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Blow to getting Britain back to work after Oxford scientist...

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    Blow to getting Britain back to work after Oxford scientist tasked with evaluating crucial coronavirus antibody tests says it may take a MONTH before one is ready for Britain to use as another expert warns the kits may only be 50% accurate

    • Government has reportedly ordered over a million tests that are no good
    • Antibody tests, which show who has already had the virus, are vital for the UK
    • But England testing chief says they aren't sensitive enough for mildly ill patients
    • Officials are now working with manufacturers to help them improve products


    Professor Sir John Bell, from the University of Oxford, said officials are struggling to find a good quality antibody test

    Professor Sir John Bell, from the University of Oxford, said officials are struggling to find a good quality antibody test

    Britain's hopes of going back to normal today suffered another blow after a top scientist checking coronavirus antibody tests for the Government said none of the ones he's seen so far are any good.

    Professor Sir John Bell, from Oxford University, said the testing kits he has examined so far 'have not performed well' and 'none of them would meet the criteria for a good test'.

    Dashing hopes of lockdown ending any time soon, Sir John said it would take 'at least a month' before antibody tests, which tell whether someone has already recovered from COVID-19, would be available for the public.

    He said: 'We see many false negatives... and we also see false positives. This is not a good result or test suppliers or for us.'

    Downing Street said today it will seek refunds from companies that cannot improve the failed antibody tests ordered by the Government.

    'No test so far has proved to be good enough to use,' the PM's official spokesman said, raising accuracy concerns.

    'We continue to work with the testing companies, we're in a constant dialogue with them and we give feedback to them when their products fail to meet the required standards.

    'If the tests don't work then the orders that we placed will be cancelled and wherever possible we will recover the costs.'

    Sir John's comments come after the head of testing at Public Health England also said none of the tests it had evaluated were good enough for public use.

    Professor John Newton, director of health improvement at Public Health England, said the tests were not accurate enough on people who had only had mild illnesses.

    The tests are considered to be crucial to ending Britain's nationwide lockdown because they will give authorities a clear picture of how many people have caught the virus already and shaken it off.

    Currently, statistical guesswork is the only way of working out how many people might already be immune and therefore potentially safe to return to normal life.

    Estimates suggest up to five million people could have been infected to date.

    Professor Newton's comments come after one expert in New York said people who catch the virus but don't get seriously ill appear not to be making many antibodies, making it hard to test them. For this reason, he suggested, even good tests might only be 50-60 per cent accurate.

    Sir John Bell added that other countries have had to send back failed tests and that it is possible that some unreliable tests could have false positive results triggered by other viruses which produce similar antibodies to COVID-19.

    Public Health England has refused to reveal what the Government considers an acceptable level of accuracy.

    The US last week launched its first antibody test after a firm in North Carolina got approval from the Food & Drug Administration (FDA). It is claimed to be 93.8 per cent accurate.

    Professor John Newton, chief of COVID-19 testing for Public Health England, said none of the tests examined so far were accurate enough to roll out across the UK

    Professor John Newton, chief of COVID-19 testing for Public Health England, said none of the tests examined so far were accurate enough to roll out across the UK

    Wondfo claims its antibody test was the first one to be approved in China, and it has been approved for emergency use in the US and Australia
    Alltest claims on its website that the antibody test is 98.6 per cent accurate

    Officials have reportedly bought test kits from the Chinese companies Wondo and Alltest but found that they are not accurate enough for official use

    In his blog post, published on the University of Oxford's website yesterday, Sir John, a royally-appointed medicine professor at the university, said the UK was not the only country struggling to find reliable tests.

    He wrote: 'The Spanish apparently returned test kits that were not working, and the Germans who are developing their own sensitive kits believe they are three months away from getting these available and validated.'

    Explaining the difficulties, he added: 'To validate these tests you need a gold standard test so you know the correct answer and you need [blood] from patients who have recovered from the virus infection they had approximately 28 days before.

    WHAT IS AN ANTIBODY TEST?

    An antibody test is one which tests 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.

    'You also need blood from people who donated before the epidemic so you know whether you falsely see positive tests when there is no Covid-19 in the sample.

    'For example, there are a number of other coronaviruses circulating that might stimulate antibodies that cross react to Covid-19 proteins.

    'It has taken some time to gather these tools for validation but the UK is now uniquely positioned to evaluate and find the optimal test for this disease.

    'We clearly want to avoid telling people they are immune when they are not, and we want all people who are immune to know accurately so they can get back to work.'

    And a boss at PHE, Professor Newton, told The Times that the antibody tests bought by the Government so far were 'not good enough to be worth rolling out'.

    Health Secretary Matt Hancock last week claimed that 3.5million of the tests had been bought but admitted officials couldn't confirm that they were any good.

    The Department of Health later rowed back and said it hadn't actually bought the tests yet, just put an agreement in place to do so if they were up to scratch.

    In a statement the Department said it had 'secured small numbers with potential to get much larger orders,' The Telegraph reported.

    HOW ACCURATE DO ANTIBODY TESTS ON THE MARKET CLAIM TO BE?

    Cellex qSARS-CoV-2 IgG/IgM

    COUNTRIES APPROVED IN: US and Australia

    MANUFACTURER: Cellex Inc, North Carolina

    ACCURACY: 93.8% true positive, 96% true negative

    2019-n-CoV IgG/IgM Rapid Test Cassette

    COUNTRIES APPROVED IN: Australia

    MANUFACTURER: Hangzhou Alltest Biotech Co Ltd (China)

    ACCURACY: Company claims up to 98.6 per cent


    COVID-19 IgG/IgM Rapid Test Cassette

    COUNTRIES APPROVED IN: Australia

    MANUFACTURER: Zhejiang Orient Gene Biotech Co Ltd (China)

    ACCURACY: 87.9-97.2% true positive, 100% true negative

    OnSite COVID-19 IgG/IgM Rapid Test

    COUNTRIES: Australia

    MANUFACTURER: CTK Biotech Inc (USA)

    ACCURACY: 96.9% true positive, 99.4% true negative

    SARS-CoV-2 Antibody Test (Lateral Flow Method)

    COUNTRIES: Australia, China

    MANUFACTURER: Guangzhou Wondfo Biotech Co Ltd (China)

    ACCURACY: Unknown

    SARS-CoV-2 IgM/IgG Antibody Rapid Test

    COUNTRIES: Australia, China

    MANUFACTURER: Hightop Biotech Co Ltd (China)

    ACCURACY: 82-93% true positive, 97% true negative

    VivaDiag™ COVID-19 IgM/IgG Rapid Test

    COUNTRIES: Australia, Singapore

    MANUFACTURER: VivaChek Biotech (China)

    ACCURACY: 81.25-97.1% true positive

    Biolidics 2019-nCoV IgG/IgM Detection Kit

    COUNTRIES: Singapore

    MANUFACTURER: Biolidics Limited (Singapore)

    ACCURACY: 91.54% true positive, 97.02% true negative

    Officials have said they were working with at least nine manufacturers to try and get the project off the ground.

    It is not clear what the threshold is for UK approval - one Chinese manufacturer believed to have been turned down by the Government claims its test is up to 98.6 per cent accurate.

    PHE's Professor Newton, however, said Government scientists were now having to go back to manufacturers and work with them to make the tests better.

    Although tests appear accurate when used on people who were seriously ill with the coronavirus, they struggle to detect antibodies in people whose illnesses were mild.

    Professor Newton said: 'The test developed in China was validated against patients who were severely ill with a very large viral load, generating a large amount of antibodies,' The Times reports.

    'We want to use the test in the context of a wider range of levels of infection including people who are quite mildly infected,' he added. 'So for our purposes, we need a test that performs better than some of these other tests.'

    Two of the tests ordered by the British Government come from Chinese firms called Wondfo and Alltest, according to ITV.

    Wondfo claims on its website that its antibody test was the first one to be approved for official use in China, and it has been given emergency approval in the US and Australia. Its accuracy, however, is unclear.

    Alltest, meanwhile, claims its tests are 98.6 per cent accurate at detecting long-term antibodies, which appear around two weeks after infection, but only 92.9 per cent accurate for antibodies produced between weeks two and four.

    Professor Newton's comments follow claims by an expert at Columbia University in New York, who said low levels of antibodies make long-term testing difficult.

    Dr David Ho said that people who don't get seriously ill appear to take much longer to develop antibodies and therefore might test negative in early stages of recovery.

    He told The Guardian: 'The problem is after a couple of weeks, the detection rate remains at about 50 per cent to 60 per cent, especially in asymptomatic or mildly symptomatic cases.

    'But this may not be a fault of the tests, because even using more sensitive methods in the lab we can see the antibody levels are quite low.'

    More detailed long-term follow-up of patients will be necessary to see whether antibody levels in the blood increase over time, he added.


 
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