Unmet clinical needs for COVID-19 tests in UK health and social care settings.

There is an urgent requirement to identify which clinical settings are in most need of COVID-19 tests and the priority role(s) for tests in these settings to accelerate the development of tests fit for purpose in health and social care across the UK. This study sought to identify and prioritize unmet clinical needs for COVID-19 tests across different settings within the UK health and social care sector via an online survey of health and social care professionals and policymakers. Four hundred and forty-seven responses were received between 22nd May and 15th June 2020. Hospitals and care homes were recognized as the settings with the greatest unmet clinical need for COVID-19 diagnostics, despite reporting more access to laboratory molecular testing than other settings. Hospital staff identified a need for diagnostic tests for symptomatic workers and patients. In contrast, care home staff expressed an urgency for screening at the front door to protect high-risk residents and limit transmission. The length of time to test result was considered a widespread problem with current testing across all settings. Rapid tests for staff were regarded as an area of need across general practice and dental settings alongside tests to limit antibiotics use.

Introduction

Testing plays an integral role in the international response to the current coronavirus pandemic, facilitating national surveillance and guiding patient management. Testing strategies have been heavily scrutinized, and it is widely acknowledged that the tests currently available are far from ideal. For example, reverse transcription polymerase chain reaction (RT-PCR) based tests, the most commonly used laboratory-based tests for determining current infection, has a false negative rate of around 20% (depending on symptom duration, sampling technique, and site) [1].

The industry response has been unprecedented; by the 17th of July 2020, 746 tests had been developed or are under development [2]. Although this extraordinarily fast development offers hope that the current testing shortfalls can be overcome, this creates a real challenge for diagnostic regulatory bodies. For many years, the conversion of diagnostic innovation from bench to clinical practice has been riddled with problems and is notoriously slow [3]. A rapid evaluation pipeline is required to ensure that tests offering real health benefits are integrated into practice within a timeframe that will support international efforts to curtail the transmission of SARS-CoV-2.

In March 2020, the World Health Organization (WHO) outlined a research roadmap recommending the development of Target Product Profiles (TPPs) to drive the research and innovation process around new diagnostic tests for COVID-19 [4]. A TPP is a document that summarises in advance the desirable and minimally acceptable specifications for a new test to address a well-defined clinical need. The overarching aim is to ensure that innovation efforts are focused on developing ‘fit for purpose’ tests [5,6]. The National Institute for Health and Care Excellence (NICE) have recently begun an economic modeling exercise to help inform TPP specifications for COVID-19 tests [7].

At the core of TPP development is the scoping and definition of unmet clinical needs [5]. Tests often have numerous roles in clinical practice across multiple clinical settings (e.g., primary and secondary care) and positions in a care pathway (e.g., to diagnose or to monitor disease) [8]. There is an urgent need to identify which health and social care settings are most in need of COVID-19 tests, and the priority role(s) for tests in these settings, particularly ahead of the winter season, where other respiratory viral-like illnesses will also be in circulation.

To this end, the National Institute for Health Research (NIHR) MedTech and In Vitro Diagnostics (IVD) Co-operatives (MICs), on behalf of the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) [9], designed an online survey at pace to gather opinion from health and social care professionals and policymakers on unmet clinical needs for COVID-19 tests in the UK. The primary objective of the survey was to determine which settings are in most need of a new COVID-19 test and determine the priority role(s) for new tests within each setting. The results will be used to help prioritise and refine TPP development, plan for winter allocation of tests, and inform economic modeling carried out by the NICE diagnostics assessment programme. Interim reports were shared with the Department of Health and Social Care (DHSC) and NICE on 29/05/2020 and 28/06/2020 to inform decisions around UK national testing policies.

Materials and methods

This project was approved as a service evaluation (ID:10151) by the Newcastle Upon Tyne NHS Hospitals Foundation Trust. Consent to participate was obtained if the respondent read the information on the first page of the survey and clicked ‘Consent to participate’ (see S1 File). The development and reporting of the survey followed good practice guidelines published by Kelley et al. [10] and highlighted by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network [11]. The survey questions were written based on an initial list of priority use cases developed by the DHSC COVID-19 Test Approvals Groups.

Survey design, development, and dissemination

Targeted respondents of this survey were health and social care professionals working in the UK across a variety of settings, and policymakers.

The survey was voluntary and anonymized, with no personal, sensitive, or patient data collected. All respondents were asked to select which setting was most in need of a novel COVID-19 test, and then health and social care professionals were asked to rate the importance of different use cases specific to the setting where they worked. The use cases described potential uses and roles of tests at specific points in the pathway; they were technology agnostic but described roles that could be fulfilled by molecular or serology tests. All respondents, apart from policymakers, were asked if diagnostic testing for COVID-19 was available in the setting in which they worked and, if so, they were asked which type of tests (e.g., molecular, serological) were available and whether they perceived any problems with the tests.

A first draft of the questionnaire was developed using Online surveys (formerly BOS) [12], with the support of two clinicians, and then the questionnaire was tested and revised by the wider authorship team to improve clarity and flow. The survey was then piloted by six hospital clinicians (one of whom worked closely with the ambulance service and another with care homes) and one dentist before its launch, with feedback incorporated into the survey’s final version. Piloting the survey identified problems with wording and confirmed whether the survey functioned as intended in terms of access, navigation and submission [13,14]. Pilot data were not included in the final analysis to avoid contamination of results [14].

The survey was launched and disseminated via a variety of networks, including the NIHR Clinical Research Network (CRN) Coordinating Centre networks, clinical contacts of the NIHR MICs, as well as social media (limited to Twitter and LinkedIn, to our knowledge). A copy of the survey is available in the S1 File.

Survey analysis

A setting was required to have at least 30 respondents in order to be included in the analysis, except for policymakers, where a smaller sample size was anticipated due to policymakers comprising a smaller proportion of the workforce compared to health and social care professionals.

Data processing and analysis were primarily conducted in the statistical programming language R [15], with qualitative free-text responses analyzed in Microsoft Excel. Where appropriate, combined heat maps and dendrograms were used to visualize results and identify similarities/differences between settings using the R function ‘heatmap.2’ from the ‘gplots’ package [16]. Hierarchical clustering was performed using the complete agglomeration method, and the Euclidean method was used to calculate the distances between the data.

Respondents selected whether they felt each use case in their specific setting was ‘More Important’, ‘Important’ or ‘Less Important’ relative to the others in the list. A scoring system was applied (More Important = 1, Important = 0, Less Important = -1), with the mean score and standard deviation calculated to summarize responses. The use cases were then ranked from the highest mean score to the lowest.

A framework for categorizing use cases was developed to facilitate the interpretation of results. Use cases were grouped in the survey based on their intended use: ‘Screening’ (to support isolation, personal protective equipment (PPE) use and cohorting decisions), ‘Diagnostic’ (to inform both infection control and treatment stratification), ‘Prognostic’ (escalation of care decisions) and ‘Monitoring’ (de-escalation of care and safe return to work) [17]. These were subsequently validated and independently re-grouped. In case of disagreement, a single arbiter resolved discrepancies. In the survey, the respondents could also suggest additional use cases via a free text field, if they perceived them to be missing from the provided list. Based on the previously defined framework, additional use cases were analyzed to identify responses similar to the provided list, then independently assigned to the ‘Screening,’ ‘Diagnostic,’ ‘Prognostic,’ and ‘Monitoring’ categories.

Patient and public involvement

Seven members of the CONDOR [9] patient and public representative panel were invited to participate in a focus group discussion. The background, methods, and results of the survey were presented to the group, who were then invited to comment on these aspects. The participants provided verbal and written feedback during and after the meeting which has been incorporated into the discussion and will form the basis of a lay summary for the public to be published on the CONDOR website [9]. They agreed that the survey addressed important questions in relation to COVID-19 diagnostics. They raised the issues of geographical and ethnic representativeness of sampling, the potential omission of settings, and the importance of including patient experiences in future surveys. This included the impact of testing on their physical and mental health and the overall confidence of the public in COVID-19 testing.

Results

The survey was launched at 4 pm on the 22nd of May 2020 and was open until 9 am on the 15th June 2020, receiving 447 completed responses (Table 1). It was not possible to estimate the number of potential respondents reached due to the variety of dissemination routes used. The distribution of survey responses over time, grouped by the setting in which the respondents worked, is presented in S1 Fig.

Table 1

Characteristics of survey respondents.

Respondents, n	447
Respondents’ location, n (%)
North East	217	(48.6)	North West	55	(12.3)
South East	33	(7.4)	South West	21	(4.7)
East Midlands	21	(4.7)	Greater London	20	(4.5)
West Midlands	19	(4.3)	Scotland	19	(4.3)
Yorkshire and Humber	16	(3.6)	Wales	12	(2.7)
East of England	9	(2.0)	Northern Ireland	5	(1.1)
Respondents’ clinical setting, n (%)
Hospital*	189	(42.3)	Primary dental care	65	(14.5)
General practice	55	(12.3)	Prison	30	(6.7)
Secondary dental care1	26	(5.8)	Care home without nursing	22	(4.9)
Care home with nursing	22	(4.9)	Hospice	14	(3.1)
Health policy	12	(2.7)	Ambulance	9	(2.0)
Hospital-at-home	3	(0.7)
*Hospital sections where respondents in that setting worked, n (%)2
Outpatient clinic	48	(20.3)	General medicine ward	28	(11.9)
Other	24	(10.2)	Ophthalmology	22	(9.3)
Emergency Department	19	(8.1)	Intensive Care Unit	19	(8.1)
Oncology	12	(5.1)	Gastroenterology/Colorectal	10	(4.2)
General surgery ward	9	(3.8)	Respiratory	8	(3.4)
Laboratory	7	(3.0)	Theatres	6	(2.5)
Infectious diseases	5	(2.1)	Haematology	5	(2.1)
Rheumatology	4	(1.7)	Neurology	4	(1.7)
Renal	3	(1.3)	Endocrinology	2	(0.9)
Transplantation	1	(0.4)
Respondents’ professional experience, n (%)
10 or more years	311	(71.5)	Between 5 and 9 years	71	(16.3)
Between 1 and 4 years	44	(10.1)	Less than 1 year	9	(2.1)
Patient groups that respondents worked with, n (%)2
Adults	344	(45.5)	Older people	232	(30.7)
Paediatrics	143	(18.9)	Neonates	20	(2.6)
None	17	(2.2)

1Secondary and community dental care;

2Multiple selection enabled question.

Demographics of respondents

The majority of the respondents were from the North East of England (n = 217, 48.6%), with 411 respondents in total from England (92%) (Table 1).

The most common setting in which respondents worked was hospitals (n = 189, 42%), followed by primary dental care (n = 65, 15%) and general practice (n = 55, 12%) (Table 1). The hospice (n = 14, 3%), ambulance service (n = 9, 2%) and hospital-at-home settings (n = 3, 1%) received less than 30 respondents.

Unmet clinical need

Settings which were deemed the highest priority were hospitals (Fig 1, 266 selections across all settings, 55.8% of respondents) and care homes (196 selections across all settings, 41.1% of respondents). This finding was apparent even when considering those who didn’t select their own setting (the red bars in Fig 1). All other settings received less than 100 selections each. Twelve policymakers completed the survey. Most of them prioritized care homes (n = 4), followed by domestic residences (n = 3) and GP practices (n = 2), with hospitals, hospices, and the ambulance service selected by one respondent each. Care homes were generally prioritized by respondents working in other settings.

Fig 1

Settings with the greatest perceived unmet clinical need for COVID-19 tests, showing votes from respondents for their own setting (blue shading) and other settings (red shading).

Use case ranking was explored in care homes with and without nursing independently, and the results were similar, as were those for primary and secondary dental care. We then pooled results from each of these two settings in order to increase the sample size for this and subsequent analyses.

The top three clinical needs for hospitals (Table 2) were all related to diagnosis to support infection control decisions for patients presenting to the hospital (1st), for workers (2nd), and for in-patients (3rd). For care homes, screening tests to support infection control decisions were the most important, with a test for those at admission and workers ranked first and second, respectively, and a test for patients potentially exposed ranked third. Respondents from GP and dental settings showed a similar focus on infection control measures for workers, identifying the two most important needs as testing to support screening and diagnosis of workers. The third most important identified need was around monitoring for both settings. The dental setting showed a preference for a test to support safe return to work and the GP setting a test discharge patients into care homes safely. Respondents from the prison setting preferred a test to identify prisoners with COVID-19 at admission with symptoms (1st), and those with infection who are asymptomatic (2nd). The third most important identified need was to support workers in their self-isolation decisions when symptomatic; however, this had a much lower score than the first two ranked needs. No respondents across settings seemed to consider the few prognostic use cases proposed as being particularly important.

Table 2

Unmet clinical need priorities in each setting from respondents who worked in those settings, ranked by mean score from highest (most important clinical need) to lowest (least important clinical need).

Use cases	Hospital (n = 189)		Care homes (n = 44)		General Practice (n = 55)		Dental setting (n = 91)		Prison (n = 30)
	Mean score	Rank	Mean score	Rank	Mean score	Rank	Mean score	Rank	Mean score	Rank
SCREENING: to support isolation, PPE use and cohorting decisions
A test for those on admission to prevent transmission to existing individuals	x	x	0.93	1	x	x	x	x	0.80	2
To determine whether an asymptomatic patient* has previously been infected with COVID-19	0.07	13	0.61	9	0.20	8	0.11	9	0.27	9
A test for asymptomatic patients who have been potentially exposed	0.42	6	0.70	3	0.22	7	-	x	0.53	5
A test for asymptomatic patients to support safe attendance at routine appointments	x	x	x	x	x	x	0.41	5	x	x
A test for asymptomatic patients to support safe attendance at urgent appointments to guide appropriate use of PPE and aerosol generating procedures	x	x	x	x	x	x	0.48	4	x	x
A test for potentially exposed, asymptomatic workers to support self-isolation decisions	0.43	5	0.77	2	0.67	1	0.81	1	0.60	4
To identify who among patients presenting to clinical setting for reasons unrelated to COVID-19 can receive emergency treatment for non-COVID-19 conditions	0.28	7	x	x	x	x	x	x	x	x
To identify among patients presenting to clinical setting for reasons unrelated to COVID-19 who can receive routine treatment for non-COVID-19 conditions	0.12	11	x	x	0.02	10	-	x	x	x
DIAGNOSTIC
To determine whether a patient with flu-like symptoms has previously been infected with COVID-19 for infection control, patient triaging and management	0.24	10	0.66	7	0.36	4	0.16	x	0.40	7
A test for symptomatic patients presenting at the clinical setting to support infection control	0.57	1	0.70	4	0.35	5	x	x	0.83	1
A test for symptomatic patients to support safe attendance at urgent appointments to guide appropriate use of PPE and aerosol generating procedures	x	x	x	x	x	x	0.33	6	x	x
A guide for symptomatic patients to support safe attendance at routine appointments to guide appropriate use of PPE and aerosol generating procedures	x	x	x	x	x	x	0.12	8	x	x
A test for symptomatic care workers to support self-isolation decisions for infection control	0.56	2	0.70	5	0.64	2	0.68	2	0.70	3
A test for in-patients who develop new clinical features of COVID-19 during their stay to support infection control	0.50	3		x	x	x	x	x	x	x
To confirm that a patient is currently infected with COVID-19 following initial/triage testing to inform treatment choices (e.g. antibiotics/antivirals)	0.26	8	0.70	6	0.27	6	x	x	0.50	6
PROGNOSTIC: escalation of care decisions
To identify who among patients with confirmed COVID-19 diagnosis could benefit from escalation of care	0.08	12	0.61	8	0.04	9	x	x	0.30	8
To identify among symptomatic individuals who could benefit from hospital admission	x	x	0.57	10	x	x	x	x	-	x
To determine whether a patient with flu-like symptoms has previously been infected with COVID-19 to support escalation of care advice	x	x	x	x	x	x	x	7	-	x
MONITORING
A test for care workers with a confirmed COVID-19 diagnosis to inform safe return to work	0.47	4	x	x	x	x	0.63	3	x	x
A test for in-patients with confirmed COVID-19 diagnosis to inform de-escalation of care/safe discharge (into care homes) and/or to move from side rooms	0.24	9	0.41	11	0.40	3	x	x	0.10	10

Table key: ‘PPE’ = ‘personal protective equipment’, x indicates use cases that were not proposed for that setting. The three most important use cases identified by the respondents in each setting are indicated in bold text and shaded cells.

* Term ‘patient’ refers to residents and prisoners for care homes and prisons, respectively.

Some respondents suggested additional needs for clinical tests for COVID-19. While 32 (66.6%) of these could be mapped to existing use cases (the majority of which were for screening tests, n = 6 for patients, n = 14 for staff and n = 4 for community screening), 16 (33.3%) were judged as new use cases by the authors (S1 and S2 Tables). Those that could not be mapped to existing use cases, highlighted the following additional needs: tests for ‘track and trace’, to detect immunity, to distinguish infective cases from non-active infections, to allow safe delivery of elective surgeries, and multiplex tests (i.e., panel tests that can detect multiple respiratory pathogens at the same time) for the winter season. Antibody tests (i.e., serology testing) were mentioned 12 times, with the majority of respondents suggesting that antibody tests would be useful to understand who had COVID-19, while some also recognized the uncertainty around antibody testing.

Problems with medical tests and their availability

The settings where the respondents most frequently stated that COVID-19 tests were available (Fig 2) were hospitals (87%), prisons (85%), and care homes (78%). The settings where the respondents most frequently stated that no COVID-19 tests were available were dental care (86%) and GP (74%). In all settings where COVID-19 testing was reported as being available, molecular laboratory testing was the most common option. Serology point of care tests were only available in GP and hospital settings.

Fig 2

The availability of COVID-19 tests in each setting as reported by respondents.

Primary and secondary dental settings were merged, in addition to care homes with and without nursing. The ‘Hospital-at-home’ (n = 3), hospices (n = 14) and ambulance setting (n = 9) were excluded due to the small number of overall respondents. Respondents were able to select multiple answers to this question. Plot key: ‘GP’ = ‘General Practice’; ‘POC’ = ‘Point of care’; ‘lab’ = ‘Laboratory.

Respondents who stated that there were no COVID-19 tests available most frequently reported (Fig 3) that ‘Potential spread of infection’ was the consequence of the lack of COVID-19 testing in the dental setting. ‘Delays in administrating treatments to patient’ was the most frequently reported response. The hierarchical cluster analysis suggested that the perceived consequences of the lack of COVID-19 testing within the dental and GP settings were similar, where the misuse of antibiotics/antibiotic resistance was frequently reported. Within the prison setting, there were lower numbers reporting hospital and treatment-associated consequences.

Fig 3

Perceived consequences of no COVID-19 tests being available in each setting.

Primary and secondary dental settings were merged, in addition to care homes with and without nursing. The ‘Hospital-at-home’ (n = 3), hospice (n = 14) and ambulance setting (n = 9) were excluded due to the small number of overall respondents. A hierarchical cluster analysis indicates how similar/dissimilar the perceived consequences of no COVID-19 tests are between settings. The numbers of responses from individual settings for this particular question are displayed on the x axis (n = x). The histogram in the top left of the plot area shows the distribution of values, and provides a key to indicate the specific color shade of different values.

Across the majority of settings, most respondents stated that there were problems with testing in the setting where they worked (Fig 4). ‘Long turnaround time’ for results of COVID-19 tests was reported most frequently as the most important problem across all settings, whereas ‘Test usability’ and ‘Too expensive’ were the least reported problem (Fig 5). There were similarities in the most important reported problems between hospital and GP respondents, with the second most frequent problem in the hospital and GP setting being the ‘Poor ability to confirm if a patient does not have COVID-19’ (sensitivity), closely followed by the ‘Poor ability to confirm if a patient has COVID-19 (specificity). Prison respondents reported a ‘Lack of established protocols to inform decision making after positive/negative results’ as their most important problem. Responses from care homes and dental settings were also similar, with issues around the availability of equipment. ‘Difficulty in obtaining a sample’ was reported more frequently for care homes than in other settings.

Fig 4

Perception of problems associated with COVID-19 testing practices in each setting.

Primary and secondary dental settings were merged, in addition to care homes with and without nursing. The ‘Hospital-at-home’, hospice and ambulance setting were excluded due to the small number of overall respondents (n<15). Respondents selected a single 'Yes', 'No' or 'Don't know' answer. The number of responses from individual settings for this particular question is displayed on the y axis (n = x).

Fig 5

Most important perceived problems associated with COVID-19 testing in each setting.

Primary and secondary dental settings were merged, in addition to care homes with and without nursing. The ‘Hospital-at-home’, hospice and ambulance setting (n<15) were excluded due to the small number of overall respondents. A hierarchical cluster analysis indicates how similar/dissimilar the perceived problems associated with COVID-19 testing are between settings. The numbers of responses from individual settings for this particular question are displayed on the x axis (n = x). The histogram in the top left of the plot area shows the distribution of values, and provides a key to indicate the specific color shade of different values.

The most frequent consequence associated with these problems (Fig 6) was consistently reported as the ‘Potential spread of infection’ along with ‘Patient anxiety/discomfort,’ especially within the GP setting and care homes, and ‘Inappropriate use of PPE’ in the dental setting. ‘Repeat testing requirement’ in prisons and GP settings was also reported as a frequent consequence of these problems.

Fig 6

Perceived consequences related to the problems associated with COVID-19 testing in each setting.

Primary and secondary dental settings were merged, in addition to care homes with and without nursing. The ‘Hospital-at-home’, hospice and ambulance setting (n<15) were excluded due to the small number of overall respondents. A hierarchical cluster analysis indicates how similar/dissimilar the perceived consequences related to the problems associated with COVID-19 testing are between settings. The numbers of responses from individual settings for this particular question are displayed on the x axis (n = x). The histogram in the top left of the plot area shows the distribution of values, and provides a key to indicate the specific color shade of different values.

Discussion

To our knowledge, this is the first survey of health and social care professionals and policymakers to identify and prioritize unmet clinical needs for medical tests for COVID-19. We focused the survey within the UK health and social care system and covered a range of settings. Results of this survey informed the recent guidelines in the UK around testing for COVID-19 in various settings and are informing NICE early economic modeling. These results are important for planning policies for the next winter season when multiple respiratory conditions will be present and diagnostic tests will be crucial for the correct identification of COVID-19 patients.

The unmet clinical need for testing

Hospital and care home settings (with and without nursing) were prioritized as being most in need of novel COVID-19 tests. Hospitals and care homes with nursing were reported as having greater access to testing compared to other settings, although care homes without nursing had minimal access to testing, highlighting a clear unmet clinical need.

The data suggested that hospitals were in most need of diagnostic tests (i.e., for symptomatic individuals), whereas respondents from care homes require tests to screen asymptomatic individuals. These differing roles were important for both patients and care workers across these settings. The current testing policy in UK hospitals implemented on the 5th of June 2020, of testing every individual with potential COVID-19 symptoms [18], addresses this clinical need (the last hospital response to the survey was on the 3rd June 2020). The more extensive need for tests in care homes appears to reflect the increased risk for older people [19], where early identification of COVID-19 is extremely important for appropriate use of isolation (to decrease the risk of infection transmission) and treatment (to decrease the risk of hospital admission or death), the two major concerns associated with the lack of testing. Although it is important for care home residents to safely receive visitors, the overall risk to wider care home residents needs to be minimal, highlighting the importance of early identification of new cases and appropriate isolation use. The UK policy for care homes changed recently (27th July 2020 [20]), requiring weekly testing of staff and monthly testing of residents. This is in line with the clinical need identified through this survey but might pose a challenge in terms of test provision. In this context, the pooling of resident samples for testing might be a reasonable solution for screening in low prevalence conditions [21]. When a positive pool is detected, individual testing of residents and staff might follow.

Care homes reported issues with patient discomfort and difficulty in obtaining samples (more than others). Therefore, there is a need to develop tests that use sample types that are more readily obtained. Multiplex tests could also be useful in this population in the winter season, where the detection of multiple viruses is made possible through the collection of a single sample.

The respondents from the prison setting indicated good availability of tests, with similar needs to the hospital setting for diagnosing and screening people at the front door to limit transmission of the virus to other prisoners. They did not have access to serology tests, but they seemed satisfied with the tests they had available, except for the long time to results and the lack of clear protocols to guide interpretation and actions following the results. Guidelines and care pathways should be developed in collaboration with health and social care professionals working in prisons to provide effective support during the winter season. This could help address health inequalities, which have been highlighted by the COVID-19 pandemic [22].

Interestingly, general practice and dental settings had similar needs which were mainly focused on identifying workers with COVID-19 (symptomatic or asymptomatic) who could transmit the disease to individuals in the community. Comparatively, these settings had limited access to COVID-19 tests and the main highlighted consequence of this was the inappropriate use of antibiotics. The most common new use cases stipulated by the respondents included tests that could support the Track and Trace program, surveillance of the general population as well as re-infection rates. Since policy decisions to limit or enhance lockdown measures are mainly based on these numbers [23], there is a need to increase testing capacity in these settings.

Across all settings, two main themes emerged. The first was the concern for the potential consequences of infection transmission, followed by the concerns around the long turnaround time for test results [24] to inform isolation decisions and PPE use. The role of treatment stratification for diagnostic tests might become more important in the future, once the clinical evaluation of treatments for COVID-19 are concluded (e.g. REMAP-CAP [25]).

Limitations

There were limitations in the design of the survey. The survey was developed at pace, and as a result, could have benefitted from more comprehensive piloting, encompassing respondents from all targeted settings. The results had to be swiftly reported to inform government testing decisions, and therefore the survey was only open for a short period of time, which resulted in small sample sizes for some settings. Results for hospitals, care homes, general practices, and dental settings are likely to be more robust compared to other settings.

Rapid development and dissemination of the survey were required to capture the current picture of a fast-moving landscape. It may not have been optimal methodologically; however, it ensured an increased impact by informing decision makers. Furthermore, the number of misinterpreted use cases was low, ranging from 5 and 11% of the total number of respondents in each setting, and also the percentage of new use cases that were not included was low (0–11%). This seems to indicate good identification and clear wording of the use cases. The higher percentage of missed and unclear use cases reported by GP respondents (11%) may reflect the lack of piloting in that setting.

The survey was intended for response by health and social care professionals, although no questions were incorporated to validate inclusion criteria explicitly. Questions to identify high-risk staff were omitted.

Settings were targeted for dissemination at different times while the survey was open (see S1 Fig for the distribution of responses over time). The responses received may reflect changing clinical needs due to the fluctuating prevalence of COVID-19 and the different availability of tests during the pandemic. However, because the survey was only open for a short period of time covering three weeks at the tail end of the first wave of the pandemic in the UK, these effects are likely to be small.

The majority of the respondents worked in hospitals and in the North East of England, so results are less representative of other settings and other regions of the UK.

Finally, a limitation of qualitative research is that people who have a strong opinion on the subject are often the ones most likely to participate, potentially introducing selection bias. These limitations should be taken into account when inferring any conclusions from the data presented.

Conclusions and next steps

In this first assessment of the clinical need for COVID-19 tests among experts in the UK, a long turnaround of results was the most commonly reported problem across all settings in May/June 2020, the consequence of which was identified as the potential transmission of infection. This would suggest a need for more rapid testing across all settings. Since it is unlikely that rapid near-patient testing will be available for the coming winter season to screen everyone, more work is needed to refine the higher priority groups and to understand the role of multiplex tests in the coming winter season.

From the current work, the groups with highest need for COVID-19 testing were identified as (in order):

staff and patients with symptoms of COVID-19 in hospitals

screening of staff, visitors and new residents in care homes

staff in general practice and dental settings

screening of new prisoners, visitors, existing prisoners and workers with symptoms of COVID-19.

These needs are most likely to be met by molecular tests, which are most accurate soon after the patient becomes infective [26]. Antibody tests seem less useful until the biology of the disease and its relationship with immunoglobulin A (IgA), G (IgG), and M (IgM) antibodies is clearer [27]. In care homes, quick and cheap tests with lower accuracy but frequent testing might be appropriate for screening, as suggested by modeling [28]. Alternatively, when prevalence is low, pooling of samples from residents could be a sensible approach for screening residents [21]. Rapid tests (under 10 minutes) that help distinguish viral from bacterial infections might be also useful in GP and dental setting to limit antibiotic resistance in the community. Despite this, more work is needed to fully characterize the unmet clinical need and optimize sample collection. It seems likely that multiplex tests will be useful in the winter season when other respiratory viruses circulate, particularly in care homes and in older populations of patients.

Distribution of survey responses over time by setting.

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Summary of the qualitative analysis of the new stipulated use cases proposed by the respondents in addition to the list designed by the authors.

Percentages in parenthesis refer to the total number of respondents for that setting.

(DOCX)

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Qualitative analysis of new stipulated use cases proposed by respondents.

(DOCX)

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COVID-19 unmet clinical needs survey.

(DOCX)

Click here for additional data file.

21 Oct 2020

PONE-D-20-28292

Unmet clinical needs for COVID-19 tests in UK health and social care settings

PLOS ONE

Dear Dr. Allen,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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We look forward to receiving your revised manuscript.

Kind regards,

Amit Sapra

Academic Editor

PLOS ONE

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2. Thank you for including your ethics statement:  "We obtained service evaluation approval from the Newcastle Upon Tyne NHS Foundation Trust to conduct the survey. The approval number is 10151.

The Human Research Authority online tool deemed that ethical approval was not required as there was no participant identifiable information obtained from the respondents.".

Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information.

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"I have read the journal's policy and the authors of this manuscript have the following competing interests:  MM is a scientific advisor to the UK Department of Health and Social Care and a paid consultant for Cepheid Inc (unrelated to COVID-19) who receives research funding from Roche (unrelated to COVID-19).

The remaining authors declare no other competing interests.  "

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5. Please include a copy of Table 2 which you refer to in your text on page 8.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: I Don't Know

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Good content but has lots of grammatical errors.

The article is well written and is relevant to the current health situation prevailing in the UK.

The study has good methodology. Authors have provided with tables with descriptive data.

Reviewer #2: Insightful research question, especially given the current times. It will help to inform future protocols in the healthcare setting especially with cold/flu season upon us. The limitations of the study are understandable given the short amount of time the study was conducted. The tables and figures were filled with information that was easy to interpret.

Reviewer #3: The following lines could be modified in the article:

"Testing strategies have been heavily scrutinised, and it is widely acknowledged that the tests currently available are far from ideal." Acknowledged by whom, please cite source.

"Although this level of innovation offers hope that the current testing shortfalls can be overcome, this creates a real challenge for diagnostic regulatory bodies." Please consider rephrasing, I could not understand what “this level of innovation" is referring to.

"The overarching aim is to ensuring that innovation efforts are focused on developing ‘fit for purpose’ tests", consider changing ensuring to ensure

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Reviewer #1: Yes: Priyanka Bhandari

Reviewer #2: No

Reviewer #3: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Submitted filename: PLOS ONE- Unmet clinical needs for COVID.docx

Click here for additional data file.

22 Oct 2020

** Apologies, Table 2 was renamed Table 3 in error. This has been corrected ***

We thank the reviewer for their helpful comments.

• We have addressed the grammatical concerns of reviewer 1 and made significant amends to the manuscript according to comments on the returned manuscript.

• We have added an ethics statement plus further information on the consenting process.

• Apologies that you were unable to view Table 2. It is included at the end of the manuscript which has been reuploaded.

• We have updated the format of our manuscript to fit within the PLOS One guidelines which have been shared

• We have also updated our Supplementary Material to ‘Supporting Material’ and uploaded copies with and without tracked changes (‘SupportingInformation’ and ‘SupportingInformation with tracked changes’ respectively).

• Our updated conflict of interest statement is ‘MM is a scientific advisor to the UK Department of Health and Social Care and a paid consultant for Cepheid Inc (unrelated to COVID-19) who receives research funding from Roche (unrelated to COVID-19). This does not alter our adherence to PLOS ONE policies on sharing data and materials.

The remaining authors declare no other competing interests.

Submitted filename: Response to Reviewers.docx

Click here for additional data file.

28 Oct 2020

Unmet clinical needs for COVID-19 tests in UK health and social care settings

PONE-D-20-28292R1

Dear Dr. Allen,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Amit Sapra

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

4 Nov 2020

PONE-D-20-28292R1

Unmet clinical needs for COVID-19 tests in UK health and social care settings

Dear Dr. Allen:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Amit Sapra

Academic Editor

PLOS ONE