PARLIAMENTARY WRITTEN QUESTION
Coronavirus: Screening (2 March 2022)

To ask the Secretary of State for Health and Social Care, what progress his Department has made on reviewing all covid-19 (a) PCR and (b) lateral flow antigen tests, which it is required to complete by 28 February 2022 under regulation 39A of the Medical Devices Regulations 2002.

Asked by:
Feryal Clark (Labour)

As of 28 February 2022, we received 214 applications for approval, with 31 being successful. Of these, 21 approvals were for extracted molecular tests of which 20 were polymerase chain reaction (PCR) tests and one LAMP test, seven were direct molecular PCR tests, two lateral flow device antigen tests and one oral fluid test.

There is no requirement for reviews to have been completed by 28 February 2022. This date refers to a temporary protocol which applied from 1 November 2021 to 28 February 2022, permitting tests to stay on the market pending the outcome of their review. Two new protocols took effect from 1 March 2022.

Answered by:
Maggie Throup (Conservative)
10 March 2022