Ministers were today asked to prove that two new rapid coronavirus tests bought to bolster Britain’s war on coronavirus even work.
The tests – which give results in 90 minutes – will start being rolled out from next week. One is so simple it could soon be deployed in airports, offices, pubs and restaurants – bringing testing to the bulk of the population.
A leading scientist today suggested they should be used to regularly screen children to prevent outbreaks in schools when pupils return in September.
But, despite being hailed as ‘life-saving’ by Health Secretary Matt Hancock, there is no publicly available data about their effectiveness. Experts today called on Number 10 to confirm both tests are accurate by releasing research on the new devices.
The government has already wasted millions of pounds by purchasing Covid tests that were later found to be inaccurate — including two different types of antibody test from China.
Professor Jon Deeks, a medical statistician at Birmingham University, warned the mistakes made in purchasing tests has even ‘put lives at risk’ because infected Brits could easily pass the virus on if they are wrongly told they are free of the virus.
He said: ‘We cannot emphasise how important it is to see independent evaluations of all tests before they are implemented.’
The tests were purchased as the Government looks to halt a second wave of the disease, stopping the need for more draconian lockdowns and restart the stalled economy.
Similar rapid diagnostic Covid-19 tests have been approved in the US for months.
Tests can be legally sold in Britain when they receive a CE mark. But one of the kits bought by ministers has yet to be given the European seal of approval. UK regulators gave the other test an ‘exceptional use authorisation’.
Under normal circumstances, health chiefs evaluate tests in a laboratory to prove they work before approving them. Ministers then release the data, like they have done for the dozen antigen tests and handful of antibody kits they have bought.
The companies involved would not reveal the cost but claim it is similar or cheaper to current tests – which are around £18 privately but less to the NHS.
DNANudge today announced the government had placed a £161million order for just 5.8million tests, the equivalent of £27 per swab.
Oxford Nanopore, which makes the other test — called LamPORE, has not revealed how much its deal was worth.
Rapid tests, also called ‘point-of-care’ tests, are those which can be operated on site, such as in GP surgeries, care homes, prisons, and potentially at airports and ports.
The aim of every part of the testing system is to make it rapid so that people with the coronavirus can be isolated quickly to stop them spreading it further.
A rapid diagnostic test would be particularly useful in the winter to quickly diagnose patients with either flu or Covid-19.
But there is currently no publicly available data on the accuracy of either of the new tests.
DNANudge, on its website, says its tests are 98 per cent sensitive. Oxford Nanopore says LamPORE is ‘in validation phase’.
But the Department of Health said in a statement the latter has ‘the same sensitivity as the widely used PCR swab test’.
Professor Deeks told The Guardian: ‘We would hope that the government would wait for proper evaluations, and consider the scientific evidence for all available tests before signing further contracts.
‘The mistakes made in test purchasing have wasted millions of pounds as well as put lives at risk.’
He added: ‘Both of these technologies are new, and it is unclear what evaluations have been done.’
Professor Deeks did not expand on why lives have been put at risk. But he may generally be referring to the risks of a test that produces false results and wrongly tell people with Covid-19 they are free from the virus.
And for antibody tests, experts warn an inaccurate result could wrongly suggest a person has already had the virus and may not catch it again.
Professor Deenan Pillay, a University College London virologist, told the newspaper: ‘They [the new tests] may be very good, and if so that’s great (although the data must be made available for scrutiny, and to avoid any suspicion of conflicts of interests).’
Professor Alan McNally, a microbiologist at Birmingham University, tweeted that it ‘would be really good if validation data could be made public’.
Regulators today said the LamPORE tests could not be used until they get a valid CE mark, meaning it has been met European health and safety standards.
It comes after the Government wasted a staggering amount of money on finding antibody ‘have you had it’ tests.
Government officials said it had to cancel orders for £70million worth of coronavirus antibody kits from two companies in China — AllTest Biotech and Wondfo Biotech that they had bought before checking they worked.
That figure was out of a total £90million, suggesting the remaining £20million could not be recouped and the tests must now be used for non-diagnostic purposes or scrapped.
Today the government said the two new rapid tests for diagnosing Covid-19 will initially be introduced in the NHS and care homes before being made available more widely over the next few months.
Unlike current tests given mainly to patients who already think they have the virus, the new methods will be used to routinely screen members of the public who show no symptoms.
Officials hope they will flag up local outbreaks before they take hold, avoiding the need for local lockdowns such as that imposed in the North West last week.
Crucially, both tests can also tell patients if they have the flu even if their result is negative for Covid-19.
This means health authorities will be able to track the spread of the viral illnesses around the country and carry out flu jab campaigns.
Ministers are anxious to avoid a major flu outbreak this winter amid fears it will coincide with a spike in Covid and put an unprecedented strain on the NHS.
The LamPORE test involves taking a sample of saliva, unlike existing methods which require invasive and difficult nose and throat swabs.
Professor Andrew Beggs, a genetics expert at the University of Birmingham, who has been trialling the LamPORE test, described it as ‘transformational’.
He said: ‘A rapid test which works off saliva and gives you a result in a maximum of two hours is enormously powerful. It’s definitely an advance on the tools we have at the moment.’
Sir John, regius professor of medicine at Oxford University, has said that the new quick turnaround tests should be used at schools.
The leading immunologist, who is spearheading the government’s ongoing search for a reliable antibody test, told BBC Radio 4’s The Today Programme: ‘If you look at schools there’s going to be a huge interest in keeping them safe the best way to do that is to screen the children at some level.’
When asked how frequently children should be tested he added: ‘I think some people have said once a week should be okay but others have said less frequently.
‘For example, in boarding schools you could screen the kids when they came back from home and probably not screen them very often until they went home again and then screen them when they reentered the school because it acts as a large bubble.’
He also sees potential for the tests to be used ‘more extensively by the private sector’ because there is a ‘huge unmet need by schools, by airports and airlines’.
Ministers are understood to have made an order for 450,000 of the tests made by Oxford Nanopore Technologies Ltd, which will be available from next week in adult care settings and laboratories.
The other test, made by London-based DNANudge, will be launched next month.
Ministers have 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.
It analyses DNA in nose swabs but saves time as the results do not need to be sent to a laboratory.
Results of current methods can take from 24 hours to four days to come back.
Sir John Bell, a professor of medicine at Oxford University, who has been advising ministers on tests, said both were just as accurate as the lab swabs currently in use in the UK.
The Government has never disclosed how accurate its current tests are, but studies have indicated they give the correct diagnosis about 80 per cent of the time.
It adds another rapid test to the UK’s catalogue, with two other point-of-care tests currently being used within the NHS.
The Samba II device, created by a University of Cambridge spin-off company called Diagnostics for the Real World, is being used at Addenbrooke’s, a teaching hospital in Cambridge.
The Covid-19 LAMP assay test, developed by UK-based manufacturer Optigene, has been trialled in a pilot study in Hampshire since May.
It can turn around results within 20 minutes, while the Samba II device takes as little as 90 minutes.
Similar rapid diagnostic Covid-19 tests have been approved in the US for months.
The Food and Drug Administration gave the green light for medics to use tests by California-based Cepheid in cases of emergency in March.
Cepheid’s on-the-spot tests have a detection time of about 45 minutes and costs between $5 and $20 (£3.84 and £15.36).
Mr Hancock described the tests as ‘life-saving innovations’.
He said: ‘Millions of new rapid coronavirus tests will provide on-the-spot results in under 90 minutes, helping us to break chains of transmission quickly.
‘The fact these tests can detect flu as well as Covid-19 will be hugely beneficial as we head into winter, so patients can follow the right advice to protect themselves and others.’
Neither of the new tests need to be administered by medically-trained professionals.
The developers of the LamPORE test, Oxford Nanopore, hope it can be routinely used at airports, avoiding the need for quarantine.
The DNANudge test has been trialled in eight hospitals, on cancer, accident and emergency and maternity wards.
The Government has the capacity to test 220,000 people a day but ministers want to increase this to 500,000 by autumn.
Niall Dickson, chief executive of the NHS Confederation, said: ‘The news of quicker tests is encouraging and should mean we have a further weapon in our armoury to defeat the virus.’
Saffron Cordery, deputy chief executive of NHS Providers, said: ‘Having the ability to rapidly test and report the results will help the NHS and other care providers with the challenge of continuing to restart routine services, plan for winter and deal with a potential second surge in Covid-19.’
The development came as ministers ditched a promise to test all residents and staff in care homes throughout the summer due to supply problems.
An email sent to local council chief executives last week from the adult social care testing director Professor Jane Cummings warned of ‘unexpected delays’.