Covid-19: US regulator raises “significant concerns” over safety of rapid lateral flow tests

The US Food and Drug Agency (FDA) has raised concerns about the safety and the marketing of rapid lateral flow covid-19 tests, which are the cornerstone of the UK’s mass testing programme. On 10 June,1 the agency warned the public to stop using the Innova SARS-CoV-2 antigen rapid qualitative test for detecting infection and suggested the tests should be destroyed and binned or returned to the manufacturer. The FDA published a class 1 recall of the test after an investigation carried out between March and April uncovered “significant concerns that the performance of the test has not been adequately established, presenting a risk to health.” Class 1 is the most serious kind of recall and indicates that use of the tests may cause serious injury or death. In addition, the FDA said that “labelling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during clinical studies,” and that the test “has not been authorised, cleared, or approved by the FDA for commercial distribution or use in the US, as required by law.”