Dutch firm creates new coronavirus test that looks for antibodies and gives results in just 15 minutes – as pressure grows on the UK to test ALL suspected cases
- Sensitest’s test, manufactured in China, shows results like a pregnancy stick
- It looks for antibodies in the blood which signal the patient has had coronavirus
- The small company said it would be open for negotiations with governments
- As global cases reached 400,000, the CEO said tests were ‘desperately needed’
- It comes as UK health officials come under fire for their testing methods
- Coronavirus symptoms: what are they and should you see a doctor?
A Dutch firm has created a new coronavirus test that can give results in just 15 minutes in the same fashion as a pregnancy stick.
Sensitest’s blood test, manufactured in China, detects antibodies that signal the body is fighting the deadly infection.
It is not able to spot the virus in its early stages, but it can reveal if someone has already beaten the virus without showing symptoms.
The small company said it would be open to negotiate a deal with governments to supply tests for the masses.
CEO Robert Das said a rapid diagnostic tool like this is ‘desperately needed’ to curb the global pandemic, as the number of cases reaches more than 400,000.
It follows increasing pressure on the UK Government to push rapid tests through the door and get more of the population swabbed.
Public Health England (PHE) is in the process of investigating tests on the market, but have not revealed which ones of the dozens emerging globally.
Former Health Secretary Jeremy Hunt warned today that Britain has lost track of the coronavirus crisis because of its controversial testing scheme to only test patients in hospital.
One million Britons will have caught the life-threatening infection by the end of next week, he predicts. Some 6,600 cases have officially been reported so far.
A Dutch firm has created a new coronavirus test that can give results in just 15 minutes in the same fashion as a pregnancy stick as pressure grows on the UK government to test more people
Sensitest’s blood test, manufactured in China, detects antibodies that signal the body is fighting the deadly infection. It shows results like a pregnancy test
In Britain routine tests are only given to people so ill they have to go into hospital, or those who are already on wards.
It means only 5,000 patients are tested for the deadly virus each day in the UK, a fraction of the numbers tested in other countries.
Even NHS staff, who are treating COVID-19 patients, don’t get tested.
The Government have promised to ramp up its daily capacity to 25,000, which will prioritise health workers first.
That means thousands are expected to be infected who will never get an official diagnosis.
Sensitest Corona Rapid test can show on the spot whether a patient has produced antibodies against the COVID-19 virus using a small sample of blood.
Within 15 minutes, it shows whether a person’s body has produced antibodies IgM and IgG, which would signal they are battling the coronavirus, even if they do not have symptoms.
CEO Mr Das told MailOnline: ‘It’s just like a pregnancy test. When you test too early it will be negative.
‘As soon as you produce enough antibodies, it will give a positive result within 15 minutes.
Sensitest Corona Rapid test can show on the spot whether a patient produces antibodies against the COVID-19 virus using a small sample of blood
The test result can be read after 15 minutes. The result is positive for two lines in the test window, and negative for one line. The result is not pictured in this test
‘The test will also give a positive result after the virus has gone and you have recovered, because your body will still be protected by IgG.’
HOW DOES THE DUTCH TEST WORK?
Sensitest Corona Rapid test can show if someone has coronavirus within 15 minutes.
It may not work in the very early stages of the disease, the CEO admitted.
Blood is collected and dropped onto a cassette. Then, two or three drops of a buffer liquid are added using a pipette.
The test result can be read after 15 minutes. The result is positive for two lines in the test window, and negative for one line.
The product can only be used by doctors, and is not ideal for patients to use on themselves.
Tests like this look at 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.
Mr Das said the test, which became available only last week, is currently being bought privately by doctors across the Netherlands.
The situation in Holland reflects that of the UK – 5,578 cases have been reported and 277 deaths.
Mr Das said: ‘In Holland, we are distributing the test among doctors all over the country especially in the east where concentrations of patients are.
‘We are getting calls from physicians all day, especially in areas where they say there are not enough tests available.
‘We can supply thousands of these tests, but not millions. We would need government support.
‘I would definitely be open to that and say let’s start to negotiate. I think this product is very important for us at the moment. We need it, desperately.’
Mr Das was not able to provide the accuracy result for the blood test, but said the manufacturers – who also make the company’s pregnancy tests – have a ‘good reputation’.
Public Health England declined to comment on which commercial tests it is looking into as a viable option to use on the general population.
As the coronavirus crisis escalates day by day in the UK, the Government continue to use a testing method which takes two days to produce a result.
Prime Minister Boris Johnson his aides have repeatedly defended the testing regime amid backlash over their efforts.
Initially the plan was to test anyone with symptoms or who had contact with a positive case. But as the outbreak worsened in February, the strategy shelved.
Now, people who believe they have the illness are urged to self-isolate unless their conditions became so severe they need medical help, at which point they will be tested.
It means health chiefs don’t know the true scale of the coronavirus epidemic in the UK.
Today the former Health Secretary Jeremy Hunt slammed the testing scheme in the UK – which is almost impossible for lay people to access.
Mr Hunt, who was the longest serving Health Secretary before Matt Hancock took over in 2018, told MPs: ‘All our public focus has on social distancing.
‘But testing and contact tracing to break the chain of transmission is every bit as important if not more important.
‘South Korea avoided national lockdown despite having a worse outbreak initially than us.
‘Taiwan introduced temperature scanning in malls and office buildings but kept shops and restaurants open, they’ve had just two deaths.
‘In Singapore restaurants remain open and schools reopening.
‘But 10 days ago in this country we went in the opposite direction and stopped testing in the community.
Mr Hunt added: ‘How can we possibly suppress the virus if we don’t know where it is?’
Mr Hunt noted that testing had not been increased in the past week despite repeated promises.
He said: ‘The concern is that we appear to be testing on a daily basis virtually no more people than over a week ago when the commitment was to increase the daily amount of tests from 5,000 to 25,000 tests.’
In response, Health Secretary Matt Hancock has revealed ‘millions’ of tests had been purchased – but he could not say when the public would be able to access them or how.
He said: ‘We are in the middle of buying the tests that are needed and especially the new tests that have just come on stream.
‘We have now purchased millions of these tests which are arriving in the next days and weeks.’
Shadow health secretary Jonathan Ashworth has also called for an overhaul on the testing strategy.
More testing was needed, he said, adding: ‘On this side of the House we have called for testing for the virus to be carried out within our communities on a mass scale starting with NHS and care staff as a priority.
‘We urge the Government to rapidly scale up testing.
‘I’m told that many labs at hospitals haven’t been able to start testing or are currently testing at under planned capacity because of supply chain issues with the relevant chemicals that are used and the kits to do the testing.
‘If this is the case, could the Government update the House on what they are doing to urgently procure the testing kits we need?’
Today it’s been claimed that a desperate appeal to research labs was made by Mr Johnson to lend the government coronavirus testing kit.
According to Politico, a Downing Street aide sent a message to research institutes on Sunday asking to borrow expensive equipment currently needed to carry out tests.
‘We urgently need to scale up testing. There is only a limited supply of these machines, so the PM is making an urgent appeal for you to lend us your machine(s) for the duration of the crisis,’ the email reportedly said.
‘We will meet all expenses and assume all liabilities and requirements associated with the use of these machines for this purpose. We undertake to return or replace the equipment when the emergency is over. We would very much like to collect any machines you have tomorrow (Mon 23) or Tuesday.
The World Health Organisation (WHO) and other experts have warned that mass checks are crucial for keeping the spread of the killer disease under control.
BioMedomics claims its test can screen for coronavirus in 15 minutes using a small drop of blood and a tiny device that can be carried into the field
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’
GOVERNMENT IS WORKING WITH FIRM TO MAKE AN ANTIBODY AND ANTIGEN TEST
The UK Government is working with the inventors of the home pregnancy test to develop a coronavirus testing kit in Britain and Senegal.
Mologic was granted £1million to produce two different types of test which reveal if someone has ever had the deadly virus in the past.
The kits – one will look for antigens in spit, the other will scour blood for antibodies – could also tell if a person currently has the infection.
But the company, who laboratory in Bedfordshire was visited by Prime Minister Boris Johnson this month, estimates it will be up to six months before Brits can use them.
Antibody tests check to see if the body has substances in the immune system which are created when it comes into contact with the virus for the first time.
They could be a game-changer for the UK and allow health officials to work out when people are safe because they’ve already had COVID-19.
However, the tests can’t accurately tell if a patient is currently infected, unlike swab tests – which take much longer to get a result.
If a test comes back positive and they have a cough or fever, it suggests the patient is currently infected – but many patients only suffer mild symptoms.
Mologic is also working on an antigen test. 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.
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, 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.’
FACE MASK TESTS
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.
Scientists have started a trial of the pioneering £2 gadget (pictured), which tests have already proven can detect tuberculosis
The researchers at the University of Leicester and the University of Pretoria designed 3D printed strips of polyvinyl alcohol that are inserted into the mask (pictured)
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.
After 30 minutes, the strips can be tested in a laboratory (pictured)
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.
Manufacturers: Northumbria University, Newcastle
Diagnostic time: Almost instantly
A breath test that helps 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 be quickly change the way the virus is spotted around the world.
A breath test that helps rapidly identify patients with coronavirus has been developed by British scientists (file)
Dr Sterghios Moschos, right, said the test could be used to produce results in minutes
The Northumbria team’s test collects breath samples which can be tested separately for biological information – known as biomarkers.
These biomarkers, which include DNA, RNA, proteins and fat molecules, can spot diseases of the lung and other parts of the body.
People simply breath into the device, which is similar to a breathalyser used by the police.
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 test is currently being trialled.
PRIVATE HARLEY STREET CLINIC
Manufacturers: Private Harley Street Clinic
Diagnostic time: Three days
How it works: Nose and throat swab
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.
On its website, the item can be easily ‘added to cart,’ much in the same way as conventional online products
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
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% 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.’
Diagnostic time: Ten minutes
British firm Mologic is working on an antigen test after receiving £1million from the UK Government.
Prime Minister Boris Johnson was taken on a tour of the Bedford laboratory of Mologic earlier this month
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
US-based firm myLAB Box is mass producing a home test that requires a saliva swab to be sent away to an overnight lab to be analysed
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 CDC 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.
FINGER PRICK TEST
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.
American startup Scanwell has produced a finger prick coronavirus test that takes just 15 minutes to complete at home. It will work in conjunction with a health app (similar to its UTI test)
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.
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>
Patients who received scans zero to two days after symptoms first appeared had little to no evidence of lung disease in their results like this 19-year-old male who had a CT scan one day after symptoms first appeared
The team said the pattern in the lung of coronavirus patients are similar to scans of patients with SARS and very different from diseases such as bacterial pneumonia (pictured)
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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