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UK Strengthening Validation Requirements for COVID-19 Tests, Proposes Mandatory Lab Validation
Sep 03, 2021 | staff reporter

NEW YORK - The UK government announced Thursday that antigen-based and molecular COVID-19 tests are now required by law to undergo a desktop review — or a review of documents and data — before being permitted for sale in the region.

The requirement went into effect on July 28, the UK government's Department of Health and Social Care said in a report published on its website.

DHSC further announced that it will evaluate proposals to require mandatory laboratory validation that raises the bar for authorization of COVID-19 tests and products.

In a desktop review, scientific advisers evaluate supplier evidence against a set of performance criteria, but it doesn't evaluate how COVID-19 test products will perform in use, DHSC said.

Laboratory validation will involve independently testing the performance of the COVID-19 testing products in a central laboratory against a specific set of criteria on behalf of the UK Health Security Agency, DHSC said.

The agency is evaluating proposals to introduce laboratory validation for COVID-19 test products under the Medicines and Medical Devices Act 2021.

"This will further strengthen consumer confidence in COVID-19 detection devices by corroborating supplier desktop evidence," it said. "A number of COVID-19 tests available on the UK market failed to replicate their stated performance in technical and in-use validation and real-world evidence collection. Information about the true performance of COVID-19 test products is not easily accessible to consumers, and this has left consumers without access to information that would allow them to make informed choices about the tests they purchase."

Though the "government established a validation process as it began the mass procurement and deployment of tests at the start of this pandemic, three in four of the tests offered to the Department of Health and Social Care failed this validation process," it said.

All of these tests were CE marked and could be legally sold in the UK. Nonetheless, "This was recognized as a potential public health risk and a market failure," DHSC said.

Mandatory laboratory validation would help identify issues with poorly performing tests so that they can be removed from the market, it said.

Overall, DHSC is seeking perspectives on desktop review; laboratory validation and its future scope; fees regime; sensitivity and specificity thresholds; sample types; the regulatory environment; the supply of COVID-19 tests, including trade flows; safety, favorability, and availability of COVID-19 tests; and extending the scope of validation to cover other pathogen diagnostics.

The government is seeking responses from businesses from all parts of the UK and internationally that are involved in the manufacture, distribution, and sale of COVID-19 tests as both a good and a service. It is also seeking responses from product users, academic experts, and health system professionals, DHSC said.

https://www.360dx.com/regulatory-news-fda-approvals/uk-strengthening-validation-requirements-covid-19-tests-proposes?utm_source=Sailthru&utm_medium=email&utm_campaign=360DN%20Fri%202021-09-03&utm_term=360Dx%20Daily%20News#.YTJOwo5KiUk