Lateral Flow Tests

Mandatory validation for lateral flow tests

June 11, 2022

lateral Flow TestsPolicy

Why the UK has mandatory requirements for testing.

The government has considered the comparable benefits of a voluntary validation policy for tests. Inclduing lateral flow tests. compared to one that is mandatory.

There is a clear dependency in the government’s long-term strategy for managing the virus on ensuring that only high performing COVID-19 detection tests (which minimise the risk of false results) are available on the market.

The government has determined that it is necessary to pursue a mandatory validation scheme due to the public health risks posed by poor performing COVID-19 tests on the market.

What is a voluntary validation scheme for lateral flow tests:

A voluntary scheme would usually represent a lower barrier to entry into a market. However, in considering likely size of businesses involved in the market and the cost of developing a test.

The UK Government do not believe a mandatory scheme would represent a significant barrier in the specific circumstances of the COVID-19 lateral flow tests to the market.

n a voluntary process unvalidated tests would represent a weak link that risks undermining the benefits of quality tests. As such a voluntary process would either carry considerable risk of further lockdowns or restrictions. Mandatory Validation scheme for lateral flwo tests.

The a UK-wide mandatory validation scheme would be easier to deliver and would ensure all tests placed on the UK market met a minimum standard.

Empowering consumers with simple and straightforward assurances of quality.

Validation is mandatory, The UK Gov intend to make the process of transitioning as easy as possible for manufacturers to comply with. Keeping costs down and avoid circumstances where their product is not available for sale unnecessarily.

The bar for test products to stay on the market at the end of that transition period will be for them to complete the desktop assessment stage as detailed in the Validation process section.

Due to the pressing urgency of managing COVID-19 pandemic and enabling people and business to return to normalcy as quickly as possible, DHSC believes a mandatory scheme is necessary.