Retailers and healthcare providers have been told to cease provision of home antibody tests for Covid-19 until their use has been ‘properly validated’.
Public Health England has now approved testing kits manufactured by Abbott and Roche and is starting to roll their use out to healthcare workers. However, the Medicines and Healthcare products Regulatory Authority (MHRA) is concerned that finger-prick tests carried out at home may not be as reliable as those taken in a healthcare setting.
A number of commercial organisations including Superdrug, Babylon and Zava have begun offering finger-prick tests, which can be carried out at home and sent off to an accredited laboratory for testing. Healthcare companies such as Rutherford Health have also started using the tests to see if their employees have had the virus.
MHRA said it was in everyone’s interests to ensure that any testing is ‘as reliable and meaningful’ as possible and confirmed it had asked ‘all providers of laboratory-based Covid-19 antibody testing services using capillary blood collected by a fingerprick to temporarily stop providing this service’.
A spokesperson for MHRA said: ‘Use of unvalidated sample types may lead to unreliable results and as such we are working closely with the service providers, laboratories and test manufacturers to resolve the regulatory and patient safety issues.
‘People who have purchased one of these sampling kits, and received an antibody test result, should not consider the result to be reliable and should not take any action on it.’