United Kingdom

Are antibody kits FINALLY on the way?

Coronavirus antibody tests may finally be on the way to Britain as one manufacturer of the kits has restricted sales to just UK healthcare providers.

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

Its kits, which work on just a finger-prick of blood, give results in 10 minutes and can tell if someone has ever had the life-threatening coronavirus.

Ministers claim to have ordered 17.5million kits in principle, with firms only securing deals if their tests pass medical checks by health chiefs.

But officials have still yet to approve any type of coronavirus antibody test, despite promises the DIY kits would be ready for use by mid-April. Health Secretary Matt Hancock first said the UK had bought antibody tests last Tuesday.

Other manufacturers of similar DIY kits have warned it could take up to six weeks for them to start supplying Britain because of the hold-up.  

Mass antibody testing will 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.

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.

It comes as ministers were today accused of 'complacence' and snubbing offers of help from labs to scale-up mass coronavirus viral testing.

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

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 government is desperately trying to ramp up the number of PCR swabs carried out, amid claims it is the only way to end the draconian lockdown. 

All testing so far has involved centralised PCR tests, which involve transport to a lab, processing by staff and a wait of up to 48 hours for a result.

But the Prime Minister is facing mounting fury over the failure to get anywhere near the levels being carried out in countries like Germany.

For reference, Germany carries out more than 90,000 coronavirus tests every day - nine times more than the UK's 10,000. 

Germany has also announced it will give 100,000 people coronavirus antibody tests in the next few weeks to get a firmer grip on its outbreak. 

Berlin has also announced it is planning to bring in 'immunity certificates' as part of preparations for the country to cease its lockdown. 

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.

Several manufacturers of coronavirus antibody tests are in discussions with Number 10 about scaling up production, if their kits pass stringent checks.  

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 company has sent hundreds of the tests to a Public Health England laboratory in Oxfordshire earlier this week but has yet to hear back.

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

The company's chief executive revealed earlier this week that it had chosen to hold off on scaling up production in case its tests fail.

Brigette Bard warned the delay in approval could mean it won't have any kits ready for Britons to use in the comfort of their own home until mid-May.

BioSure already makes a home-testing kit for HIV, which looks for antibodies in the blood and gives a result in 15 minutes. 

Its test, which is also still being evaluated, has been recalibrated to look for SARS-CoV-2 antibodies. 

MailOnline has asked Biopanda Reagents whether it is also in the running to provide antibody tests in Britain but has yet to hear back. MailOnline has also asked the Government for clarity on whether Biopanda was instructed to halt international orders, or if it chose to do so itself.

On its website, the firm says its kits are 'easy to use' and that the results can be read visually - but also says they are only to be used by healthcare professionals. 

It is unclear which countries was buying its kits before the ban. It is also unknown as to when the message was posted on the firm's website.

There was little activity at the Chessington coronavirus testing site which was set up as a drive-thru for NHS workers who need to get tested 

Workers were seen sitting, standing around and stretching at the testing centre in Chessington, south-west London yesterday as the Government was blasted for a lack of testing, especially for NHS staff 

Pictured: Stewards organise traffic at a Covid-19 test centre for NHS workers which has opened at Ikea's store in Wembley, north-west London

Professor Yvonne Doyle, PHE's medical director, revealed earlier this week the tests would be point-of-care, meaning they could be done 'in the home'. 

MINISTERS TOLD TO GET A GRIP OF MASS TESTING IN BRITAIN 

Ministers have been told to get a grip of mass testing after Britain endured its darkest day so far in the coronavirus epidemic yesterday. 

The Government is under pressure for failing to ramp up its testing quickly enough - only 8,240 patients were tested in the last 24 hours.

One British firm which claims it could be supplying more tests to the NHS is selling them to 80 countries abroad, including India and the Middle East.

Novacyt - which has a subsidiary firm based in Southampton - suggested the reason it was unable to supply more kits was a shortage of lab space.

Separately a former director of the World Health Organisation, Professor Anthony Costello, said the Government’s health protection agency had been ‘slow and controlled’ over testing, claiming that 44 labs in the UK were underused.

Meanwhile, Number 10 admitted that the Government target of carrying out 25,000 tests a day may not now be hit until the end of next month. 

Ministers had previously implied they would have reached this rate already, while NHS officials said it would be achievable within the next three weeks.

Last night, Michael Gove blamed the fiasco on a ‘critical shortage’ of chemical reagents, crucial substances in test which enable them to detect the virus.

However former health secretary Jeremy Hunt expressed disquiet at the Government’s strategy and called for mass-testing, or so-called ‘community testing’, to help Britain through the outbreak. 

In a Downing Street press conference, she said: 'This needs to be evaluated to make sure it is valid. In other words, that it does what it says and at scale.

'This would be large numbers. We want to make sure we are doing something that is safe and is actually valid and correct when it is ready.'

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.

Professor Doyle said samples would need to be sent to a laboratory and analysed by specialists - a process that could take as long as a day.

It is unclear who makes the antibody kits that would need to be posted - Number 10 has been tight-lipped regarding the whole testing regime.

But the Government is also in talks with firms that produce home-testing kits, which can give results in 10 minutes.

Number 10 originally claimed to have ordered 3.5million kits in principle. It is unclear whether these relate strictly to just the postal kits.

But ministers have now claimed to have ordered 17.5million kits. It is thought most of these will be home-tests, which will be available in batches.

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. 

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.

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

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

MANUFACTURER OF ANTIBODY KITS WARNS IT COULD TAKE SIX WEEKS TO GET ANY MADE FOR THE GOVERNMENT 

A manufacturer of an antibody test warned it could take six weeks for them to have any antibody tests ready for Britons to use at home.

BioSure, one of the firms in talks with the Government to make 17.5million home-kits, has been asked to get ready to ramp up production.

But no DIY antibody tests have been approved yet, meaning the company is holding off on mass-producing the kits in case stringent medical tests fail.

Brigette Bard, BioSure's chief executive, warned the delay could mean it won't have any kits ready for Britons to use in the comfort of their own home until mid-May.

BioSure already makes a home-testing kit for HIV, which looks for antibodies in the blood and gives a result in 15 minutes. 

Its test, which is also still being evaluated, has been recalibrated to look for SARS-CoV-2 antibodies. 

Britain has repeatedly been criticised for its controversial testing policy to only swab patients in hospital for the killer coronavirus.

It means the true size of the Britain's outbreak is a mystery because officials have no idea who is actually infected. 

Leading Government adviser Professor Neil Ferguson - whose predictions sent the UK into lockdown - suggested up to 2million people may already be infected.

And University of Oxford scientists last week claimed that up to half of the UK could have already caught COVID-19. 

But official figures show 25,000 patients have tested positive. The death toll stands at around 1,800. 

The World Health Organization earlier this month warned the only way to get a grip on the escalating pandemic was to 'test, test, test'.  

It comes after it was revealed last night a British firm producing millions of pounds worth of PCR tests is selling most of them abroad.

Novacyt has made £17.8million selling its equipment to more than 80 countries via its Southampton-based subsidiary Primerdesign. 

But only £1million worth has been sold to the UK, raising questions about why Britain is not buying more at a time when there are global shortages of tests.

It came as a huge NHS coronavirus swabbing site stood deserted yesterday despite the urgent need for more patients and medics to be examined. 

Pictures surfaced that showed a deserted testing site for NHS staff in Chessington, London, while one at Ikea in Wembley was also quiet. 

Damning truth about the nation's testing scandal: After a strong start in coronavirus battle, the UK is lagging behind the rest of the world and the Government doesn't have the testing capacity to cope, writes BEN SPENCER

As the world battles the deadly coronavirus outbreak, Britain's response has faced savage criticism, particularly the Government's handling of testing.

Here, Medical Correspondent Ben Spencer investigates what has been going wrong for our testing programme – and what steps can be taken now to fix it and save thousands of lives across the country.

Medical Correspondent Ben Spencer investigates what has been going wrong for our testing programme (stock image)

TESTING IS CRUCIAL

Until scientists develop a vaccine, mass testing will be our most powerful weapon in the war against coronavirus.

Testing tells experts who has the virus, how it is being transmitted and where the hotspots are. The World Health Organisation (WHO) has told every country to 'test, test, test' – and said any nation which fails to will be fighting the virus 'blindfolded'.

Countries such as South Korea and Singapore have already shown it is possible to curb national outbreaks with aggressive testing programmes.

These countries, which were hit badly in the early days of the pandemic, made sure every suspected patient was properly diagnosed, their contacts tracked, and anyone who had been in touch with them put into isolation.

AFTER STRONG START, UK IS FIGHTING BLIND

The country started strongly in its fight against coronavirus.

The initial 'contain' phase of the campaign identified suspected cases as travellers arrived from China, northern Italy and other countries affected early on.

People were tested, isolated and all their contacts traced. A testing protocol – one of the first outside China – was set up in January at Public Health England's main lab at Colindale, north-west London, then expanded to 12 other public health laboratories.

But on March 12, with 600 people diagnosed with the virus, the Government admitted the containment strategy had failed and that the virus was freely spreading throughout the population.

At that stage ministers decided to change tack and said they would only test those in hospital and would stop contact tracing. In doing so, they gave up all knowledge of how the virus was spreading outside hospitals. The information is now based on death rates and hospital admissions.

Pictured: A nurse adjusts her face mask before taking swabs at a COVID-19 Drive-Through testing station for NHS staff on Monday

GOVERNMENT DOESN'T HAVE TESTING CAPACITY

Officials say they can only test so many people – and must reserve this for the very ill.

The testing programme was expanded to an additional 40 labs in NHS hospitals last month, but it has still not been enough.

On March 18, the Department of Health said it would ramp up testing to 10,000 a day by the following week and hit 25,000 a day within four weeks. But, a fortnight later, it has yet to hit 10,000 once. Over the last week just 51,000 people have been tested – an average of 7,300 a day.

UK LAGGING GLOBALLY

As of last night, the US – which was slow to start its response to the crisis – had tested more than one million people, equivalent to 3,058 per million Americans.

The UK has done 143,186 tests – or 2,169 for every million people. Two weeks ago Germany had tested 167,000, and has boosted that figure to 500,000 a week.

But Italy had only carried out 47,000 tests as of Monday night – just 783 per million people.

LACK OF EQUIPMENT

Every country in the world is trying to ramp up coronavirus testing, and there is a major race for equipment.

Testing is done by taking a cheek swab, which is sent to a lab to seek evidence of the 'antigen' – the virus causing the illness.

The process, called a polymerase chain reaction (PCR) test, is nothing new – the same machines are used to test for seasonal flu.

But existing equipment is not sufficient for the scale of testing.

British suppliers of testing swabs, such as Surrey-based Novacyt, are selling their kits abroad as there are not enough UK machines to process the results.

Officials have requisitioned university equipment and struck a deal with Roche Diagnostics to supply two high-capacity machines to process tests, but it will only boost UK capacity by 5,000 a day by the end of April.

TOO FEW CHEMICALS

Cabinet Office minister Michael Gove last night claimed testing 'reagents' are in short supply.

The testing process involves certain chemicals that are added to a cheek swab and then run in the testing machine. These reagents help spot strands of coronavirus DNA in samples.

Officials are looking for alternative sources of these chemicals and investigating whether different substances could be used.

NHS STAFF TESTS VITAL

One in four NHS doctors is now off work self-isolating.

Thousands of key workers could be allowed back to work if they were proven clear of the virus. But testing of staff is minimal.

Last weekend, the NHS announced a new staff testing procedure involving the establishment of three new testing hubs. These hubs have been equipped by two private companies – Thermo Fisher Scientific and Randox. Staff are being tested by Boots workers at drive-through centres around the UK.

The NHS aimed to initially test 800 staff. Insiders last night said the numbers of tests completed are still 'in the hundreds'.

USE PRIVATE FIRMS

Use of private firms in the staff testing programme shows what can be achieved by looking outside the closed world of the NHS and other health agencies.

But businesses are not being used nearly enough in the testing war. In Germany, anyone can be tested with even mild symptoms, because they have a network of private labs which anyone can use through their health insurance.

There are not as many labs in Britain as the strength of the NHS means the private health market is smaller – but there are enough to boost capacity if used.

But officials have been reluctant to use these labs because they say they may not guarantee accuracy.

Britain also has 44 unused molecular virology labs in research institutes, according to former WHO director Anthony Costello.

RAPID TESTS ARE KEY

All testing so far has involved centralised PCR tests, which involve transport to a lab, processing by staff and a wait of up to 48 hours for a result.

The Government has appealed to companies to develop rapid 'point-of-care' antigen tests that could give a result in half an hour.

An emergency summit was held at Downing Street to discuss the challenge on March 17, with Roche, Thermo Fisher, Boots and Amazon in attendance.

US medical firms Abbott and Cepheid have since developed two such tests, and have already received approval from the FDA, the US medical watchdog.

But these are likely to be swallowed up by the US so it is vital that UK companies make their own breakthroughs.

ANTIBODY TESTING OFFERS A ROUTE OUT

Every test so far has involved 'antigen' testing – determining whether someone suffering symptoms has Covid-19.

But ministers have pinned their hopes on an 'antibody' test, which shows whether someone has carried the virus in the past.

The Government is planning to use these tests in a randomised testing programme across the population. Such a project – which may start as early as mid-April – would mean officials were not blind in their fight against the virus.

If it showed a high percentage of people are immune it could mean an early lifting of the lockdown.

Some 17.5million tests have been earmarked for the testing programme but still need to pass stringent quality-control checks.

If they pass these hurdles, it would solve many problems – and could pave the way to a return to normality for us all. 

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