UK authorises 30 minute self-test kit to detect asymptomatic Covid-19 cases
14 January 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued exceptional use authorisation for an NHS Test and Trace Covid-19 Self-Test device.
The Department of Health and Social Care was granted authorisation to use the rapid test kit for detecting infection in asymptomatic people. This is an antigen lateral flow test (antigen LFT) which is capable of delivering results in 30 minutes.
The device can be used to detect new Covid-19 cases in those individuals who do not have symptoms. Individuals with no prior knowledge of testing can use a self-test device in their own home or another community setting. In a separate development, Public Health England (PHE) Porton Down laboratory scientists have conducted a rapid evaluation to test whether the new VUI 202012/01 variant can be identified by lateral flow devices (LFDs) currently used in the UK.
The evaluation was carried out with clinical and lab-grown samples containing the variant and tested five LFDs. Each device is either in use as part of mass testing or in the final stages of validation at PHE and could detect samples with the new variant. One of the new tools being used for detecting Covid-19, LFDs can provide results rapidly in under 30 minutes.
They can be used to detect people who have high levels of Covid-19 virus but are not having symptoms and would not otherwise be coming forward to get tested. Furthermore, as the new variant affects the spike protein on the virus surface, the LFDs work by detecting the nucleocapsid protein located inside the virus which is less likely to be affected.
Published by medicaldevice-network.com on December 24, 2020