Two British firms leading the race to develop coronavirus antibody tests for the UK say they still haven't received orders to make any despite the Government promising millions would be ready in days.
SureScreen Diagnostics, headquartered in Derby, and Bedfordshire-based Mologic Ltd say they have not been told to start mass producing their rapid DIY tests that can diagnose patients in minutes.
The devices are still being trialled at Public Health England labs around the country, despite health chiefs promising 3.5million of them would be on shelves at Boots 'within days'.
SureScreen said it had sent hundreds of its finger prick tests to a lab in Oxfordshire where they were being validated by scientists - a process it admitted could take weeks.
Meanwhile Mologic, which was awarded £1million to make the tests for the UK, said its antibody test was still at least 'five to six months' away.
The test, which uses technology similar to a home pregnancy kit, started its validation process today.
The news has raised doubts about whether the UK will be able to meet its promise of delivering millions of home testing kits in a matter of days.
The new antibody tests snapped up by the Government are thought to use a lateral flow device (LFD) which takes a drop of blood by a finger prick (like this one, pictured)
They work like an at-home pregnancy test and a colour develops if the patient is positive
Speaking alongside Boris Johnson at a press conference in Downing Street this evening, Prof Whitty warned that the 'one thing worse than no test is a bad test'
Prof Whitty (left) took questions alongside Boris Johnson (centre) and chief scientific officer Patrick Vallance
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.
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.
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.
A senior health official yesterday told MPs that 3.5million home-testing kits had been ordered and could get clearance to start being distributed for use 'within days'.
Professor Sharon Peacock, director of Public Health England's National Infection Service, said the devices would be available to pick up in Boots or on Amazon.
Boots then begged Britons not to turn up at its stores expecting coronavirus tests because it has yet to receive any despite the Government pledging to stock the Beauty retailer with millions of them.
But Boots said that while it was keen to work with the Government, it had not yet heard about the plan to stock tests in its stores.
The Beauty retailer is now worried Professor Peacock's comments will encourage Britons to turn up in droves to get their hands on the home screening kits.
It comes after Good Morning Britain's resident doctor warned the tests could be dangerous and shouldn't be sold to the public.
A spokesman added: 'We are keen to work with the Government to explore opportunities to support COVID-19 testing and to support the NHS in any way we can.
'However we do not have any type of COVID-19 tests in our stores. Customers should not make a trip to a Boots store or pharmacy for this purpose.'
The confusion deepened last night when England's Chief Medical Officer Chris Whitty backtracked on Professor Peacock's claims, saying the tests were still being evaluated and could take 'a few weeks' before being rolled out.
Professor Paul Hunter, an infectious diseases expert at the University of East Anglia, said the confusion 'was a nightmare' and said the Government had to work on providing a clear message.
He told MailOnline: 'Hopefully its a nightmare that has a light at the end of the tunnel, its a bit confusing at the moment.
'The only thing worse than no test is a bad test, and i think that's absolutely right.
'It'll take a couple of weeks - I don't know how long, I don't know whether it was the Chief Medical Officer or a PHE person that was correct. I hope it was PHE - then it'll be ready sooner -
'I think they need to work on providing a clear message.'
Despite repeated pleas from MailOnline, the Department of Health has still yet to reveal who makes the kits - which could give patients a result within 10 minutes.
In a Downing Street press conference last night, Professor Whitty tried to dampen expectations of an imminent testing breakthrough.
Speaking alongside Prime Minister Boris Johnson, he warned that the 'one thing worse than no test is a bad test' - incorrect results could lead to Britons unknowingly spreading the virus.
Professor Whitty added the 'technology is quite close and it is being evaluated this week, but it is not there'.
The finger-prick tests will scour blood samples for antibodies, substances created by the immune system to train itself to fight off an infection.
Good Morning Britain's resident doctor agreed with Professor Whitty this morning and said the tests need to be completely accurate before they are made widely available.
Dr Hilary Jones warned: 'If we have this test they have to be really accurate and specific. There's no point having unreliable tests.
'People could go back to work without immunity and causing more harm than good.
'We shouldn't be selling this to the public. Who is controlling the results and says who can go back to work or not?
'I hope these won't be made available on Amazon and Boots to buy. They need to be used by health care professionals first.
'It should be done officially by health care professionals.'
Professor Whitty said once the tests are accurate enough to be rolled out, the first people that need to be tested are frontline healthcare workers.
Good Morning Britain's resident doctor agreed with Professor Whitty this morning and said the tests need to be completely accurate before they are made widely available
He said he hoped the finger prick tests (a Chinese one shown here) won't be made available on Amazon and Boots to buy. They need to be used by health care professionals first
A prototype coronavirus test which claims to deliver a result in ten minutes, is being fast-tracked into development in Senegal.
Mologic was granted £1million to produce a test which looks for antigens in spit.
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 Bedfordshire-based firm says a finished test is still 'five to six months' from being mass produced.
It uses technology similar to a home pregnancy kit and will begin a validation process today.
The company is manufacturing the tests in Senegal to make them cheaper.
But the test will be trialled in Senegal, the UK as well as the Chinese city of Wuhan where the pandemic began.
Mologic said it wanted to sell the tests to governments around the world 'at cost', meaning without making any profit.
While the firm says tests will be rolled out globally, it is focused on halting the spread of the virus in Africa in particular.
Experts fear the continent could be devastated if a full-blown outbreak took place due to huge amounts of poverty and vulnerable health systems.
He told the No10 briefing last night: 'The thing we would like to do next which would certainly make a difference less to the disease but definitely to the NHS is being able to test NHS and other critical workers who are self isolating who currently are not being tested because we do not have sufficient testing.
'This is a global problem because basically every country is wanting this new test which for a disease which wasn't actually being tested for anywhere three months ago so everybody wants this and there is a global shortage and that is a bottleneck for us.
'But the next priority is to get critical workers back to work or to say to them you have got this. We definitely would like that not to fight the disease but to support the NHS.'
In terms of tests for people who currently have the virus, Professor Whitty defended the government's decision to stop doing routine tests for those with symptoms.
'When that ceased to be a sensible policy we moved onto testing people in intensive care and in hospitals and we have sufficient tests for that. At the moment the system for that is working fine and is being scaled up,' he said.
'That side of testing is in place and is working well. So if a patient gets as far as a hospital we are confident on the testing and the scale up.'
He said 'once we have more testing than we need for that capacity then we want to go out to test a much wider range of people with mild symptoms'.
'Some people are already having it as part of our surveillance system but we would obviously like to go wider.'
He added: 'Our bottle neck is largely global shortages which we are obviously doing our level best to free up because it would make it a lot better for us to be able to test health care workers and know for sure.'
Professor Whitty said there were shortages along many supply chains in the production of tests because 'every country in the world is simultaneously wanting this new thing'. He added: 'It's not that there is no testing going on, what we need, clearly, is to be able to scale it up.'
The World Health Organisation (WHO) and other experts have been warning that mass checks are crucial for keeping the spread of the killer disease under control.
Countries like South Korea and China have been praised for their wide-scale testing regimes, which seem to have helped limit cases.
However, the UK shelved efforts to test everyone with symptoms earlier this month, when the response moved into a 'delay' phase.
Instead people who thought they had the illness were urged to self-isolate unless their conditions became so severe they needed medical help.
Amid criticism, Mr Johnson then declared last week there would be a big expansion of tests from under 5,000 a day to 25,000.
Ministers now hope a test could be ready soon that does not need to be processed in a lab and will give results much more quickly.
Professor Peacock yesterday told MPs the Government had bought 3.5million tests which will be available in the 'near future'.
'Several million tests have been purchased for use. These are brand new products. We have to be clear they work as they are claimed to do,' she said.
'Once they have been tested this week and the bulk of tests arrive, they will be distributed into the community.'
Asked whether this could be days rather than weeks or months, she told the Science and Technology Committee 'absolutely'.
Professor Peacock did not explain if the test were free on the NHS or if suspected patients would have to pay.
PHE has not revealed who is manufacturing the tests, which detect if someone has had the infection previously and is now immune.
It is hoped that once the coronavirus lockdown is lifted the infection can be kept at manageable levels, an expert has said.
Professor Neil Ferguson, who is recovering from COVID-19 himself, told the Science and Technology Committee measures taken by the Government could tip the outbreak from a growing epidemic to a declining epidemic.
He also explained there was some uncertainty, but that if current measures work as expected, then intensive care demand would 'peak in approximately two to three weeks and then decline thereafter'.
Professor Ferguson, of Imperial College London, told the committee current predictions were that the NHS would be able to cope if strict measures continued to be followed.
He said: 'There will be some areas that are extremely stressed but we are reasonably confident - which is all we can be at the current time - that at the national level we will be within capacity.'
Drinking from a Keep Calm and Carry On mug, he explained: 'There will be some resurgence of transmission but the hope is that by employing more focused policies to suppress those local outbreaks, we can maintain infection levels at low levels in the country as a whole indefinitely.
'It remains to be seen how we achieve this and how practical it proves to be.'
Appearing via videolink, he added that it was 'plausible' COVID-19 could behave like other coronaviruses and transmission could be somewhat reduced in the summer months but perhaps not by more than 10 per cent to 20 per cent.
Professor Ferguson said it was clear that the country could not be in lockdown for a year, and that 'the long-term exit from this is clearly the hopes around a vaccine'.
'The challenge that many countries in the world are dealing with is how we move from an initial intensive lockdown... to something that will have societal effects but will allow the economy to restart,' he said.
'That is likely to rely on very large-scale testing and contact tracing.
'It should be stated that the entire world is in the very early stage of developing such strategies.'
The committee heard that the current strategy aim is to suppress transmission indefinitely until other counter-measures are put in place, including a vaccine.
It was also told that widespread testing was needed to help move the country from suppression measures and lockdown into something the country can manage longer-term.
Professor Peacock explained a small number of tests would be tested in a laboratory before being distributed via Amazon and in places like Boots.
She added: 'Once we are assured that they do work, they will be rolled out into the community. Testing the test is a small matter, and I anticipate that it will be done by the end of this week.
'In the near future people will be able to order a test that they can test themselves, or go to Boots, or somewhere similar to have their finger prick test done.'
The UK's deputy chief medical officer today said antibody tests will 'initially' be available for frontline healthcare staff.
Speaking on a webchat on Mumsnet - a popular forum for parents - Dr Jenny Harries said this was 'so we can manage patients and vulnerable people safely and keep our NHS and care systems running.
'But we will be able to roll out to other people after that,' she added.
The new antibody tests are thought to use a lateral flow device (LFD) which takes a drop of blood via a finger prick and a colour develops if the patient is positive.
The test looks for antibodies, the immune system's defence mechanism, which are produced to fight off the killer virus.
They work like an at-home pregnancy test and take just minutes to produce a result.
But the deal has raised fears about whether the Government has rushed into buying the tests.
In the UK routine tests are only given to people so ill they have to go into hospital, or those who are already on wards - even NHS staff don't get tested.
It means the official tally of just over 8,000 coronavirus patients is much lower than the reality.
Those who test positive will have already been infected - sometimes without knowing or showing symptoms - and are likely to be immune to reinfection.
But they are only around 80 per cent accurate, according to Professor Ian Jones, a virologist at the University of Reading.
And the devices are even less effective at spotting if someone is currently infect, he added.
Professor Jones told MailOnline: 'They [antibody tests] are typically around 80 pe cent efficient and at this figure I guess they are good enough to give an idea of what percentage of the population has been infected, which is the denominator that nobody really knows.
'It would be important to stress that they should only be used as directed and they are only a backwards look at the infection, they cannot be used in real time.'
Professor Jones stressed the importance of scaling up testing methods which can tell if someone is currently contagious so patients are not roaming the streets infecting others.
'...as far as I know only hospitalised patients [are being tested]. Ideally this would extend to random testing as capacity cranks up.
'This is obviosly more important when dealing with a current rather than historic infection - you wouldn't want to send someone home if they were actually infected.
'So in my view current tests would be better kept to reference centres where there is level of quality assurance.
'Its the scaling up of the throughput so that these could take general population samples that should be the focus.'
Test by test: The types of coronavirus kits from 10-minute finger-prick results to a mask which can diagnose instantly that the government could be using amid row over shortage – as PM brands impending antibody check a 'game changer'
Boris Johnson yesterday announced that coronavirus testing was to be ramped up to 25,000 per day after the government was slammed for potentially allowing tens of thousands of infected people to walk the streets undiagnosed.
Only 5,000 were being swabbed for COVID-19 previously, a fraction of the number seen elsewhere.
Mr Johnson said a new 'game changing' coronavirus test which analyses antibodies in the blood could detect asymptomatic patients and those who have already shrugged off the bug.
The Prime Minister said this would allow people to know whether they had gained immunity and get back to their working and social lives as soon as possible.
Public Health England previously said that only patients who meet certain criteria will be able to be tested for the bug and those who were being screened were having nasal swabs.
The Prime Minister conceded that the NHS will continue to use nasal swab tests that take up to 48 hours to be analysed in a lab.
Other countries around the world - including the US, China, South Korea, Japan and Italy - have been using testing kits that take just minutes to produce results.
And in a further development, Oxford University researchers claimed that they have created a new test which analyses viral RNA to detect COVID-19 in just 30 minutes.
Here, MailOnline looks at the cutting-edge testing kits currently being rolled out in other counties and at private clinics in Britain:
FINGER PRINT TEST
Name: COVID-19 IgM IgG Rapid Test
Diagnostic time: 15 minutes
The blood test is not being used in the UK, despite health bodies in China, Italy and Japan diagnosing patients with it.
On March 5, BioMedomics claimed its 'quick and easy' test was ready and being used in South Korea, Japan, Italy, China and some countries in the Middle East.
After the sample of blood is collected, a technician injects it into the analysis device - which is about the size of an Apple TV or Roku remote - along with some buffer, and waits 15 minutes.
One line means negative, two lines in a spread-out configuration means the sample contains antibodies that the body starts making shortly after infection.
A blood sample is collected, inserted into the reader, a buffer is combined, and results come back within 15 minutes, the company claims
Two lines closer together mean the person is positive for the later-stage antibodies, and three lines mean the patient is positive for both types of antibodies.
A small study showed the test produced a correct response 80 per cent of the time.
PHE confirmed it was not using the advanced blood test because it was not accurate enough, and are hoping to develop their own. The US Food and Drug Administration (FDA) is also yet to approve it.
A former PHE strategist said he was 'not confident' the test could produce correct results and is therefore unlikely to be rolled out. However, the method was desirable.
Name: TaqPath COVID-19 Combo Kit
Diagnostic time: Four hours
The DIY test detects specific DNA given off by the coronavirus in the noses of infected patients.
Samples are then delivered to labs where they are analysed and results are produced within four hours.
The test was approved by the US Food and Drug Administration this week and 5million kits will be sent across America in the coming days.
It is hoped the UK will follow suit after representatives from ThermoFisher, based in Waltham, Massachusetts, were seen entering Downing Street last night carrying a box with the tests.
It is understood ministers were giving a demonstration of how the test works.
FINGER PRICK TEST
Name: COVID-19 Rapid Test Cassette
Manufacturers: SureScreen Diagnostics
Diagnostic time: Ten minutes
The private firm, based in Derby, has created a test which can allegedly determine with 98 per cent certainty if a person is infected.
It involves taking a blood sample via finger prick and then putting it into a screening device.
SureScreen Diagnostics says a prick of blood from the fingertip is sufficient to determine with more than 98 per cent accuracy
The private firm says its test has been validated and is already being used in the UK, Ireland, Germany, Spain, Switzerland, Netherlands, Turkey, UAE, Kuwait and Oman. Currently, official swap-based methods take between 24 and 48 hours for results to come back
Public Health England cautions members of the public against using such tests amid fears they are unreliable, saying there is 'little information on the accuracy of the tests'
Results are displayed in a similar fashion to those of an at-home pregnancy test within minutes and could potentially save delays in diagnosis.
SureScreen says its test has been validated and is already being used by private buyers in the UK,