Coronavirus antibodies test ‘put public risks’

Poor regulation of antibody tests – which could indicate if someone has coronavirus – could put the public at risk, doctors have warned.

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

The letter warns that they “could mislead the public and endanger individuals”.

No antibody test is officially approved for home use in the UK – but many different types are available.

It is not yet known whether having antibodies will protect people against a second infection.

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The letter sent to Matt Hancock calls for urgent action.

The doctors say that the tests should not be used without “professional backup”, should “give the right result” and should be “well readable”.

An official from the Regulatory Agency for Medicines and Healthcare Products said it had “partnered with cross-government agencies in pace to prevent non-compliant anti-antibody test kits from being placed in the UK market”.

But Royal College of Pathologists president Jo Jo Martin said: “At the moment, if you buy a test on the internet or you buy it in certain boutiques or shops, we can not guarantee that its quality is of an appropriate standard.

“We can not guarantee that the result will be easy to interpret or that it will not be misleading.”

An analysis of 41 antibody tests sold to the public in the UK, seen by the BBC’s Newsnight program for publication in the medical journal BMJ Open, found almost a third provided incomplete and inaccurate information.

A number claimed to offer “peace of mind.”

But just 10% had made documents available to support their claims, academics from the Universities of Birmingham and Warwick found.

What information has been released on how kits were assessed shows most were only tested on small numbers of patients – but a few dozen, all of whom were admitted to hospital.

At present, antibody testing is a Class 1 medical device – meaning that companies can certify themselves as certified and immediately start selling to consumers, without a strictly independent testing process.

In contrast, HIV and pregnancy tests are listed on “Annex Two” of the European Directorate for Medical Devices – which means that manufacturers must provide information on the effectiveness of their tests.

‘Wild West’

Lead researcher Jon Deeks, professor of biostatistics at the University of Birmingham, said more studies were needed with much larger sample sizes to assess how tests were used by patients in practice.

“These regulations are inappropriate for purpose and do not protect the public from bad testing,” he said.

“If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test, because there is no control over whether it works, it’s just a marketing claim registered and we’re left in a Wild West of antibody testing.

“For drug licenses, the onus is on companies to go through clinical trials.

“We need the same obligation to apply for test devices as well as the Covid antibody tests.

“In the long run, testing evaluations need to be added to existing pre-clinical trial registers.

“This will stop manufacturers from reporting only the most favorable results to report.”

‘Smart regulation’

An official from the Department of Health and Social Care said: “Antibody tests must meet the standards for clinical use.

“And at the moment no antibody test has been approved for individuals for home use. Action is being taken by the government to enforce these strict regulations.

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

You can watch Newsnight’s report on this story on BBC iPlayer.

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