Retailers in England selling home antibody tests, including Superdrug and Babylon, have been told to stop sending them out, and labs must not process them, while the regulatory body examines how well they work.
Although the kits are made by the healthcare technology firm Abbot and have been approved by Public Health England (PHE) for the NHS to use for frontline health and care workers, people who buy them privately must prick their own finger and draw blood to post off to the lab.
The authorities appear to be questioning whether a home blood sample leads to a result that is as accurate as one taken by a nurse in a clinic.
The Medicines and Healthcare products Regulatory Authority has contacted all the private providers and the labs they use to tell them to halt the tests while they assess their accuracy. Babylon said it can process tests that are in the system, but cannot send people their results until given the green light.
PHE has approved two antibody tests, by Abbott and also by Roche. The Department of Health and Social Care has bought 10m for the NHS. A third test, from the Cardiff-based diagnostics company Ortho, has been approved in Wales.
Adding to the confusion, Prof John Newton, from PHE, who is in charge of speeding up testing, cast doubt on the accuracy of home tests at the science and technology select committee of MPs last week and indicated the government could be intending to approve a test for home use.
“The public need to be aware that those tests are not the same as those we have evaluated and approved for use. The laboratory-based tests have a much higher standard of accuracy,” he said.
“We wouldn’t recommend at the moment that people rely on the tests that are becoming widely available. My advice would be to wait until we have better tests which will be available in a similar form very soon, though they are still under evaluation at the moment.”