Innova tests’ performance not proven and they should be returned to manufacturer or thrown in bin, says FDA
The US Food and Drug Agency (FDA) has raised significant concerns about the rapid Covid test on which the UK government has based its multibillion-pound mass testing programme.
In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to the California-based manufacturer Innova.
…In its report, the agency accused the company of “false or misleading” estimates of the clinical performance of certain configurations of the test, saying the estimates did not accurately reflect the performance of the diagnostic devices during clinical studies.
This is the first instalment of my three-part investigative report on the Chinese-made Innova lateral flow test. Vast sums of UK taxpayers’ money have been paid to a California start-up for tests that have failed to stand up to scrutiny.
…Innova Medical Group, the company benefiting from the UK Government’s huge testing contract, is owned by the private equity group Pasaca Capital which was founded by a Chinese investment banker, the enigmatic Dr Charles Huang, in 2017. It has been revealed to be the single largest recipient of the Department of Health’s Covid contracts after signing a £496million deal to supply LFTs last year. An earlier contract with Innova cost the taxpayer £107million.
Most people infected with SARS-CoV-2 are contagious for 4–8 days.7 Specimens are generally not found to contain culture-positive (potentially contagious) virus beyond day 9 after the onset of symptoms, with most transmission occurring before day 5. This timing fits with the observed patterns of virus transmission (usually 2 days before to 5 days after symptom onset), which led public health agencies to recommend a 10-day isolation period. The short window of transmissibility contrasts with a median 22–33 days of PCR positivity (longer with severe infections and somewhat shorter among asymptomatic individuals). This suggests that 50–75% of the time an individual is PCR positive, they are likely to be post-infectious.