Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the accuracy of over-the-counter SARS-CoV2 testing kits in respect of the variants of the virus currently circulating; what plans they have to inform the public about the accuracy of such tests; and what plans they have to reduce the incidence of COVID-19 over this winter.

Since 2020, the Medicine and Healthcare products Regulatory Agency (MHRA) has collaborated closely with the UK Health Security Agency (UKHSA), the National Health Service, and other external partners to monitor the potential impact of circulating SARS-CoV-2 variants on in vitro diagnostic tests. Monitoring is carried out through a voluntary system, with manufacturers submitting bi-monthly analysis reports.

The UKHSA and MHRA also meet regularly to discuss the sequence and prevalence of variants of SARS-CoV-2 that are circulating in the United Kingdom. This data is generated by the UKHSA and looks at both the nucleic acid sequence across the virus and the predicted amino acid sequence of the nucleocapsid protein, which is the target antigen of over the counter, lateral flow tests. The outputs predict whether there is a theoretical risk of tests failing to detect a circulating variant. If so, this would prompt the need for laboratory testing of kits by UKHSA laboratories.

The UKHSA continues to monitor the ongoing impact of COVID-19 through a variety of surveillance systems, including in general practices, through the Royal College of General Practitioners’ Surveillance Centre, in healthcare settings, and via the testing of patients in NHS and public health laboratories. In addition, a selection of these positive tests are sequenced to provide data on circulating variants, and to potentially detect the arrival of new variants. This data is published on the data dashboard, and in surveillance reports, which are published weekly during the winter season, and fortnightly otherwise. The dashboard and surveillance reports are available in an online-only format.