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Written question asked by Daisy Cooper (Liberal Democrat) on Wednesday, 20 April 2022, in the House of Commons. It was due for an answer on Monday, 25 April 2022. It was answered by Maggie Throup (Conservative) on Tuesday, 26 April 2022 on behalf of the Department of Health and Social Care.

Coronavirus: Screening

Question

To ask the Secretary of State for Health and Social Care, what comparative assessment his Department has made of the impact of the coronavirus test device approvals (CTDA) process on (a) domestically- and (b) foreign-manufactured covid-19 tests which are not subject to the CTDA process.

Answer

The coronavirus test device approval (CTDA) is required for all molecular and antigen tests to enter the United Kingdom market. Non-antigen and non-molecular detection tests such as antibodies or biomarker-based testing technologies are currently excluded from the scope of validation. However, these will be monitored and revised as necessary, particularly as technologies become more mature and widespread. Regardless of the country of origin, all tests must meet the standards established in the CTDA regulations.

The ‘Validating COVID-19 tests in the private market’ has assessed the impact of CTDA for UK based and international companies and is available at the following link:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1053516/Validating_COVID_19_tests_in_the_private_market.pdf

Further to the legislation, we have committed to review this policy by the end of 2022.

Secondary information

Type
Written question
Reference
156594
Session
2021-22
Subjects
Standards Screening Coronavirus
Link
View this Written question on www.parliament.uk