Coronavirus: Screening

(asked on 18th February 2022) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will introduce a central repository of PCR tests in use in the NHS and publish evidence validating each test's effectiveness.


Answered by
Maggie Throup Portrait
Maggie Throup
This question was answered on 23rd February 2022

Manufacturers and distributors wishing to place a COVID-19 test on the market in the United Kingdom, including for sale to the National Health Service, must seek approval under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021. The approval process involves a review of evidence provided by the manufacturer about the performance of the test. Tests are approved where the manufacturer has provided suitable evidence that it meets performance thresholds in the Regulations. Tests which have been approved are available at the following link:

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products

Several tests procured by the Department for use in NHS trusts have received validation which involves laboratory testing. The results of this process are available at the following link:

https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/coronavirus-covid-19-serology-and-viral-detection-testing-uk-procurement-overview

For those tests without national validation, tests are validated and verified at each NHS site as part of the requirements of their ISO15189 accreditation.

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