Britain’s antibody testing fiasco | Daily Mail Online

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BioSure


BioSure’s chief executive revealed the firm was ‘ready to go’ but had been snubbed

Britain’s testing fiasco deepened today after an Essex-based maker of antibody fingerprick kits claimed Public Health England bosses won’t even ‘look’ at them because they are DIY.

BioSure’s chief executive revealed the firm – which already makes HIV tests – was ‘ready to go’ but had been snubbed by health officials who are allegedly not looking at self-testing kits. 

In hope of getting the Government-run body to change its mind and put its test through its paces, Brigette Bard called for Britons to share the message because the kit ‘needs to be in the UK’.

Other manufacturers known to have sent their tests to PHE for trials today admitted there was still no clarity on whether they were going to be used.

Some kits Number 10 are known to be looking at in their promise to start rolling out antibody tests in mid-April claim to be up to 98 per cent accurate. 

Antibody tests are the only ones that can tell if someone has ever caught the deadly infection, which has struck 1million people worldwide and killed more than 50,000. 

Experts say screening to see if people have already fought off COVID-19 will be the biggest breakthrough in getting the country back on its feet and ending the Prime Minister’s draconian lockdown. 

Ministers have already promised 17.5million of the blood tests, with Health Secretary Matt Hancock claiming they would be ready by mid-April.

But in another blow to the plan, it was claimed today that none of the antibody tests officials have already evaluated work. 

PHE is understood to be looking at 150 kits – but it is unclear how many have already been checked. It is also unknown how accurate they have to be to get approved.

Last night in a Downing Street press conference Mr Hancock warned approving tests that don’t thoroughly work is dangerous, adding: ‘I will not do it.’ 

He claimed the Government was working with nine companies who make the blood tests – but revealed one unnamed kit was wrong 75 per cent of the time.

As Britain scrambled to find an accurate test, US regulators last night approved the first antibody test in hope of jump-starting the economy.

BioSure claims to have developed an at-home finger prick test that takes a quarter of an hour

BioSure claims to have developed an at-home finger prick test that takes a quarter of an hour

It works exactly like the firm's HIV self test, which requires the user to take a drop of blood using a safety lancet before using its pen device to scan the sample for COVID-19 antibodies

It works exactly like the firm’s HIV self test, which requires the user to take a drop of blood using a safety lancet before using its pen device to scan the sample for COVID-19 antibodies

WHAT IS AN ANTIBODY TEST, AND HOW IS IT DIFFERENT TO AN ANTIGEN OR PCR TEST? 

ANTIBODY TEST

An antibody test is one which tests whether someone’s immune system is equipped to fight a specific disease or infection.

When someone gets infected with a virus their immune system must work out how to fight it off and produce substances called antibodies.

These are extremely specific and are usually only able to tackle one strain of one virus. They are produced in a way which makes them able to latch onto that specific virus and destroy it.

For example, if someone catches COVID-19, they will develop COVID-19 antibodies for their body to use to fight it off.

The body then stores versions of these antibodies in the immune system so that if it comes into contact with that same virus again it will be able to fight it off straight away and probably avoid someone feeling any symptoms at all.

To test for these antibodies, medics or scientists can take a fluid sample from someone – usually blood – and mix it with part of the virus to see if there is a reaction between the two.

If there is a reaction, it means someone has the antibodies and their body knows how to fight off the infection – they are immune. If there is no reaction it means they have not had it yet.

PCR TEST

Antibody tests differ to a swab test, known as a PCR (polymerase chain reaction) test, which aims to pick up on active viruses currently in the bloodstream.

A PCR test works by a sample of someone’s genetic material – their RNA – being taken to lab and worked up in a full map of their DNA at the time of the test.

This DNA can then be scanned to find evidence of the virus’s DNA, which will be embroiled with the patient’s own if they are infected at the time.

The PCR test is more reliable but takes longer, while the antibody test is faster but more likely to produce an inaccurate result. It does not look for evidence of past infection.

ANTIGEN TEST

Antigens are parts of a virus that trigger the immune system’s response to fight the infection, and can show up in blood before antibodies are made.

The key advantage of antigen tests is that it can take several days for the immune system to develop enough antibodies to be picked up by a test, whereas antigens can be seen almost immediately after infection.

Antigen tests are used to diagnose patients with flu, as well as malaria, strep A and HIV. They can also be done using swabs.

The US Food and Drug Administration (FDA) authorized the use of the kit by Cellex on an emergency basis, saying it is ‘reasonable’ to believe the kit works.

In a letter to North Carolina-based firm, the FDA wrote: ‘The known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.’

China, where the pandemic began in December, approved eight antibody tests in its fight against the virus – including one that Britain bought a fortnight ago and is expected to arrive this week. 

Antibody kits have also been approved in Singapore and Australia.    

When someone gets infected with a virus their immune system must work out how to fight it off and produce substances called antibodies.

The body then stores versions of these antibodies in the immune system so that if it comes into contact with that same virus again it will be able to fight it off.

Germany is also planning on starting a mass antibody testing regime in the next fortnight as part of a major trial to get millions of workers out of lockdown.

The Helmholtz Centre for Infection Research in Braunschweig is overseeing the project. It is unclear which antibody tests they will use.

As part of the project, German scientists have announced they will roll out ‘immunity certificates’ to try and ease the country of its lockdown. 

Britons who have already have fought off the coronavirus could also be given immunity certificates or wristbands, ministers last night confirmed. 

One district in North Rhine-Westphalia in Germany is already offering antibody tests, with doctors taking blood from patients. 

It is unclear who makes the kits but Krone Laboratory is analysing the samples. Local media reports claims the firm can analyse 2,000 results each day.

In a plea on Twitter, Ms Bard said: ‘We are ready to go with the validation of this test at PHE. But they won’t look at it because it’s a self-test.

‘We need some help guys, please work with us. This test needs to be in the UK market.’

MailOnline has asked the Department for Health for comment because Public Health England says it is not responsible for approving the tests. 

Confusion has surrounded Britain’s plan to buy millions of antibody kits, which last week it was revealed would have to be sent off in the post – known as home-sampling.

PHE’s medical director Professor Yvonne Doyle said samples would need to be sent to a laboratory and analysed by specialists – a process that could take days.

Professor Doyle also spoke earlier this week about tests that would be point-of-care, meaning they could be done ‘in the home’. It now raises the question over whether the home-testing will be carried out by a health professional who goes door-to-door. 

Mr Hancock said on March 24 that Britain had already purchased 3.5million antibody tests – but the deal was only ever in principle. PHE has also said the tests would be available for home delivery on Amazon or in Boots.

Oxford Biosystems and Regenerus Laboratories in Surrey are also known to make antibody tests

Oxford Biosystems and Regenerus Laboratories in Surrey are also known to make antibody tests

It comes as BBC Radio 4 Today’s science correspondent Tom Feilden this morning described antibody kits as a ‘get out of jail card’.

He said they could be thought of as the ‘golden ticket’ to allow thousands of Britons who have had COVID-19 to go back to normal life. 

But Mr Feilden added: ‘As I understand it, none of the antibody tests the Government has been looking at so far… have worked.’ 

He added that health chiefs have been ‘working their way through about 150’ – but did not reveal how many have already been evaluated.

MailOnline has repeatedly asked officials to name which companies are in talks with the Government but has never been offered clarity.

One of these firms is thought to be Derby-based SureScreen, which has shipped its tests to be used in Germany and Spain, among other nations.

The company sent hundreds of the tests – which trials have shown are 97 per cent accurate – to a PHE laboratory in Oxfordshire almost two weeks ago.

Another of the firms was believed to be BioSure, an Essex-based manufacturer which has been asked to get ready to ramp up production.

Despite repeated requests from MailOnline, the Department of Health has refused to confirm which businesses are in the running. One of these firms includes Derby-based SureScreen, which has shipped its tests to be used in Germany and Spain, among other nations

Despite repeated requests from MailOnline, the Department of Health has refused to confirm which businesses are in the running. One of these firms includes Derby-based SureScreen, which has shipped its tests to be used in Germany and Spain, among other nations

The other million, which are reportedly being held-up, are being made by AllTest, a diagnostics firm based in Hangzhou

The other million, which are reportedly being held-up, are being made by AllTest, a diagnostics firm based in Hangzhou

Half of the rapid fingerprick kits are being made by Guangzhou-based firm Wondfo and will arrive in Britain by the end of the week

Half of the rapid fingerprick kits are being made by Guangzhou-based firm Wondfo and will arrive in Britain by the end of the week

Belfast-based Biopanda Reagents posted an alert on its website to say the ban on all international orders was 'effective immediately'

Belfast-based Biopanda Reagents posted an alert on its website to say the ban on all international orders was ‘effective immediately’

But the company’s chief executive warned it could take six weeks before it had any tests to sell to the Government because of the approval hold-up. 

MailOnline earlier this week revealed Belfast-based manufacturer Biopanda Reagents had opted to restrict sales to just UK healthcare providers.

Mologic – a Bedfordshire-based business awarded £1million by Number 10 to make antibody tests – this week began the evaluation of its kits.

Its kits are being evaluated at labs at the Liverpool School of Tropical Medicine and St George’s, University of London. It is unclear if PHE is testing them yet.

But the company, whose laboratory was visited by Prime Minister Boris Johnson last month, estimates it will be up to five months before Brits can use them.

Belfast-based manufacturer Biopanda Reagents has already announced it has opted to restrict sales of its antibody kits to just UK healthcare providers. 

MailOnline has also asked the firm whether it is in the running to provide antibody tests in Britain but has yet to hear back.

Oxford Biosystems and Regenerus Laboratories in Surrey are also known to make antibody tests. It is unclear if their kits are being evaluated by PHE.

Earlier this week it was revealed officials had already bought 2million antibody tests from two Chinese manufacturers – Wondfo and AllTest. 

It was alleged PHE had not assessed whether the tests are suitable, despite having had a fortnight to do so ‘for reasons that are extremely unclear’, ITV reported.

Countries have already had to send back defective coronavirus medical kits bought from China during the pandemic.

Spain returned tens of thousands of testing kits, while the Netherlands recalled half a million ‘defective’ face masks it brought from Beijing. 

The UK is able to conduct antibody tests at its specialist military laboratory at Porton Down in Wiltshire. 

Around 3,500 of those tests are currently being carried out as part of a sampling effort to establish how many people have had coronavirus.

But that test is laboratory-based and apparently cannot be scaled up or put into a form which could reach out to people’s homes.  

As Britain scrambled to find an accurate test, US regulators last night approved the first antibody test - made by Cellex - in hope of jump-starting the economy

As Britain scrambled to find an accurate test, US regulators last night approved the first antibody test – made by Cellex – in hope of jump-starting the economy

Britain could roll out coronavirus ‘immunity wristbands’ for people who have already fought off the deadly infection under antibody testing scheme

Britons who have already have fought off the coronavirus could be given ‘immunity wristbands’, ministers last night confirmed.

Health Secretary Matt Hancock admitted Number 10 was looking at the move at a Downing Street press conference tonight.  

He told last night’s Question Time on BBC1: ‘When the science is good enough, we are looking at introducing something like an immunity certificate or a wristband that says “I’ve had it and I’m immune and I can’t pass it on and I’m highly unlikely to catch it”.’

German scientists have already announced they will roll out the certificates, to try and ease the country out of its draconian lockdown.

Discussing the prospect of introducing certificates, Mr Hancock said the evidence about the truth on immunity is not yet clear enough.

Fears have been raised that people can be struck down twice after reports in China and Japan of patients being reinfected. 

Other scientists believe the evidence for immunity is convincing and even claim that it could be life-long. 

Antibody tests are the only ones that can tell if someone has ever caught the deadly infection, which has struck almost 1million people worldwide. 

Health Secretary Matt Hancock admitted Number 10 was looking at the controversial move at a Downing Street press conference tonight

Health Secretary Matt Hancock admitted Number 10 was looking at the controversial move at a Downing Street press conference tonight

GERMANY TO ISSUE IMMUNITY CERTIFICATES AS PART OF PREPARATIONS TO CEASE LOCKDOWN 

‘Immunity certificates’ are set to be introduced in Germany as part of preparations for the country to cease its lockdown.

MailOnline reported earlier this week that researchers want to bring in the documents for citizens not at risk of contracting the novel coronavirus.

As part of Germany’s fight against the virus, scientists are using antibodies in test participants to find out which of them have had the illness and healed.

The Helmholtz Centre for Infection Research in Braunschweig, 41miles (66km) east of Hanover, is overseeing the project, Der Spiegel reports.

The academic team plans to test 100,000 people at a time, issuing documentation to those who have built up an immunity.

They will then use the information gleaned from the testing to assess how and when the lockdown should conclude.

Researchers will utilise the data as they advise the government on when schools will be re-opened and mass gatherings permitted once again.

Germany has repeatedly been praised for its rigorous testing regime, which has seen 100,000 people get swabbed every day across the nation.  

When someone gets infected with a virus their immune system must work out how to fight it off – it does so by producing substances called antibodies. 

Patients who catch COVID-19 develop and store COVID-19 antibodies for their body to use to battle the life-threatening virus in future.

But Number 10 has yet to approve any antibody tests in the UK, despite promises the DIY kits would be ready for use by mid-April.   

In the press conference tonight, Mr Hancock revealed nine firms were in the running to produce the 17.5million blood tests it had ordered.

Experts say screening for if people have already fought off COVID-19 – antibody testing – will be the biggest breakthrough in getting the country back on its feet.  

In a stark warning, Mr Hancock said the evaluation of the kits – which rely on just a finger-prick of blood and can give results in ten minutes – was still ongoing.

He said some kits had failed, adding: ‘In one case, a test that I am being urged to buy missed three out of four positive cases of coronavirus.

‘That means in three-quarters of cases that test would have given the false comfort of sending someone with coronavirus back on the wards.’

In a comment suggesting officials still need to evaluate the kits further, he added: ‘Approving tests that don’t work is dangerous and I will not do it.’ 

Mr Hancock first promised antibody tests last week. MailOnline understands the process of validating kits should only take a matter of days. 

Discussing the potential of immunity certificates, he added: [It] is an important thing that we will be doing and are looking at.

‘But it’s too early in the science of the immunity that comes from having had the disease. It’s too early in that science to be able to put clarity around that. 

‘I wish that we could but the reason that we can’t is because the science isn’t yet advanced enough.’ 

Mass antibody testing could allow the UK to slowly ease its draconian lockdown, which senior officials have warned could last for months.

The regime would paint a clear picture on who has already caught the killer infection and is immune to being struck down again. 

SCIENTISTS WHO OFFERED HELP TO UK TESTING EFFORT SAY THEY NEVER HEARD BACK FROM OFFICIALS 

Scientists who offered their help to the British Government’s coronavirus swab testing effort say they never heard back from officials.

Universities, private laboratories and research institutes could have been processing thousands of coronavirus tests for weeks, they say, if they had been enlisted.

A COVID-19 testing row erupted this week after Germany scaled up its testing capability to 93,000 per day while the UK was still managing fewer than 10,000.

Public Health England, a government body separate from the Department of Health, is facing the burden of blame for insisting on developing its own tests and analysing results in its own eight laboratories along with around 40 NHS sites.

Academics and private sector scientists, however, say they have the machines capable of interpreting swab tests if they were given the right information.

There are believed to be thousands of the machines – PCR machines – ready and waiting in laboratories around the country and many owners are willing to help test NHS staff to help them keep working.

Some have already taken matters into their own hands and begun testing medical workers in their local areas.

The scientists are capable of doing PCR tests, which look for evidence of the coronavirus inside people’s DNA and are different to antigen tests, which also test for current infection but do so by trying to trigger a reaction from viruses in a sample.

It would allow frontline NHS staff who are stuck at home – estimates suggest around a quarter of doctors are in lockdown – to get back to work. 

But leading scientists warn the truth on immunity is still murky, with laboratory tests on monkeys proving they could not be reinfected.

Other experts have claimed similar coronaviruses also induce immunity for around three months – the UK is braced for a second wave of cases this winter.

And they warn that because the virus had never been seen before until the pandemic began in Wuhan in December more trials are urgently needed.

It comes after one health chiefs in one Chinese region revealed in February that around 14 per cent of coronavirus patients tested positive a second time.

Some researchers believe this is down to unreliable tests and are optimistic that people can become immune to the virus, called SARS-CoV-2. 

MailOnline reported earlier this week that researchers in Germany want to bring in the documents for citizens not at risk of contracting the novel coronavirus.

As part of Germany’s fight against the virus, scientists are using antibodies in test participants to find out which of them have had the illness and healed.

The Helmholtz Centre for Infection Research in Braunschweig, 41miles (66km) east of Hanover, is overseeing the project, Der Spiegel reports.

The academic team plans to test 100,000 people at a time, issuing documentation to those who have built up an immunity.

They will then use the information gleaned from the testing to assess how and when the lockdown should conclude.

Researchers will utilise the data as they advise the government on when schools will be re-opened and mass gatherings permitted once again.

Germany has repeatedly been praised for its rigorous testing regime, which has seen 100,000 people get swabbed every day across the nation. 

Swab tests are different to antibody tests and can tell if someone is currently infected. 

British health chiefs have said they could give out coronavirus ‘immunity’ certificates like Germany to allow millions of Britons out of isolation.

Otherwise, there is no official way of keeping track of who has already battled the virus and has developed some form of immunity. 



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