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

by Toby Young
11 June 2021 5:43 PM

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.

Tags: FDAInnovaLateral Flow Tests
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59 Comments
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Cecil B
Cecil B
4 years ago

And then throw the dictators in the bin

58
-1
TORs
TORs
4 years ago
Reply to  Cecil B

Just reading “The Drug that Cracked COVID“, the story of Ivermectin (the forbidden cure) and it mentions that the FDA’s budget is “75 percent funded by big pharmaceutical companies”. I checked and officially it’s 45%, but maybe this means the lateral flow tests are actually very good. I used to trust medical science…

Last edited 4 years ago by TORs
5
0
Tee Ell
Tee Ell
4 years ago

Us sceptics knew this from the start.

40
-1
paul smith
paul smith
4 years ago
Reply to  Tee Ell

…yup.

8
0
wendy
wendy
4 years ago
Reply to  Tee Ell

Oh but what do we know ….. we are just conspiracy theorists!!!!!!!!

27
0
Manjushri
Manjushri
4 years ago
Reply to  wendy

…and they are merely complicity theorists 😊

9
0
C S
C S
4 years ago

I was literally about to post this link when I came back to the site and saw it had already hit the headline…

10
0
C S
C S
4 years ago

Here is a link to another article on it from Fierce Biotech…

https://www.fiercebiotech.com/medtech/place-them-trash-fda-warns-against-using-innova-s-rapid-covid-19-antigen-tests

2
0
Hopeless
Hopeless
4 years ago

“Follow the Science” leads our Great Leader and his stooges up an expensive garden path. “Follow the Money” is probably a more worthwhile task.

38
0
silverbirch
silverbirch
4 years ago
Reply to  Hopeless

The Conservative Woman has been following this scandal. Innova owned by one Chinese man who is/was something in a Wuhan lab. Up to the 1st June the UK has paid £3.5 billion to this one company. All products made in China. Company registered in California.

36
0
Hopeless
Hopeless
4 years ago
Reply to  silverbirch

I’ve been following the CW articles, and there is plainly much chicanery. In the “Normal”, such things usually led to Organised Crime, Mafia and so on. Now the dowsing rods always swing to anything Chinese.

13
0
CovidiousAlbion
CovidiousAlbion
4 years ago

I’d always wondered whether LFTs were too good to be true.

However, from the reporting in LDS, I’d formed the impression that they were reliable. There was a mass testing programme, in Liverpool, that found extremely few “cases”, and this, as I remember, was touted as indicating that the surge, in the city, either had finished or was a myth (https://dailysceptic.org/2020/11/11/latest-news-190/#mass-testing-by-the-army-turns-out-to-be-a-good-thing). Similarly, I think, there was a report of few cases amongst students (but those may have been RT-PCR tests).

What is the true status of lateral flow tests?

5
0
OKUK
OKUK
4 years ago
Reply to  CovidiousAlbion

I’ve no idea. But as people have pointed out, it’s weird that with this disease people need to wear masks because droplets are supposedly so infective but there is no simple spit test to identify people who are infected.

31
0
landt2020
landt2020
4 years ago
Reply to  OKUK

There is a kind of spit test- Hampshire and Isle of Wight has a saliva test
https://www.hiowsalivatest.nhs.uk/
No idea why this hasn’t been rolled out further.

4
0
realarthurdent
realarthurdent
4 years ago
Reply to  CovidiousAlbion

I think the problem with the LFT tests is they don’t find enough positives for the purposes of TPTB and also their sensitivity cannot be adjusted upwards or downwards to allow results to be generated which fulfil a particular political purpose at any one time.

47
0
Old Maid
Old Maid
4 years ago
Reply to  realarthurdent

… their sensitivity cannot be adjusted upwards or downwards to allow results to be generated which fulfil a particular political purpose …

This.

22
0
awildgoose
awildgoose
4 years ago
Reply to  Old Maid

Bingo!

7
0
eastender53
eastender53
4 years ago
Reply to  realarthurdent

Absolutely right. They are out of manipulative control.

10
0
Occams Pangolin Pie
Occams Pangolin Pie
4 years ago

Well, that has to be the most uplifting bit of literal flow I’ve read in a very long time. (The Guardian though?) The wheels have all but fallen from the wagon. One wheel on my wagon, and SAGE keeps rolling along. The Cherokees (an Indian variant) are after me… etc.
So the Indian variant is being measured using the Innova kazoos, and someone continues to trouser a great deal of money. But finally, the FDA has said, return these to sender, they are as much use as a face mask or a PCR test. The whole thing disintegrates before our very eyes. Operation Moonshot in a moment transforms into Operation Doomshit and the world begins to shake off its enchantment.
Trials, investigation, unlock your own freedoms.
The government and opposition are dupes and villains. Down with them.

45
0
Liam
Liam
4 years ago
Reply to  Occams Pangolin Pie

Unfortunately the whole sham completely fails to ever disintegrate. It just lurches on and on and on.

25
0
James Kreis
James Kreis
4 years ago
Reply to  Occams Pangolin Pie

Why the Guardian indeed. If it wasn’t for government advertising revenue and ‘grants’ from the Bill and Melinda Gates Foundation, it would have folded before now.

Last edited 4 years ago by James Kreis
13
0
RickH
RickH
4 years ago
Reply to  James Kreis

… as is the case for all the printed media.

4
-1
JayBee
JayBee
4 years ago

Throw every test into the bin and stop all testing.

28
0
Prester John
Prester John
4 years ago

‘FDA’ is ‘The Food and Drug Administration’ not ‘Food and Drug Agency’, presumably for the UK government, the errors are a feature, not a bug, as it keeps the figures up.

4
0
MikeAustin
MikeAustin
4 years ago

Oh well, back to that reliable old gold standard – the PCR test – then.

9
0
OKUK
OKUK
4 years ago
Reply to  MikeAustin

the brain-damaging PCR test I think you meant to put.,

11
0
OKUK
OKUK
4 years ago

This cannot be true. Mike Wendling and Marianna Spring of the BBC Disinformation Unit have made clear such observations are a conspiracy theory.

13
0
Annie
Annie
4 years ago
Reply to  OKUK

Those notorious conspirators, the FDA.

2
0
RickH
RickH
4 years ago

I’m certainly not flogging such tests … but they’ve probably (if by accident) given a more realistic picture of infection.

Which is why the action against their inaccuracy has been swift, whilst the manipulable PCR test carries on regardless.

22
-1
realarthurdent
realarthurdent
4 years ago
Reply to  RickH

^^^^^^^^
THAT.

4
0
helenf
helenf
4 years ago

The Guardian article is all about “cases” being missed because of false negatives, and nothing about false positives. So basically they’re suggesting that there are many more people out there who are “infected” and are potentially spreading this “virus” to others having been falsely reassured they are covid-free. So, more fear porn from the MSM. The fact that a positive lateral flow test result at times of very low prevalence in the community is likely to be a false positive seems to have passed them by. The problem is, there just aren’t enough cases out there to keep people afraid and compliant. What they need is another lateral flow test that has a much higher false positive rate. That’ll fix it! The fact that they have to test the hell out of people to see if anyone actually has “covid” goes to show just how deadly this virus is!!

28
0
Julian
Julian
4 years ago
Reply to  helenf

Someone I know was explaining to their child the other day the difference between LFT and PCR and nodded sagely that PCR was more accurate.

4
0
helenf
helenf
4 years ago
Reply to  Julian

A bit like saying Boris Johnson is more accurate than Neil Ferguson.

8
0
DevonBlueBoy
DevonBlueBoy
4 years ago
Reply to  helenf

Are we comparing their accuracy at shagging outside wedlock? 😱

1
0
Manjushri
Manjushri
4 years ago
Reply to  helenf

The Guardian lost its publishing independence when it was sold in 2008.
Its now a dangerous controlled opposition propaganda tool.
(In my humble opinion 😊)

5
0
Prester John
Prester John
4 years ago
Reply to  Manjushri

It was an apologist for Stalin’s terror famines in the 1930s, so this ‘independence’ or the lack of it is meaningless.

0
0
RickH
RickH
4 years ago
Reply to  Prester John

No, it didn’t excuse them. Certainly not in the way the Mail backed Hitler in a situation where more was known. The reporting was much more varied and balanced in the context of what was known. It is a different paper now.

Last edited 4 years ago by RickH
0
0
RickH
RickH
4 years ago
Reply to  Manjushri

Yes – the Guardian has been sequestered as a channel for government/establishment propaganda aimed at a particular demographic.

1
0
helenf
helenf
4 years ago
Reply to  Manjushri

Agree entirely! I don’t know how these so-called journalists sleep at night.

2
0
DevonBlueBoy
DevonBlueBoy
4 years ago
Reply to  helenf

Having a large salary and always being right helps

2
0
helenf
helenf
4 years ago
Reply to  DevonBlueBoy

That doesn’t stop them or their children from being vaccine injured.

0
0
isobar
isobar
4 years ago

My take on this is that the Government, having already spent over £1.6 billion over useless PPE has now spent more billions on a test that is probably equally useless as the ‘gold standard’ (sarcasm intended) PCR test. This is criminal as is the use of these tests to keep us locked down.

25
0
AndyPandy
AndyPandy
4 years ago

This news won’t be reported by BBC, Sky, ITV etc.

10
0
peyrole
peyrole
4 years ago

It might be true that the motives of the FDA are not ‘pure’, they might want to kill a test that is less malleable than the RT-PCR test. I don’t know. But then why not kill the quickie antigen test?
Whatever their motives, its a damning indictement on the UK govt that they have poured yet more £billions to a Chinese company ( fronted in CA) without the faintest idea if its any good.

5
0
isobar
isobar
4 years ago
Reply to  peyrole

Spot on. Our useless Government seems expert in throwing taxpayers money down the drain. Why isn’t the Office for Budget Responsibility looking at this?

0
0
Bill Grates
Bill Grates
4 years ago
Reply to  isobar

I’m sorry about this but the system isn’t going to come to our rescue.

Why are there no court proceedings, no reviews of govt process, not even any intellectual analysis allowed ?

Anyone within reach of any authority position is either ideologically committed to the cause , or compromised to ensure obedience to it.

This is the culmination of decades of planning, indoctrination and corruption.
The governing institutions in all western countries have been used to undermine western culture and society , this has been accelerating since Blair’s time.
The aim is to erase western dominance , particularly anglosphere race dominance in global affairs. This may seem unpalatable but it needs to be recognised for what it is.

We are witnessing the Marxist take over of the west and wider world.

By the way Toby, wasn’t it Lenin who said something like “the best way to control the opposition is to lead it ourselves “
…… just a thought.

6
0
CovidiousAlbion
CovidiousAlbion
4 years ago
Reply to  Bill Grates

https://www.thebernician.net/an-integrous-judge-vallances-prior-knowledge-of-adverse-events/

0
0
I am Spartacas
I am Spartacas
4 years ago

If you haven’t seen this video yet then please do – its an excellent interview with Dr Roger Hodkinson warning about this vaccine.

You must watch this video …

https://www.youtube.com/watch?v=HwM_1R79maE

2
0
Marcus Aurelius knew
Marcus Aurelius knew
4 years ago
Reply to  I am Spartacas

THIS INTERVIEW NEEDS TO GO FAR AND WIDE.

0
0
Marcus Aurelius knew
Marcus Aurelius knew
4 years ago
Reply to  I am Spartacas

If everyone who watches this youtube interview (and so many others like it) saves a copy of it on their personal hard drive using something like yout.com , then we can beat the censorship, perhaps. The only way we win is through each of us administering 1000 tiny cuts…

0
0
BeBopRockSteady
BeBopRockSteady
4 years ago
Reply to  I am Spartacas

That was powerful. Anna could don’t with letting him speak more but still, outstanding.

0
0
Tillysmum
Tillysmum
4 years ago
Reply to  I am Spartacas

It’s gone.

0
0
Butties
Butties
4 years ago
Reply to  Tillysmum

iT’S HERE https://ukreloaded.com/as-the-evidence-becomes-overwhelming/
and can be tracked elsewhere, spread the info!

0
0
Bill Grates
Bill Grates
4 years ago

And the question remains unanswered,

testing for what ?

Toby how can you watch Fatso at the G7 parroting the WEF propaganda and not be even remotely uneasy about all this ?

By the way how are the summer holiday plans going ? Bwahhahahah ,

4
-2
huxleypiggles
huxleypiggles
4 years ago
Reply to  Bill Grates

Out of order.

1
0
CovidiousAlbion
CovidiousAlbion
4 years ago

“The only confirmatory testing carried out has shown no Covid. Army testing in Liverpool uses a different and more reliable test – the ‘Lateral Flow Test’ (LFT). It has demonstrated that there is minimal Covid in the Liverpool community, the alleged hotspot. The numbers testing positive are barely above the false positive rate reported for the LFT meaning there were no real Covid cases found.” (https://dailysceptic.org/pcr-based-covid-testing-has-failed-us/)

The continual changing of the “facts” is rather confounding for us sceptics. Moreover, it can lead to us being pilloried, as the mass media trumpets the foundering of sceptics’ conclusions, while leaving the somersaults of the official narrative completely unremarked.

Back in November, “Extensive clinical evaluation from Public Health England and the University of Oxford show Lateral Flow Tests are accurate and sensitive enough to be used in the community, including for asymptomatic people. … overall sensitivity of 76.8% for all PCR positive individuals but detects over 95% of individuals with high viral loads” (https://www.ox.ac.uk/news/2020-11-11-oxford-university-and-phe-confirm-lateral-flow-tests-show-high-specificity-and-are)

2
0
C S
C S
4 years ago

Is this a way of discrediting the very test that people are able to use for travelling etc though. I thought these were less likely to at least give a false psitive? Will they try and spin it such that you can’t rely on a negative LFT, therefore needing a PCR test or of course a vaccine, to “prove your status”. This, despite many many cases of vaccjnated getting infected (and presumably passing it on!?)

1
0
huxleypiggles
huxleypiggles
4 years ago

How many billions has Bozo SPAFFED on this company?

4
0
DevonBlueBoy
DevonBlueBoy
4 years ago

And who will pay the postage to China – covid central?

0
0

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