Thursday, March 10, 2022

FROM THE UK: There are consistent Disparities between Manufacturers’ Claims and Actual Performance of Covid Tests, says UKHSA

Source:

"Buried in a 110-page impact assessment (“IA”) titled ‘Validating Covid-19 Tests in the Private Market’, the UK Health Security Agency (“UKHSA”) admitted the quality of Covid tests used in the UK is poor.

It is not a health impact assessment.

 It is a report to estimate the economic impact if health authorities were to validate whether Covid test kits meet quality standards.

From the outset these unvalidated poor-quality tests have been used to underpin the Government’s “pandemic” response. 


Anyone who died within, initially 60 days and then later, 28 days of a positive test was labelled as a Covid death. 

These deaths were then used to ramp up the fear of a deadly virus in the public’s psyche in order to shut down businesses, schools and to restrict and control almost every aspect of life.

Only now, after years of immense damage and harm, do public health authorities recognise that they should have been, at the very least, validating the accuracy of these tests

rather than simply rely on claims made by suppliers,

as “there are consistent disparities between manufacturers’ claims and the actual performance of Covid tests, even for well-performing tests.”

“To address the problem, the Government has chosen to implement the policy [see Option 1 below] in 2 stages.

The Government took steps to introduce legislation (on 28 July 2021), which introduced a mandatory requirement for antigen and molecular Covid-19 detection test products to undergo a ‘desktop review’ before being permitted for sale on the UK market.

This next iteration of the Impact Assessment has been developed in advance of implementing a second stage of mandatory ‘laboratory validation’, which will introduce further scrutiny of Covid-19 test products, in addition to the ‘desktop review’ stage.” – UKHSA, Validating COVID-19 tests in the private market, para. 4

So not only for more than a year, prior to July 2021, did the UK public health authorities not even conduct a “desktop review” of the medical products being widely enforced on the population

– of all ages and at their direction

– but for almost two years they have not validated the quality and, so it follows, the safety of routinely used Covid tests.

In their economic IA, UKHSA put forward five options to correct the problem including “do nothing,” where manufacturers would continue to self-certify Covid tests.

The validation option preferred is Option 1, “the only option that successfully aligned manufacturers’ and consumers’ incentives,” UKHSA stated.

In this IA, signed by Minister for Vaccines and Public Health Maggie Throup on 18 January 2022, UKHSA assessed the economic impact, the costs and profits, for 10 years.

“Orion Market Research forecasts the UK Covid-19 diagnostic market value until 2026.

This IA uses this forecast and then extrapolates from 2026 to show 10-year business and market impacts.” – UKHSA, Validating COVID-19 tests in the private market, para. 49

Starting from their base year of 2020, their 10-year forecast ends in 2030.  Let that sink in.

To reiterate, their concern with poor quality tests is one of economics, not health and wellbeing.

Of the 11 “headline impacts” (para. 12-21), only one (para. 20) relates to health, and even that contains an implied reference to financial interests as

“improved test performance can be expected to … drive up participation in testing” thereby improving sales and profits. 

The remaining 10 “headline impact” paragraphs expressly relate to costs, market share, profits and/or financial investments. 

This IA is very much in line with a business plan and not a “pandemic” health plan.

Inaccurate Test Results, The Fraudulent Use of Covid Tests

“Validation of Covid-19 test devices for use in the national mass testing programme and parts of the NHS by the Lateral Flow Device Validation Group (LVG) and Technical Validation Group (TVG)

established consistent disparities between manufacturers’ claims (including field outcomes for selected products) for their devices and the actual performance of those devices,

even for well-performing devices.

This may lead to an increased risk of inaccurate test results when used for testing.” – UKHSA, Validating COVID-19 tests in the private market, para. 1

UKHSA noted that, to date, approximately 114 products have been through TVG the validation process and only 14 have been validated.

This is similar for LFD validation, where 101 have gone through the validation process and only 20 validated.


Even when used correctly and accurately, a PCR test cannot diagnose a disease or determine if a person is ill or infectious.

 It is a research tool not a diagnostic tool.


From as early as July 2020, Prof. Dr. Ulrike Kämmerer, a German virologist and immunologist, has been warning that the PCR test is not suitable for determining a coronavirus infection;

it’s like “reading coffee grounds.” 


During Day 3 of the Grand Jury Proceedings Prof. Kämmerer, testified as to what a PCR test can and cannot do.

“The PCR is not able to identify persons that are so-called super-spreaders or transfer the virus.

 This is the point in a pandemic. 

You should identify the persons who infect others. 

And the PCR is definitely not a technique for this,” Prof. Kämmerer explained. 

Adding that the PCR test cannot diagnose the disease. 

Because, especially in respiratory viruses, it’s normally a combination of different viruses, often three or four viruses are present at the same time. 


If a patient is symptomatic, the PCR test can be used to confirm that a patient has a particular virus but the test cannot determine if it is that virus causing the symptoms or disease.

“Entry to the market was, until 28 July 2021, ‘controlled’ only by CE marking.

This performance is not independently verified ahead of sale.” – UKHSA, Validating COVID-19 tests in the private market, para. 2

“Overstated performance permitted under CE marking, currently allowing performance to be evidenced as the manufacturer sees fit

… There is a clear problem that the quality of tests available on the market were inconsistent in their real-world performance and so those relying on their results would risk relying on false results.”
  – UKHSA, Validating COVID-19 tests in the private market, para. 2

The UKHSA states they are “responsible for protecting every member of every community from the impact of infectious diseases, chemical, biological, radiological and nuclear incidents and other health threats.”

By not validating medical products widely used by the public, they are failing in their duties and responsibilities.

During her testimony on Day 3 of the Grand Jury Proceedings Soňa Peková, a molecular biologist from the Czech Republic, explained what the test accreditation meant

and how fraud was committed by Covid test manufacturers who simply marked their tests with this accreditation. 

Peková has been designing PCR tests since 2006, including tests to detect coronaviruses. 

Unsurprisingly, considering the business implications UKHSA identified, it seems that testing is the last measure the Government is planning to remove.

The British Medical Association (“BMA”) summarised the Government’s recent strategy for “living with Covid” in England. 

Regarding testing the Government strategy states that from April Fools’ Day: excepting for “at risk groups,” Government will no longer provide “free universal testing.”

What’s remarkable is ~99.7% of the population have been “living with Covid” for years, it’s Government diktats that people have not been able to live with.

 In their impact assessment UKHSA, at least, has told us what their priority is – business profits. 

It’s time for the Government to look the public in the eye and come clean."