Five million coronavirus antibody kits are on standby for NHS use after a second test was approved by health officials.
The new test – produced by medical giant Abbott – has been given the green light by Public Health England as spotting 100 per cent of those who have had the virus.
It is the second antibody test to be ratified in two days, following the approval of a kit made by Roche Diagnostics. Abbott last night said it had already started shipping equipment to NHS laboratories in preparation for the tests to be given to the first recipients within days.
A spokesman for the firm said it had capacity to provide five million tests a month to the UK ‘with immediate effect’.
Medical giant Abbott has produced the second coronavirus antibody test kit to be ratified in two days with five million kits currently on standby for the NHS
The test has been given the green light by Public Health England as spotting 100 per cent of those who have had the virus, after a test made by Roche Diagnostics was also approved
They are the first antibody tests to be ratified as accurate by Public Health England, after weeks of disappointments. The tests detect whether someone has had the virus and then recovered – which could indicate they may be immune.
The Department of Health is in conversations with both firms about incorporating the kits into its testing programme, with NHS staff likely to be first to get access. The Abbott test is also being sold privately for home use by health tech firm Babylon for £69.
Home use of the test – which uses a spot of blood from a finger prick rather than a full blood sample – has only been confirmed as accurate by an independent lab, and not yet by Public Health England.
PHE said the ratification of the two tests performed in its labs was a ‘very positive development’.
Both are likely to be used in the ‘test, track and trace’ programme being launched next week, in which anyone who has been in contact with a coronavirus patient will be tested. Scientists last night stressed that although the two tests offer useful information about who has been infected, it is not yet clear what proportion of these people will be immune to the disease.
The idea of ‘immunity certificates’ has been shelved for now because of this, although No 10 said it was still exploring it.
Hopes have run high since March that antibody tests could allow employees to return to work.
Health Secretary Matt Hancock ordered 3.5million tests but it turned out the best of them could spot only 70 per cent of those who had been infected. The new tests resolve that problem by using proven lab-based technology, rather than the ‘pregnancy-test’ style kits Mr Hancock had pinned his hopes on. They also generate very few ‘false positives’ – which means indicating someone has been infected when they have not.
Professor Matt Keeling, of the University of Warwick, said: ‘This could be a complete game-changer.’ It is expected that both tests will eventually be available for free as part of the national testing programme, though it is not clear whether people will be able to simply order them.
What are the coronavirus antibody tests?
What are the tests?
Antibody tests detect those who’ve recovered from Covid.
How are they done?
The two ratified tests use a vial of blood, taken via needle by a nurse then processed in a lab.
How can I get one?
They will initially be for NHS staff but are likely to be used in the ‘contact tracing’ scheme.
Will it say I’m immune?
At least 95 per cent of people with the antibodies retain some protection – but it is not clear if this lasts weeks or years.
Why are they useful?
To track the virus and help find out how many have had it.
Are they accurate?
Both catch 100 per cent of cases where someone has had Covid and give few ‘false positives’.
‘Game-changing’ antibody test will go to NHS frontline workers first and could be rolled out in ‘days’, government advisor says
- New Roche antibody tests will be made available to frontline workers first
- The tests, which are 100% accurate, will then be rolled out across the UK
- Test determines if patient was exposed to Covid-19 and developed antibodies
- Health Department in talks with Swiss pharmaceutical firm to buy millions of kits
Frontline workers, including those in the NHS, will be the first to get a new antibody test for Covid-19, England’s deputy chief medical officer has said.
Professor Jonathan Van-Tam said it was clear that people who had Covid-19 generated an antibody response, but it would ‘take time’ to understand whether in all cases people developed immunity against coronavirus.
He said data needed to be gathered over time to understand whether any immune response offered life-long protection or just for a few years.
Public Health England (PHE) has approved a new test from the pharmaceutical giant Roche after experts at its Porton Down facility gave it the green light.
Professor Jonathan Van-Tam pictured during today’s remote press conference to update the nation on the novel coronavirus COVID-19 pandemic. Van-Tam said it was clear that people who had Covid-19 generated an antibody response, but it would ‘take time’ to understand whether in all cases people developed immunity against coronavirus
Public Health England have announced that a new coronavirus antibody test by Swiss pharmaceutical company Roche has been found to be 100 per cent accurate. The FDA in America has already issued emergency use approval
The test – which Prime Minister Boris Johnson has previously called a ‘game-changer’ – picks up cases where somebody has had coronavirus in the past, and can be used on people who experienced no symptoms. Pictured: A drive-through test centre in Chessington
The test – which Prime Minister Boris Johnson has previously called a ‘game-changer’ – picks up cases where somebody has had coronavirus in the past, and can be used on people who experienced no symptoms.
Swiss pharmaceutical giant Roche’s test is 100 per cent accurate, meaning it will identity everyone who has had COVID-19. Experts are hopeful these people could be immune from catching the infection again for up to three years.
WHY IS ANTIBODY TESTING IMPORTANT?
WHAT IS AN ANTIBODY TEST?
Unlike tests to diagnose diseases, antibody tests show who has been infected and recovered.
The body makes antibodies in response to many illnesses and infections, including other coronaviruses. New blood tests are being developed to identify antibodies unique to SARS-CoV-2, the official name of the new coronavirus.
The tests look for two kinds of antibodies: immunoglobulin M (IgM) and G (IgG). The body quickly produces IgM antibodies for its initial attack against infections. It makes IgG antibodies more slowly and retains them longer; IgG antibodies suggest possible immunity.
WHAT IS THE DIFFERENCE BETWEEN RAPID TESTS AND ASSAYS?
Some companies are developing finger-prick tests that get results in minutes. These are called immunoassays and will form the basis of home testing kits.
Others are developing far more accurate tests called enzyme-linked immunosorbent assays (ELISA) that require sending blood samples to a lab for analysis.
HOW CAN ANTIBODY TESTS HELP END LOCKDOWNS?
Antibody tests can help calculate what portion of the population has already been infected, as well as whether infections were mild or severe.
Governments and companies could use antibody tests to determine who would most likely be safe to return to work and public interactions, and whether it is safe to lift stay-at-home orders all at once in some regions or in stages based on infection risk.
People with negative antibody tests or very low antibody levels would likely have higher risk of infection than people with high antibody levels.
DO ANTIBODIES TO THE NEW CORONAVIRUS CONFER IMMUNITY?
While antibodies to many infectious diseases typically confer some level of immunity, whether that is the case with this unique coronavirus is not yet known.
And how strong immunity might be, or how long it might last in people previously infected, is not clear. With some diseases like measles the immunity can be lifelong. With others, immunity can wane over time.
Scientists cannot know with certainty that reinfection is not possible until further research.
Antibody tests could inform not just lockdown exits, but the best approach to treatments and vaccines.
Ministers are now in talks with Roche to buy millions of the kits, which officials today announced would be given to NHS and social care workers first before being rolled out more widely. It requires blood samples to be taken by trained medics.
Insiders say it is unlikely that the lab-based test, which isn’t designed to give people a result in their own home, will be available to purchase privately, at least initially. It is not clear how much the tests could cost, if and when they can be purchased.
As well as the US, Germany also jumped ahead of Britain in the race to get the lab-based tests, ordering millions of the tests at the beginning of the month after the kit was granted the vital ‘CE mark’ that shows it is safe to use in Europe.
Antibody tests – which can require only a small amount of blood – are designed to tell if someone has contracted the virus in the past. They do not accurately tell if someone is currently infected.
They are considered key to easing lockdown because they paint the clearest picture about how widespread COVID-19 is. The true size of Britain’s outbreak is a mystery because health chiefs abandoned a mass-testing regime early on in the crisis.
Prof Van-Tam said the test would be ‘incredibly important’ in the weeks and months ahead, telling the Number 10 press briefing: ‘I anticipate that it will be rapidly rolled out in the days and weeks to come – as soon as it is practical.
‘I also anticipate that the focus will be on the national health service and on carers in the first instance.’
Experts believe those who have had Covid-19 develop a degree of immunity, meaning the test could prove a useful tool for helping to ease lockdown restrictions.
Number 10 said the new antibody test would ‘certainly’ be available on the NHS, but commercial discussions with Roche are ongoing.
The Prime Minister’s official spokesman said the idea of an ‘immunity certificate’ was also still under consideration if science showed that people developed immunity to Covid-19.
Professor John Newton, national coordinator of the UK Coronavirus Testing Programme, said although it was still unclear to what extent the presence of antibodies indicated immunity, the test was a ‘very positive development’ and was a ‘very reliable marker of past infection’.
He added: ‘This in turn may indicate some immunity to future infection, although the extent to which the presence of antibodies indicates immunity remains unclear.’
Roche said it could supply hundreds of thousands of the tests each week. The tests run on fully-automated equipment already widely installed by Roche at NHS sites across the UK.
Professor John Newton (pictured), national coordinator of the UK Coronavirus Testing Programme, said although it was still unclear to what extent the presence of antibodies indicated immunity, the test was a ‘very positive development’ and was a ‘very reliable marker of past infection’
The pharmaceutical firm said it would prioritise tests for distribution via the NHS before looking at how they may be sold to individuals.
Professor Sir John Bell, regius professor of medicine at Oxford University, said the development of the antibody test was ‘a good result’.
He told Radio 4’s Today programme: ‘It’s a step in the right direction. In the evolution of these antibody tests, to get one that works really well is a major step forward.’
Sir John said antibodies ‘stick around probably for a year or two’, adding that the Roche test was the ‘best approved test available on the market now’.
Health minister Edward Argar said the Government intends to roll out the new test to frontline workers first.
THE TIMELINE OF UK’S ANTIBODY TESTING DEVELOPMENTS
March 25: Professor Sharon Peacock, the director of the national infection service at PHE, told MPs antibody kits would be ready within days.
But confusion was sparked when chief medical officer Professor Chris Whitty told revealed the tests would not be ready to buy online within days.
March 26: Professor Yvonne Doyle, medical director at PHE, told MPs she expected home antibody tests to be available within a ‘couple of weeks’.
April 1: In the Downing Street press conference, Professor Doyle disputed the claim that PHE was ‘dragging its feet’ in approving antibody tests.
She said: ‘The important thing about theses antibody tests, this is not a matter of dragging our feet, it’s important that the test is valid, that it does what it says it does.’
April 6: Sir John Bell, one of the Oxford University team evaluating antibody tests for the government, revealed none of them performed well.
April 17: The New York Times reported that Britain was seeking a £16million refund after two antibody tests it had bought from Chinese companies were not accurate enough to be rolled out.
April 21: University of Oxford experts published anonymised results of the nine tests the government had bought – they showed all were deemed too weak to use.
Their sensitivity – ability to correctly spot people who had had the disease – ranged from 70 per cent to just 55 per cent.
May 3: US regulators gave the ‘game-changing’ antibody test made by Swiss pharmaceutical giant Roche the green light.
May 4: German health bosses announce a deal with Roche to buy 3million of its kits in May, as well as 5million per month from June.
May 13: Public Health England follows suit, approving the test to be used. It was revealed that health chiefs were planning to buy millions.
Speaking on BBC Breakfast, Mr Argar said: ‘It’s only just gone through the Public Health England assessment as being reliable, as doing the job, and therefore we are having those discussions.
‘But we are keen to get as many as quickly as we can and get them out, primarily to the front line first, the NHS, social care and then more widely.’
Mr Argar stressed that the public could not yet get their hands on the test, saying: ‘We’re not in a position yet to roll it out to the public and have those tests ready to go.’
A Department of Health and Social Care spokeswoman said: ‘We are exploring the use of antibody testing across the NHS and ultimately the wider public.’
But Professor Matthew Baylis, an expert in veterinary epidemiology at the University of Liverpool, cast doubt on the test – suggesting it could produce false positive results and lead to people being reassured when they should not be.
The findings have been hailed as a ‘very positive development’ in Britain’s antibody testing plans, following weeks of disappointment regarding the promised roll-out of home DIY kits.
Despite promising home tests, the UK has yet to approve any because health chiefs insist they can’t find a DIY finger-prick kit accurate enough – despite only evaluating a handful of tests.
One firm awarded millions of pounds by heath chiefs – Bedfordshire-based Mologic – hopes to have its kit ready for Britons to buy from online retailers such as Boots and Amazon for the start of June.
Sir John Bell, an immunologist at Oxford University involved in evaluating antibody kits for the government, today said the approval of the Roche test was a ‘step in the right direction’ but admitted approval takes ‘longer than it should’.
He suggested officials wanted to be completely sure that the tests were accurate, telling BBC Radio 4 Today’s programme: ‘I think you have to be a bit cautious. It’s taken a week or two longer than it might have.’
‘But remember when the home-based test came out and people were rushing around saying these are all terrific. We decided we should stop and pause and just make sure that they were what they were cut out to be.
‘And when we tested them they of course didn’t work, so I think you have to be a bit cautious. It’s taken a week or two longer than it might have.’
Sir John added: ‘This is not like the swab test where there is a certain urgency to get that in play. Once you get antibodies your antibodies stick around probably for a year or two.
‘And all it tells you, just to be crystal clear, is whether you’ve had the infection or not, so in terms of treating patients where there is real urgency I think its less important.’
‘To be clear, its the best approved test available on the market now but there will be further iterations of these tests because there are ways to make them better.’
Following the announcement today, shares for Roche – which is also carrying out swab tests for the government – rose slightly to 45,03 this morning, up slightly from the 44.86 recorded at the end of yesterday.
News of the test comes as:
- Communities Secretary Robert Jenrick admitted the situation in care homes was ‘absolutely terrible’ as the Government prepared to set out more details on how a £600 million package for infection control will be spent in England
- Some 126,064 tests were carried out on Wednesday.
- An average of 148,000 people in England had Covid-19 between April 27 and May 10 (lockdown period), according to new estimates by the Office for National Statistics – the equivalent of 0.27% of the population.
- Transport Secretary Grant Shapps said more than half of people on the Isle of Wight have now downloaded the NHS contact tracing app.
The findings come as A&E attendances and emergency admissions to hospitals in England have fallen to their lowest figure on record in the face of coronavirus.
Data published by NHS England shows 0.9 million A&E attendances were recorded in April 2020, down 57% from 2.1 million in April 2019.
The number is the lowest for any calendar month since current records began in August 2010.
NHS England, which published the figures, said the fall was ‘likely to be a result of the Covid-19 response’ – an indication that people have been staying away from A&E departments because of the coronavirus outbreak.
Emergency admissions to A&E departments at hospitals in England also showed a sharp fall last month, down 39% from 535,226 in April 2019 to 326,581 in April 2020.
This is the lowest number reported for any calendar month since current records began.
Data on all cancer referrals also showed a drop of 8%.
Following the announcement today, shares for Roche rose slightly to 44.95, the highest in several weeks, according to Yahoo! Finance
Some 181,873 urgent cancer referrals were made by GPs in England in March 2020, down from 198,418 in March 2019.
Urgent breast cancer referrals showed a bigger drop – down from 17,137 in March 2019 to 12,411 in March 2020, a fall of 28%.
Lynda Thomas, chief executive of Macmillan Cancer Support, said: ‘Cancer must not become the forgotten ‘C’ in this pandemic.
‘Government guidance for urgent cancer services to continue during the virus did not happen uniformly and now it is vital that we see comprehensive plans for how the NHS will catch up.’
Admissions for all routine surgery in hospitals in England in March 2020 totalled 207,754, compared with 305,356 in March 2019 – a drop of 32%.