Recent updates by the UK MHRA have been made to the guidance for COVID-19 tests and testing public and professional users, regarding efficacy and use of the product.
The updates have emphasised that no at-home antibody testing kits for COVID-19 have received a CE mark, therefore, the devices do not meet current industry standards. There is concern that the testing kits may result in a false-negative result, thereby failing to indicate presence of the virus in the sample. As such, these devices are illegal to sell.
It has been suggested that the kits may not be able to test if a recent infection was COVID-19, or another virus. Furthermore, the testing kits have been designed to be used by healthcare professionals, therefore, there are concerns about the ability to perform the tests by unqualified personnel, and the danger this may pose to the patient.
These testing kits are not the same as the home sample kits, which are being issued by the NHS, and have the CE mark. Subsequently, the MHRA have also updated performance evaluation requirements for home testing kits in the UK. See here for updated requirements.
See here for updated MHRA guidance.