Lateral Flow Tests

FDA Tells People to Throw Innova Lateral Flow Tests in the Bin

The American Food and Drug Agency (FDA) says the performance of the Innova-manufactured lateral flow test – the one in use across Britain, including in schools – has not been proven to be reliable and, for that reason, the test should either be returned to the manufacturer or thrown in the bin. The Guardian has more.

The FDA has raised significant concerns about the rapid Covid test on which the U.K. 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 the UK, these lateral flow Innova tests form the cornerstone of Operation Moonshot, the mass-testing scheme championed by the prime minister’s former chief adviser. The idea was that the ability to deliver results within 30 minutes – without the need for processing in a laboratory – provided a cheap, pragmatic and efficient way to identify people who had caught the virus but not fallen ill. But critics have raised concerns about accuracy.

Given the tests have been offered free to millions in England, for use at home or at test centres, workplaces and schools, with the aim of detecting more cases, breaking chains of transmission and saving lives since April, the FDA announcement is particularly damning.

The US agency has not authorised the use of the Innova test in the US, although the manufacturer has submitted a request for authorisation. But when the FDA discovered the Innova test was being distributed for US use regardless, it conducted an inspection of Innova’s medical device operations between March and April 2021.

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.

The FDA also highlighted that the clinical study data submitted by Innova as part of its request for US authorisation was identical to data previously provided by other manufacturers in separate requests.

Worth reading in full.

More False Positives Than True Positives in the First Two Weeks of School Testing

A member of SAGE warned back in February that the return of unvaccinated children to the classroom would create a “significant risk of a resurgence” of Covid infections. This was not the case – only 0.06% of rapid Covid tests of students produced positive results in the week that schools reopened. But how many of these results were actually positive? Professor Jon Deeks, a biostatistician from the University of Birmingham, said in March: “We would expect far more false positives than true positives amongst those testing positive in schools.” New data from the Department of Health and Social Care has now confirmed that more false positive results were produced than true positives in the first two weeks of school testing.

Department of Health and Social Care

This data, as Professor Deeks points out, is a damning indictment of the use of rapid Covid testing in schools and has resulted in many children having to isolate at home unnecessarily – with their classmates often being sent home too. (At one stage, more than 200,000 schoolchildren were having to self-isolate, forcing them to miss out on much-needed catch-up work in classes.)

[The] proportion[s] false were 62% and 55% in these two weeks.

Of 2,304 positive tests, 1,353 were likely false, with one positive per 6,900 tests done.

The use of PCR tests to confirm or (in more cases) deny lateral flow test results is itself a strange choice, as Lockdown Sceptics’ Will Jones points out, and could mean that the true impact of rapid testing in schools is even worse than this data suggests.

It is interesting that they assume confirmation from a PCR test defines true and false positives, even though PCR tests are more sensitive than LFTs so are no less likely to give a positive from fragments or contamination. What if in some cases the PCR tests are just confirming the false positive of the lateral flow tests?

The British Medical Journal has been warning against the use of PCR tests for “case finding, mass screening, and disease surveillance” since last September (if not before):

PCR is not a test of infectiousness. Rather, the test detects trace amounts of viral genome sequence, which may be either live transmissible virus or irrelevant RNA fragments from previous infection. When people with symptoms or who have been recently exposed receive a positive PCR result they will probably be infectious. But a positive result in someone without symptoms or known recent exposure may be from live or dead virus, and so does not determine whether the person is infectious and able to transmit the virus to others.

Clearly, testing requirements for schools must now change. But the problem is not limited to the classroom. Professor Deeks says that false positive data should now be released for all forms of lateral flow testing.

Pepsi Max Tests Positive for COVID-19

There follows a guest post by Nic Elliott, host of the Sounding Board podcast.

I decided to order some lateral flow tests now that anyone can request to be regularly tested.

My aim – a simple testing of household available items to see what the results would be. The results are crazy.

  • 3 gave a negative result.
  • 1 gave a void.
  • But 3 out of the 7 tests gave a positive result.

I make that a false positive rate of 43%, or 50% if you remove the voided result from the sample.

First I tested water – that came up negative. Then some tea left in my teapot, also negative.

Then I decided to test my own saliva (but not a swab stuck anyone official). That was negative, and still no voided results in sight.

I decided at this point to get serious and brought out the Lee & Perrins. This did give a void result, so it was time to bring out the big guns.

Pepsi Max (other vegetable extract-based drinks are available) – positive for SARS-CoV-2!

Then milk – a very faint line, but still classed as a positive according my official NHS leaflet.

And finally, mango chutney, the third positive COVID-19 test result.

Obviously, I am not going to report these staggering results, but maybe I’m looking for a conspiracy in the wrong area… Maybe the real bombshell is that COVID-19 is being spread through cola, cow’s milk and curry condiments.

Mass Covid Testing a “Waste of Time and Money”, MPs Told

Biostatistics Professor Jon Deeks has criticised the Government’s mass Covid testing plan as a waste of “time and money”, highlighting that in some areas only one positive case has been found after 10,000 tests. Professor Deeks, a Senior Researcher at the Institute of Applied Health Research at Birmingham University, told the All Party Parliamentary Group (APPG) on Coronavirus that there is “no evidence” to show mass testing works. He is quoted in the Telegraph:

“For this mass test, the Innova test, we have the Liverpool study and the University of Birmingham study, that’s a total of 78 cases where we know how well it detects (positive cases).

“That is absolutely outrageous that we are now testing the whole population based effectively on data from 78 people, which actually showed it doesn’t work very well…

“In the South West at the moment, I think we are down to 0.09% prevalence and that probably means we would be using 10,000 tests to find one case in the next few weeks.

“I don’t think that’s a good use of people’s time or money or public health capital to do that. There are far better things we could be doing.”

The APPG is chaired by Liberal Democrat MP Layla Moran, who said: “[Mass testing] seems to be the panacea at the moment… [but] how reliable is it?”

Earlier this month, the Government promised twice-weekly Covid tests for everyone in England. Sky News had the story.

The Government says the offer is currently for England only and the devolved administrations in Scotland, Wales and Northern Ireland will make their own decisions.

A major marketing campaign encouraging people to take up the offer of twice-weekly lateral flow tests will also start in England this Friday…

The programme is effectively the long-delayed “Operation Moonshot” of 10 million Covid tests a day, costing an estimated £100 billion, promised by Health Secretary Matt Hancock last summer.

When he told the Commons it would start as early as December, MPs laughed, prompting Mr Hancock to brand them “nay-sayers” and telling them to “get with the programme”.

Now the Government says that alongside vaccination, regular Covid testing will be an essential part of easing lockdown restrictions and help quickly suppress the spread of variants.

The Telegraph report is worth reading in full.