Government pens open letter pleading for PPE and antigen and antibody kits

The Government today penned an open letter pleading for firms who can make personal protective equipment (PPE) and coronavirus tests to come forward – despite firms who offered help weeks ago saying they still have not heard back about helping tackle Britain’s growing crisis.

In a desperate attempt to get a grip of the testing fiasco and nationwide shortage of protective equipment for NHS staff, the Department for Health and Social Care supplied two forms for British manufacturers to fill out if they could step up to help.

But MailOnline can reveal one firm poised to supply DIY coronavirus antibody tests to Number 10 – kits deemed crucial in ending Britain’s draconian lockdown because they reveal who is immune to the disease – has yet to hear back on how it can get its test approved despite approaching them last month.

Brigette Bard, chief executive of Essex-based firm BioSure – which already makes HIV self-tests, demanded Public Health England offers clarity on what it needs, saying ‘there is nothing more critical at the moment’ than getting antibody tests approved.

Commercial laboratories and scientists drafted in to help yesterday after a screeching U-turn by ministers also exposed Downing Street’s incompetence today, claiming they had offered two weeks ago to help the Government dramatically scale-up its swab testing capacity but were ignored. 

Ramping up swab testing – often called antigen testing – is also viewed as crucial because it allows officials to test thousands of self-isolating health workers and to say for certain whether they have the disease, allowing those who are free of the killer infection to return to the NHS frontline.

Health Secretary Matt Hancock last night unveiled a five-point plan to boost COVID-19 testing capacity to 100,000 a day by the end of April – levels similar to those seen in Germany, which has been praised for its quick reaction to keeping the pandemic under control. 

But Mr Hancock was forced to admit the six-figure target did not include antibody tests. None of the fingerprick kits have yet to be approved by health chiefs amid fears over their accuracy. Mr Hancock last night claimed one of the tests he was being urged to buy was wrong 75 per cent of the time. 

Medics fighting the coronavirus crisis on the frontline have begged the Government to provide proper face masks, gloves and aprons amid claims of a nationwide shortage. The British Medical Association has already warned that doctors will die unless they are given adequate protection.

In other developments in the worldwide coronavirus crisis today:

• The UK announced 684 more coronavirus deaths and 4,450 cases – taking the total number of fatalities to 3,605 while more than 38,000 Britons have now officially been struck down;
• Mr Hancock admitted next week is likely to be even worse for coronavirus-ravaged Britain, warning more than 1,000 deaths could be recorded every day by Easter Sunday;
• The family of Britain’s youngest coronavirus victim – 13-year-old Ismail Mohamed Abdulwahab – will not be able to attend his funeral because they are in self-isolation after his brother and sister developed symptoms;
• A frontline nurse – 36-year-old Areema Nasreen – died after testing positive for the coronavirus, becoming the country’s youngest health worker to be killed with the disease;
• The Prince of Wales officially opened the new NHS Nightingale Hospital for intensive care coronavirus patients, saying from 530 miles away that it was a message of hope for those who may need it most;
• Health chiefs urged locked-down Britons to continue staying at home to help fight the coronavirus pandemic this weekend as a mini-heatwave is due to sweep the country;
• Heathrow Airport announced it will remain operational with one runway amid falling flight numbers and fury from passengers at lack of medical advice when they arrive back from coronavirus hotspots;
• Global coronavirus cases soared past one million as the pandemic explodes in the US and the death tolls continue to climb in Italy and Spain.

In an attack on the Government’s handling of the antibody testing shambles, Ms Bard said: ‘We urgently need a specification from Public Health England, so we know what we have to achieve. 

‘Matt Hancock has been on all the press this morning saying “antibody tests don’t work, self-tests don’t work” but nobody knows what they are supposed to be working to.

‘I want to know, if all these tests are failing and they’re no good, what are they being benchmarked against? Saying a test is a failure when you don’t know what failure is. I just don’t understand it.’ 

She added there is an industry-recognised specification needed for the HIV self-testing kits BioSure makes to be brought to market, with the products needing to be at least 99.5 per cent accurate. 

But Ms Bard, who yesterday resorted to social media for Britons to share a post calling on health chiefs to look at the firm’s kit, fears the Government does not yet have a standard for COVID-19 tests.

She warned the company cannot start to manufacture the kits – which are just its HIV tests recalibrated to pick up on the coronavirus – until it knows what the benchmark for accuracy is. 

Ms Bard told MailOnline: ‘We have spent five years very successfully in the market generating masses of evidence, data, everything, so we have proven we have a highly usable, highly accurate test.’

In a plea on Twitter last night, she added: ‘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… This test needs to be in the UK market.’

MailOnline has asked the Department for Health and Social Care for comment because Public Health England says it is not responsible for approving any kind of test – even though its laboratories are being used to evaluate some.

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

Some kits Number 10 are known to be looking claim to be up to 98 per cent accurate. Ministers promised the kits – similar tests have already been approved in China – would be ready to start being rolled out in mid-April. 

Public Health England is believed to be assessing up to 150 different antibody tests but several kits have already failed medical checks, including one that was wrong 75 per cent of the time. 

Officials have not revealed how accurate the tests need to be before they will finally approve them. Mr Hancock warned last night that approving tests that don’t thoroughly work is dangerous, adding: ‘I will not do it.’

The UK is able to conduct 3,500 antibody tests every week at its specialist military laboratory at Porton Down in Wiltshire. But that specific test is laboratory-based and allegedly cannot be scaled up. 

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

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.

Antibodies are substances produced by the immune system in response to an infection. They stored away so that if it comes into contact with that same pathogen again it knows how to fight if off.

The benefits of the UK’s lockdown are expected to start filtering through to hospitals in the coming weeks and widespread testing to see who has had the coronavirus already is believed to be key to getting the country back on its feet. 

But the government continues to face intense criticism with its opponents arguing that testing capacity should have been ramped up as soon as coronavirus emerged as a global threat.

Scrutiny of the approach taken in Whitehall has only increased after it was claimed that public health planners tasked with preparing the UK for a global health crisis ignored warnings from the World Health Organisation to prepare a mass testing programme.

Officials ‘did not discuss’ implementing such a programme because they assumed that a new strain of influenza was the most likely threat and testing in that scenario is ‘not important’, according to the Telegraph. The decision appears to contradict guidance on bird flu issued to countries by the WHO in 2005.  

MailOnline has repeatedly asked officials to name which companies are in talks with the Government to make antibody tests 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. 

MailOnline earlier this week revealed Belfast-based manufacturer Biopanda Reagents had opted to restrict sales to just UK healthcare providers, suggesting it was gearing up for an order.

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

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 the tests to tell if they are immune. 

Oxford Biosystems and Regenerus Laboratories in Surrey are also known to make antibody tests against COVID-19. It is unclear if their kits are being evaluated by PHE.

In another twist in the saga, it was revealed earlier this week that officials had already bought 2million antibody tests from two Chinese manufacturers – Wondfo and AllTest – a fortnight ago.

But it was alleged health chiefs had not even assessed whether the tests are suitable and that they still needed to be evaluated even though Number 10 had already parted with millions to buy them.

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

Spain was forced to return tens of thousands of testing kits and officials in the Netherlands recalled half a million ‘defective’ face masks it brought from Beijing.  

Mr Hancock, who returned to work yesterday after spending a week in isolation after catching coronavirus, was today grilled on his test pledge during numerous broadcast interviews.

Journalists repeatedly asked him what proportion of the 100,000 tests would be antibody. He said: ‘I think that the antibody test, the blood test, at the moment we haven’t got a reliable home test. If we manage to get one then that can be easily replicated and we can get into even higher figures, much higher figures.’

Asked why the government was factoring in the antibody test for its end of April deadline given that it does not currently have a test to use, Mr Hancock then replied: ‘Yes, but I am not assuming any come on stream, that is pillar three as we call it, in order to hit the 100,000 target.’ 

Health experts have said they cannot yet guarantee that people who have had the virus will have total immunity but they do believe those who have already had it will have some resistance to catching it again. 

The row over antibody testing came as Mr Hancock signalled the nation could have a long wait for the end of lockdown. He suggested a mass testing and tracing programme will have to be put in place before restrictions can be lifted.

Such a programme would allow health experts to stop a second wave of the outbreak because people who catch coronavirus could be isolated quickly and all the people who they had come into contact with could also be found and tested.

He told the BBC: ‘The first step is to get the rate of infection down so that that isn’t increasing and as you say it takes some time after the lockdown is put in place to get that rate of infection, the rate of transmission down. That is the first step.

‘Then we need to make sure that we have the testing in place and the tracking so that if we release any of the measures we don’t simply then have the infection spread again in the way that it was starting to spread when we brought the measures into place. So it is a very difficult thing.’

Mr Hancock painted a tough picture of contracting the virus as he said he had lost half a stone in weight during his week in self-isolation with the killer bug. He said it was a ‘pretty unpleasant experience’ and felt like he had ‘glass in my throat’. 

The Health Secretary said that at the moment approximately 8,000 patients a day are taking the swab test but the hope is that number will fall as social distancing measures slow the spread of infection. He also said around 1,500 frontline medics are being tested at drive-through centres each day – but the number is ‘ramping up fast’.

He added: ‘At the moment we think that there are around 35,000 frontline NHS staff who aren’t in work due to coronavirus. The number is much smaller than some of the anecdotal evidence that we’ve been hearing, although of course there may be pockets.’

Mr Hancock has placed Public Health England director of health improvement Professor John Newton in charge of overseeing the UK’s testing efforts. Mr Newton warned today that testing right now would not lift the lockdown as testing ‘doesn’t really’ help flatten the curve – a phrase for controlling the outbreak.

He was asked what percentage of the 100,000 tests would be antigen and what percentage would be antibody and he suggested the latter will play a role. He told the BBC: ‘The Secretary of State’s target was for all of those tests together. He was very clear about that.’ 

The government has been slammed in recent days over the ’embarrassing’ performance of ministers at its daily conferences in Downing Street, with Mr Hancock’s return yesterday viewed by many as a major improvement as he signalled a U-turn on the UK screening regime.

Emerging for the first time since being struck down by the disease himself, the Health Secretary said he ‘gets’ why there has been criticism as he abandoned the previous centralised approach and urged the wider science industry to help boost capacity. He said the longer-term goal was to have capacity for 250,000 checks every day.

Defending the government’s response, a querulous and at times emotional Mr Hancock said that Public Health England had been ‘working round the clock’ and could be ‘proud’ of what it had done. Taking the press briefing in No10 this evening after a week in isolation recovering from the virus, he listed five ‘pillars’ for the new strategy.

Swab tests at PHE labs will be increased dramatically to 25,000 a day; research institutions and private sector firms will be brought into the screening system; antibody tests will be introduced if they can be proved effective; community testing will be bolstered; and the overall UK diagnostics industry will be enlarged.

The previous approach on swab tests was meant to ensure checks are conducted properly, but the 10,000 per day level achieved so far contrasts sharply with the decentralised tactics deployed successfully in countries like Germany, which is carrying out up to 100,000.  

Explaining the sluggishness in hiking test numbers, Mr Hancock said approving faulty tests would put people at risk by giving them false hope they are free of the virus. He added: ‘I understand why NHS staff want tests, so they can get back to the frontline. Of course I do.

‘But I took the decision that the first priority has to be the patients for whom the result of a test could be the difference in treatment that is the difference between life and death I believe anybody in my shoes would have taken the same decision.’

Mr Hancock said the UK lacked a large diagnostics industry so was having to build from a ‘lower base’ than the likes of Germany, which is testing at greater levels for coronavirus. He also confirmed the Government was looking at ‘immunity certificates’.

But leading scientists have said the evidence about the truth on immunity is not yet clear enough. Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh, warned they could give Britons a ‘false sense of security’.

Fears have been raised that people can be struck down twice after reports in China and Japan of patients catching the disease after recovering. Other scientists believe the evidence for immunity is convincing and even claim that it could be life-long. 

It comes after it was revealed this morning that 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. 

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 comes as an NHS trust is conducting a search for PPE suppliers amid the coronavirus outbreak and a nationwide shortage of face masks, gloves and aprons, which saw Mr Hancock insist the required stocks exist but argue there had been challenges in distribution.

The University Hospitals of Derby and Burton NHS Foundation Trust (UHDB) issued the tender document listed as ‘Covid-19 – PPE’ on April 1. It described it as an ‘information gathering exercise’ to identify those who could supply or manufacture PPE should it need additional supplies in future.  

Thousands of items of PPE were donated in recent weeks to help keep UHDB trust staff safe while treating Covid-19 patients, either suspected or confirmed. This included goggles, gloves, surgical masks and protective suits from the University of Derby and 10,000 surgical masks from Rolls-Royce.  

Doctors’ Association chairman Dr Rinesh Parmar last month made an appeal to Boris Johnson, warning doctors and nurses feel like ‘cannon fodder’ because of a lack of protective equipment and kits.

It also followed a letter in the Sunday Times from almost 4,000 NHS workers who called on the Prime Minister to ‘protect the lives of the life-savers’ and resolve the ‘unacceptable’ shortage of protective equipment.

The Royal College of Nursing (RCN) last week revealed there are medical staff working to save lives and turn the tide in Britain’s war with coronavirus that have no access to basic protective clothing at all. 

Medics at Southend Hospital in Essex warned on Wednesday they may need to limit services to a ‘bare minimum’ amid concerns over a shortage of protective equipment for staff. 

While staff at The Tees, Esk and Wear Valleys NHS Foundation Trust, in County Durham,were last week warned not to resuscitate patients during the coronavirus crisis because of a lack of protective equipment. 

The British Medical Association yesterday launched a campaign to urge the Government to send more protective gear to the NHS frontline amid complaints there isn’t enough go around. 

And GP practices say that, when they’ve appealed for equipment from the NHS, they have been told to buy their own from other suppliers. 

Some staff said they have seen colleagues fall ill because of ‘inadequate PPE’  and others are having to buy their own. One doctor revealed to their MP, Twickenham member Munira Wilson, that they had bought motocross goggles for their staff to wear.

The little ships sailing to the rescue: Prestigious Oxford University department famed for helping to create penicillin, the world-leading Francis Crick Institute and a private lab in Oxfordshire claim they could carry out thousands of tests a day  

Number 10 yesterday abandoned the centralised testing approach of control freak health chiefs and urged the wider science industry to help boost capacity.

Matt Hancock declared the UK will conduct 100,000 coronavirus tests a day by the end of the month as he finally signalled a U-turn on the UK screening regime.

It came amid warnings ‘time is running out’ to scale up mass coronavirus testing to allow Britain to get a grip of the escalating crisis – which has killed almost 3,000 people.

The chief executive of one of the UK’s leading laboratories urged the Prime Minister to summon the Dunkirk spirit and let ‘small ship’ labs start screening for the deadly infection spreading rampantly on British soil.  

The Francis Crick Institute has started swabbing NHS staff at one trust and aims to ramp up to 500 per day by next week and expand to other overwhelmed hospitals across the capital. 

Other smaller laboratories say they have volunteered to help with testing, too, among them the Sir William Dunn School of Pathology at Oxford University and the Jack Birch Cancer Research Unit in York.

Another – Systems Biology Laboratory in Abingdon – is testing local GP staff already and Cancer Research UK said it is also providing equipment and expert staff to help with swabbing Britons.

But scientists say there are dozens of laboratories in the UK that already have the equipment needed to process coronavirus tests, and that any ‘self-respecting’ facility would be equipped to start immediately.

So where are the little ships that are sailing to the rescue? And how many tests can they carry out every day? 

Francis Crick Institute, London 

The Francis Crick Institute, a leading biomedical science lab in London, has already started using its facilities to test NHS staff from the University College London Hospitals NHS Trust.

It hopes to scale up to 500 tests per day by early next week with the ultimate aim of doing 2,000 every day – the equivalent of around 14,000 each week. 

The institute – a partnership of leading charities and universities – will aim to provide results within 24 hours, to enable NHS staff to return to work as quickly as possible.

In comparison, only around 10,000 patients are being tested every day in Public Health England’s centralised approach. 

Sir Paul Nurse, director of the Crick, said: ‘Testing is an essential part of the national effort to tackle the spread of COVID-19. We wanted to use our facilities and expertise to help support NHS staff on the front line who are battling this virus.

‘Institutes like ours are coming together with a Dunkirk spirit – small boats that collectively can have a huge impact on the national endeavour.’ 

Cancer Research UK has scientists at the Crick Institute who are involved with carrying out the tests and is also using its staff and equipment around the country to help test medical workers so they can continue working on the frontline without fears they are spreading the infection.

Executive director of research at the charity, Iain Foulkes, said: ‘They are providing desperately needed capacity at a time of national crisis, and testing NHS staff quickly so they can decide if they can return to their life-saving work. 

‘As a scientific research community, we need to beat the pandemic together – the sooner we do that the sooner our researchers can get back to beating cancer.’

Sir William Dunn School of Pathology, University of Oxford 

Some scientists with the right facilities have already volunteered to help the government effort but not had their offers taken up.

Matthew Freeman, at the Sir William Dunn School of Pathology at Oxford University, said in a tweet: ‘We have many people experienced in PCR.’ 

The PCR machines examine DNA taken from a nose or throat swab to look for signs of viral genetic material (RNA) left behind by the coronavirus. 

This is the kind of testing currently being used by Public Health England, which has eight of its own laboratories and access to 40 in NHS hospitals around the country.  

Mr Freeman added: ‘We’d love to help and have been trying to volunteer for weeks. Must be many university departments and institutes in similar position. 

‘I’d love to know more about why we can’t be used. Would be interested to hear if others have been more successful in offering services.

‘I understand how complex it is: quality control, biosafety, ethics… But can’t help feeling that in an emergency these could have been sorted. Less complex than constructing a 5,000 bed hospital in two weeks.’

The department – famed for the development of penicillin – would normally use its machines to examine the minute workings of human infections and diseases. 

Another lab at Oxford – the Butt Group, which studies genetics – added on Twitter: ‘I echo this sense of frustration: we volunteered on day 1 and beyond being asked 3 times to list our expertise, have heard nothing.’ 

Marc Dionne, a researcher at Imperial College London, replied: ‘Many from Imperial in the same position. I’ve heard that one of the personnel shortages now is not people capable of running PCR but people capable of directing them’.

Systems Biology Laboratory, Abingdon, Oxfordshire

Systems Biology Laboratory, a not-for-profit science company, has taken local matters into its own hands and is already testing staff at 14 GP surgeries in Oxfordshire twice a week.

The tests – it is doing around 100 per day, according to The Times – mean staff can continue to work safe in the knowledge that they don’t have the coronavirus so aren’t passing it on to patients.

Director of the lab, Mike Fischer, said he started buying the testing kits online around two weeks ago and they cost about £10 per time. He hopes to scale up to be able to do 800 tests every day. 

Mr Fischer said the lab was also using PCR tests and had ordered another 15,000. It is unclear who they bought them from or how much they cost.

He said: ‘I wouldn’t be surprised if there are 1,000 labs like that. We actually have this incredibly valuable strategic resource distributed around the country.’ 

Although Mr Fischer doesn’t have official approval as a testing centre he said the Government was aware of what he was doing and was ‘supportive’. 

Mr Fischer, who also co-founded the stock imagery company Alamy, said his team of five people could scale up tests to 500 each day once they have honed the process. 

Jack Birch Cancer Research Unit, York

One of the founders of the Jack Birch Cancer Research Unit in York yesterday claimed the facility – which mainly focuses on studying bladder cancer – was capable of carrying out potentially thousands of tests every day.

Professor Colin Garner, who said the UK must take war-time measures to fight the outbreak, claimed ‘every self-respecting laboratory will have the equipment to conduct hundreds, if not thousands, of these tests every day’.

In a call to action, he said: ‘My understanding is that the UK is building a large testing centre in Milton Keynes. Why wait for this to be built when there are labs and people sitting idle around the UK who could conduct these tests now?’

Professor Garner urged the Government to create an immediate task force comprised of the university medical and bioscience sector, cancer research labs, pharma giants, the NHS and other bodies. 

He said: ‘Just as the government called for volunteers to help vulnerable people and got 750,000 people applying, they should now put out an immediate call to all UK lab scientists and enlist them in this national effort.’

‘It is heart breaking that we are putting our medical front-line staff at risk when there is a national testing capability that could be used now.

‘A centralised lab is not the answer. Regional labs should be created and all the above organisations enlisted… The UK has some of the best scientists and facilities in the world. Let’s get them working to beat COVID-19.’