In the fight against Covid-19, moving towards mass-testing is essential – both for getting people the treatment they need now and for eventually easing lockdown measures and enabling people to get back to work. It is a point that cannot be overstated: The only viable solution to return to some sort of normality is mass-testing at scale, with the capability of doing it several times for a large part of the population.
With this in mind, TBI has put together a comprehensive review of testing in the UK. This report brings together a range of the best publicly available information on Covid-19 testing and is informed by a number of conversations with experts, including scientists, health-care professionals and key figures from industry.
There are three key strands to the UK government’s approach to testing:
To ramp up existing 24-hour turnaround PCR swab testing
To trial and bring online rapid point-of-care tests
To support the development of an antibody test, which it says it intends to buy millions of in the coming weeks
The NHS is currently using a PCR swab test, which takes around 24 hours to process. At the moment this testing is focused mainly on critical-care patients. The number of PCR swab tests being conducted has been rising from just over 1,000 a day at the end of February, when testing began, to around 6,000 per day. (As of 9am 27 March 2020, a total of 113,777 people have been tested for the coronavirus in the UK, of which 99,234 were confirmed negative and 14,543 confirmed positive.[_]) The government has said it plans to increase this to 10,000 a day initially, with a goal of reaching 25,000 tests a day within weeks.
The route to doing this will be the creation of “supercentres” to process the tests on a larger scale. The government, we believe, will do this in partnership with the private sector. Through this ramping up via supercentres, we believe the testing capacity could reach 100,000 to 200,000 tests per week.
PHE is also trialling rapid-test kits, which again will tell whether a patient has the virus. Once these tests have been approved, they will go online and could speed up the time it takes to get a test result to around an hour. Depending on the nature of the test (and if it is compatible with the equipment of larger pharmaceutical firms), it could be scaled or the PHE may pursue a diverse ecosystem of suppliers.
In terms of an antibody test – which is the test that can tell you if you’ve had the virus – the government has said it intends to buy millions of these and that they will be a “game changer”.
At the moment there are some antibody tests in the private sector, but PHE have not approved any for use in the NHS. We believe PHE is seeking to validate a number of tests by smaller companies while working with larger international companies to source supply. Talk of having 3.5 million tests available within weeks is an ambitious target.
What is it?
At the moment the key test being used is a PCR (polymerase chain reaction) test. These tests involve extracting RNA (ribonucleic acid) from nose or throat swab samples and converting it into DNA.
The antibody test looks for Covid-19 IgG antibody in the blood, which develops around two weeks after the infection.
How does it work?
This is then replicated many millions of times so that a significant quantity of DNA can be detected by a PCR machine. Detection indicates that the virus is present in the patient’s system. Generally, results take roughly a day to come through with this type of test. The NHS is generally taking around 24 hours to process these PCR swab tests.
Covid-19 antigens are placed on the surface of a microtiter plate. Patient serum is then incubated in each well and the IgG antibody from the patient is detected using a secondary antibody that binds human IgG. If the patient has antibodies to the Covid-19 antigen, this patient will be called “seropositive for the Covid-19 antigen”. This process is typically done via a blood test (finger prick).
Is it available?
The PCR test is widely in use. It is available for mass order via major companies, including ThermoFisher, who are supplying tests and equipment to many governments. The UK is understood to be developing supercentres to process a large number (they are aiming for 200,000 tests per week) of swab PCR tests. In the US ThermoFisher will this week make 5 million test kits.
Some antibody tests are commercially available but have not been authorised by health bodies such as Public Health England (PHE). US-based company BioMedomics claims it has a “quick and easy” fingerprint test that can detect Covid-19 antibodies. The firm says the test is already being used in South Korea, Japan, Italy, China and in the Middle East. PHE has announced in the UK that it is testing a number of antibody tests with an aim to produce millions in the coming weeks.
Generally very accurate as long as the sample has been taken correctly, which is via a swab at the back of the nose or throat.
The antibody test will be vital in working out who has had the virus but won’t be able to tell who currently has the virus. These tests would detect antibodies in the blood. These could potentially mean getting people who are immune back to work.
The PCR test is less effective towards the end of the infection period and slower to produce a result.
The antibody test produces a result quickly but is less effective during the earlier stages of infection and may therefore produce a false negative.
The sensitivity test tells you if it is likely to produce a false negative; the specificity test will tell you if you have false positives. To be verified, a test needs to score highly on both.
PHE’s diagnostic test for Covid-19 was originally rolled out to 12 laboratories across the UK, and the NHS is now ramping up so that 10,000 patients can be tested a day.
PHE’s strategy on testing has three key prongs:
Increase the PHE and NHS laboratory-based testing capacity from 5,000 to 25,000 per day to meet the clinical priorities of the NHS. PHE’s National Infection Service will be leading this with scientific colleagues at NHS England and the plan is to maximise as much as possible the existing technology already on hospital campuses, and to supplement this with commercial support.
The Office for Life Sciences is expanding, through universities and commercial partners, the capacity for antigen testing in order to create a fast-track route back to work for frontline NHS and social-care staff who are not infectious and are much needed at work.
PHE will be supporting the rollout of a mass home-based antibody test to confirm whether a person has had the virus but is no longer contagious and therefore can return to their normal life.[_]
As mentioned earlier in this report, in order to scale the PCR swab-testing capacity, we understand the government is working with the private sector to create supercentres to conduct approximately 200,000 tests per week in due course.
In terms of the antibody tests, it is understood that the government is looking at a number of tests being produced by domestic biotech firms and seeking to validate these. It is also working with international suppliers to procure largescale supply – albeit in the context of high demand globally. Talk this week of the government having 3.5 million tests available within weeks is an ambitious target.
Trials are ongoing for rapid point-of-care test kits in UK hospitals, supplied by smaller biotech firms.
Quadram Institute, based in Norwich, started developing a rapid-test kit earlier this month with microbiologist Jonathan Edgeworth at Guy’s and St Thomas’ NHS Foundation Trust in London. This test is being reviewed by the NHS at the moment. Dr Justin O’Grady, research group leader at Quadram, has said the test would take 50 minutes from sample to result and that it could be available for use on NHS staff within weeks.
Several global firms are also working on rapid tests. BioMérieux, a French biotech firm, says it aims to have a test available by the end of March and has an emergency-use authorisation for it from the FDA. Cepheid, a company based in California, will try to use a similar approval process to get its own test to market.
The main question with the innovative rapid tests is whether they are scalable. The value add in terms of a quicker result time is potentially negated if they cannot be produced at scale.
These tests would detect antibodies in the blood. It would take just a few minutes to give a result and could be used to find out if someone has had the virus in the past – going back weeks.
Antibody tests are commercially available, but UK authorities have until recently questioned the accuracy of antibody tests on the market. Chief medical officer Professor Chris Whitty described existing antibody tests as “not reliable”. Last week Prime Minister Boris Johnson announced that an antibody test was “coming down the track” and was “progressing very fast”. The government said this week it hopes to have millions of these tests available in the coming weeks.
Health Secretary Matt Hancock announced last Tuesday that the country had bought 3.5 million tests. Sharon Peacock, of PHE, said on Wednesday these tests would be available within weeks from Amazon and Boots. Chris Whitty said on Thursday the tests were still, however, being validated and were some weeks away, with NHS staff the priority.
US-based company BioMedomics claims it has a “quick and easy” finger-prick test that can detect Covid-19 antibodies. It says the test is ready and already being used in South Korea, Japan, Italy, China and some countries in the Middle East. The diagnostic time is around 15 minutes.
How it works
Using the BioMedomics test a blood sample is collected. A technician then injects the sample into the analysis along with some buffer and waits 15 minutes.
A one-line result means negative, two lines means the sample contains antibodies that the body starts producing shortly after infection.
A small study showed the test produced a correct response 80 per cent of the time.
PHE and FDA are yet to approve the test.
The Economist has reported that, once validated, serological tests are fast and cheap to run at scale. They have already been deployed in China, Singapore and South Korea. Data on their efficacy haven’t been publicly released or independently verified.
America’s CDE is evaluating two serological tests and PHE is also working on validating an antibody test.
Key Biotech Companies
What they do
This US-based provisioner of scientific instrumentation, reagents, software and services is producing PCR swab kits (5 million last week in the US) and PCR testing machines.
This Swiss multinational health-care company operates worldwide under two divisions: Pharmaceuticals and Diagnostics. They also produce PCR test kits and the testing machines. Their CEO said last Monday they had provided 400,000 kits in the US over the last week alone.
This German provider of sample and assay technologies for molecular diagnostics, applied testing, academic & pharma research produces RNA extraction kits that are used as part of workflows around the world to detect nucleic acid from SARS-CoV-2. Qiagen has recently been bought by ThermoFisher.
A US-based company that produces tests for viruses, bacteria and antimicrobial resistance genes. It produces a rapid antibody test. The test is being used in South Korea, Italy and Japan but has not received FDA approval.
This British firm is working with partners in Africa to develop tests that will be manufactured in Senegal. It has been granted £1 million to produce two different types of test by the UK government: one antigen, one antibody.
A Northern Irish biotech company that produces a rapid antibody test. The company is taking on extra staff to help with packing and dispatch for orders “throughout Europe and across the world
UK Biotech Companies
What they do
Quadram Institute in Norwich has produced a kit that works from a throat-swab sample and is a molecular test to establish if a person currently has Covid-19 (rapid-test kit). They say it could be used in a hospital anteroom, processing 16 samples at a time and displaying the result on a smartphone.
Crumlin, Northern Ireland-based Randox Laboratories has also developed a "multiplex viral respiratory infection array" that tests for Covid-19 and nine other infections simultaneously. Randox said the test is capable of processing 324 patient samples, generating 3240 reportable results, in just eight hours. The company is distributing the tests to more than 40 countries worldwide. We believe they are the preferred provider to the NHS in Northern Ireland.
Publicly listed company Novacyt, which has an office in Surrey, is working on a rapid-test kit. Novacyt says it has enough raw materials to manufacture 3.5 million PCR tests that can provide results in a couple of hours.
SureScreen is a private firm based in Derby. They say they have created a test (Rapid Test Cassette) that can determine with 98 per cent accuracy if a person is infected. It involves taking a blood sample via a finger prick and using a screening device. They say diagnostic time is ten minutes. SureScreen says its test has been validated and is already being used by private buyers in the UK, Ireland, Germany, Spain, Switzerland, Netherlands, Turkey, UAE, Kuwait and Oman. It is believed that around 175,000 tests have been conducted with the SureScreen kit so far. The company claims it has had more than 2 million orders for next month.
The PCR swab test is currently the gold standard. Increasing the capability to do these tests – through the plan of harnessing supercentres and working with the private sector – will provide important capacity to increase testing capacity for health-care workers and those presenting with Covid-19 virus symptoms.
While a rapid point-of-care test would help, the question is scalability. The value added in terms of a quicker result may ultimately be negated by lack of scale.
The potential for the government to work with the private sector and tech companies to expand capacity for PCR testing is likely to be useful, particularly in terms of community testing.
We understand that PHE is seeking to validate a number of potential antibody tests, while also working with international suppliers to increase capacity. An aim of having millions of these tests available within weeks seems ambitious without changes in how the procurement is taking place. To scale properly, the government must fully harness the potential for business leaders to assist with overseeing procurement and managing supply chain.
Combining antibody testing with PCR swab tests will be critical for protecting key workers and reviving the economy. This combination will identify those who aren’t infectious and have immunity, allowing them to return to the frontline and/or become economically active. It will also enable the government to lockdown smaller areas and communities in the event of further waves of the virus.
To do this, the government should build an ecosystem of testing suppliers and distribution networks that will allow for this mass testing. Crucially, this will mean organising the centre of government to assist and support with scaling, including fully utilising the know-how of business to procure industrial scale supply and fast-tracking procedures where possible.
An important element of this strategy will be tracking the data of people who test themselves. Unlike point-of-care tests, home testing will need a parallel process to keep track of those testing themselves and the results. For instance, the NHS patient number could be used to do this and details of those who have developed immunity kept track of.