Testing efforts have been ramped up as the Government has announced it will trial antigen swabs than can tell if someone has coronavirus ‘on the spot’, and 10million antibody tests have been ordered.
Around 4,000 patients in a pilot study in Hampshire will be the first to try the new antigen test, which looks for signs of current coronavirus infection.
The Covid-19 LAMP assay test, developed by UK-based manufacturer Optigene, can turn around results within 20 minutes.
It means people don’t have to wait days to find out if they can go back to work or self isolate.
Current PCR tests take 48-72 hours to produce a result because they need to be sent to a laboratory. But the LAMP test can be processed in a GP surgery, care home or hospital.
Health Secretary Matt Hancock revealed the trial while also confirming 10million antibody tests had been ordered at the daily Downing Street briefing.
NHS and care home staff will be the first to get the free COVID-19 antibody test, which detect if someone has ever been infected with the disease, from next week.
Number 10 agreed a deal to buy kits from Swiss pharmaceutical giant Roche and US-based healthcare company Abbott.
With most viral infections, the presence of antibodies reduces or removes the risk of reinfection.
But this has not yet been proven with coronavirus and there is no guarantee they will show people are immune.
Experts say positive tests should not simply be seen as a ‘green light’ to reduce PPE or other protections for staff.
The Roche test, called Elecsys (pictured), produces results in a laboratory and is said to be 100 per cent accurate
The Department of Health today announced the study of a new, quicker antigen test that boasts results in just 20-minutes.
The trial of the LAMP (loop-mediated isothermal amplification) test began in Hampshire today after being proven effective in clinical settings.
In contrast to the widely used PCR tests, which need be processed at different temperatures, the LAMP swab test does not require a change in temperature to detect results.
It means it can be processed on site – and will be first trialled at a number of A&E departments, GP coronavirus testing hubs and care homes across Hampshire.
Receiving results quickly and on site will mean people with symptoms will be given immediate certainty as to whether or not they have the virus.
Up to 4,000 people of all ages and backgrounds will participate in the pilot, which will run for up to six weeks. It will be led by Hampshire Hospitals NHS Trust.
Following a successful clinical trial, the rapid test will then be rolled out more widely if the pilot in Hampshire proves effective.
Hampshire Hospitals NHS Foundation Trust chief executive Alex Whitfield said: ‘We are tremendously excited to be able to support the government’s efforts for ever more accessible, faster coronavirus testing.’
Health Secretary Matt Hancock said: ‘This new test could provide accurate results almost on the spot.
‘This will enable health and care workers to carry on with their shift or immediately isolate on the same day, and could eventually offer the same benefit to the whole country.
‘This could change the way that we control COVID-19 across the country, getting those with negative results back into society as quickly as possible.’
Mr Hancock also revealed today at the daily briefing that antibody testing will soon be underway.
He said: ‘We’ve signed contracts to supply in the coming months over 10 million tests from Roche and Abbott.
‘From next week we will begin rolling these out in a phased way, at first to health and care staff, patients and residents.
‘This is an important milestone and it represents further progress in our national testing programme.’
The Prime Minister’s official spokesman said earlier today: ‘The tests will be free for people who need them, as you would expect. NHS and care workers will be prioritised for the tests.’
Hundreds of thousands of frontline health workers will be offered the tests, which detect if someone has ever been infected with the disease.
Priority will be given to frontline hospital staff in coronavirus specific wards, as well as ICU and A&E departments.
These staff members will be monitored by scientists to see whether they fall ill again and paint a clearer picture of the protection antibodies provide.
But it is not clear how they will reach NHS workers or the public in the future.
Known as the ‘have you had it’ tests, antibody tests reveal whether someone has been infected with COVID-19 in the past and recovered from it.
But it’s still not clear whether this means a person is protected from catching the virus again, therefore some scientists say antibody tests have limited value.
Dr Claudia Paoloni, president of the Hospital Consultants and Specialists Association, urged caution to those who test positive for antibodies.
She told The Guardian: ‘As we learn more about the role of antibodies, this could open the door to different ways of working and reduce the level of risk to NHS staff by allocating those who have had the virus to care for Covid-19 patients.
‘But we must be clear that huge uncertainties remain while we do not know the level and length of any immunity which antibodies will offer.
‘The new test’s arrival should not simply be seen as a green light to reduce PPE and other protections for NHS staff who test positive.’
The Roche test, which is called Elecsys, was given the seal of approval by Public Health England on 14 May after scientists at its Porton Down facility evaluated how reliable it was.
Abbott’s test also looks for antibodies, substances produced by the immune system in response to COVID-19.
It is believed deals are also being worked up with Welsh company Ortho Clinical Diagnostics which also makes an antibody test given the green light by PHE.
The Welsh firm’s test is the only UK-validated device which is manufactured in Britain. Roche and Abbott both produce their devices overseas, which can cause delays in the supply chain.
The Roche test, which is called Elecsys, was given the seal of approval by Public Health England on 14 May after scientists at its Porton Down facility evaluated how reliable it was
Roche said the amount of tests it would be able to make each month for the US and countries accepting the CE mark would be in the ‘high double-digit millions’. Pictured: Prime Minister of Bavaria holding the Elecsys test on May 4
According to Roche, their COVID-19 antibody test has ‘a specificity greater than 99.8 per cent and a sensitivity of 100 per cent’ – as long as it is used at least 14 days after someone has developed symptoms.
The Roche test has a ‘specificity’ of 99.8 per cent, meaning it generates very few ‘false positives’ – when it indicates someone has been infected when they have not.
For every thousand people who take the test only two will be given a false positive result, according to its claim.
Sensitivity is the rate of all positive samples that are truly positive. A rate of 100 per cent suggests very few, potentially zero, will get an inaccurate result – known as a false negative result.
Sensitivity is considered the area authorities can afford to compromise on – not specificity.
False positives, caused by poor specificity, may lead people to believe they are immune when they’re not, causing their behaviour to become riskier, or to receive treatment that they don’t need.
The FDA gave the Roche test the green light on May 3, allowing laboratories across the US to use it even though it has yet to be formally approved.
German officials already signed a deal at the beginning of May to buy five million of the Roche kits every month.
Roche said the amount of tests it would be able to make each month for the US and countries accepting the CE mark would be in the ‘high double-digit millions’.
But neither Roche nor the Government has revealed how much the antibody test will cost to purchase in bulk at this stage.
It is not designed to give people a result in the comfort of their own home – referred to as the ‘pregnancy test’ style kits.
The test requires blood samples to be taken by trained health professionals, and then it will be processed by machines already used in NHS labs across the country. Medics can get results in just 18 minutes.
Experts say the fact the test needs to be sent off to a laboratory is a limitation of the test because it could lead to delays in results.
‘It will be important to understand how widespread this equipment is and how testing could be organised regionally and locally to provide a rapid and high throughput system,’ said Dr Colin Butter, an associate professor and programme leader in bioveterinary science, University of Lincoln.
The Government’s track record for testing has been abysmal so far. The UK tests fewer people per capita than most European countries.
Experts blame this on PHE’s ‘control freakery’ in reluctance to involve private labs that offered to help process tests. The agency has denied this.
The three new antibody tests are the first to be ratified as accurate by PHE. The body does not ‘approve’ tests, just evaluate how good they are.
As well as detecting which healthcare staff have previously been infected, antibody tests are considered key to easing lockdown.
They are able to paint the clearest picture about how widespread COVID-19 is in the community by seeing how many individuals have already had the disease.
The true size of Britain’s outbreak is a mystery because health chiefs abandoned a mass antigen-testing regime early on in the crisis.
PHE is conducting a surveillance programme to understand how many of the population have had the virus using their own, high accuracy antibody test operated at their Porton Down science campus.
Results have not been published yet but suggest that less than 10 per cent of people in the UK have antibodies, with more in London than rural areas.
All three antibody tests approved by ministers are laboratory-based and can take up to a day to produce results.
No home ‘pregnancy-test’ kits that can be done in the comfort of someone’s own home and without processing by a lab, have yet been approved.
That’s despite promises in March that one would be available and ministers buying millions of pounds worth of commercial tests from overseas.
None of them have met the high accuracy standards set out by PHE after an Oxford University trial found they returned inaccurate results.
The failure was a significant setback because it had been hoped the antibody tests would be the route out of lockdown.
However, versions of Abbott’s test have been launched on various websites for a fee of £69 – £100.
Superdrug were the first high-street retailer to launch Abbott’s antibody test for £69, which sold out within hours with Brits eager to find out if they have any kind of immunity.
It is not a ‘home testing’ kit because the blood sample, which a person collects in their home, has to be sent to a laboratory.
But medical giant Abbott, which makes Superdrug’s tests, has insisted that its tests were not intended to be used by people taking their own blood samples.
Instead, the Illinois-based firm says its tests have only been evaluated to be accurate on blood samples taken by trained healthcare providers directly from patients’ veins.
Commenting on the launch, scientists said they would not buy the tests themselves because the results are meaningless.
Even if the results return as positive, they may be inaccurate and there is no proof the person has immunity and therefore return to work.
The idea of ‘immunity certificates’ has been shelved for now because of this, although No 10 said it was still exploring the idea.
How accurate is Roche’s newly-approved antibody test and will it show you if you are immune?
Here, MailOnline reveals everything you need to know about Roche’s antibody test, from how accurate it is to how it will be used in the UK.
HOW WILL IT BE USED IN THE UK?
The kits are lab-based tests and require blood samples to be taken by trained health professionals.
The blood sample kit can be processed by machines already used in NHS labs across the country. Medics can get results in just 18 minutes.
Health minister Edward Argar said the tests would mainly be given to NHS and social care workers to start with.
Insiders say it is also likely to play a role in the government’s ‘surveillance’ schemes, which will help track how far the virus has spread in Britain.
Ministers are currently clueless about the true size of Britain’s outbreak because health chiefs abandoned a mass-testing regime early on in the crisis.
One of the current antibody schemes already underway has seen nurses take blood samples from a thousand households.
Early results – not yet published by officials – suggested up to four per cent of Britain has developed antibodies to the coronavirus.
CAN I USE THE ROCHE TEST MYSELF?
The Roche test, which is called Elecsys, is simply not designed to give people a result in the comfort of their own home.
Ministers have promised ‘pregnancy-test’ style kits, which would see Brits take their own blood sample and get a result in as little as 10 minutes.
But no DIY test – scientifically called an immunoassay – has yet to be approved by officials despite promises one would be available back in March.
One firm – awarded millions of pounds by the government to produce home-testing kits – hopes to have its product ready by the start of June.
Mologic’s serology test will be available for Britons to purchase online, from retailers such as Boots and Amazon, according to reports.
It has not yet been approved by the Bedfordshire-based company is in ‘urgent talks’ with ministers to fast-track approval, The Telegraph says.
HOW MUCH WILL THEY COST THE GOVERNMENT?
Roche – which plans to produce millions of the kits each month – has not revealed how much the antibody test will cost to purchase in bulk.
Britain did, however, pay two Chinese firms around £16million for 2million antibody tests that failed strict accuracy tests – suggesting each kit cost around £8.
No details of any deals struck between Roche – based in Basel – and other countries have been made public.
This means it is not known whether Britain will pay more or less than other nations desperately seeking the antibody tests as draconian lockdowns are eased.
Roche – which operates two offices in Britain – has not revealed if it will manufacture the tests in the UK. The firm says it has ‘extensive global manufacturing capabilities’ to meet demand.
Following the announcement today, shares for Roche rose slightly to 44.95, the highest in several weeks, according to Yahoo! Finance
WILL PRIVATE FIRMS BE ABLE TO BUY THE TESTS?
Officials have yet to come forward with a concrete plan about how the tests will be used, or whether private firms will be able to buy them.
Many companies keen to restart operations want to use antibody testing kits to work out how much of their staff may be immune to the virus.
Insiders say it is unlikely the Roche tests will be available to purchase privately, at least initially.
This is because officials wouldn’t be able to access the data they desperately need to plot the spread of the virus.
It remains unclear exactly how much the lab-based tests could cost, if and when they can be purchased.
WHO ELSE HAS APPROVED THE ROCHE ANTIBODY TEST?
Roche first announced it was developing the antibody on April 17, revealing it had plans to put it on the market in early May.
At the time, it announced it was working the US health regulator the Food and Drug Administration (FDA) for an ’emergency use authorisation’.
The FDA gave it the green light on May 3, allowing laboratories across the US to use it even though it has yet to be formally approved.
Roche also announced that the blood sample kit was also granted the vital ‘CE mark’ that shows it is safe to use within the EU.
German officials already signed a deal at the beginning of May to buy five million of the Roche kits every month.
Roche said the amount of tests it would be able to make each month for the US and countries accepting the CE mark would be in the ‘high double-digit millions’.
SO WHY HAS IT TAKEN THE UK SO LONG TO APPROVE ANY TEST?
Sir John Bell, an immunologist at Oxford University involved in evaluating antibody kits for the government, admitted approving tests 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.’
Sir John accepted it has ‘taken a week or two longer than it might have’, while other experts have said ‘every day counts’ amid a pandemic.
But he pointed out the failure of DIY antibody tests, which were described as ‘terrific’ and offered hopes of a way out of lockdown – but none turned out to work.
Professor Paul Hunter, an infectious disease expert at the University of East Anglia, told MailOnline: ‘In the grand scheme of things, 11 days would be nothing.’
But he added that ‘when you are in a situation like this when every day counts, it is indeed concerning’.
HOW ACCURATE IS THE TEST?
As long as it is used at least 14 days after someone has developed symptoms, it has a 100 per cent sensitivity rate, Roche claims.
Sensitivity is the rate of all positive samples that are truly positive. For example, if a test has an accuracy rate of 99 per cent, it means 99 out of every 100 people who test positive have actually been infected.
The other one person, however, would have been given an inaccurate result – known as a false negative result.
The Roche test also has a ‘specificity’ of 99.8 per cent, meaning it generates very few ‘false positives’ – when it indicates someone has been infected when they have not.
For every thousand people who take the test only two will be given a false positive result, according to its claim.
Sensitivity is considered the area authorities can afford to compromise on because testing errors in that area lead to false negatives – people being told they haven’t had the disease when they actually have – which would lead to relatively few consequences for most.
False positives, however, caused by poor specificity, may lead people to believe they are immune when they’re not, causing their behaviour to become riskier, or to receive treatment that they don’t need.
HOW COME THIS ONE WORKS WHEN OTHERS HAVE FAILED?
Roche scientists have managed to develop a test that only picks up the virus that causes COVID-19, scientifically known as SARS-CoV-2.
Previous tests assessed struggled to differentiate COVID-19 antibodies from four other types of human coronaviruses which cause the common cold.
The body makes antibodies in response to many illnesses and infections, including other coronaviruses.
But independent experts have also called for transparency over the results, which haven’t been made publicly available.
Professor Carl Heneghan, from Oxford University, said: ‘Without seeing the study methods and the data it’s impossible to verify these claims of accuracy.’
Professor Sheila Bird, a bio-statistician at Cambridge University, also called on the government to reveal the study design to allow scientists to scrutinise the work.