Innova recall undermines case for Covid-19 antigen testing

Company subject to scathing review, withdrawal from market by US health regulator

An employee conducts quality control inspections on self-use rapid antigen test kits used to test for Covid-19 at the Mylab Discovery Solutions manufacturing facility in Lonavla, India on June 10th.  Photograph: Indranil Mukherjee/AFP via Getty

An employee conducts quality control inspections on self-use rapid antigen test kits used to test for Covid-19 at the Mylab Discovery Solutions manufacturing facility in Lonavla, India on June 10th. Photograph: Indranil Mukherjee/AFP via Getty

 

Antigen testing is the subject of much debate right now. Public health, which has tended to the conservative during the course of the Covid pandemic, is wary of such tests being used as the key to unlock the door to a more rapid reopening of society. Those on the other side of the debate argue that health officials are actively trying to undermine the recovery of the economy.

The decision by the US drug regulator to order the withdrawal from the market of one of the leading antigen tests will do nothing to settle then argument. But it will give pause for thought.

In an unusually scathing letter, the FDA urged anyone who had bought the Innova antigen test to bin it. It said the test boasted performance claims that “did not accurately reflect the performance estimates observed during the clinical studies of the tests”.

In any case, it had not yet been approved for sale in the US. Worse still, the FDA said data the company submitted as part of an emergency authorisation process “was identical to data previously provided by other manufacturers” – an allegation that raises serious questions for the company.

The FDA has issued a warning letter to the company and triggered the highest level of product recall.

None of this is good news for antigen tests or for the UK, where the Innova test is at the heart of its reopening efforts. The UK government has bought 380 million of the tests and they are being used in workplaces, schools and at homes despite concern that they only pick up cases when the person has high levels of the virus. The fear is that early stage cases are therefore missed and that people in that situation testing negative are given false reassurance by the result and let down their guard.

Ultimately, doubts over performance and allegations of sharp practice by Innova in the US by marketing its test ahead of approval will do little to persuade public health officials to change their mind on antigen tests despite the clamour from vested interests.

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