The US Food and Drug Administration yesterday asked Innova to stop sales of its Innova SARS-CoV-2 Antigen Rapid Qualitative Test.
The FDA also warned the American public against using the Innova lateral flow test, on the grounds of concerns about its accuracy. Their release states "The FDA has classified the recall of this test as a Class I recall, the most serious type of recall".
Debate about the specificity and sensitivity of Innova lateral flow tests is not new: biostatistician Jon Deeks has been consistently warning about this issue for months.
The UK Test And Trace programme used Porton Down laboratory to test the lateral flow devices it approved for use, and found Innova's suitable.
Innova's claims of 97.0 percent sensitivity and 99.9 percent specificity for detecting people infectious with Covid19 has not been replicated in real-world data, as clearly shown by the SAGE publication of its Liverpool review.
Why does this matter?
This is important because of the extent to which UK Test And Trace policy is predicated on Innova's tests being as good as the manufacturers claim, and as validated by the Porton Down research.
This matters because the contracts with Innova have been for huge quantities of tests - and thus for huge sums of public money: over a billion pounds.
The UK is not the US, of course.
The FDA's writ does not apply.
But with the increased infectiousness of the Delta variant (as confirmed by the latest PHE data), the issue of lateral flow tests' accuracy becomes highly salient.
The Science Media Centre release from 3 June offers a range of sensible comments on the Delta variant's implications, and the 9 June reaction on the antibody survey data is also pertinent.
Vaccination now mainly focuses on the under-40 population, for whom the AZ vaccine is not recommended. So we are currently at the mercy of the UK's supply of Pfizer/BioNTech and Moderna.
We remain in a race between vaccination and virus variation.
UPDATE: I understand that there was a phone call yesterday between the FDA and their colleagues at the UK's Medicines and Healthcare Regulatory Agency about this issue. It was the phone call equivalent of a 'meeting without coffee'. (Yes, that bad.)
The consequence is that there is more than a slim chance that the MHRA will be issuing a Field Safety Notice for Innova LFTs.
It is not unknown in the diagnostics industry that Secretary Of State For Health But Social Care Matt Alan Hancock pushed for Innova LFTs' adoption as hard as it could be pushed. "A-ha", as they say in the trade.