The Department of Health has been accused of ‘panic buying’ coronavirus antibody tests from the pharmaceutical company Roche before publicly revealing their accuracy.
Officials spent £13.46million on the blood tests — now used to tell which NHS staff have already had Covid-19 — on May 15, government contracts show.
But Public Health England hadn’t officially evaluated any other companies’ tests before it consented to buy Roche’s, so did not know how good they were compared.
The Roche purchase was 10 days after scientists at PHE’s Porton Down laboratory first started looking at the tests but three days before their report was launched.
Results of PHE’s tests were leaked to the press on May 13 and reports claimed it had achieved 100 per cent accuracy in the evaluations.
But this later ended up being on only 1 of two measures and health chiefs actually deemed the test to be 84 percent sensitive, meaning it could properly detect past infection in around eight in 10 people.
In later evaluations other tests performed better than Roche’s but contracts were not announced for those. Ones made by Abbott Laboratories, of 94 percent accurate, were bought in the same week in May for an undisclosed price.
Another made by the German firm Siemens last month achieved 86 percent sensitivity in PHE’s evaluation. These were bought by officials but to no fanfare.
There was a prior understanding between Roche and the Government that its tests – which were the first to ever be evaluated – could be bought if PHE approved of them, MailOnline understands.
Professor Jon Deeks, a University of Birmingham testing expert who the other day published a prestigious 300-page review of Covid-19 antibody testing up to now, told MailOnline that PHE appeared to be facing ‘pressure’ to approve the test. He said the Government was ‘panic buying not following science’.
The days between PHE looking at the tests and purchasing them left no time for independent boffins to check what officials were doing, Professor Deeks said.
And the purchase – which came after Roche was awarded a £21million swab testing contract in March – caused it to be look like the Swiss firm’s tests had be ‘pre-selected’ by UK officials, Professor Deeks added.
The Department of Health insists the complete process was ‘standard practice’.
It comes amid a string of missteps in the UK’s try to get hold of the antibody tests, which has seen it cancel £70million worth of orders for tests that ended up being no good, and left unable to send back an additional £20million worth from China.
And a MailOnline investigation unveiled in June that a test being used by PHE for the population testing misses up to and including third of cases.
Roche’s Elecsys Covid-19 antibody test is being useful for NHS staff and care workers to work through who has received the disease already, but it isn’t the best performing test Public Health England has evaluated
Government documents show that Roche was given a contract to provide PHE with antibody tests on May 15, with the deal starting on May 18 and lasting for six months.
PHE is officially listed as the human anatomy that awarded the contract but the decision was actually taken by ministers in the Department of Health.
The £13.4m contract was a direct award meaning Roche, a Swiss company, didn’t have to pitch its services and products against the others so PHE could decide which was most readily useful.
Roche had already been given a contract in March, worth a further £21million, to provide swab tests for the Department of Health.
And the company’s CEO, Severin Schwan, had laid the groundwork for Roche’s antibody test in April when that he announced it absolutely was in development and said of other companies’ services and products: ‘I can tell you, it’s a disaster… These tests aren’t worth such a thing. Or have very little use.’
The timing of the antibody tests contract has raised concerns because PHE consented to buy the tests three days before it publicly unveiled the results of its evaluation, on May 18 – 11 days after it first took delivery of Roche’s kit on May 4.
Professor Deeks, a biostatistician at the University of Birmingham, told MailOnline: ‘This is not normal.
‘There was almost no time for any scientific scrutiny of the results, which was the very first time PHE had done an assessment of a Covid-19 antibody test similar to this.
‘There was no time for independent review of their report or findings.’
Government contract information shows PHE bought the tests three days before publishing its report of how well they performed, which came on May 18
Professor Deeks said PHE appeared to need to ‘rush to finalise their reports to obtain them out,’ adding: ‘It seems likely that there was pressure to get a contract signed as quickly as possible.’
Professor Sheila Bird, a biostatistician at the University of Cambridge, added: ‘Everything in a pandemic with high a R [rate] and worrying lethality is rushed’.
A second deal was announced in the exact same week, for the Government to buy an antibody test from a company called Abbott, but financial details of this haven’t been published.
That and Roche’s were the very first two tests to be evaluated by PHE and a combined 10million were bought almost instantly. Other tests since then have now been evaluated and none have performed in addition to Abbott’s test but one or more was a lot better than Roche’s.
Professor Deeks said: ‘The other issue here was PHE raced through both tests from Roche and Abbott for evaluation – nothing else was completed for any other competitor test for weeks afterwards, and I know the others have been looking forward to weeks without getting an assessment done.
‘The idea that there clearly was a fair assessment to see what tests were planning to be the most readily useful before deciding things to buy isn’t there.
‘It appears that Roche and Abbott were somehow pre-selected to possess their assessments accelerated ahead of other competitors.
‘It doesn’t seem that it was a good competition or done in ways to make sure we get the most readily useful test.’
A Department of Health and Social Care spokesperson said: ‘As is standard practice, contracts were only placed when Public Health England’s evaluation of each test was confirmed, also to suggest such a thing otherwise could be completely incorrect.’
The Department said it was working ‘at pace’ to secure antibody tests and that it desired to avoid delays to getting them in to use.
Government contracts show that PHE has bought other, worse-performing, tests than Roche’s before publishing evaluations of them, costing at least £1.8m.
But we were holding not given lavish publicity and hailed as ‘game-changers’ by top politicians, as Roche’s test was.
WHAT ANTIBODY TESTS HAS PHE LOOKED AT AND WHICH ONES ACHIEVED IT BUY?
Public Health England has published evaluations of seven lab-based Covid-19 antibody tests and these are its results.
Sensitivity denotes how many very good results the test would properly identify in an organization of individuals who have had Covid-19.
Specificity denotes how many negative results the test would correctly identify in a group of people who have not had Covid-19.
- Evaluation published: May 18
- Did it buy? £13.46million on May 15
- Sensitivity: 83.9%
- Specificity: 100%
- Evaluation: May 18
- Did it buy? Yes. Date/cost unknown
- Sensitivity: 92.7%
- Specificity: 100%
Ortho Clinical Diagnostics (1)
- Evaluation: May 29
- Did it buy? Unknown
- Sensitivity: 77.4%
- Specificity: 99.7%
- Evaluation: June 18
- Did it buy? £1.5m on May 12
- Sensitivity: 72%
- Specificity: 99%
- Evaluation: June 18
- Did it buy? £300,000 on April 22
- Sensitivity: 64%
- Specificity: 97.7%
Ortho Clinical Diagnostics (2)
- Evaluation: June 22
- Did it buy? Yes. Date/cost unknown
- Sensitivity: 85%
- Specificity: 99.5%
- Evaluation: June 22
- Did it buy? Yes. Date/cost unknown
- Sensitivity: 86%
- Specificity: 100%
When Roche received the results from PHE’s evaluation, they were leaked to the press and newspapers published front page stories on May 13 hailing the test’s ‘100 per cent accuracy’.
And the next day, health minister Edward Argar MP did an appearance on BBC Radio 4 when he said: ‘We are keen to obtain as many as quickly as we can and get them out, primarily to leading line first, the NHS, social care and then more widely.
‘Because this really will undoubtedly be – because the Prime Minister said – this has the potential to be always a game-changer.’
But when PHE published its evaluation of Roche’s test later that week, it emerged that it only achieved 100 percent accuracy using one measure.
It was 100 percent specific, meaning it didn’t react to other viruses and cause false positive results.
But PHE found it absolutely was only 84 per cent painful and sensitive, meaning it might miss 16 out of every 100 positive results.
Roche insists that an unique evaluations found the test to be 100 percent sensitive.
A spokesperson for Roche Diagnostics UK and Ireland said: ‘From the early stages of the pandemic, we now have supported the collective reaction to Covid-19 and so are one of a number of companies working together with the NHS to help increase testing capacity.
‘Our tests are highly accurate and reliable, and have withstood rigorous review. The diagnostics industry is heavily regulated and all commercial contracts are at the mercy of EU instructions and procurement law. In line with your requirements, and alongside lots of others, we submitted our antibody test to PHE for independent evaluation after it received its CE mark.’
Other tests evaluated later turned out to be more accurate than Roche’s.
One made by Abbott Laboratories, that was bought in the same week, was 93 per cent painful and sensitive and 100 per cent specific – definitely the best one evaluated up to now. It isn’t clear just how much PHE has spent on these tests.
A test made by Siemens turned out in June to be 86 per cent painful and sensitive and 100 per cent specific – a lot better than Roche’s.
The Department of Health confirmed it was being used nevertheless the quantity and cost of the deal is unknown.
A Siemens Healthineers spokesperson said: ‘The SARS-CoV-2 total antibody test from Siemens Healthineers has been appraised by Public Health England and comes in the UK.
‘The test is in use in UK laboratories and we actively encourage NHS pathology testing facilities to further ponder over it due to its timely availability, quality, scalability and accessibility.’
And a test manufactured by the company Ortho Clinical Diagnostics was found to be 85 per cent painful and sensitive (higher than Roche) and 99.5 per cent specific (lower than Roche). These were also bought in undisclosed deals.
Roche may have got a fast handle PHE because labs across the country have its machines and utilize them for other tests, one scientist said.
The tests which have to be purchased are disposable cassettes containing chemicals to mix with blood samples, and their results are read with ELISA lab machines that are already widely used.
Dr Al Edwards, a pharmacy researcher and medical test developer at the University of Reading, said this was an unavoidable fact of business.
He told MailOnline: ‘There’s a pure infrastructure argument. It may simply be that individuals have most of the Roche machines lying around. You cannot run a Siemens test on a Roche machine.
‘There are three, four or five multinational companies running systems in hospitals and you also can’t just buy new machines.
‘If you have Roche, Abbott and something other company offering tests but hospitals have only got Roche and Abbott machines, another company won’t ever get in.
‘If you’ve already got Apple and Windows you are not going to get yourself a Linux computer.’
Professor Jon Deeks said ‘Lucky Roche’ in a tweet where he accused the government of ‘panic buying not following science’
The British Government’s attempts to get antibody tests for Covid-19 have now been plagued by wasted money and setbacks.
A ‘buy first, test later’ approach had already stung officials out of £20million by May.
The Department of Health confirmed that it had cancelled orders for £70million worth of tests after striking deals for them, because they ended up being bad.
That figure was out of an overall total £90million, suggesting the remaining £20million could not be recouped and the tests must now be used for non-diagnostic purposes or scrapped.
WHAT IS DEFINITELY AN ANTIBODY MAKE SURE WHAT IS IT USEFUL FOR?
Antibody tests are ones which search for signs of past illness in someone’s blood.
Antibodies are substances made by the defense mechanisms which store memories of how to fight off a particular virus. They can only be created if the body is exposed to the herpes virus by getting infected for real, or through a vaccine or other type of specialist immune therapy.
Generally speaking, antibodies produce immunity to a virus because they are redeployed if it enters the human body for an additional time, defeating the bug faster than it can take hold and cause an illness.
An antibody test, , involving analysis of someone’s blood sample, has two purposes: to reveal whether a person has been infected before and may therefore be protected against the virus, and to count those people.
Knowing you might be immune to a virus – even though whether people actually develop immunity to Covid-19 remains unknown – can affect the way you act later on. Someone might need to protect themselves less should they know they’ve been infected, for example, or medical staff could possibly return to work in the data they are maybe not at risk.
Counting the numbers of people who have antibodies is the most accurate way of calculating how many people in a population experienced the virus already.
This can be done on a small sample of the people and the figures scaled up to offer a picture of the country in general.
In turn, this could inform boffins and politicians how devastating a second outbreak might be, and how close the country is always to herd immunity – a predicament in which more and more people have had the herpes virus already that it would maybe not be able to spread quickly an additional time.
Experts think that around 60 per cent exposure would be needed for herd immunity from Covid-19, but the UK does not seem to be anywhere near that.
Early estimates suggest 17 per cent of Londoners experienced the virus, along side five percent of the others of the united states – about 4.83million people.
This means the virus may spread slightly slower in future nevertheless the risk of second outbreak and hundreds or thousands more deaths remains very real.
The Department said some of the tests are now being used for research.
And it emerged in May that Public Health England is employing a test which study found was just 67 percent sensitive, meaning it missed a third of positive cases.
Government contracts data shows PHE paid £1.5million for this test, named the EuroImmun IGg ELISA test, in March and an additional £2.5m in May.
A study of the test’s accuracy, by the Statens Serum Institut in Copenhagen, found that it absolutely was 67 percent sensitive and in addition that it cross-reacted – gave a false positive result – when subjected to a different type of coronavirus and also two adenoviruses, which cause coughs, colds and sore throats.
‘That’s not accurate,’ said Dr Simon Clarke, a cellular microbiology expert at the University of Reading.
‘The problem could it be will underestimate the positives and they [PHE] won’t appreciate how quickly or how extensively it [Covid-19] has spread through the population.
‘If you’re underestimating it by up to and including third – it’s important to say up to – then what’s the point? There are more accurate tests in route.
‘Throughout this whole saga there is a lot of doing what to create the impression of activity. While it’s important to be active, you’ll want to be accurate and if which means waiting then that’s what should be done.’
Scientists are no more even confident that antibody tests ought to be used at all for anything apart from surveillance – working out exactly how many people have had Covid-19.
In general medical terms the presence of antibodies in the blood shows that someone is immune to a disease.
For this reason, people receiving a positive antibody test may believe they are protected from the condition and not abide as strictly by lockdown rules.
But boffins still have no idea if people can catch Covid-19 over and over again, or whether or not they build up all kinds of immunity to it after a first infection.
Some individuals who are known to experienced Covid-19 are producing test outcomes which do not show any antibodies at all, raising questions concerning the immune response it triggers.
This is the reason the Government has held off offering the tests to the public after originally promising them in March.
Reading University’s Dr Edwards explained: ‘The tests remain useful for such things as the Office for National Statistics surveillance but if we’re rolling out tests indiscriminately you will see a problem.
‘People wish to know [if they’ve had Covid-19] for lots of reasons but what they perhaps do not realise is that they’ll suddenly be up against not really once you know what the test means.
‘The tests are incredibly very important to lots of different research reasons that feed in to public health powerfully, however they don’t help anybody on an individual level.’
HOME ANTIBODY TESTS MISS A THIRD OF VERY GOOD RESULTS, STUDY WARNS
Coronavirus antibody tests that can be done in the home would obtain the results wrong a third of the full time, a damning study has found.
A review of research found that rapid ‘have you’d it’ coronavirus kits, which screen the blood to find signs of past illness, have major flaws.
They properly identify somebody who has had the condition only 66 per cent of the time, normally – and also this could drop as low as 49 per cent in some instances.
Officials in the UK have refused to supply antibody tests to people because they fear people will minimize following social distancing rules if they think they’re immune to Covid-19. In reality, there is no proof that people can not get the disease twice.
The study in the British Medical Journal unearthed that lab-based tests were more accurate but nevertheless not perfect, correctly pinpointing positive results between 84 and 97.8 per cent of the time.
The findings, based on 40 studies from around the world – most of them in China – suggest the tests aren’t ready for mass use.
A review of research found that rapid ‘have you’d it’ coronavirus kits, which give a result on the spot, properly identify somebody has had the condition just 66 per cent of the time. This compares with laboratory-read antibody tests – which can properly identify somebody who has had Covid-19 at least 84 per cent of the time