SUPERDRUG has pulled its home coronavirus antibody test kits over fears that it could give false results.
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The Medicines and Healthcare products Regulatory Agency (MHRA), which governs the rules over medicines used in the UK, has said Brits should ignore any result they get from the private kits.
Superdrug has been offering what it calls an “accurate and reliable” home finger-prick test.
The pharmacy giant became the first high street shop to start selling the £69 coronavirus antibody tests to the public earlier this month.
However, officials have now ordered labs to stop processing them because the results could be unreliable.
Graeme Tunbridge, director of devices at the MHRA, said: “Patient safety and public health are our main priorities — and it is in the interests of everyone for antibody tests to be as reliable and meaningful as they can be.
“There are several UK providers of testing services who offer Covid-19 antibody testing.
“We are asking all providers of laboratory-based Covid-19 antibody testing services using capillary blood collected by a finger prick to temporarily stop providing this service until home collection of this sample type has been properly validated for use with these laboratory tests.
“Use of unvalidated sample types may lead to unreliable results and as such we are working closely with the service providers, laboratories and test manufacturers to resolve the regulatory and patient safety issues.
Coronavirus testing: What is the difference between antigen and antibody tests?
Coronavirus tests are key to getting a clearer idea of the scale of the outbreak in the UK and getting a handle on it.
In recent days, there’s been a lot of talk about the two different types of tests that the government are ramping up.
The government refers to them as the ‘have you got it’ antigen test or the ‘have you had it’ antibody test.
Here we explain the difference between the two…
What is an antigen test?
Antigens are found on the surface of invading pathogens, including coronavirus.
Testing for antigens can determine whether someone is currently carrying the virus and are actively infectious.
The NHS is currently using antigen tests in hospitals to determine if someone is currently infected with Covid-19.
Samples are taken using a swab – which resemble a large cotton bud – from deep inside the nose and throat before being sent off to a lab for testing.
Most labs use a method called the polymerase chain reaction (PCR), which takes several hours to get a result.
It can take days for labs to run the tests and tell people their result.
Several companies are working on ways to fast track this type of testing.
What is an antibody test?
When a person gets infected with antigen, the body starts making specially designed proteins called antibodies in response – as a way to fight the infection.
After they recover, those antibodies float in the blood for months, maybe even years.
That’s the body’s way of defending itself in case it becomes infected with the virus again.
So an antibody test specifically looks for antibodies which will be able to tell whether you’ve already been exposed to Covid-19.
Anyone who has already had the illness is presumed to be immune to getting it again – at least, in the intermediate term.
This would allow them to go back to work safe in the knowledge that they are unlikely to become infected again or pass the virus on.
The check that has been developed for Covid-19 is a finger-prick blood test, with the samples sent to laboratories and results available within a few days.
Dr Hilary Jones, a GP and resident doctor on Good Morning Britain, explained that it works “almost like a pregnancy test, except you need a drop of blood”.
“People who have purchased one of these sampling kits, and received an antibody test result, should not consider the result to be reliable and should not take any action on it.
“This does not affect rapid point-of-care tests or laboratory tests performed using venous blood.”
According to The Times, private antibody testing has been suspended while health bosses examine the effectiveness of home pin-prick sampling for widespread government use.
Superdrug, Lloyds Pharmacy and the private GP service Doctorcall are among the providers who stopped selling the kits last week on instruction from the MHRA.
The antibody home test requires a few drops of blood to be collected in a vial before it is delivered to a lab.
It is in the interests of everyone for antibody tests to be as reliable and meaningful as they can be
Graeme TunbridgeDirector of devices at the MHRA
The test used by companies like Superdrug is part-approved by health authorities in the UK, but the process of pricking a finger is not – though the test is still legal.
The Government’s testing chief warned Brits not to buy antibody test kits at the weekend, saying people should wait for official checks to become available.
Professor John Newton warned: “The public need to be aware that those tests are not the same as those we have evaluated and approved for use.
“The laboratory-based tests have a much higher standard of accuracy.
“We wouldn’t recommend at the moment that people rely on the tests that are becoming widely available.
“My advice would be to wait until we have better tests which will be available in a similar form very soon, though they are still under evaluation at the moment.”
The Government announced last week that more than ten million antibody kits have been bought in a deal with pharmaceutical firm Roche.
They will first be rolled out in hospitals and care homes.
A spokeswoman for Superdrug said that it was “contacting all our Covid-19 antibody testing service customers today to provide further information about the quality and safety of our Covid-19 antibody laboratory-based testing service”.
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Dr Hilary shows how a potentially ‘game changing’ coronavirus antibody test works