Coronavirus antibody tests bought online or from shops ‘put public at risk’

Doctors have warned that poor regulation of antibody tests could be putting the public at risk.

The tests, which could indicate whether someone has contracted the killer coronavirus, are being sold online.

The NHS states : “An antibody test can tell you if it's likely you've had coronavirus before.

“But it does not work for everyone, as some people who've had the virus do not have antibodies.”

The health service points out that antibody tests cannot tell you if you are immune to coronavirus.

Nor can it tell you if you can or cannot spread the virus to others.

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The CDC also claims that a positive antibody test could actually mean “that you have antibodies from an infection with a virus from the same family of viruses, such as the one that causes the common cold.”

The Royal College of Pathologists has written to the health secretary, asking for rules to be tightened on kits sold directly to consumers.

In the letter, it states that such tests can “mislead the public” and “put individuals at risk.”

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While no tests of this kind have been approved of for at-home use in the UK, the market is growing.

A number of different types are now available, claims the BBC.

The letter sent to Matt Hancock asks for swift action against such tests.

They claim that antibody tests should be conducted with a professional “back up”.

This is because the tests need to be “properly readable” and accurate.

Otherwise, the public could be in danger from incorrect or unreadable results.

A spokesperson for the Medicines and Healthcare products Regulatory Agency sad that they had "worked collaboratively with cross-government agencies at pace to prevent non-compliant antibody test kits being placed into the UK market".

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But, Prof Jo Martin said: "Currently, if you buy a test on the internet or you buy it in certain boutiques or shops, we can't guarantee that the quality of that is of an appropriate standard.

"We can't guarantee that the result will be easy to interpret or that it will be not misleading."

Thus far, it is not known whether having anti-bodies for coronavirus will protect people from becoming re-infected with the virus.

Analysis of 41 antibody tests available to buy in the UK found almost a third offered incomplete or inaccurate information.

The tests were checked by the BBC Newsnight programme.

Only 10% had documents to back their claims, claimed academics from the Universities of Birmingham and Warwick.

Some kits have been tested on a small number of patients – just a few dozen.

They are legal to sell in this way because the tests are a “class one” medical device.

This allows companies to self-certify their tests as effective and to sell them to consumers.

They do not need to have passed rigorous testing processes to go on sale.

A Department of Health and Social Care official said: "Antibody tests must meet the standards for clinical use.

"And currently no antibody test has been approved for individuals for at-home use.

“Across government, action is being taken to enforce these tough regulations.

"There have been a number of arrests. And over 47,000 tests have been seized."

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