Update 22nd September, 2020
There are now approximately 50 testing sites in England. Judged by the number of tests conducted, the UK’s response to COVID-19 seems a success. About 16 million reverse transcriptase polymerase chain reaction (RT-PCR) swabs were processed in hospitals and commercial laboratories between April 1st and September 10th, with over half a million in the second week of September alone. In terms of population, this is one of the highest rates anywhere. The large-scale testing in England is prioritised by risk; in most areas community testing is, formally, restricted to those with one of cough, fever or anosmia. Exceptions include care home staff and residents, who have been offered regular asymptomatic testing since July, hospital pre-admissions and people living in high incidence ‘areas of intervention,’ where asymptomatic testing may be undertaken through local initiatives. In practice, the system is struggling. Many of those seeking tests are unable to access them and testing in care homes was unreliable until mid-August, with many tests unexplainably voided. Laboratories are not coping, with under 40% of tests reported the next day, and many taking over a week and samples being sent abroad for testing. The Executive Chair of the National Institute for Health Protection admitted that testing demand is currently ‘multiples’ of capacity.
The government has recently announced a £100 billion venture (approximately two-thirds of the entire national annual budget of the NHS), called Operation Moonshot, which involves regular mass population testing using rapid tests, which are typically less sensitive than RT-PCR. The details are unclear as yet but it is believed that rapid antigen tests are currently being tested and validated for use in high risk settings including care homes and hospitals. This plan to use COVID testing as a screening test has not yet involved the National Screening Committee or the National Institute for Clinical Excellence who usually oversee screening programmes (see: https://www.bmj.com/content/370/bmj.m3580 and
The government has announced that staff in schools and healthcare will now receive priority tests for COVID-19.
The Welsh Government have also announced their new testing plans, increasing access to mobile testing units and expanding testing in the lighthouse labs by 28,000 tests per week in addition to the existing 10,000 tests per day (https://gov.wales/written-statement-responding-current-challenges-covid-19-testing-update).
Update 4th August, 2020
DHSC have announced that they have purchased millions of new point of care tests for use in healthcare and in care homes and these have been shown to produce results in 90 minutes. The accuracy of these tests is not known publicly. They have said that these will be rolled out in the next few weeks and a validation study will be carried out simultaneously. There have been significant delays to swab testing following recall of a specific brand of test kits, the use of which has now been suspended. Meanwhile, care homes in areas on who are on the watchlist of concern will receive tests.
Update 28th July, 2020
Shortly after weekly testing was announced for staff in care homes, with monthly testing for residents, the government recalled half a million test kits, made by Randox, one of the main suppliers of pillar 2 tests. There is no data published so far on how this has affected regular testing in care homes.
Update 5th July, 2020
Testing measures are due to change in care homes with the publication of the results from the whole home testing, which found that 90% of cases in care homes were asymptomatic. The change in policy will allow for staff to be tested once a week and for residents to be tested every 28 days. A similar process has not yet been rolled out in the NHS, but some private hospitals have since implemented a similar process.
Update 12th June, 2020
Swab tests are now available to anyone with symptoms and their contacts on the online portal and also to care homes with residents under 65 years old.
Testing has increased, and antibody tests have now been rolled out to NHS trusts and to GPs who have been told that they can offer antibody tests to their patients. This has been predominantly managed locally but is restricted to antibody tests using blood samples drawn from a vein and not finger prick, home tests, which have been withdrawn from the market. PHE have now published some of their work to validate the initial antibody tests by Roche and Abbot. There has been much scrutiny over the inability to report the number of tests performed for pillar 2, as described in the final paragraph of ‘testing: targets’. Testing statistics for pillar 2 are documented when a test is sent out and it remains unclear how many tests have been reported and confirmed. It also remains unknown how quickly people with symptoms are accessing testing and how much testing is being undertaken for the test, trace isolate process as well as for surveillance.
Update May 7th, 2020
A key criteria that must be met to be able to transition out of the current lockdown is that testing capacity must be increased. It is unclear whether this refers to the 100,000 per day target or the more ambitious 200,000 tests per day.
Care homes are currently predicted to experience half the mortality burden, according to European estimates and surveys from care home providers, and therefore there is a particular scrutiny on care home testing. The government has pledged to make tests available to asymptomatic contacts in care homes, although this is not yet widely available and it is unclear whether this will include serial testing. Unpublished studies in the UK have recently been undertaken by Public Health England that have shown that many residents and staff in care homes test positive for COVID-19 but do not display symptoms, as reported by the government lead for testing, John Newton. This is consistent with two studies in the US, which suggest pre-symptomatic transmission may be at the root of care home outbreaks (see: https://www.nejm.org/doi/full/10.1056/NEJMoa2005412 and https://www.nejm.org/doi/10.1056/NEJMoa2008457).
This would presumably require serial testing of all asymptomatic hospital patients, care home residents and all health and social care staff. The underlying principles that might guide this strategy are described in a paper published by infectious diseases epidemiologists in Imperial College London (https://www.imperial.ac.uk/mrc-global-infectious-disease-analysis/covid-19/report-16-testing/). As of the 28th April, approximately 25,000 tests had been carried out in care homes but no contact tracing.
The increase in testing capacity to around 100,000 tests per day has been dependent on commercial providers and has been facilitated by the army and with the multi-agency support of the Department of Health and Social Care, the Care Quality Commission, Public Health England, Local Authorities and Clinical Commissioning Groups. There has been a recent move (29th April) to expand testing to members of the public in the community who are either at risk (>65 years old) or need to go out in order to work. This will be an important measure, which releasing lockdown will be entirely dependent upon.
Suspected cases were initially tested and sent home to isolate; Their close contacts were also requested to isolate pending testing. The case criteria for possible cases, requiring testing has changed throughout the course of the epidemic. In chronological order, possible cases were defined as:
• Category 1: Asymptomatic travellers returning from Wuhan (and later Hubei Province) in China, Iran, Daegu or Cheongdo (Republic of Korea), or Northern Italy
• Category 2: Symptomatic travellers returning from a country subsequently deemed at risk (eg. Singapore, Thailand, Myanmar, Republic of Korea, Malaysia, and subsequently Italy)
• A contact of a confirmed case (not a suspected case)
And subsequently as:
• Anyone with a new fever or persistent new cough hospitalised with signs of pneumonia.
• Key workers with symptoms of cough or fever (including healthcare workers since 29th March 2020, social care workers since 15th April and other key workers, including the police, the fire service, frontline benefits workers and those working with vulnerable children and adults among others since 17th April). This has now been extended to include all keyworkers, including teachers.
• All critical care admissions, anyone tested for flu (as of 19th March 2020) and symptomatic care home residents and prisoners in local outbreaks are tested for COVID-19 (with the latter two organised by PHE).
• Since 16th March, the Secretary of State has also committed to testing suspected cases in social care whose symptoms began after the initial outbreak was determined. The implementation of this took about two weeks to put in place and is now co-ordinated by the Department of Health and Social Care who post self-testing kits to care homes. In some areas, local clinical commissioning groups, have also been arranging this but care homes have reported that in reality many still can’t actually access these tests.
• Anyone being discharged from hospital to a care home will also now be tested according to the government and this is now understood to be working better, although there are anecdotal reports from several care homes that this is not always the case.
• Since April 29th, asymptomatic GP’s and care home residents, and members of the public over the age of 65 or those who have to go out to work can also now receive testing.
• Since May 3rd, health and social care workers became eligible for testing even without symptoms through a separate portal. The self-swab referral pathway was quickly used up and many were still only offered testing by travelling to drive-in centres
• From June 1st, when schools start again pupils, teachers and their families will be eligible for testing.
Laboratory testing capacity has not historically been a priority area in the UK. Resources were scarce before the pandemic begun and the commercial laboratory testing sector was very small. Some 20 years ago, there were more than 30 public health laboratories in the UK, but this had reduced to about 8 just before the pandemic. Initially, all tests were conducted in one PHE centre (Colindale). It was subsequently rolled out to a PHE laboratory in Bristol and is now conducted in PHE laboratories and acute trusts. Commercial laboratories were not invited to contribute to expanding testing capacity until mid-March and offers of support from many laboratories were not accepted until April. Initially swab samples were taken in emergency care isolation rooms and with high grade personal protective equipment (PPE). This was later moved into special pods outside the emergency care units and was subsequently undertaken in ambulances and the PPE requirements were downgraded to the use of fluid resistant masks, aprons and gloves.
Most recently, around 50 drive through testing facilities have also been implemented for key workers but many were unable to access them as they were very far away. To increase access, self-testing kits have now been made available via a national self-referral portal. COVID-19 laboratory testing capacity has grown but much more testing is required and as the capacity for self-testing scales up rapidly (particularly in the social care sector), so too does the need for very clear guidance on how to take the swabs, when to take them, how to ensure they are returned to a lab promptly and how to act on the results.
In early April, the government expressed a commitment to expand testing from 10,000 to 100,000 tests per day by the end of April and eventually to 250,000 tests per day to enable population wide testing (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/878121/coronavirus-covid-19-testing-strategy.pdf). This included five pillars of testing, which include: 1) NHS swab testing, 2) commercial, research institute and university swab testing, 3) Antibody testing, 4) surveillance testing and 5) national effort to boost diagnostics. These pillars will involve facilitating a more flexible use of supplies such as reagents and co-ordinating testing in alternative settings including universities, research institutes and private labs. To improve standardisation of results, a control reagent was also made available on May 6th to ensure that samples were valid (https://www.gov.uk/government/news/new-reagent-available-to-support-global-diagnostic-testing-of-coronavirus-covid-19).
In the middle of April , approximately 20,000 tests were being performed per day, with an equal proportion in public and commercial laboratories. Much of the scale-up in testing has taken place in 4 centralised lighthouse labs, mostly using donated machines from universities and research institutes as well as a large number of commercial labs at large sites, for example in Milton Keynes and Glasgow. By the end of April, this had risen to approximately 55,000 tests per day, which represented substantial progress, but still at only half the expected target. The Department for Environment, Food and Rural Affairs (DEFRA) are also supporting the use of animal testing labs but the role of these is still unclear.
The testing programme is being led by John Newton, while the test trace isolate programme has been placed under the leadership of Baroness Dido Harding. However, behind the increase in numbers there have been serious procedural questions about testing in some (but not all) parts of the UK with some NHS trusts choosing in the early stages to send self-administered swabs to Germany as processing was reported to be faster and appointment slots made testing in the UK inaccessible to many. Even now (May 15th), the lag for test results is often over 4 days and at times up to a week – long after the isolation period is over.
On the 1st May, the government announced that 122,000 tests had been completed and despite fluctuations down to 70,000 on the 6th May, this had increased again on May 15th to 134,000 tests. However, these tests are reported at as having been ‘performed’, but the definition of performed also includes all 4 pillars and includes tests that have been delivered and are yet to be collected.
Testing in Care Homes:
Access to testing for social care staff has been more limited than that for NHS staff – prior to publication of the action plan, social care staff were simply told to self-isolate if they, or a member of their household were displaying symptoms. This was the primary guidance until access to tests became possible on April 15th (https://www.gov.uk/government/publications/coronavirus-covid-19-adult-social-care-action-plan/covid-19-our-action-plan-for-adult-social-care#controlling-the-spread-of-infection-in-care-settings). The action plan stated that the government was “rolling out” testing of social care workers across the country and mentioned that 3,000 workers had been referred to testing centres. Given the size of the social care workforce (1.5 million people UK-wide), this number represents an extremely small sample. The plan stated that there is “capacity available for every social care worker who needs one”. Until 24th April, social care employers were required to identify social care workers and their families who were eligible for testing. These workers are being referred to local testing centres but there are some practical difficulties for some staff in accessing them.
This approach to testing staff changed on 24th April with social care staff and their families who are showing symptoms, being able to self-refer. In this new system, individuals can book tests themselves online and opt to either attend one of the now 48 drive-through testing sites or receive a home testing kit (https://www.gov.uk/government/news/coronavirus-testing-extended-to-all-essential-workers-in-england-who-have-symptoms). However, on the first morning of its launch, the site was overwhelmed and was forced to close after 5,000 home testing kits were ordered within two minutes and 15,000 drive through test slots were booked (https://www.bbc.co.uk/news/uk-52405852). There was no route for social care workers without symptoms to be routinely tested until May 3rd.
On 26th April government further announced that mobile testing units for frontline essential workers would be ready to be rolled out by early May and operated by the Armed Forces (https://www.gov.uk/government/news/mobile-coronavirus-testing-units-to-target-frontline-workers). Priority locations listed include care homes. By 29th April, testing was announced for asymptomatic residents in care homes and as stated above, on May 3rd, testing was also rolled out to asymptomatic social care staff via an employer portal.
The rationale for testing asymptomatic residents:
Rather than the usual approach to test, trace isolate, the strategy in care homes had until this point still been based on influenza. Influenza is transmissible in the symptomatic phase only and so syndromic surveillance and isolation of cases and contacts in care homes is usually effective without further testing, once an outbreak has been confirmed. Although elderly populations may not have the immune reserve to mount a fever and often develop atypical symptoms, this approach usually works, and in practice outbreak management teams and care home staff are generally quick to detect these atypical symptoms. However, published studies in the New England Journal of Medicine (on March 27th https://www.nejm.org/doi/full/10.1056/NEJMoa2008457 and April 24th https://www.nejm.org/doi/full/10.1056/NEJMoa2005412) and several pilot studies in London showed that COVID-19 is somewhat different and that asymptomatic staff and residents are at risk of shedding the virus and subsequently developing symptoms of COVID. Although it remains unclear how infectious the virus may be in those who never develop symptoms, when the Secretary of State announced that testing would now be made available to care homes (via the pillar 2 commercial testing route) for both symptomatic and asymptomatic staff and residents, care homes were elated because until this point, they had found that isolating only symptomatic residents and their contacts was not controlling transmission. Following the announcement, the care home regulator (CQC) was asked to offer urgent self-testing to care homes with recent outbreaks. A ‘pillar 2 helpline’ was also established by the Department of Health and Social care, manned by newly trained but inexperienced private staff. Many care homes who called the helpline received conflicting advice and were paradoxically told that they could not test residents with symptoms of Coronavirus. Care homes were caught in confusion between PHE, DHSC and CQC about who was indeed responsible for providing which tests. The CQC route proved slightly more successful although initial ‘whole home’ testing also highlighted a number of procedural difficulties. Swabbing technique is likely to vary widely between residential homes and those with nurses and many homes took swabs from residents (an unpleasant process for many) but received no courier collection for several days, after which, the samples were no longer valid; others reported a very high proportion of unexplained void results. Two weeks later, a new portal was established to facilitate testing, with a new system in place to expedite testing for homes at greatest risk. Care homes in general report that this is better than before, but many still report 5-7 day lead times in receiving the tests and even longer delays in receiving results. Given the evidence that the tests are most sensitive in the initial 3-5 days after symptom onset (https://www.acpjournals.org/doi/10.7326/M20-1495), timing is crucial for effective testing, tracing and isolation in a care home and there is a lot of pressure on the government to improve this process, at the very least to prevent onward transmission after an outbreak has been established. One of the key issues at present is also that care homes have been told they should access tests, which for the most part have been extremely difficult to access but have not been told how to use them tactically, who to swab and when and whether these tests are for blanket serial testing, or whether they should instead be used more strategically as part of a test, trace and isolate process.
Importantly, commercial (or Pillar 2) COVID test results are also not routinely shared with either local Health Protection Teams or the General Practitioner, who are responsible for supporting the outbreaks. Incidentally, GPs also cannot also order COVID19 tests for their patients at present when needed. Instead, tests are ordered centrally and the data is also collected centrally by the government with little understanding as yet about how NHS test data is integrated with commercial test data. There also has been little progress made so far about testing in domiciliary care.
There is also an intention to implement point of care antibody testing and tests produced by Roche and Abbott were endorsed by Public Health England with 100% specificity. It is presumed this will shortly be rolled out to health workers and social care staff and will hopefully provide some point of care rapid testing to identify who has been exposed to the virus and to therefore track its spread. However, it provides little information at present on immunity per se and can only be used some 7-10 days after the initial infection. There has been some scepticism about which CE marked antibody tests were selected for validation by PHE, which remain unanswered as yet. Other critics have also asked that the data used in the validation are now published for transparency.