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Coronavirus test confusion as No 10 admits it has no idea if they work

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.  

Derby-based SureScreen Diagnostics and Mologic Ltd, headquartered in Bedfordshire, are the frontrunners to mass produce the home-screening kits.

But neither has received the go-ahead from the Government to scale up manufacturing yet, even though health bosses have promised 3.5million of the tests ‘within days’. 

The news has sparked fears the UK will not be able to meet its promise of delivering the devices by the end of the month. 

The rapid tests, which can diagnose patients in minutes, are still being validated at Public Health England labs around the country – a process which could take weeks. 

Sources have told MailOnline it was unlikely one firm would be able to manufacture all 3.5million kits, raising questions over who the government is working with to meet its promise. 

Despite repeated pleas from MailOnline, the Department of Health has still yet to reveal who is making the 3.5million kits. 

SureScreen said it had sent hundreds of its £6 finger prick tests to a lab in Oxfordshire earlier this week but has yet to hear back. 

The firm’s director, David Campbell, said he believed they were in the running to be selected to produce tests for the UK. 

Mologic said it did not expects its tests to be included in the 3.5million announced earlier this week.  

The company, which was awarded £1million by the Government to make tests, said its devices were still at least ‘five to six months’ away. 

The test, which uses technology similar to a home pregnancy kit, started its validation process today.  

It comes after 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 ‘within days’.  

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.    

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.’ 

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.

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.   

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.’ 

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.

Name: COVID-19 IgM IgG Rapid Test

Manufacturers: BioMedomics

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.

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 

Manufacturers: ThermoFisher

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.

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.

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, Ireland, Germany, Spain, Switzerland, Netherlands, Turkey, UAE, Kuwait and Oman. 

It is believed around 175,000 tests have been conducted with the SureScreen kit so far. The company claims it has had over two million orders for next month. 

Director David Campbell said: ‘We’ve been working hard to produce a coronavirus test (COVID19) that can be used at the patient side, with capillary blood, easily taken from someone’s fingertip and diagnose them within 10 minutes.

‘There is a big problem with the diagnosis of the disease currently because the standard method of screening is to send samples to the laboratory, which takes a lot of time. 

‘Meanwhile, someone could be spreading the virus without knowing, or having the issue of self-isolation.’ 

Manufacturers: University of Leicester

Diagnostic time: 12 hours

How it works: Breath test inserted in a mask

Scientists have started a trial of the pioneering £2 gadget, which tests have already proven can detect tuberculosis, a deadly lung infection.

The masks, which could cost pennies if manufactured on a wider scale, are fitted with strips that soak up droplets from the wearer’s breath, which may be carrying traces of bacterial or viral infection.

The strips can be tested in labs with results coming back within hours. Current tests for coronavirus can take up to 48 hours. 

University of Leicester researchers believe it will be at least two months before they can test the masks on actual COVID-19 patients.

But they are hopeful it will work because it is a respiratory disease, meaning it infects the lungs and can is present in the air people breathe out.  

First, the team have to test the gadgets on dozens of patients with other lung infections to prove they can pick up bugs other than tuberculosis, which they were designed for.

Patients with infections such as flu and bronchitis will have the results from their mask tests compared to those from throat swabs, which are known to be accurate. 

Tests on tuberculosis patients, the only ones that have been done so far, show the masks can detect the killer disease almost 90 per cent of the time.

Leicester’s Professor Mike Barer and colleagues are hopeful they will be successful because the coronavirus infects the lungs in a similar way to tuberculosis.

BREATH TEST 

Manufacturers: Northumbria University, Newcastle

Diagnostic time: Almost instantly 

A breath sampling device that could rapidly identify patients with coronavirus has been developed by British scientists.

The technology, developed by a team at Northumbria University in Newcastle, is still in development and needs further testing.

But experts believe it could change the way the virus is spotted around the world.

The Northumbria team’s device collects breath samples which can then be tested separately for biological information – known as biomarkers.

These biomarkers, which include DNA, RNA, proteins and fat molecules can signal diseases of the lung and other parts of the body.

People simply breathe into the device, which collects a sample of the breath.

Dr Sterghios Moschos, associate professor at Northumbria University, said: “Our ambition is to reduce the need for bloodletting for diagnosis in its broadest sense.”

The device is currently being trialled.

Manufacturers: Private Harley Street Clinic

Diagnostic time: Three days

How it works: Nose and throat swab

Price: £375  

More than 2,000 people have ordered a £375 home testing kit from a Harley Street clinic in London after being turned down by the NHS, according to the Daily Telegraph.

In addition to individuals, some 60 firms including oil and telecoms companies, have bought them for their staff. 

The test is posted to the client’s home or preferred address, where the client takes swabs from both the nostrils and throat. 

The sample is then placed in the box provided and posted back as per the instructions. 

Dr Mark Ali, director of the Private Harley Street Clinic on London’s world-renowned medical avenue, said his practice was offering a new kit for £375 each.

On its website, the item can be easily ‘added to cart,’ much in the same way as conventional online products.

The practice says the test is ‘performed by a world renown UKAS accredited British laboratory and the test results are 100 per cent accurate and do not require further tests to confirm any diagnoses.’

The website hastens to add, that though it oversees the entire process, patients should not attempt to pick up their kits from Harley Street.

‘Please note under no circumstances can this test be done in our clinic or be collected from our clinic.’ The website states.

‘It is sent to your designated address by courier service within 48 hrs. Please refer to the details below and order through the link at the bottom of this page.’

Dr Ali told The Telegraph he has received countless requests from buyers.

‘People are worried sick. They want to get some clarity back in their lives,’ he told The Telegraph. 

‘We’ve got university students in England who want to go back to Nepal, but need to know if they have the disease so they can be let back into their own country.

‘We’ve got a businessman who owns a construction company employing 60 people. He needs to know the state of play, or he risks letting down his customers. So every single person in that company is being tested.’ 

Manufacturers: Mologic

Diagnostic time: Ten minutes 

British firm Mologic is working on an antigen test after receiving £1million from the UK Government. 

The firm hopes it will take just 10 minutes to produce a result, like that of the antibody 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. 

Manufacturer: myLAB Box

Diagnostic time: One day  

US-based firm myLAB Box announced this week that it has opened pre-sales of its COVID-19 home test for health professionals, doctors surgeries and pharmacies. 

They require suspected patients to self-collect a saliva swab sample. These samples are sent away to a CLIA-certified lab to be analysed overnight.

myLAB Box also said that free telephone consultations will be made available to those who test positive for the virus.

It is planning to process up to 20,000 tests per day once it is approved by the FDA. It is currently under review. 

Manufacturer: Scanwell 

Diagnostic time: 15 minutes 

American startup Scanwell has produced a finger prick coronavirus test that takes just 15 minutes to complete at home.

It is posted to users via next-day delivery and is used alongside the Scanwell Health App. 

The test can be completed and uploaded through the app within 15 minutes, according to the company  

The test is being fast-tracked for approval by the FDA but isn’t expected to hit the US market for another six to eight weeks.

Scanwell is best known for its smartphone-based urinary tract infection screening platform. 

Manufacturer: Cepheid 

Diagnostic time: 45 minutes 

Last week, the U.S. Food and Drug Administration authorised the first ‘point-of-care’ coronavirus test which can be used in hospitals and emergency rooms, delivering test results in 45 minutes.

The new test was developed by the company Cepheid which plans to have it on sale in the US by the end of March. 

The test will importantly deliver results onsite in 45 minutes at the hospital or emergency room where it is taken, cutting out the time-consuming step of sending the test to a lab. 

A swab is inserted into a screening device, known as GeneXpert Systems, which scours for COVID-19 genes and takes less than an hour to deliver a result. 

There are 5,000 of these machines located around the U.S. and 23,000 around the world.

Manufacturer: Bosch

Diagnostic time: Two-and-a-half hours 

The home appliances firm has created a test provides that gives results in less than two-and-a-half hours.

The sample is taken from the nose or throat of the patient using a swab and placed inside a ‘cartridge’ and inserted into a device which scours for genes of the virus.

Vivalytic is said to be ‘easy and intuitive’ to operate, according to Bosch.

The system does not require any additionally trained personnel, so that even hospital or doctor’s practice staff without special laboratory experience can operate the machines.

Who came up with the idea? Mount Sinai Health System, New York

Diagnostic time: 1 hour 30 minutes

How it works: Detects lung damage  

Doctors from The Mount Sinai Health System in New York say CT scans may be faster than nasal and throat swabs at diagnosing coronavirus patients. 

The team were the first in the US to analyze lung scans of patients in China with the highly contagious disease.   

They said they were able to identify specific patterns in the lungs as markers of the virus, also known as COVID-19, as it developed over the course of about two weeks>

The researchers say these quicker diagnoses could help keep patients isolated in early stages of the disease, perhaps even before symptoms appear and when it may not show up on other scans such as chest X-rays. 

‘CT scans are an extremely powerful diagnostic tool, because you can seen the inner organs in a three-dimensional way,’ lead author Dr Adam Bernheim, an assistant professor of diagnostic, molecular and interventional radiology at the Icahn School of Medicine at Mount Sinai, told DailyMail.com.

‘And you can see the manifestation of many diseases.’ 

For the study, published in the journal Radiology, the team analyzed scans of 94 patients at four medical centers in four Chinese provinces.

The patients had been admitted between January 18 and February 2, and all had either recently traveled to Wuhan – the epicenter of an outbreak – or had come into contact with an infected person.

Radiologists reviewed the scan and took notes based on when symptoms first appeared and when the CT scan was performed.

Thirty-six patients received scans zero to two days after reporting symptoms and more than half showed no evidence of lung disease.

The team says this is important because it suggests that CT scans cannot reliably detect coronavirus in its very earliest stages.

Nasal and throat swabs test can identify patients even before patients become symptomatic, although some may still have the virus if they first test negative. 

Its results, however, may take days to get back from the agency’s labs.

But 33 patients who received scans three to five days after symptoms developed had patterns of ‘ground glass opacities,’ or haziness in the lungs. 

‘The lung abnormalities are very round in shape and affect the perimeter of the lung,’ co-author Dr Michael Chung, an assistant professor of diagnostic, molecular and interventional radiology at the Icahn School of Medicine at Mount Sinai, told DailyMail.com.

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