Private Covid tests to be subject to quality checks after more than 75pc found insufficient

All private coronavirus tests will be subject to UK quality assurance checks, it has emerged as the Government admits too many are hitting the market that do not work properly.

Ministers have set out plans to ensure that all new tests meet “minimum performance standards” because as few as 25 per cent of privately-made lateral flow devices are "of sufficient quality for procurement".

The news comes after Number 10 announced that everyone in England will be offered twice-weekly Covid-19 tests as part of the push to “reclaim a more normal way of life”.

Lateral flow test kits, which can provide results in just three minutes, are available for free through workplaces, at testing sites and via the post from last Friday.

Under the plans, the Government will establish “a requirement that all Covid-19 tests placed on the UK market undergo a mandatory validation process”.

Any changes could be introduced under the Medicines and Medical Devices Act 2021 before the end of this year, officials said.

A consultation document titled “Private Covid-19 testing validation” recommended tough action on inadequate kits saying: “Tests that fail this process would be barred from sale.

“Retailers, distributors and manufacturers of tests that attempt to sell unvalidated tests would face sanction.

“This will apply equally to those companies based in the UK and overseas who are importing into the UK.”

The consultation warned that “there is currently no legal requirement available for independent validation of Covid-19 tests performance.

“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.

“This means performance is not independently verified ahead of sale.”

It said: “Currently the data used by each manufacturer to achieve its CE marking is unique and designed by each manufacturer.

“This allows manufacturers to tailor their use cases to ensure the most optimal performance of their tests.

“This prevents consumers comparing the data and acts as a barrier to effective competition."

Officials had found “evidence that some Covid-19 tests do not perform as expected and as disclosed in their instructions for use (IFU)", the document said.

“For example, only 25 per cent passed through all stages of DHSC lateral flow validation to be considered of sufficient quality for procurement.”

It warned that currently “tests are permitted to enter the market without going through the process of an independent validation of their performance and not all tests are performing to a sufficiently high standard.

“This is despite nine in 10 suppliers having the CE mark, with three-quarters meeting the ISO 13485 standard in relation to post market surveillance.

“Though we would expect the market to drive up quality in time, this is insufficient to meet our goals around managing Covid-19 and we need to rapidly increase quality in the private market to at least the same baseline as those procured for the NHS.”

The Department for Health and Social Care has been approached for comment.