British heads of health finally approved an antibody test last night, after several weeks of disappointment in the British plan to roll out the game-changing kits.
Ministers are in talks with the Swiss firm Roche to purchase millions of tests that will be given to NHS and aid workers before they are rolled out more widely.
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 announced that a new coronavirus antibody test from the Swiss pharmaceutical company Roche has been found to be 100 percent accurate. The FDA in America has already approved emergency
WHY IS ANTIBODE TEST IMPORTANT?
WHAT IS AN ANTIBODE TEST?
Unlike tests to diagnose diseases, antibody tests show who is infected and recovered.
The body produces antibodies in response to many diseases 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 types of antibodies: immunoglobulin M (IgM) and G (IgG). The body quickly produces IgM antibodies for the first attack of infections. It slows down and retains IgG antibodies; IgG antibodies suggest possible immunity.
WHAT IS THE DIFFERENCE BETWEEN QUICK TESTS AND ASSAYS?
Some companies develop finger prick tests that deliver results within minutes. These are called immunoassays and will form the basis of home test kits.
Others are developing much more accurate tests, called enzyme-linked immunosorbent assays (ELISA), which require blood samples to be sent to a laboratory for analysis.
HOW CAN ANTIBODE TESTS END THE LOCKDOWNS?
Antibody tests can help calculate which portion of the population has already been infected and whether the infections have been mild or severe.
Governments and companies could use antibody testing to determine who is most likely safe to return to work and public interactions, and whether it is safe to take home orders at once in some regions or in stages based on infection risk to lift.
People with negative antibody tests or very low antibody levels are likely to have a higher risk of infection than people with high antibody levels.
DO THE ANTIBODIES FOR THE NEW CORONAVIRUS PROMOTE IMMUNITY?
Although antibodies against many infectious diseases usually confer some degree of immunity, it is not yet known whether this is the case with this unique coronavirus.
And how strong immunity can be, or how long it can last in people who were previously infected, is not clear. In some diseases such as measles, immunity can last a lifetime. In others, immunity may decrease over time.
Scientists cannot be certain that re-infection is not possible until further investigation.
Antibody tests can inform not only the outputs of the lock, but also the best approach to treatments and vaccines.
HOW IS IT USED IN THE UK?
Ministers are now in talks with Roche to buy millions of kits, these are laboratory tests.
The blood sample set, which can be processed by machines already used in NHS laboratories across the country. Doctors can get results in just 18 minutes.
Health Minister Edward Argar said today that the tests would initially be primarily given to NHS and emergency responders, but did not say when the tests would begin.
Insiders say it will likely also play a role in the government’s ‘surveillance’ schemes, which will help keep track of how far the virus has spread in Britain.
Ministers currently have no idea of the true magnitude of the British outbreak, as the heads of health gave up a mass testing regime early in the crisis.
One of the current antibody regimens already underway has led nurses to take blood samples from a thousand households.
Early results – not yet published by officials – suggested that up to four percent of Britain has developed antibodies to the coronavirus.
CAN I USE THE ROCHE TEST ON MYSELF?
The Roche test, called Elecsys, is simply not designed to give people a result in the comfort of their own home.
Ministers have promised ‘pregnancy test’ kits, in which the British would take their own blood sample and get a result in ten minutes.
But no do-it-yourself test – scientifically called an immunoassay – has yet to be approved by officials, despite promises that one would be available in March.
A company – which has received millions of pounds by the government to make self-tests – hopes to have the product ready by early June.
Mologic’s serology test will be available online for Britons, from retailers such as Boots and Amazon, according to reports.
It has not yet been approved by the Bedfordshire-based company in ‘urgent talks’ with ministers to accelerate approval, says The Telegraph.
HOW MUCH WILL THE GOVERNMENT COST?
Roche – which plans to produce millions of kits every month – has not revealed how much the antibody test will cost to buy in bulk.
The government is said to be negotiating with Roche to buy millions of Elecsys tests, but the exact amount is unclear.
However, Britain paid two Chinese companies about £ 16 million for 2 million antibody tests that failed strict accuracy tests – suggesting that each kit cost about £ 8.
No details have been disclosed about the deals between Roche – based in Basel – and other countries.
This means that it is not known whether Britain will pay more or less than other countries desperate for antibody testing as the draconian lockdowns are eased.
WILL PRIVATE FIRMS BUY THE TESTS?
Officials have yet to come up with a concrete plan on how the tests will be used, or whether private companies can buy them.
Many companies that want to restart their operations want to use antibody test kits to determine how much of their workforce may be immune to the virus.
Insiders say the Roche tests are unlikely to be available privately, at least initially.
This is because officials would not have access to the data they desperately need to map the spread of the virus.
THE TIMELINE OF THE ORIGINATING UK TEST DEVELOPMENTS
March 25: Professor Sharon Peacock, the director of the National Infection Service at PHE, told MPs that antibody kits would be ready in a few days.
But confusion arose when Chief Medical Officer Professor Chris Whitty told that the tests would not be available to purchase online within days.
March 26: Professor Yvonne Doyle, medical director of PHE, told MPs that she expected that antibody tests would be available for home within a few weeks.
April 1st: At the Downing Street press conference, Professor Doyle contested the claim that PHE was “dragging his feet” in approving antibody tests.
She said, “The most important thing about these antibody tests, this is not a matter of dragging our feet, it is important that the test is valid, that it does what it says it does.”
6 April: Sir John Bell, one of the Oxford University teams evaluating government antibody tests, revealed that none of them performed well.
April 17: The New York Times reported that Britain was seeking a £ 16 million refund after two antibody tests it bought from Chinese companies were not accurate enough to be rolled out.
April 21: Experts from the University of Oxford published anonymized results from the nine tests the government had bought – showing that they were all considered too weak to use.
Their sensitivity – the ability to correctly recognize people who had had the disease ranged from 70 percent to just 55 percent.
3rd of May: US regulators gave the “breakthrough” antibody test by Swiss pharmaceutical giant Roche the green light.
may 4th: German health bosses are announcing a deal with Roche to buy 3 million of the kits in May, and 5 million a month from June.
13 May: Public Health England follows this example and approves the test to be used. It was revealed that health leaders planned to buy millions.
It remains unclear exactly how much the lab tests can cost, if and when they can be purchased.
WHO ELSE APPROVED THE ROCHE ANTIBODY TEST?
Roche first announced that it was developing the antibody on April 17, and revealed it had plans to release it in early May.
At the time, it announced that it was working for the U.S. health regulator the Food and Drug Administration (FDA) for an “ authorization for use in emergency situations. ”
The FDA gave the green light on May 3, allowing laboratories in the United States to use it, although it has not yet been formally approved.
Roche also announced that the blood sample set has also received the essential ‘CE Mark’ indicating that it is safe to use within the EU.
German officials already signed a deal in early May to buy five million Roche kits every month.
Roche said the number of tests it could conduct monthly for the U.S. and countries that accept the CE mark would be in the “high double digits.”
SO WHY HAS THE UK APPROVED SO MUCH A TEST?
Sir John Bell, an immunologist at Oxford University who is involved in evaluating government antibody kits, admitted that the approval of tests “takes longer than it should.”
He suggested officials wanted to be absolutely sure the tests were correct and told BBC Radio 4 Today’s program, “I think you should be a little careful.”
Sir John accepted that it “took a week or two longer than it could have,” while other experts have said that “every day counts” during a pandemic.
But he pointed to the failure of DIY antibody tests, which were described as ‘great’ and hoped for a way out of the lockdown – but none of them worked.
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 worrying.”
HOW ACCURATE IS THE TEST?
As long as it’s used at least 14 days after someone develops symptoms, it has a 100 percent sensitivity rate, Roche claims.
Sensitivity is the speed of all positive samples that are really positive. For example, if a test has an accuracy of 99 percent, it means that 99 out of 100 people who test positive are actually infected.
However, the other person would have got an inaccurate result – also known as a false negative result.
The Roche test also has a “ specificity ” of 99.8 percent, meaning it generates very few false positives – when someone is indicated to be infected when they are not.
Of every thousand people who take the test, only two get a false positive, according to the claim.
Sensitivity is considered to be the area authorities who can afford a compromise because test errors in that area lead to false negatives – people are told they didn’t have the disease while they did – which would have relatively little impact on most.
False positives, however, caused by poor specificity can lead people to think they are immune if they are not, making their behavior more risky or getting treatment they don’t need.
HOW DOES THESE WORKS WHEN OTHERS ARE GIVEN?
Roche scientists have managed to develop a test that only picks up the virus that causes COVID-19, known scientifically as SARS-CoV-2.
Previous tests that were reviewed struggled to distinguish COVID-19 antibodies from four other types of human coronaviruses that cause colds.
The body produces antibodies in response to many diseases and infections, including other coronaviruses.
But independent experts have also called for transparency about the results, which have not been made public.
Professor Carl Heneghan, from the University of Oxford, said, “Without seeing the study methods and the data, it is impossible to verify these claims of accuracy.”
Professor Sheila Bird, a bio-statistician at Cambridge University, also called on the government to disclose the research design so that scientists could investigate the work.