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Private Covid tests to undergo mandatory sign-off before sale under Government proposals

lateral flow tests wales

By Isabel Shaw
Reporter

12 Apr 2021

All private Covid tests could be subject to mandatory checks before being sold in the UK, after it was discovered that the majority of tests currently available are not performing ‘as expected’.

In a consultation document published last week (8 April), the Government outlined plans to ensure all Covid tests in the UK market ‘are of satisfactory quality’.

‘This requires tests with sensitivity that is high enough to apply in ‘real world’ settings that provide accurate results and avoid spreading the virus,’ the document said.

The Government is concerned that tests that do not work properly could have ‘detrimental outcomes for society and the economy’.

It comes after only 25% of privately-made lateral flow devices passed through all stages of the Department of Health and Social Care’s lateral flow validation to be considered ‘of sufficient quality for procurement’.

The Government’s proposals highlighted that there was currently ‘no legal requirement’ available for independent validation of the performance of Covid-19 tests.

‘Entry to the market is controlled by CE marking which is currently a self-declaration process for the performance of this type of test kit or equipment,’ the document said, which means ‘performance is not independently verified ahead of sale’.

The document went on to explain that despite ‘nine in 10 suppliers having the CE mark, with three-quarters meeting the ISO 13485 standard in relation to post-market surveillance’, tests that do not perform to a sufficiently high standard are still entering the market.

The Government is therefore proposing the mandatory validation process, which would see any tests that fail barred from sale.

‘Retailers, distributors and manufacturers of tests that attempt to sell unvalidated tests would face sanction,’ the document said.

It added: ‘This will apply equally to those companies based in the UK and overseas who are importing into the UK.’

This comes after the Government announced that all adults, including those who are asymptomatic, will be able to access free coronavirus tests up to twice a week from workplaces, testing sites and pharmacies.

Meanwhile in February, The General Pharmaceutical Council (GPhC) announced it would no longer advise community pharmacies against providing rapid point of care/near person antibody tests for Covid-19 after reviewing updated guidance from Public Health England (PHE).

The regulator said it will expect pharmacies who do supply the tests to ‘carefully consider the PHE guidance’ and all ‘other relevant guidance’ when deciding which tests are appropriate.

The GPhC initially said in July last year that it was ‘not appropriate’ for pharmacy teams to be selling or recommending rapid antibody tests in line with advice published by PHE at the time.

The Government consultation closes on 5 May.


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