How the UK aims to drive up standards and removing poor performing tests.

There is evidence that some COVID-19 tests especially lateral flow tests do not perform as expected and as disclosed in their instructions for use (IFU).

For example, only 25% passed through all stages of DHSC lateral flow validation to be considered.

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 for lateral flow tests to at least the same baseline as those procured for the NHS.

Mandatory validation.

The risk of tests issuing false results with lateral flow tests could have detrimental outcomes for society and the economy.

Without independent mandatory verification of private tests on the market, there is an increased risk of COVID-19 tests on the market producing the following 2 outcomes:

False negative

A person receives a negative lateral flow test result when they are in fact contagious and they proceed to spread the virus in the community, for example in the community, their workplaces or through social interactions.

A proportion of these cases will go to develop serve disease and will require hospitalisation as well as develop long term (long COVID) with long-term health and economic impact.

False positive

A person receives a false positive lateral flow result when they are not infected.

That person will proceed to self-isolate and the knock-on impact for individuals and businesses that have been in contact with the individual causes personal and financial costs (for example if a business is forced to close unnecessarily).

More data on this can be found here.