NHS and care home staff will get access to coronavirus antibody tests from next week


NHS and care home staff will finally get free COVID-19 antibody tests after Number 10 agreed a deal to buy kits from pharmaceutical giant Roche. 

Health Secretary Matt Hancock is expected to reveal further details about the deal this afternoon. 

The Prime Minister’s official spokesman said: ‘The tests will be free for people who need them, as you would expect. NHS and care workers will be prioritised for the tests.’ 

Hundreds of thousands of frontline health workers will be offered the tests, which detect if someone has ever been infected with the disease.

Roche’s blood test looks for antibodies, substances produced by the immune system in response to COVID-19. 

With most viral infections, the presence of antibodies reduces or removes the risk of reinfection, but this has not yet been proven with coronavirus.

Experts say positive tests should not simply be seen as a ‘green light’ to reduce PPE or other protections for staff.

The Roche test, called Elecsys (pictured), produces results in a laboratory and is said to be 100 per cent accurate

The Roche test, called Elecsys (pictured), produces results in a laboratory and is said to be 100 per cent accurate

WHY IS ANTIBODY TESTING IMPORTANT? 

WHAT IS AN ANTIBODY TEST?

Unlike tests to diagnose diseases, antibody tests show who has been infected and recovered.

The body makes antibodies in response to many illnesses and infections, including other coronaviruses. New blood tests are being developed to identify antibodies unique to SARS-CoV-2, the official name of the new coronavirus.

The tests look for two kinds of antibodies: immunoglobulin M (IgM) and G (IgG). The body quickly produces IgM antibodies for its initial attack against infections. It makes IgG antibodies more slowly and retains them longer; IgG antibodies suggest possible immunity. 

HOW CAN ANTIBODY TESTS HELP END LOCKDOWNS?

Antibody tests can help calculate what portion of the population has already been infected, as well as whether infections were mild or severe.

Governments and companies could use antibody tests to determine who would most likely be safe to return to work and public interactions, and whether it is safe to lift stay-at-home orders all at once in some regions or in stages based on infection risk.

People with negative antibody tests or very low antibody levels would likely have higher risk of infection than people with high antibody levels.

DO ANTIBODIES TO THE NEW CORONAVIRUS CONFER IMMUNITY?

While antibodies to many infectious diseases typically confer some level of immunity, whether that is the case with this unique coronavirus is not yet known.

And how strong immunity might be, or how long it might last in people previously infected, is not clear. With some diseases like measles the immunity can be lifelong. With others, immunity can wane over time.

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Scientists cannot know with certainty that reinfection is not possible until further research.

Antibody tests could inform not just lockdown exits, but the best approach to treatments and vaccines.

Ministers have been in talks with Roche to buy millions of the kits and Matt Hancock is expected to reveal later today what kind of deal has been struck. 

It follows England’s deputy chief medical officer, Professor Jonathan Van-Tam, promising last week the tests would be rolled out ‘rapidly’.

Priority will be given to frontline hospital staff in coronavirus specific wards, as well as ICU and A&E departments.

These staff members will be monitored by scientists to see whether they fall ill again and paint a clearer picture of the protection antibodies provide. 

Known as the ‘have you had it’ tests, antibody tests reveal whether someone has been infected with COVID-19 in the past and recovered from it.

But it’s still not clear whether this means a person is protected from catching the virus again, therefore some scientists say antibody tests have limited value. 

Dr Claudia Paoloni, president of the Hospital Consultants and Specialists Association, urged caution to those who test positive for antibodies.

She told The Guardian: ‘As we learn more about the role of antibodies, this could open the door to different ways of working and reduce the level of risk to NHS staff by allocating those who have had the virus to care for Covid-19 patients. 

‘But we must be clear that huge uncertainties remain while we do not know the level and length of any immunity which antibodies will offer.

‘The new test’s arrival should not simply be seen as a green light to reduce PPE and other protections for NHS staff who test positive.’

The Roche test, which is called Elecsys, was given the seal of approval by Public Health England on 14 May after scientists at its Porton Down facility evaluated how reliable it was.  

PHE said the test is ‘a very positive development’ and that assessments found it was ‘highly specific’.

According to Roche, their COVID-19 antibody test has ‘a specificity greater than 99.8 per cent and a sensitivity of 100 per cent’ – as long as it is used at least 14 days after someone has developed symptoms. 

The Roche test has a ‘specificity’ of 99.8 per cent, meaning it generates very few ‘false positives’ – when it indicates someone has been infected when they have not.

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For every thousand people who take the test only two will be given a false positive result, according to its claim.

Sensitivity is the rate of all positive samples that are truly positive. A rate of 100 per cent suggests very few, potentially zero, will get an inaccurate result – known as a false negative result.

Sensitivity is considered the area authorities can afford to compromise on – not specificity. 

False positives, caused by poor specificity, may lead people to believe they are immune when they’re not, causing their behaviour to become riskier, or to receive treatment that they don’t need. 

The FDA gave the Roche test the green light on May 3, allowing laboratories across the US to use it even though it has yet to be formally approved. 

German officials already signed a deal at the beginning of May to buy five million of the Roche kits every month.

Roche said the amount of tests it would be able to make each month for the US and countries accepting the CE mark would be in the ‘high double-digit millions’.

It is not designed to give people a result in the comfort of their own home – referred to as the ‘pregnancy test’ style kits.

The test requires blood samples to be taken by trained health professionals, and then it will be processed by machines already used in NHS labs across the country. Medics can get results in just 18 minutes.

Last week the Government also approved antibody tests from US firm Abbott – which works in a similar fashion to that created by Roche. 

This week PHE also validated tests made by the Welsh company Ortho Clinical Diagnostics. All three devices are laboratory-based and can take up to a day to produce results.    

The Welsh firm’s test is the only UK-validated device which is manufactured in Britain. Roche and Abbott both produce their devices overseas, which can cause delays in the supply chain.

As well as detecting which healthcare staff have previously been infected, antibody tests are considered key to easing lockdown because they paint the clearest picture about how widespread COVID-19 is in the community.

The true size of Britain’s outbreak is a mystery because health chiefs abandoned a mass antigen-testing regime early on in the crisis. 

No home ‘pregnancy-test’ kits that can be done in the comfort of someone’s own home and without processing by a lab, have yet been approved.

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That’s despite promises in March that one would be available and ministers buying millions of pounds worth of commercial tests from overseas.

None of them have met the high accuracy standards set out by PHE after an Oxford University trial found they returned inaccurate results. 

The failure was a significant setback because it had been hoped the antibody tests would be the route out of lockdown. 

But yesterday, Superdrug were the first high-street retailer to launch an antibody test that the public could buy for £69.

It is not a ‘home testing’ kit because the blood sample, which a person collects in their home, has to be sent to a laboratory.

Commenting on the launch, scientists said they would not buy the tests themselves because the results are meaningless.

Even if the results return as positive, they may be inaccurate and there is no proof the person has immunity and therefore return to work.

The idea of ‘immunity certificates’ has been shelved for now because of this, although No 10 said it was still exploring the idea.  

Britons were still keen to discover if they have antibodies and the Superdrug kits sold out within a few hours.

The medical giant Abbott, which makes Superdrug’s tests, has insisted that its tests were not intended to be used by people taking their own blood samples. 

Instead, the Illinois-based firm says its tests have only been evaluated to be accurate on blood samples taken by trained healthcare providers directly from patients’ veins.

Roche first announced it was developing the antibody on April 17, revealing it had plans to put it on the market in early May.

At the time, it announced it was working the US health regulator the Food and Drug Administration (FDA) for an ’emergency use authorisation’.

The FDA gave it the green light on May 3, allowing laboratories across the US to use it even though it has yet to be formally approved.

Roche also announced that the blood sample kit was also granted the vital ‘CE mark’ that shows it is safe to use within the EU.

German officials already signed a deal at the beginning of May to buy five million of the Roche kits every month.

Roche said the amount of tests it would be able to make each month for the US and countries accepting the CE mark would be in the ‘high double-digit millions’.



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