12 Oct 2020

How accurate is the COVID-19 test system?

The UK government has drawn up plans to carry out up to 10 million covid-19 tests a day by early next year as part of a huge £100bn expansion of its national testing programme.  Critics have already rounded on the plans as “devoid of any contribution from scientists, clinicians, and public health and testing and screening experts,” and “disregarding the enormous problems with the existing testing and tracing programmes”, which some are saying has resulted in a misleading "Casedemic".

 
The increases which are widely reported in the media are now termed coronavirus “cases”. This terminology changed from COVID-19 deaths into coronavirus “cases” when the Gompertz curve rejoined the x-axis and PCR testing took over as a means of ‘informing’ the public.  

Previously, in the world of infectious diseases, it has been accepted that a ‘case’ represents someone with symptoms, usually severe symptoms, usually severe enough to require medical intervention and possibly be admitted to hospital.  However, now we stick a swab up someone’s nose,  even if they feel completely well and display no symptoms, and if some virus fragments are detected we call them a case of COVID-19.  But technically these are not clinical cases, they are merely swab results which cannot and should not be taken at face value.

This graph represents the current situation with UK "cases":


The following graph represents the current situation with UK deaths:


Not only is the terminology misleading but so are the numbers of “cases” which are a confounding metric because PCR test results are known to be very inaccurate, returning high numbers of ‘false-positives’.  A positive test does not necessarily mean that someone is sick or even infectious. Further, one person may be tested multiple times thereby generating multiple "cases".

The test is called a "COVID test", however it is actually testing for markers associated with the potential presence of the virus SARS-CoV-2, which for an unfortuante minority can sometimes lead to the disease COVID-19.

The test involves taking a swab of the inside of your nose and the back of your throat, using a long cotton bud, but as UK Prime Minister Boris Johnson stated early in the 'epidemic', when trying to defend decisions not to use the PCR swab testing kits at airports, the PCR test has probelms with inaccuracy, which he stated himself in a BBC TV interview as being as low as 7% accuracy

This was echoed by the First Secretary of State, Dominic Raab, who also stated in an interview on Sky News that the test has a very high false-positive rate and was only 7% accurate.

The inaccuracy of the test exists both with the sample collection method, the swabbing, which is vulnerable to the environment and other outside factors, and the way in which the sample is later analysed in the laboratory.

The 'specificity' of the PCR swab test is a crucial factor in determining the test's accuracy in terms of its ability to correctly assess who is negative, in other words who genuinely does NOT have the virus.  A test with a 'specificity' of 99%, if carried out within a population where the virus absolutely does NOT exist, will correctly indicate that 99 people out of every 100 do not have the virus, however it will falsely identify one person as having the virus when we know they do not actually have it.  This one person is what's called a "false-positive" result.

The Lancet - "The current rate of operational false-positive swab tests in the UK is unknown; preliminary estimates show it could be somewhere between 0·8% and 4·0%.  This rate could translate into a significant proportion of false-positive results daily due to the current low prevalence of the virus in the UK population, adversely affecting the positive predictive value of the test. Considering that the UK National Health Service employs 1·1 million health-care workers, many of whom have been exposed to COVID-19 at the peak of the first wave, the potential disruption to health and social services due to false positives could be considerable." (Ref)

"A recent BMJ review reported that the specificity of PCR tests could be as low as 95 per cent, as PCR test performance can be much worse in low prevalence community settings." (RefThis would mean that out of 10,000 tests, if only one person in every thousand people in the community actually had the virus, we’d have 500 false positives amongst the ten genuine positives. So hundreds of false-positive Covid-19 results would dwarf the genuine results – meaning an apparent surge in infections that is not followed by a corresponding surge in hospital admissions or deaths.

When analysed at the laboratory the sample's inaccuacy can be increased by the way in which the sample isteslf is magnified. The Centre for Evidence Based Medicine at Oxford University gives the following explanation -

"RT-PCR uses an enzyme called reverse transcriptase to change a specific piece of RNA into a matching piece of DNA. The PCR then amplifies the DNA exponentially, by doubling the number of molecules time and again. A fluorescent signal can be attached to the copies of the DNA, and a test is considered positive when the fluorescent signal is amplified sufficiently to be detectable.

The cycle threshold (referred to as the Ct value) is the number of amplification cycles required for the fluorescent signal to cross a certain threshold. This allows very small samples of RNA to be amplified and detected.

The lower the cycle threshold level the greater the amount of RNA (genetic material) there is in the sample. The higher the cycle number, the less RNA there is in the sample.

What does this mean?

This detection problem is ubiquitous for RNA viruses detection. SARS-CoV, MERS, Influenza Ebola and Zika viral RNA can be detected long after the disappearance of the infectious virus."

The Lancet published an article, "SARS-CoV-2 shedding and infectivity", reporting the same observations:

"For many viral diseases it is well known that viral RNA can be detected long after the disappearance of infectious virus.

With measles virus, viral RNA can still be detected 6–8 weeks after the clearance of infectious virus."

Public Health England (PHE) in a public information post on their website, "Assurance of SARS-CoV-2 RNA positive results during periods of low prevalence", acknowledged that there is a problem with the PCR coronavirus test system returning high ‘false-positive’ results when the virus prevalence in the community becomes low (Ref)

The UK Government Office for Science acknowledged in June that “When only a small proportion of people being tested have the virus, the operational false positive rate becomes very important”, and that “There are no published studies on the operational false positive rate of any national COVID-19 testing programme”. 

The following is a clip from BBC Newsnight regarding the known problems with the tests inaccuracy.  Unfortunately, the mainstream media is currently failing to give this problem the coverage it deserves, preferring instead to generate more fear over "case" numbers. 


New Zealand Family medical Doctor Sam Bailey, voiced her concerns about how the PCR test is being improperly used in her country to justify unnecessary measures.  She explains the importance of "pre-test probability" in relation to the likelihood of false readings.  Dr Bailey states that the PCR test is being used inappropriately and that it is only supposed to be used as a diagnostic tool, and not in the way that it currently is as a screening tool.
"There are major problems with this 'diagnostic test' in that it doesn't test for the virus. It tests for a piece of genetic material that we don't know the significance of. The PCR test has never been compared to a gold standard, because there is none for COVID19, and that in itself makes interpreting the accuracy of positive and negative results very problematic."
 
Dr Thomas Cowan explains that the PCR test may be vulnerable to abuse through the deliberate misinterpretation and misrepresentation of what its measurement actually demonstrates.  He states that the PCR test is only a surrogate test, and "in a situation where you are trying to prove causation you have to have a gold standard test"... "You cannot use a surrogate test to prove anything, and that is what is happening with these tests".

For two centuries, Koch’s postulates have set the gold standard for establishing the microbiological aetiology of infection and disease. He says, “That gold standard has not been met for SARS-COV-2.  In the wrong hands, this test process is fraught with problems, and through the alteration of test cycles, the test process can potentially be controlled to misrepresent the reality of our current situation.

 
British family General Practitioner and author, Dr Malcolm Kendrick, writing about the PCR test, states:

“[I]t is totally inappropriate to use RT-PCR as a screening test for a virus in an asymptomatic population when the prevalence of the infection is very low. 

Even if there were a test with 99% specificity, you would still expect to get 3500 false positives from performing 350,000 tests – which is still greater than the number of “cases” reported. When the number of “cases” is lower than your rate of false positives, then a positive result on its own is virtually meaningless.

The PCR test is best utilized as a diagnostic test to confirm the diagnosis of an infection based on clinical signs and symptoms. It certainly should not be used as a screening test when there is low prevalence of disease and should NEVER be used as the sole determinant in the diagnosis of a case.” …

Politicians and Health Officials are basing their numbers of cases entirely on the results of these tests, which are not fit for this purpose.

They are then using these figures to terrorise the population, and to justify decisions to impose local lockdowns, and increase nonsensical general restrictions which are having a massive impact on people’s lives and their health, and also on the economy, particularly hitting small businesses hard.”  (Ref)

 
The level of the PCR test’s inaccuracy was compounded further after May-June because of the very low virus prevalence in the community leading to a 90-100% proportion of false positives, which have in turn been misrepresented as clinical "cases".

With an increasing percentage of the general population starting to question the validity and basic lack of common sense behind many of the contradictory measures being imposed upon them, questions are being focussed on the actual numbers and what they really mean.  The term ‘casedemic’ is being used to describe the late summer epidemic of "cases" while hospitalisations due to COVID have remained extremely low. 

The following short film demonstrates how the UK epidemic waned in early summer, only to be replaced with an irrational and unscientific ‘casedemic.

 
It has been proposed that with the currently low virus prevalence in parts of the UK at only 0.11% according to the Office for National Statistics (ONS), the PCR test's realistic ‘positive predictive value’ is only 2%, with 98% of the positive results being false-positives. In areas of the UK, like the West Midlands or the South West, where virus prevalence is sitting at only 0.04% (ONS), the positive predictive value is lower at 0.75%, meaning that nearly all of "cases" could potentially be false positives in these very low prevalence areas. Explained here by Dr. Verkerk.

Leaked documents reveal a heavy reliance on the private sector to achieve the mass testing and give details of “letters of comfort” that have already been signed with companies to reach three million tests a day by December. Firms named are GSK for supplying tests, AstraZeneca for laboratory capacity, and Serco and G4S for logistics and warehousing.( Ref )  Its worth noting that GSK and AstraZeneca are heavily invested in a vaccine being the preferred exit route from this situation.

The test methodology in some countries is also introducing problems, as multiple samples are often taken in some test protocols, with any one positive sample over-ruling all the negatives, a bias which obviously leads to the false positive rate being considerably higher.

On March 5th 2020 some Chinese scientists reported that according to their analysis, based on reasonable assumptions for asymptomatic people (e.g. contacts of other cases), “the false-positive rate of positive results was 80.33%” [Ref].  This is based on a mathematical analysis using reasonable assumptions for the actual prevalence of the virus, and the performance of the test.  The best case, with the most optimistic assumptions, was still more than 40% false positives.

Some people have fully recovered from illness blamed on COVID-19, started to test negative, and then tested positive again.  According to a news report [Ref] patients are not considered cured in China until they no longer have symptoms, have clear lungs, and have two negative COVID-19 tests.  Despite this, 14% of discharged patients in Guangdong Province later tested positive, but with no relapse of symptoms.  This is very difficult to explain if the test is accurate, biologically much easier to explain if the RNA that the test is looking for is also associated with something else.  Later analysis showed similar results in Wuhan, with 5-10% declared to be “recovered” (negative tests after cessation of symptoms) later tested positive, often without symptoms [Ref].  Chinese scientists reported that 29 out of 610 patients at a hospital in Wuhan had 3-6 test results that flipped between Negative, Positive and ‘Dubious’ (undefined, but probably means a PCR cycle number between positive and negative) [Ref].  One patient, for example had three negative tests interspersed by two positive tests.  Others had one test result in each of the three categories.  This echoes what British GP Malcolm Kendrick stated in the above video interview.

Trust in this PCR test system was so low in some countries that random control samples were taken to test their validity.  In Tanzania samples were taken from a goat and a pawpaw fruit, which returned positive identifications for SARS-CoV-2, what the media would call more "cases" of COVID-19.

Covid-19 test kits in Tanzania have raised suspicion after samples taken from a goat and a pawpaw fruit came back with positive results, as the president said there were “technical errors”.” –The Independent Newspaper
Perhaps the best evidence is now what we see in the graphs and the data.  A picture paints a thousand words, and in the following graphics we can see the lack of association or correlation between the "cases" being produced by the PCR test system, and popularised by the media as part of their fear-mongering campaign, in relation to the actual number of deaths being attributed to COVID-19.
 
Dab to enlarge:
 
 
 

 

Please share and help others see that there is a serious problem with the testing system.