British health chiefs last night finally approved an antibody test, after several weeks of disappointment in the UK’s plan to roll-out the game-changing kits.
Ministers are in talks with Swiss firm Roche to buy millions of the tests, which will be given to NHS and social care workers before being rolled out wider.
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.
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
HOW WILL IT BE USED IN THE UK?
Ministers are now in talks with Roche to buy millions of the kits, which are lab-based tests.
The blood sample kit, which 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 today said the tests would mainly be given to NHS and social care workers to start with – but did not say when testing would start.
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.
The government is understood to be in negotiations with Roche to buy millions of the Elecsys tests – but the exact amount is unclear.
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.
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.