Britons could soon be diagnosed with coronavirus by simply exhaling into a tube, if a trial of breathalyser-like technology is successful.
NHS doctors are testing out the machine, which could give results in as little as 10 minutes, its creators say.
The device works by the analysing the chemicals in the air someone breathes out after they blow into a mouthpiece for a minute, and is already used for other illnesses.
Manufacturers of the kit say it could be a ‘game-changer’ because it is so much faster than a swab test, but it is too early in trials to know how accurate it is.
Currently, Britons suspected of having Covid-19 must wait up to 48 hours to get the results of their test back because it has to be processed in a laboratory.
Number 10 is desperate to approve rapid tests as it scales up testing ahead of winter to try and keep on top of coronavirus when millions develop Covid-like symptoms as normal coughs, colds and flu come back in the colder weather.
And last week a top government adviser claimed pregnancy-style tests were set to be approved imminently, being sold on Boots and Amazon for just £5.
Matt Hancock is planning an astonishing rise in the number of Covid-19 tests carried out to get the economy back on track. The Health Secretary is said to be preparing what has been dubbed ‘Operation Moon Shot’, an ambition to test four million people each day.
The test will not require any swabs or blood samples to be given but only for the patient to breathe into a tube for one minute so a sample of their breath can be collected for analysis
ANCON Medical — a diagnostics firm based in Canterbury — is behind the Covid-19 breath test.
The company has already made a breathalyser that detects lung cancer in as little as six minutes by looking for chemicals released by tumours in the airways.
Experts believe the technology could work the same way for Covid-19, if they can prove that infected patients exhale tell-tale substances.
The mixture of chemicals and substances people breathe out changes according to their diet and health, and laboratory computers are able to pick up on these changes when presented with breath samples.
The ANCON scientists hope they will be able to accurately recognise a signature found only in Covid-19 patients and to pick up on it immediately when people take the test.
No swabs are needed for the technology and no blood has to be taken, as in some coronavirus tests.
All someone would have to do would be to breathe into a tube. Their breath is then analysed by a computer with a screen which returns a positive or negative result.
The team are hopeful the technology will work for Covid-19 because it is a lung infection and people are known to breathe out coronaviruses when they are sick – this is how the illness spreads.
Consultants at Ashford and St Peter’s Hospitals NHS Foundation Trust, which runs two hospitals in Surrey, will carry out the trial on at least 200 people.
They will test it on samples taken from both infected patients and ones proven to not have the disease, to ensure it works.
The test itself — which requires patients breathe into a mouthpiece for one minute —will only be rolled-out wider if it is proven to be successful.
There are other types of rapid test being trialled in the UK but none have yet been put into regular use by the Government.
The highest-profile rapid tests being used still rely on swabs of the mouth and nose and the technology is based on analysing these swab results faster than a traditional lab test, which is called a PCR test.
A PCR test takes hours to produce a result because genetic material (RNA) must be extracted from the swab sample and then amplified into DNA in a lab in a process called a reverse transcriptase polymerase chain reaction (RT-PCR).
This DNA is mixed with chemicals called reagents that can detect the presence or absence of the coronavirus and produce a positive or negative result.
A breath test, if it works, could be one of the only ways to diagnose Covid-19 without a swab or blood sample being taken.
Scientists hope their technology will be able to accurately recognise a signature found only in Covid-19 patients and to pick up on it immediately when people take the test
Dr Stephen Winchester, a medical virologist at Ashford and St Peter’s, said the tech would be ‘ground-breaking’ if it works.
He said: ‘This may significantly boost rapid diagnosis and management of patients presenting with acute symptoms.
‘It has the potential to provide an improved experience for patients and aid clinical decision making.’
Dr Linda Pomeroy, chief executive of ANCON, said: ‘This could be a game-changer in testing and crucially, screening.
‘Our system has the potential to drastically reduce the time it takes for diagnosis and makes it easier to perform tests at the point of use.’
She added it ‘could allow us to mass test people returning from abroad on flights or on entering schools to ensure the continued safety of the general population’.
Mr Hancock’s pledge to dramatically ramp-up testing followed months of calls from top experts and politicians.
Former Prime Minister Tony Blair said it was the only way to prevent a second wave and said Britain was ‘running out of time’ to get a scheme up-and-running.
Health chiefs currently have the capacity to swab around 330,000 people each day but there are plans to dramatically expand this first to 500,000 and then into millions.
Mass-testing allows ministers to see exactly where outbreaks are and stops infected people unknowingly spreading it.
Spotting outbreaks quickly is key to increasing local testing or imposing local lockdown rules to keep any small surges in cases under wraps before they spread more widely.
Fast testing could also be helpful in hospitals, helping staff to be sure they are safe to work with patients and to remain at work without self-isolating or waiting for results.
Rapid coronavirus tests could also mean travellers do not need to quarantine for the full two weeks if they come back and test negative.
Mr Hancock said some tests being trialled give results in just 10 minutes and rely on saliva — cutting out the need to have long swabs stuck down throats.
Number 10 has already wasted millions of pounds by purchasing tests later found to be inaccurate, including two different types of antibody test from China.
WHAT OTHER RAPID COVID-19 TESTS IS THE UK GOVERNMENT TRIALLING?
DNANudge
One of the new test kits, made by London-based DNANudge, will be launched next month. It analyses DNA in nose swabs but saves time as the results do not need to be sent to a laboratory
The DnaNudge test does not require any medical expertise and can detect the virus from just a nostril sample – much less invasive than some throat swabs.
After successful trials on 500 patients in London hospitals, the ‘lab in a cartridge’ device was approved for clinical use by the Medicines and Healthcare Products Regulatory Agency (MHRA) at the end of April.
The Government has purchased 5,000 of the DNANudge machines, which can process up to 15 tests a day, to provide 5.8 million tests in the coming months.
The test, developed by Imperial College London’s Chris Toumazou, is based on the design of a DNA test and can give a result in just over an hour, significantly cutting down on the 48-hour wait for a laboratory diagnosis.
Once a swab is taken, it’s inserted into a handheld reader that provides results within just 75 minutes.
The DnaNudge has a sensitivity of over 98 per cent and specificity of 100 per cent.
It can tell the difference between a person who doesn’t have the disease at all and a sample which wasn’t taken properly, meaning there aren’t any false negatives.
Oxford Nanopore
The other test, called the Lampore, involves taking a sample of saliva, unlike existing methods which require invasive and difficult nose and throat swabs
Biotech company Oxford Nanopore has developed a portable swab-recording device called LamPORE, which can determine whether a user has coronavirus in the space of an hour.
As well as being able to process around 30,000 samples a day, the device can also be used to determine whether hard surfaces in schools, hospitals and care homes have traces of COVID-19.
The LamPORE device, which also comes in a desktop version which is about the size of a printer, uses electronic means to record and analyse the samples.
Each test is given a barcode which is individually assessed before returning back with the result – without having to wait for swabs to be sent to the laboratory.
The portable version of the LamPORE device is believed to be the same size as a CD player.
Ministers are understood to have made an order for 450,000 of the tests, which were made available in adult care settings and laboratories last month.
Millions more are due to be rolled out later in the year if they prove to be effective.
The makers of the test have not revealed how accurate it is, and the Government has refused to divulge that information, too.
OptiGene
The Genie HT processes nasal and throat swab samples and can return results in 20 minutes
A Government trial of OptiGene’s rapid antigen test is still currently underway in Hampshire.
The Genie HT processes nasal and throat swab samples and can return results in 20 minutes without needing to be sent to a lab and processed.
Once swabs have been collected from patients, the samples are loaded into the devices, which look for tiny traces of the virus in their DNA.
The machines amplify the DNA billions of times chemically so they can detect the virus with extreme sensitivity.
The device has proven to be just as accurate as PCR swabs, which take days to give results, in clinical trials by Public Health England.
But the gadget is now being tested at a number of A&E departments, GP coronavirus testing hubs and care homes across Hampshire.
Up to 4,000 people of all ages have been involved in the trial, which is being led by Hampshire Hospitals NHS Trust.
In contrast to the widely used PCR tests, which need be processed at different temperatures, the Genie HT does not require a change in temperature to detect results.
SAMBA II
The SAMBA II was created by University of Cambridge spin-off company Diagnostics for the Real World
The SAMBA II has shown to be almost 99 per cent accurate at analysing swabs and can give a result in just 90 minutes.
The portable machine can diagnose Covid-19 in less than 90 minutes, but only has the capacity to process 15 tests a day.
It was developed by University of Cambridge spin-off company Diagnostics for the Real World.
It scours DNA in throat and nose swabs to detect the virus.
Addenbrooke’s Hospital in Cambridge has been trialling the device since April.
They have shown to be so effective that the hospital switched nearly all of its coronavirus testing from standard lab tests to the Samba machines in May.
A Samba test, costing approximately £30 per sample, would outweigh the cost of each additional bed day at around £200 ‘many times over’, the team said.
Its creators say the tests have been validated by Public Health England and are expected to be launched in hospitals across the country.
The machines are already used to diagnose other blood-borne diseases like HIV and hepatitis C.
Randox
Randox’s portable antigen test, called the Vivalytic, can process five swabs an hour
The Government partnered with Northern Irish firm Randox in April to ramp up testing in the nation.
Randox’s portable antigen test, called the Vivalytic, can process five swabs an hour.
It has been scaled up across multiple hospitals in Northern Ireland.
The device is also used at the point of care and operated by a healthcare professional.
Randox says its device works by ‘identifying SARS-CoV-2 and differentiating it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses’.
The devices are still being trialled.
Last month, 750,000 swabs were recalled after they failed to meet the required safety standards.
Randox said the issue was with one of its suppliers of its swabs.
The machines which process the swabs have not been deemed unsafe.
Abbott
American giant Abbott developed a rapid antigen test thought to be the quickest on the market
American giant Abbott developed a rapid antigen test thought to be the quickest on the market.
The ‘ID NOW COVID-19’ can deliver positive results in as little as five minutes and negative results in 13 minutes.
The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) in March.
It quickly became the most widely available molecular point-of-care testing platform in the States.
It is unclear if Public Health England is looking into the device.
Intelligent Fingerprinting
The rapid test scours sweat for the virus and takes just 10 minutes
British diagnostics firm Intelligent Fingerprinting and Imperial College London joined forces to develop a rapid test that scours sweat for the virus.
The test is said to take just 10 minutes to produce a diagnosis. It works by collecting fingerprint sweat onto a small test cartridge for analysis. The sample is then analysed by a portable DSR-Plus analysis unit.
The machine uses sensitive lateral flow technology and fluorescence measurement methods.
Its makes say the test is more hygienic and has less chance of being done wrong because it utilises sweat samples rather than a throat or mouth swab. It’s unclear how accurate the test is or whether UK ministers are looking into it.
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