This is my 1st attempt at posting on substack so apologies in advance for any errors, ommisions, spelling and so on.
The story of the Innova Lateral Flow Device Tests (LFTs):
The original LFTs supplied to GPs, pharmacies and dentists had Innova, an American
company, listed as the manufacturer on the MHRA Exceptional Use Authorisation.
Innova never made them, they were manufactured by Xiamen Biotime Biotechnology Co Ltd in China.
Innova then purchased them as they had the contract with the UK Government to supply LFTs at the time.
Here is a link to Innova’s product information and instructions for use:
In this information sheet it contains the following statements:
“for use on individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.“
There is also this information on page 3:
The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals.
And this lot:
LIMITATIONS OF THE PROCEDURE
Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples.
2. Users should test specimens as quickly as possible after specimen collection.
3. Positive test results do not rule out co-infections with other pathogens.
4. Results from SARS-CoV-2 Antigen Rapid Qualitative Test should be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.
5. A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 infection.
6. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5 of illness are more likely to be negative compared to a RT-PCR assay.
Quite clear and easy to understand as to the test’s performance and limitations.
There are also many other caveats about the test on page 4 which are very interesting.
I have photos of the shipping boxes.
So anyway Innova, by pure coincidence, just after the Innova paperwork was released onto social media by the legal team at laworfiction (their website and twitter account) were replaced by a new manufacturer for the supply of LFTs to schools and colleges and they were removed from the MHRA’s list of authorised medical devices:
They were replaced by a device that was “manufactured” by the Department of Health and Social Care (DHSC).
On the MHRA webpage it states quite clearly:
"Device/model name: COVID-19 Self-Test to detect infection in asymptomatic individuals
(Repurposed Innova/Biotime Test Kit) to detect positive cases amongst asymptomatic
people, one-off testing prior to an activity to reduce risks, outbreak testing and
asymptomatic testing"
MHRA reference number: DEU/012/2020/003”
They are exactly the same tests made in the same factory by the same company.
Other than the MHRA quote how do I know this?
Because I actually found some boxes with the shipping labels still on them and have the photos.
I even managed to remove for posterity one of the shipping labels.
I then started contacting the MHRA and the DHSC asking them for the technical documentation that shows that the DHSC manufactured LFTs are materially different from the Innova manufactured LFTs so that their repurposed use so that they can be used on asymptomatic persons who self-swab as stated in the new MHRA Exceptional Use Authorisation.
The DHSC’s answer (remember as the “manufacturer” they have a legal duty to supply the relevant technical documentation to the regulators so that the regulator can investigate the product, confirm it is fit for purpose and does exactly what is claimed) was “we have no documentation, ask the MHRA”.
The MHRA’s response to the exact same question was “we cannot release that document as it contains sensitive commercial information and is exempt under the FOI legislation. Ask the company that manufactures them”.
I asked them for the company details they have on record of the “manufacturer” as the DHSC is not listed at Companies House as a company and that as a Government Department it cannot be a “company” nor “commercial”.
I also asked them for the DHSC document name and reference number they had used to do their investigations into the DHSC’s claims for repurposed LFTs.
I also asked them how did they have documentation in their possession from the DHSC but the DHSC categorically state they supplied nothing to the MHRA nor do they have any relevant technical information on record.
No acceptable answers so far have been forthcoming forthcoming from the MHRA.
I then asked the DHSC how the MHRA claims they have technical information supplied by the DHSC when the DHSC claim not to have any.
The answer?
“Give us some time and we’ll get back to you”.
In the meantime they suggested I contact the UKHSA as they have taken over test and trace from the DHSC so I did.
Their answer?
There are NO material differences between the original Innova tests and the repurposed Innova/DHSC tests which is why there is no documentation available.
They did say there was some sort of study done or ongoing to sort of justify it but they did not supply it so I've asked for it. Awaiting an answer.
Now request gone in to the Information Commissioner's Office asking for them to order the MHRA to identify the documentation they have in their possession from the DHSC that was used for their appraisal of the LFTs that shows they are "materially different".
In a separate FOI answer I also received this link (but I had already found this report on the internet independently) of an evaluation of LFTs by Oxford University and Porton Down:
In this evaluation it states there are problems with batch quality and consistency and also the tests are very dependent on the training of those taking the samples and swabs so "self swabbing" is not recommended.
Exactly as per the manufacturer’s paperwork which says the taking of the sample is critical to get an accurate result within the LFTs limitations.
This agrees with this UK Government document that covers all lateral flow device tests and RT-PCR test by any manufacturer that wants to supply them to the Uk Government:
It says:
Sample type
Desired
Sputum, saliva or other method not using invasive swab
Acceptable
Nasopharyngeal or oropharyngeal swabs, lower respiratory tract aspirates,
bronchoalveolar lavage, nasopharyngeal wash/aspirate or nasal aspirate
Comment
Methods not using invasive swabs are desirable due to patient discomfort, pre-analytical errors and issues with supply chain.
So any test that swabs deep into the nose and mouth is 2nd choice at best and has too many problems associated with it.
The same document also states:
Target user
Desired
Trained healthcare professional (i.e. one of the 10 health and social care professional bodies that are overseen by the professional standards authority)
Acceptable
Trained healthcare professional (i.e. one of the 10 health and social care professional bodies that are overseen by the professional standards authority)
Comment
A healthcare professional will select the right test to use with the patient, perform the test and then interpret and communicate the results. There may be some scope for supervised self-sampling where the sample collection device is CE marked for this purpose (eg. saliva samples).
Full training appropriate to the intended user is required.
Again, quite clear as to the preferred requirements as to how the sample is to be taken, who by and so on.
So when asked why the LFTs and Rt-PCR tests were using sampling methods not as per the Government’s own preferred requirements the answer was basically, to paraphrase:
“It’s a nice to have wishlist. We just take what the manufacturer says they want to give us. Ask someone else who might know, maybe the DHSC.”
Now the MHRA has supplied a little more information about the LFT approval process. In a FOI they sent this link:
In it is the quote:
"Saliva will be collected from healthy adult volunteers at PHE Porton Down" which is then spiked with virus stock.
"Saliva samples from 15 different individuals will be spiked with SARS-CoV-2 virus stock (7.8x106 plaque forming units(pfu)/mL VIC/1/2020) "
But they have never categorically stated they have SARS-CoV-2 virus fully isolated, only some genomes and proteins.So I've asked why are saliva samples being used to "test" the LFTs as opposed to the swabbing almost to the brain and to the back of the throat.
I received an answer back from the UKHSA about where the original SARS-CoV-2 virus stock came from. The answer was basically "we don't know, ask the DHSC, they may know".
Also asked them how they knew what they were using to calibrate the tests with was SARS-CoV-2. Their answer was when translated from their gobbledlygook to plain English "we were told to look for something in March 2020 by the WHO, took swabs from some people ill with cold like symptoms that matched what they wanted, this we assume is SARS-CoV-2 and we use that".
They also admit that whatever they have found in these samples has not been proven to cause problems in humans and that back in 2020 they thought it wrong and unethical to inject it into healthy people to see what happened as they claim that they did not know how to cure it but now 2 years later they have started to run trials doing exactly that. Here are the links they sent:
https://www.imperial.ac.uk/news/233514/covid-19-human-challenge-study-reveals-detailed/
https://www.researchsquare.com/article/rs-1121993/v1
https://www.ox.ac.uk/news/2021-04-19-human-challenge-trial-launches-study-immune-response-covid-19
So for over 2 years they had no idea if what they found in the swabs and called SARS-CoV-2 as it matched what they had been told to look for but could not prove was even SARS-CoV-2 even made anyone ill.
I also received from them this link:
https://www.gov.uk/government/publications/lateral-flow-device-performance-data
In it is this document:
For 2 years Government has been claiming that the PCR test for coronavirus is "the gold standard" and that this test is what the lateral flow tests were calibrated and tested against to prove how accurate they are.
Pity that in the document above it contains the following statements:
"There is currently no gold standard test for transmissible virus "
and
"As PCR is an imperfect gold standard"
So not quite what Government has led people to believe is it?
Digging into the documents supplied above they do not prove beyond doubt that LFTs should be used on asymptomatic people or those with a low viral load:
"The LFD antigen test detected 100% of the most infectious high viral load, 50% of people with a low viral load, and 9% of those with minimal viral load."
So why spend all that money on testing asymptomatic people?
This document was also supposed to justify the use of LFTs on asymptomatic people and does nothing of the sort. It just raises more questions on their effectiveness to do what Government claim they do.
They also sent a pdf copy of a report with the title "SUMMATIVE STUDY REPORT FOR LFD IFU REMOTE BASED USABILITY STUDY" by the Cambridge Office, Global Innovation and Technology Centre of paconsulting.com dated 26 Nov 2020 author Antonia Burt which they claim justifies the self-swabbing of the LFTs and their accuracy compared to being swabbed by a professionally trained medical person in a laboratory setting.
I do not have a direct link to the report but I have the pdf file supplied in the fOI answer. It was written by this company:
https://www.paconsulting.com/about-us/global-innovation-and-technology-centre/
Unfortunately and yet again it does not justify their use as some steps report a 58% error rate in following the instructions - this was on step one, putting the test on a lean surface prior to use - and 15% could not wash their hands properly before using the swab. And this was with them knowing they were part of an assessment study which begs the question in real-life what was the actual failure rate for each step if the test cohort could not follow these 2 simple steps?
It also used a hand-picked cohort of just 60 participants.
I have now had an answer back from the DHSC to my request for an internal review on why the different answers from the MHRA and DHSC on the same question about Innova/DHSC LFT tests. It was:
"DHSC was not required to compare the device to the Innova lateral flow device as part of its application or provide justifications for any differences (should there be any) to this device. “
It’s still a complete farce.
I have posted this previously here:
https://www.reddit.com/r/LockdownSceptics/comments/prvkq2/let_em_tell_you_a_story_about_lfts/
Let me tell you a story about LFTs
I hope you are giving this info to a lawyer. Attorney Thomas Renz in Ohio, USA is a good one who has a lawsuit going with inaccurate PCR tests part of it.
the imperial link is about a study where they claim they gave people "sars-cov2" but it doesn't have a control group. what they gave them is a manufactured product. It says "the virus was isolated by inoculation of a qualified cGMP Vero cell line with the clinical sample", a "nose/throat swab" i.e. they made something and called it "the virus" rather than isolated 'a virus' from nature. Then:
" A seed virus stock was then generated by a further passage on the same cGMP Vero cell line. The seed virus stock was then used to manufacture the challenge virus in accordance with cGMP at the Zayed Centre for Research GMP manufacturing facility of Great Ormond Street Hospital, and a challenge virus master virus bank (MVB) was produced. Individual dose inoculum vials were then produced in accordance with cGMP by dilution of the cGMP MVB with sucrose diluent. "
This in no way represents something that would actually happen in normal life. The participants might been stressed by the belief they were being infected with a dangerous virus with symptoms that they had already been conditioned to expect. This could thus have caused a nocebo effect together with a reaction to the decaying proteins or 'live vaccine' whatever they were investingating etc..
Participants were "paid about £4,000 for their two to three-week stay" and shown pictures of people playing computer games, reading books, smiling at their clipboards etc. in corporate quarantine faciltites owned by the 'challenge virus' manufacturers. They were told it was to "develop vaccines" rather than establish if there was a virus: