BySam Blanchard Senior Health Reporter for Mailonline
Number 10's ambitious Operation Moonshot came under attack by top scientists today amid concerns that rapid coronavirus tests rolled out across the UK will not be good enough as ministers postponed plans to open mass test centers over Christmas.
Moonshot was envisioned as a way to use the quick kits, which cost a fraction of the price of gold standard PCR testing, to test millions of people and help them get back on overseas flights, stadiums and venues, and children in them to keep classroom.
Lateral swabs provide results in a few minutes, but according to the Ministry of Health, they miss about half of the infections. Damn evidence, however, shows they can be effectively useless in self-management, even though Downing Street's current testing scheme relies on people taking their own swabs.
French President Emmanuel Macron has even specifically requested that truck drivers traveling across the English Channel from the UK be tested with higher quality PCR as nations continue to argue over the Kent roadblock.
The UK mass test trials of Operation Moonshot require members of the public to do their own coronavirus test swabs. However, studies show that the tests are much worse if trained medical professionals don't take the samples (Image: A woman making her own swab in Liverpool in November))
If rapid tests miss large proportions of cases, they trigger outbreaks caused by people who believe they have the all-clear but are actually infected, experts fear.
Tests are more accurate when swabs are done by trained professionals as they have to be pushed deep into the nose or throat. Scientists fear, however, that the UK simply doesn't have the money or the free doctors to do it across the country every day. Instead, health bosses are accepting DIY swabs to save time.
Government departments have spent hundreds of millions of pounds on various types of cross-flow tests for the public and in hospitals, and they are being tested by councils across the country to try to weed out silent infections.
Concerns about their accuracy have reportedly led to plans to open mass testing centers over Christmas being put on hold, raising fears among public health directors that resulted in the program being scaled back, The Guardian reported.
Companies that run the three tests approved by the Department of Health say they are between 95 and 99 percent accurate in detecting cases under laboratory conditions. However, early real-word studies suggest that tests fail to meet manufacturers' demands for accuracy. However, some companies insist that their tests are for medical use only, which means the government is not using them properly.
Scientists caution against giving a false sense of security, as no test is good enough to rule out infection in someone who is not symptomatic and does not prevent them from picking up the virus on their way home from the test.
It comes from the fact that the UK Medical Device Regulatory Authority approved a side flow test for home use, but said it should not be used to allow people to change their behavior if they get a negative result.
Another 36,804 positive coronavirus test results were confirmed in the UK today – twice as many as last Tuesday – along with 691 deaths.
And scientists today confirmed that the new, more infectious variant of the coronavirus has already been found in all regions of England, but there is still no evidence that people are getting sick or dying more often than other strains.
Operation Moonshot could one day be used to help people get to busy places or on flights or ferries abroad, the government has suggested. However, there are concerns that inaccurate tests may give infected people a false sense of security (Image: People queuing for tests Liverpool)
WHAT LATERAL FLOW TESTS DOES THE UK GOVERNMENT USE?
There are currently three cross-flow testers on the government-approved list.
SD Biosensor Standard Q Antigen Test
Manufacturer: SD biosensor
When testing: August
Claimed accuracy: 95.5%
Real accuracy: Thought to be around 70% – source
Rapid Coronavirus Test from SD Biosensor
Innova Tried & Tested Antigen Test
Manufacturer: Tried and tested Innova
When testing: August
Claimed accuracy: 99%
Real accuracy: "At least 50 percent," according to Dept Health
Price: £ 8.69 per test (bulk order)
Innova's rapid coronavirus test
Healgen Rapid Covid-19 Antigen Test
When testing: September
Claimed accuracy: 97.3%
Real accuracy: Unknown
Healgen's rapid coronavirus test
Professor Jon Deeks, a testing expert at the University of Birmingham, told The Tab yesterday that cross-flow tests used by the government were "not useful".
The results of a study at his university indicated that the rapid tests gave two positive results out of around 7,000 swabs, while students who made their own swabs may have missed another 60 – a sensitivity of just three percent.
The Department of Health said a study of the same tests on members of the public in Liverpool found "at least 50 percent" of the infections found.
This was dramatically lower than the 77 percent that Public Health England believed possible in its own studies. It found that the tests were significantly less accurate when performed by people themselves.
Even so, officials moved on with a pilot from Moonshot who asked people to wipe their own noses and then train army personnel to examine the samples.
The government has announced that the same tests will be carried out in schools in the New Year so that not all classes have to self-isolate if a student gets a positive result.
Instead, everyone in the class will be tested regularly and will be allowed to stay in school if they continue to test negative.
Professor Deeks warned on BBC Radio 4 today: "We will allow teachers and students to stay in school who have Covid and we will miss people who have Covid …"
"We will see outbreaks at school that our current policy of sending children would not have."
Lateral flow tests are being introduced by the government because they want to use a rapid test scheme to minimize the risk of virus transmission to the public.
PCR tests, while far more accurate, are more expensive and take days from swab removal to result, which is useless for most uses other than medical diagnosis.
Rapid tests that get a result in minutes could allow people to be safer when attending major events, getting on a plane, going to school, or crossing a line because – in theory – they are sorting out people who are likely virus.
However, the tests are only considered good if the swab contains a relatively large amount of virus.
This is less likely to happen if people made their own swabs, scientists say, even if they are infected.
The tests are performed on a swab sample from the person's nose or throat, which is then processed into a small cassette that tries to detect the coronavirus by mixing the sample with something that the virus would react with.
If there is a reaction in the mixture, it suggests that the person is carrying coronavirus. If not, you will get a negative result. This process can be completed in just 15 minutes.
In the UK community testing programs, people usually take their own swab and then have a trained professional on-site process them and analyze the result.
The results of the studies varied widely, showing that the tests performed better when the swabs were done by trained medical professionals and worse when people did them themselves.
The tests can cost around £ 15 per person.
The UK Medical Device Regulatory Authority, MHRA, has now approved these types of tests for home use, but with reservations about how they can be used.
The MHRA said the test should not be used on people to rule out coronavirus infection so they can come out of isolation, the Financial Times reported.
The newspaper said regulators would only allow the tests to be used for isolating people if they found out they had the virus.
This likely means that the tests could be offered to people who would have to continue to follow social distancing rules and lockout guidelines if they tested negative, but would then have to isolate themselves if they tested positive.
Experts had concerns about what motive people would have for taking the tests if they did.
Lateral flow tests are contrasted with PCR tests, known as polymerase chain reaction, which can cost up to £ 180 per person, requiring the swab to be processed in a laboratory and taking hours but usually days to get results at best.
A swab is also used in PCR testing, but it is processed using high-tech laboratory equipment to analyze the genetic sequence of the sample and determine if any of them match the genes of the coronavirus.
This is a much longer and more expensive process that involves multiple types of trained personnel. The analysis process can take hours, with the entire process from swab to receiving the result taking days.
However, it is much more accurate. Under ideal conditions, the tests detect the virus with almost 100 percent accuracy, although this is closer to 70 percent in the real world.
Commenting on concerns about the tests, Professor Gary McLean, an immunologist at London Metropolitan University, said, “I think these tests are valuable but cannot be relied on by themselves. Remember, they are designed for asymptomatic testing only. Hence, it is not surprising that the positive rate is low. & # 39;
And Professor Alex Edwards, a testing expert at the University of Reading, added, “There are two known weaknesses in this type of lateral flow test.
First, they are best able to spot really common targets where the marker being measured is present in high concentrations. When the virus levels are lower – which is often the case with swabs – they are not as effective.
Second, they are great for community testing because they are portable and fast. However, community testing comes with an added burden: the people performing the tests have less experience with diagnostic tests than the technical staff in an approved laboratory, and the test results are recorded by eye. & # 39;
The tests will lead to school outbreaks if the government continues its national rollout plans, warned Professor Deeks.
He said he was "surprised at how bad" the Innova Tried & Tested Lateral Flow Kits were when tested on more than 7,000 students at the University of Birmingham.
The 15-minute tests, which the UK spent more than £ 600 million on, captured just three percent of asymptomatic students infected with the virus.
When asked what the result would be if the tests were used for schools, Professor Deeks told the BBC Radio 4 Today Program, “We're going to allow teachers and students to stay in schools who have Covid, and we're going to be people miss the covid have got covid.
“The worst part is suggesting that students, if they are in a class where one (other student) has Covid, that they stay in school and be tested with this test until they get positive.
"We are going to see outbreaks at school that our current policy of sending children would not (if another student in their class has the virus).
"I have three children myself. I want them to be in school, but I don't want them to get Covid in school."
"We have a very low detection rate (with these tests). We were surprised at how bad it was." It might be better in schools, but the data shows these tests don't work anywhere in asymptomatic people with no symptoms. "
The tracking of samples of the new variant by COG-UK shows that cases have been found across England, as well as in South and North Wales and Scotland. The green dots do not refer to the number of people infected and may only represent one person. Experts said that by far the highest concentration of cases is in London, the east and south-east of England
Simple statistic laws mean that even a highly accurate test will produce a large number of false results when used on millions of people
Professor Deeks' study found the test gave two positive results from 7,189 people and possibly missed 60 positive results.
Students did the nasal swabs on themselves and trained staff – in this case final year science students – analyzed the sample. The same self-test procedure is used across England for people with no symptoms, especially in high-risk areas.
WHAT IS OPERATION MOONSHOT AND WHAT HAS BEEN TRIED IN LIVERPOOL?
Operation Moonshot is the government's plan to have millions of people tested and given a result on the same day.
Hospital staff, nurses and many employees would be routinely tested to help boost the economy.
However, there have been serious doubts as to whether number 10 is capable of achieving this.
The Ministry of Health currently states that it has a testing capacity of around 540,000 swabs per day.
Moonshot is seen as the only way out of the constant loosening and tightening of lockdown curbs without a viable vaccine.
The city of 500,000 people was used by officials as a pilot to see if it could run rapid, large-scale tests.
The study will use tests that give results in less than an hour, as well as the normal PCR swab tests already done in centers across the country.
Originally, hospitals in the city were supposed to have a 20-minute test that could be used to routinely test all employees. Today it turned out that the machines are less than 50 percent accurate.
The tests continue to be done in small programs for hospital staff in Liverpool but there are now concerns that they are not good enough.
The results of the studies varied widely, showing that the tests performed better when the swabs were done by trained medical professionals and worse when people did them themselves. But the large number of tests planned for Operation Moonshot would make it impossible for healthcare professionals to perform them all.
Laboratory experiments by Public Health England showed that the test successfully caught 77 percent of cases. The Ministry of Health reduced this to "at least 50 percent" after a real process in Liverpool.
The company itself claims that the test can detect 96 percent of infections under laboratory conditions. It said it "does not recognize" the outcome of the Birmingham trial.
Birmingham University students received the rapid tests as part of a nationwide campaign to help young people get home to their families over the Christmas break.
To see how well the tests were working, university experts retested some of the students on a PCR machine, which is the government's correct test.
When they retested about one in ten students in the study (710 out of 7,189), they found that six of them had falsely negative results and were indeed infected.
Multiply this by 10 to account for the total group size, and up to 60 cases may have been missed
So the two true positives found made up only three percent of the estimated 62 positive results that would have been found with a better test.
Professor Deeks said on Twitter Monday that the results were "not easy to read".
Although the results weren't a perfect analysis of the test, Professor Deeks asked questions about how well it worked that definitely should have been answered before the Department of Health spent that much money on them.
The company bought at least 20 million tests from the US-based company with no other companies citing "extreme urgency" to compete for the contract.
Professor Deeks said, “Most importantly, is this a safe use of a test? Does it protect students and employees in school and university? Is it an efficient use of valuable resources? (Actually, that's not a serious question.) What should universities do in January? What should happen in schools?
“This shows how important it is for evaluation to precede implementation – these are the only evaluations done on the student population – all after implementation by the government.
“It's important to plan the right assessments first – more will be needed.
"It is insane and dangerous not to check that a test is suitable for the purpose for which it was intended."
Professor Francois Balloux, director of the Genetics Institute at University College London, was not involved in the study but said on Twitter: "This raises some serious questions about the value of mass testing with lateral flow antigen testing."
The results of the University of Birmingham are expected to be published in full in a scientific article soon.
Innova Tried & Tested said in a statement: 'Innova is not aware of the record referenced in the tweet.
“The proposed low effectiveness is not known. A careful and thoughtful examination of the methodology used is therefore advisable.
"When used correctly, the Innova test is a highly effective tool for identifying infectious individuals and providing an appropriate response to reduce the spread of the SARS-CoV-2 virus."
The results come from a report on the use of the tests among members of the public in Liverpool which found they fared worse than expected.
In a report from the study, Health Department officials attempted to claim success by writing, "These tests are still effective and detect at least 50 percent of all people who are PCR positive."
However, the program, which tested around half of the city's 500,000 residents over the course of a month, fell short of the 77 percent accuracy that the test was capable of, according to Public Health England.
The Ministry of Health wrote: "Often tests in the field are a little less good than under perfect laboratory test conditions …
"In field assessments like Liverpool, these tests are still effective, detecting at least 50 percent of all PCR positive people and more than 70 percent of those with higher viral loads in both symptomatic and asymptomatic individuals."
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