reading ease score of 60.1. This indicates that material should be comprehensible to a person aged 13-15 years. The instruction leaflet for participants undertaking swabbing had a score of 74, which indicates greater readability. The text for participants opening an online account had a score of 46.8, which indicates that the reader requires a university education to understand the text. Participant acceptability was assessed in two rounds; first by encouraging email comments during the testing process and second by a formal questionnaire. Key themes emerging from participant emails included eligibility and logistical questions. There were very few emails regarding the process of self-swabbing. 458 participants (57%) responded to the survey. Responders were generally positive about their experience of the project, and the overall mean response score was 4.51 stars out of 5. 89% of those who responded to the survey returned all four swabs. 34% of responders were working or studying onsite, with the rest working either partly or exclusively from home. 77.5% of survey responders lived 5 miles or less from the NRP. Responders were not significantly more likely than all 798 participants to have returned all 4 swabs (89% and 86% respectively, p=0.46). There were no statistically significant differences between those who provided all 4 swabs (n=409) and those who provided fewer than 4 (n=49) in demographics or any answers, including the mean response score (4.54 and 4.50 stars out of 5 respectively, p=0.83). 43 of the 49 responders who provided fewer than 4 swabs gave a reason: 21 (48%) were away during part of the study, and another 8 (19%) forgot or were unexpectedly busy with other commitments. 266 responders (59%) answered the free text questions ("Is there any feedback you would like to share about any aspect of your participation in the project?" and "Is there a reason why you were unable to take any selfswab samples?"). Responses were generally positive and included requests for ongoing testing, feedback on results of the study and praise for organisation and response to enquiries. Responders recommended clearer communication on the variability of time to receive results, as some interpreted a longer wait as being suggestive of a positive result. They also requested clearer instructions regarding packing samples. Main findings of this study 827 participants took and delivered their swabs over a two-week period. The relatively low uptake can be explained by the timing of the study during the summer break, the absence of staff from campus due to working-from-home policies and a short run-up to the study. Nearly a quarter of participants dropped out of the study prior to returning any samples. The reasons for this were unclear from the evaluation, however there was no significant demographic difference between those who enrolled in the study but did not participate, and those who did participate. The sex distribution of the eligible population was not available, it is therefore not possible to determine whether the sample population (55% women) was reflective of the eligible population. The ethnic distribution of the study population was broadly reflective of the population of Norwich: 10.9% of participants were of Asian, black, mixed or 'other' ethnicity, compared to 9.1% for Norwich (9) . The study did not identify any false positives, despite this being considered a risk of universal testing (10) . An analysis of guidance documents and participant emails indicates a need for clearer information tailored to the eligible population. The participant questionnaire revealed a high level of participant engagement and acceptability. Combined with the low drop-out rate (86% of participants who returned at least one swab . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medRxiv preprint 6 returned all four), this suggests that participants found self-swabbing and the collection and delivery of samples generally acceptable. The laboratory processed 3046 swabs during the study. Lab processes were effective, with an average processing time of just over 24 hours during the week. The reagent cost per test of £3.61 was for under 6,000 tests which were ordered quickly from outside the UK, and we would expect lower costs per test in a larger initiative. What is already known on this topic The evidence base for use of asymptomatic testing for COVID-19 as an infection control measure remains limited. Universal, repeat testing has been advocated however, as a means of avoiding lockdown (11) . Universities across the world are now considering universal testing despite the pitfalls of this strategy, which include false positive and negative tests, the difficulty of defining an active infection and significant cost (10) . Colleges in the USA have already reported outbreaks of COVID-19 (12) . Modelling studies have indicated that the potential for COVID-19 transmission in universities is significant, particularly shortly after the beginning of term when students return to campus (4, 5) . They demonstrate that universal testing may have a significant impact on control of the virus, depending on the ability of the setting to implement other control methods (13) . There is however, no published study of a universal programme for repeat testing for COVID-19 on a university campus. What this study adds This pilot study indicates that universal testing on a university campus is both feasible and acceptable to the population. A strength of this study is that it trialled the feasibility of repeat testing for COVID-19 in a relatively large, asymptomatic population within a research park and university campus. Participants included both staff and students and the findings can be applied both to a larger study on the same site and to other university contexts. There was a high level of patient engagement with the study. This study has demonstrated that clear, consistent communications are necessary for helping participants to understand the need for testing and the process of undertaking and returning the test. Both universal testing and the current national public health strategy of testing symptomatic people via a local testing site have strengths and weaknesses. The current national strategy of symptomatic testing is adequate when there are few cases in the community, and is cheaper in the short term, but risks allowing undetected spread of COVID-19 when cases start to rise in a community. The main potential problem with universal testing is that it may generate false positives, and therefore unnecessary contact tracing and isolation. It is also more expensive in the short term. There were no false positives out of 3,046 tests in this study. The main advantage of universal testing is that it can identify infectious asymptomatic cases and isolate them before they can infect others in the community. This is a major benefit on a campus university expecting large numbers of students to come together in a community where isolation and social spacing may be challenging to maintain, and where the financial and reputational costs of responding to a major outbreak would be substantial. Limitations of the study include the relatively low uptake and the low prevalence of COVID-19 in this population, which meant that processes for managing positive results could not be tested. As this was a selfselecting cohort of university staff and students, motivation to participate may be higher than in the general population. The findings are generalisable to university staff but may be less generalisable to new undergraduates. This study used PCR swabs but acceptability of some alternative testing methods, such as saliva testing, may be even higher. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint The copyright holder for this this version posted September 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medRxiv preprint Age-dependent effects in the transmission and control of COVID-19 epidemics Covid-19 Social Study: results release 17 Simulating COVID-19 in a university environment The Small-World Network of College Classes: Implications for Epidemic Spread on a University Campus Colleges ask students to leave campus amid COVID-19 outbreaks Press release: £500 million funding for quick result COVID-19 test trials. Department of Health and Social Care Multidisciplinary Task and Finish Group on Mass Testing: Consensus Statement for SAGE. UK Government. 31 st Covid-19 mass testing programmes Universal weekly testing as the UK COVID-19 lockdown exit strategy. The Lancet COVID-19 Outbreak Among College Students After a Spring Break Modelling testing frequencies required for early detection of a SARS-CoV-2 outbreak on a university campus. medRxiv : the preprint server for health sciences Thanks to the volunteers who assisted with this project. Thanks also to Jeannette Chin and members of the EI Covid-19 Testing Initiative (Neil Shearer, Naomi Irish, Chris Watkins, Alex Durrant, Suzanne Henderson, Leah Catchpole, Fiona Fraser, Tom Barker, Jose Carrasco-Lopez, Geoff Plumb). Funded in part by UK Research and Innovation (UKRI) Biotechnology and Biological Sciences Research Council (BBSRC) Core Capability Grant BBS/E/T/000PR9816.