15-minute coronavirus blood test is being used in China, Italy and Japan – but NOT in the UK or US because health officials have yet to approve it
- BioMedomics says its blood test can diagnose the virus in the field in 15 minutes
- It takes a small amount of blood and shows results in a pregnancy-test fashion
- Public Health England confirmed the test is not in use on suspected patients
- Currently swab tests take up to 48 hours to be read by lab specialists
- An ex strategist at PHE said he was ‘not confident’ the test was accurate
- The FDA has also not approved the blood test in the US
A 15-minute coronavirus blood test is not being used in the UK, despite China, Italy and Japan diagnosing patients with it.
The test, which takes a blood droplet from a finger prick, allegedly shows the severity of coronavirus infection in a patient even if they don’t show symptoms.
Results are displayed in a similar fashion to those of an at-home pregnancy test within minutes and could potentially save delays in diagnosis.
Currently, swab tests used by Public Health England take 24 to 48 hours to be read by a specialist in a lab. In that time, suspected patients could be spreading germs to other people.
PHE confirmed they were 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.
A small study by Biomedomics showed the test produced a correct response 80 per cent of the time.
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
PHE confirmed they were not using the advanced blood test because it is not accurate enough. They are hoping to develop their own. Pictured travellers on London Underground
As of March 6, 20,338 people have been put through PHEs diagnostic test in the UK, of which 163 were confirmed as positive for COVID-19. Two people have died of the disease
The world total of coronavirus cases tipped 101,000 today, with 3,451 deaths
The world total of coronavirus cases tipped 101,000 today, with 3,451 deaths. China, South Korea, Italy and Iran are the worst affected.
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.
The BioMedomics test – called COVID-19 IgM/IgG Rapid Test – takes a human finger-prick or venous blood sample.
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.
A hospital patient in his 80s with underlying health conditions has become Britain’s second coronavirus death.
The unnamed man is thought to have died from the killer virus last night at Milton Keynes University Hospital last night.
He had tested positive for the bug once already but the NHS must carry out further tests to confirm the case and rule out a false positive, MailOnline understands.
Fellow patients and hospital staff on his ward have been isolated this morning and a deep clean has been carried out.
Health officials are now tracking down anyone who had been in contact with the patient and will test them for the highly contagious illness.
The man has tested positive once for coronavirus, but a patient must have three positive results for it to be considered accurate.
Today services at MK Hospital are running as normal. The hospital has been contacted for comment.
The first death, a woman in her 70s who also had long-term health troubles, was recorded on Thursday at the Royal Berkshire Hospital in Reading.
Results are displayed in a similar fashion to those of an at-home pregnancy test. But instead of a ‘yes’ or ‘no’ answer, it can reveal at what stage of disease the infected person is at.
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.
The UK – which is currently seeing the coronavirus outbreak escalate every day – is unlikely to adopt the blood test any time soon.
A spokesperson for PHE said there is not sufficient understanding of how the body responds to coronavirus, and therefore measuring antibodies in the blood may not be accurate.
They added PHE are working with a ‘number of commercial companies to validate tests for use and we are also working to develop a blood test’.
Dr Bharat Pankhankia, a senior clinical lecturer at the University of Exeter, who used to work in testing systems and control strategies at PHE, was not surprised to hear of PHE’s stance.
He told MailOnline: ‘I wouldn’t want a test I wasn’t absolutely confident in.
‘It is very important to get a test right. To be a good test, it has to be sensitive, specific and reproducible.’
A sensitive test means it only picks up the smallest amount of coronavirus genes in the blood. Specific means it will only pick up this coronavirus, and not others such as influenza. Reproduceable means it doesn’t produce a random result that is sometimes incorrect.
A blood sample is collected, inserted into the reader, a buffer is combined, and results come back within 15 minutes, the company claims
It can be read similarly to a pregnancy test, with one line for a negative test, two signifying it’s positive for either early or late antibodies, and three when the sample is positive for both
There are now 90 confirmed cases of the coronavirus in Britain, after three more were confirmed in Scotland this morning
‘These 15 minute tests do not have those three things.
‘It leads to errors because you will get false negative results, where the test says people who are infected are not, or false positives, where they are not infected but it says they are.
‘The UK and other countries have a robust mechanism for doing testing. The test is repeated at PHE Colingdale or a reasonable lab who confirm results. Our results are very good and precise.’
Dr Pankhankia said a blood test is ‘exactly what I want’ and the government will spend a lot of money to achieve it. But it’s going to ‘take time’.
BioMedomics suggest the test could speed up diagnoses and possibly contain infected people far quicker. It could also be used as a screening tool in schools, airports and railway stations, the company claims.
Professor Richard Tedder, a visiting professor in medical virology at Imperial College London, disagreed.
He said: ‘The approach of using antibody for diagnosis does not let you screen people for the virus, it relies solely on the individual’s response to their infection.
‘It does not have value during the incubation period, nor does it confirm that an individual has cleared the virus in the recovery phase. For these two investigations the current methods for detection of the virus itself remain invaluable.’
CORONAVIRUS PATIENTS TOLD TO RECOVER AT HOME
Anyone confirmed to have the virus who is not seriously unwell or at risk of becoming more dangerously infected can recover at home.
At least 45 people out of the 116 confirmed in the UK have already been instructed to stay in their own houses and wait for their illness to blow over.
Until the new rule was drafted – it is not clear when it began – all confirmed patients had to be taken to a specialist hospital unit in one of five locations around the country, some hundreds of miles from their hometowns.
An extra 29 cases of the coronavirus have been diagnosed in the UK today, bringing the total to 116 – 105 in England, six in Scotland, three in Northern Ireland and two in Wales.
Officials said it was ‘perfectly reasonable’ for people to recover at home because COVID-19 is a ‘mild illness’.
Chief medical officer for the government, Professor Chris Whitty, said that most people with minor cases of the virus will no longer be hospitalised.
Instead they will be asked to stay at home, where they pose less of a risk to other people.
There are 12 laboratories in the UK which analyse swabs taken from Britons who think they have coronavirus.
As of March 6, 20,338 people have been put through PHEs diagnostic test in the UK, of which 163 were confirmed as positive for COVID-19. Two people have died of the disease.
Samples are tested for reactions that indicate genetic material of COVID-19.
These types of test are considered the gold-standard for diagnosing infectious diseases, but they involve multiple components, which are notoriously complex, they have to be run by specially trained technicians, using specialized equipment.
Officials in the US – where 267 people have been confirmed to have coronavirus – use similar tests. The FDA has also not approved the rapid blood test as a means of speeding up diagnoses.
The FDA gave broad approval to any companies, states or institutions to develop their own tests and use it on patients without approval, as long as they have a certified clinical lab able to handle it.
However, it’s not clear what the qualifications are for sure a lab. BioMedomics apparently doesn’t have them – though it is trying to sway US officials.
‘We are in contact with the Centers for Disease Control and Prevention, and have approached the FDA to inquire about US market,’ CO Dr Frank Wang told WRAL TechWire.
COVID-19 IgM/IgG Rapid Test hasn’t been as widely studied as have others. The company’s website cites a study of just 525 suspected patients.
Of those, the test correctly identified 352 patients as positive, making it about 89 per cent sensitive, or accurate. Twelve were false positives.
It may not be as precise as the gold standard, but it is certainly faster.
Dr Wang said: ‘Because there is no medicine or vaccine, the best way to combat this infection is isolation. A lot of people don’t have symptoms.
‘Because of that, quick diagnostics are very important. You can identify infection and isolate people.’
The CDC and FDA have not specified why the rapid test isn’t being used and did not respond to request for comment at the time of publication.
The blood test (right) is fast, but it’s not as well tested as the gold standard used by CDC (right)
WHAT IS TAKING THE US SO LONG TO TEST PATIENTS FOR CORONAVIRUS?
Within days of shipping its tests, several states reported that the CDC’s diagnostic was returning ‘inconclusive’ results. The agency was forced to re-make one of the test components are reissue kits.
Even since the CDC started to address this issue, delays have continued.
US officials previously promised a million tests could be run by the end of this week, but Health and Human Services Secretary Alex Azar admitted ‘we currently have capacity to send tests for 15,000 people’ on Thursday.
Vice President Pence reiterated the woe of US doctors Thursday, but said that the US has tested the patients it absolutely needs to.
‘We don’t have enough tests today to meet what we anticipate will be the demand going forward,’ he admitted after a meeting with 3M, which is expected to help ramp up mask production.
‘For those that we believe have been exposed, for those who are showing symptoms, we’ve been able to provide the testing.
The US coronavirus task force promised Monday that, by the end of the week, about a million coronavirus tests would be available.
Now, it’s clear that goal won’t be nearly met.
Secretary Azar explained Thursday the three steps that stand in the way to broader, faster testing.
He said that even when the Centers for Disease Control and Prevention (CDC) itself developed a test, it had to get approval from the Food and Drug Administration (FDA) before distributing it.
That request was submitted February 3 and approved February 4.
The CDC didn’t start shipping its first batch of tests until February 6.
Shortly after those tests arrived to labs, it was discovered a reagent was flawed, forcing the CDC to reissue the test.
Right now, doctors have to call in to one of just over 70 labs in the US, describe the patient they suspect may have coronavirus, get approval for a test to be sent to them, then test the patient, and send the kit back to one of those 70 labs.
On Saturday, the FDA gave approval for other states, companies and research institutions to make their own coronavirus tests to expedite increase the number of people who can be tested.
CDC’s own manufacturer, IDT, is ramping up production, and Azar thinks that they’ll distribute enough kits to test about 75,000 people for the virus.
With the addition of outside tests, Azar estimated that enough tests will be sent out to screen about 400,000 people – because two of the nearly one million tests to be shipped have to be used to test each patient under current guidelines.
He thinks that will happen by the end of the weekend.
But even then, it could be ‘a week, a week-and-a-half, two weeks’ before they are ‘up and running.’
Data to allow the CDC to ‘validate’ the tests has to be sent within 15 days of when these labs started administering them.
So far, University of Washington scientists have begun using their own test, and is running samples 24-hours a day.
They believe they’ll soon be processing some 1,000 samples each day.
New York state – where at least 22 people now have coronavirus – as well as partner labs at Northwell Health and Stonybrook are now working on their own test, as well. New York was the first state to get authorization to start distributing its test.
Meanwhile, Texas Governor Greg Abbott has quickly created an entire public testing lab network across the US to help the state – where so far four positive tests have been confirmed – to help expedite the process.
He said so far half of the labs spread across 10 US cities are functional and ready to begin testing.
WHAT DO WE KNOW ABOUT THE CORONAVIRUS?
Someone who is infected with the coronavirus can spread it with just a simple cough or a sneeze, scientists say.
More than 3,300 people with the virus are now confirmed to have died and over 98,000 have been infected. Here’s what we know so far:
What is the coronavirus?
A coronavirus is a type of virus which can cause illness in animals and people. Viruses break into cells inside their host and use them to reproduce itself and disrupt the body’s normal functions. Coronaviruses are named after the Latin word ‘corona’, which means crown, because they are encased by a spiked shell which resembles a royal crown.
The coronavirus from Wuhan is one which has never been seen before this outbreak. It has been named SARS-CoV-2 by the International Committee on Taxonomy of Viruses. The name stands for Severe Acute Respiratory Syndrome coronavirus 2.
Experts say the bug, which has killed around one in 50 patients since the outbreak began in December, is a ‘sister’ of the SARS illness which hit China in 2002, so has been named after it.
The disease that the virus causes has been named COVID-19, which stands for coronavirus disease 2019.
Dr Helena Maier, from the Pirbright Institute, said: ‘Coronaviruses are a family of viruses that infect a wide range of different species including humans, cattle, pigs, chickens, dogs, cats and wild animals.
‘Until this new coronavirus was identified, there were only six different coronaviruses known to infect humans. Four of these cause a mild common cold-type illness, but since 2002 there has been the emergence of two new coronaviruses that can infect humans and result in more severe disease (Severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) coronaviruses).
‘Coronaviruses are known to be able to occasionally jump from one species to another and that is what happened in the case of SARS, MERS and the new coronavirus. The animal origin of the new coronavirus is not yet known.’
The first human cases were publicly reported from the Chinese city of Wuhan, where approximately 11million people live, after medics first started publicly reporting infections on December 31.
By January 8, 59 suspected cases had been reported and seven people were in critical condition. Tests were developed for the new virus and recorded cases started to surge.
The first person died that week and, by January 16, two were dead and 41 cases were confirmed. The next day, scientists predicted that 1,700 people had become infected, possibly up to 7,000.
Just a week after that, there had been more than 800 confirmed cases and those same scientists estimated that some 4,000 – possibly 9,700 – were infected in Wuhan alone. By that point, 26 people had died.
By January 27, more than 2,800 people were confirmed to have been infected, 81 had died, and estimates of the total number of cases ranged from 100,000 to 350,000 in Wuhan alone.
By January 29, the number of deaths had risen to 132 and cases were in excess of 6,000.
By February 5, there were more than 24,000 cases and 492 deaths.
By February 11, this had risen to more than 43,000 cases and 1,000 deaths.
A change in the way cases are confirmed on February 13 – doctors decided to start using lung scans as a formal diagnosis, as well as laboratory tests – caused a spike in the number of cases, to more than 60,000 and to 1,369 deaths.
By February 25, around 80,000 people had been infected and some 2,700 had died. February 25 was the first day in the outbreak when fewer cases were diagnosed within China than in the rest of the world.
Where does the virus come from?
According to scientists, the virus almost certainly came from bats. Coronaviruses in general tend to originate in animals – the similar SARS and MERS viruses are believed to have originated in civet cats and camels, respectively.
The first cases of COVID-19 came from people visiting or working in a live animal market in Wuhan, which has since been closed down for investigation.
Although the market is officially a seafood market, other dead and living animals were being sold there, including wolf cubs, salamanders, snakes, peacocks, porcupines and camel meat.
A study by the Wuhan Institute of Virology, published in February 2020 in the scientific journal Nature, found that the genetic make-up virus samples found in patients in China is 96 per cent identical to a coronavirus they found in bats.
However, there were not many bats at the market so scientists say it was likely there was an animal which acted as a middle-man, contracting it from a bat before then transmitting it to a human. It has not yet been confirmed what type of animal this was.
Dr Michael Skinner, a virologist at Imperial College London, was not involved with the research but said: ‘The discovery definitely places the origin of nCoV in bats in China.
‘We still do not know whether another species served as an intermediate host to amplify the virus, and possibly even to bring it to the market, nor what species that host might have been.’
So far the fatalities are quite low. Why are health experts so worried about it?
Experts say the international community is concerned about the virus because so little is known about it and it appears to be spreading quickly.
It is similar to SARS, which infected 8,000 people and killed nearly 800 in an outbreak in Asia in 2003, in that it is a type of coronavirus which infects humans’ lungs. It is less deadly than SARS, however, which killed around one in 10 people, compared to approximately one in 50 for COVID-19.
Another reason for concern is that nobody has any immunity to the virus because they’ve never encountered it before. This means it may be able to cause more damage than viruses we come across often, like the flu or common cold.
Speaking at a briefing in January, Oxford University professor, Dr Peter Horby, said: ‘Novel viruses can spread much faster through the population than viruses which circulate all the time because we have no immunity to them.
‘Most seasonal flu viruses have a case fatality rate of less than one in 1,000 people. Here we’re talking about a virus where we don’t understand fully the severity spectrum but it’s possible the case fatality rate could be as high as two per cent.’
If the death rate is truly two per cent, that means two out of every 100 patients who get it will die.
‘My feeling is it’s lower,’ Dr Horby added. ‘We’re probably missing this iceberg of milder cases. But that’s the current circumstance we’re in.
‘Two per cent case fatality rate is comparable to the Spanish Flu pandemic in 1918 so it is a significant concern globally.’
How does the virus spread?
The illness can spread between people just through coughs and sneezes, making it an extremely contagious infection. And it may also spread even before someone has symptoms.
It is believed to travel in the saliva and even through water in the eyes, therefore close contact, kissing, and sharing cutlery or utensils are all risky.
Originally, people were thought to be catching it from a live animal market in Wuhan city. But cases soon began to emerge in people who had never been there, which forced medics to realise it was spreading from person to person.
There is now evidence that it can spread third hand – to someone from a person who caught it from another person.
What does the virus do to you? What are the symptoms?
Once someone has caught the COVID-19 virus it may take between two and 14 days, or even longer, for them to show any symptoms – but they may still be contagious during this time.
If and when they do become ill, typical signs include a runny nose, a cough, sore throat and a fever (high temperature). The vast majority of patients will recover from these without any issues, and many will need no medical help at all.
In a small group of patients, who seem mainly to be the elderly or those with long-term illnesses, it can lead to pneumonia. Pneumonia is an infection in which the insides of the lungs swell up and fill with fluid. It makes it increasingly difficult to breathe and, if left untreated, can be fatal and suffocate people.
Figures are showing that young children do not seem to be particularly badly affected by the virus, which they say is peculiar considering their susceptibility to flu, but it is not clear why.
What have genetic tests revealed about the virus?
Scientists in China have recorded the genetic sequences of around 19 strains of the virus and released them to experts working around the world.
This allows others to study them, develop tests and potentially look into treating the illness they cause.
Examinations have revealed the coronavirus did not change much – changing is known as mutating – much during the early stages of its spread.
However, the director-general of China’s Center for Disease Control and Prevention, Gao Fu, said the virus was mutating and adapting as it spread through people.
This means efforts to study the virus and to potentially control it may be made extra difficult because the virus might look different every time scientists analyse it.
More study may be able to reveal whether the virus first infected a small number of people then change and spread from them, or whether there were various versions of the virus coming from animals which have developed separately.
How dangerous is the virus?
The virus has a death rate of around two per cent. This is a similar death rate to the Spanish Flu outbreak which, in 1918, went on to kill around 50million people.
Experts have been conflicted since the beginning of the outbreak about whether the true number of people who are infected is significantly higher than the official numbers of recorded cases. Some people are expected to have such mild symptoms that they never even realise they are ill unless they’re tested, so only the more serious cases get discovered, making the death toll seem higher than it really is.
However, an investigation into government surveillance in China said it had found no reason to believe this was true.
Dr Bruce Aylward, a World Health Organization official who went on a mission to China, said there was no evidence that figures were only showing the tip of the iceberg, and said recording appeared to be accurate, Stat News reported.
Can the virus be cured?
The COVID-19 virus cannot be cured and it is proving difficult to contain.
Antibiotics do not work against viruses, so they are out of the question. Antiviral drugs can work, but the process of understanding a virus then developing and producing drugs to treat it would take years and huge amounts of money.
No vaccine exists for the coronavirus yet and it’s not likely one will be developed in time to be of any use in this outbreak, for similar reasons to the above.
The National Institutes of Health in the US, and Baylor University in Waco, Texas, say they are working on a vaccine based on what they know about coronaviruses in general, using information from the SARS outbreak. But this may take a year or more to develop, according to Pharmaceutical Technology.
Currently, governments and health authorities are working to contain the virus and to care for patients who are sick and stop them infecting other people.
People who catch the illness are being quarantined in hospitals, where their symptoms can be treated and they will be away from the uninfected public.
And airports around the world are putting in place screening measures such as having doctors on-site, taking people’s temperatures to check for fevers and using thermal screening to spot those who might be ill (infection causes a raised temperature).
However, it can take weeks for symptoms to appear, so there is only a small likelihood that patients will be spotted up in an airport.
Is this outbreak an epidemic or a pandemic?
The outbreak is an epidemic, which is when a disease takes hold of one community such as a country or region.
Although it has spread to dozens of countries, the outbreak is not yet classed as a pandemic, which is defined by the World Health Organization as the ‘worldwide spread of a new disease’.
The head of WHO’s global infectious hazard preparedness, Dr Sylvie Briand, said: ‘Currently we are not in a pandemic. We are at the phase where it is an epidemic with multiple foci, and we try to extinguish the transmission in each of these foci,’ the Guardian reported.
She said that most cases outside of Hubei had been ‘spillover’ from the epicentre, so the disease wasn’t actually spreading actively around the world.
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