Did Operation Moonshot inadvertently reveal the pseudo-pandemic?
The adoption of Lateral Flow Tests may have revealed more than intended.
The efficacy of mass population testing for SARS-COV-2 virus is critically dependent on the reliability of the test applied, whether it be a PCR or lateral flow test (LFT)
Our view is that PCR tests and lateral flow tests (LFTs) were adopted to enable mass testing resulting in associated high SARS-CoV-2 positivity to enhance the public perception of a pandemic.
The £200bn UK moonshot programme ultimately selected the Innova LFT. Unlike PCR this test did not inflate SARS-CoV-2 positives and thus revealed that 2020 through to 2021 was a pseudo-pandemic.
At the time few noticed how important this gap between LFT and PCR positivity was, or commentators still wrongly believed that PCR could be trusted in the right hands and simply ignored the low SARS-CoV-2 positivity from LFT tests.
The deployment of the Innova LFT may have inconveniently highlighted how bad the PCR testing was and how inflated the PCR positive numbers were, thus revealing very low SARS-CoV-2 positivity rates.
‘Coincidentally’ the FDA demanded the Innova LFT be withdrawn from the US market in 2021, despite it being the largest investment in a single medical test from a single manufacturer in human history.
It is conceivable that the FDA may have withdrawn the product simply because it exposed the inaccuracy of PCR, and this was an undesired outcome.
The UK DHSC distributed ‘re badged’ Innova FTAs as NHS tests, rather than Innova, tests shortly after the FDA decision.
The latest data available suggest LFTs are highly specific and reasonably sensitive and as such ‘better’ than PCR. Given this the motivation for the FDA decision is puzzling at best.
Without prejudice to any considerations as to whether such testing was necessary, desirable, counterproductive or cost-effective, the usefulness of mass population testing for SARS-COV-2 virus is critically dependent on the reliability of the test applied, whether it be a PCR or lateral flow test (LFT)1. We have previously written a series of articles about PCR tests here but to date we have not examined LFTs, which we do so in this article.
Why re-examine what we know about LFTs now? Keeping up with events during the ‘pandemic’ was difficult to do in real time but now sufficient time has passed that we can look at things in the round and with the benefit of more complete data and information from recently published studies, and therefore join the dots more effectively. Our motivation is to look back, as if we were scientific historians, to examine the wider picture given new evidence. Therefore, in this article we are looking at data and papers from 2020 through to 2023 with a particular focus on events in the UK and, to a lesser extent, the USA.
The claimed massive second wave of the pandemic between autumn & winter 2020 and early spring 2021 coincided with the mass testing program, including the routine testing of asymptomatic people returning to workplaces, schools etc. We were consistent in arguing that this claimed mass second- wave was a pseudo pandemic of false positives and we published many regular articles providing evidence of this, that can be accessed here and here.
However, increasingly the evidence from testing was used to counter our claim. In fact, even close colleagues who had originally agreed with our belief about this being a pandemic of false positives were swayed into changing their minds. For instance, whereas in this interview our colleague Dr. Clare Craig claimed, “We Are In A False Positive Pseudo-Epidemic”, in her book (pp 221) she recants, saying:
“…government testing did broadly work to diagnose the covid cases in the community. My concerns and those of others were exaggerated concerning the scale and true level of false PCR positives. We were wrong on the big picture for community testing.
The impact of false positives was therefore mostly felt in the community between covid waves, in people who never developed symptoms and in the diagnosis of hospitalisations and deaths.”
However, had we known at the time about the problems with PCR testing and had more insight into the accuracy of LFTs our own claim of a pandemic of false positives would have been strengthened, while colleagues like Clare may also have stuck to their original correct intuition.
In this article we would argue that based on what we know now about PCR, and more importantly what we now know about LFTs the evidence suggests there was no pandemic and the winter 2020/21 was indeed a pseudo pandemic of false positives which helped to create the appearance of a spreading disease2. Given this all commentators might wish to look again at this important period.3
Sonia Elijah wrote extensively about the scandal of the UK adoption of LFTs in the Conservative Woman in four parts titled ‘the Innova Scandal’ part 1, part 2 and part 3 and part 4. This article complements her investigative work by focusing on the accuracy of the LFT tests, compared to PCR, and what data from the use of both tests tells us about whether there was a ‘pandemic’.
Early studies on LFTs
Let’s start by looking at early studies on LFTs and what LFTs were adopted in the UK.
First some necessary background. When judging the accuracy of a diagnostic test we are interested in two statistics representing test accuracy:
Sensitivity – the probability that the test will be positive given you have the disease.
Specificity – the probability the test will be negative given you do not have the disease.
Typically, we more often talk of the false positive and false negative rates, which are simply the mathematical compliments respectively of specificity and sensitivity. A high false positive rate (low specificity) means we would be wrongly diagnosing people as having the disease who do not, and a high false negative rate (low sensitivity) means we would be overlooking people who have the disease.
Note that these test accuracy statistics are somewhat dry and abstract. What does a false positive actually mean? Does it mean the absence of the pathogen might be enough to trigger a false positive or can the presence of one or more competing pathogens trigger the false positive? Likewise, ‘legitimate’ false positives may be ‘cold’ in that they represent fragments of viral material. It matters but this is often glossed over.
The second mechanism, called cross reactivity, is also often overlooked, yet is crucial when understanding what is going on in testing. If a SARS-CoV-2 test is evaluated for cross reactivity against widely circulating pathogens, such as common colds, this tells us something different from a test against a known ‘true negative’ compound like water. After all, water does not cause respiratory symptoms, yet SARS-CoV-2 and common colds do.
Specificity can only be estimated by testing against the known universe of viruses but given we don't know the size of the viral universe there will be clear limits on what can be known. Hence no test can ever be 100% specific in principle. Additionally given that coronaviruses rapidly mutate and move in and out of animal reservoirs they present a moving target. Hence ultimately, we can't test against what we don't know exists and thus our tests can only have a limited longevity.
Also, it is worth bearing in mind that coronaviruses are highly seasonal so a test that appears specific when validation is done might not be during a different month of the year.
The WHO are keenly aware of cross reactivity as an issue. In September 2020 the WHO documented their interim guidance on diagnostic testing for SARS-CoV-2:
“Additionally, false positive (indicating that a person is infected when they are not) results may occur if the antibodies on the test strip also recognize antigens of viruses other than SARS-CoV-2, such as other human coronaviruses."
Thus, the way the test is evaluated is important. Evaluating a test against the pathogenic competition is a much more rigorous ‘gold standard’ than evaluating it against another test. However, what we find is that in 2020 and 2021 evaluation of LFTs was not being done against competing pathogens, but solely by comparing against PCR test results as if the PCR test result was indeed the ground truth, when plainly it was and is not.
In 2021 studies such as this compared LFT with previously collected positive and negative PCR test results rather than against the gold standard of cultured viruses or bacteria. They found that sensitivity ranged from 75.7% to 83.3% among evaluated LFTs and for the majority of LFTs specificity was 100% except for Lumipulse which was a very low 72.7%.
In this Dutch 2021 study they tested the Abbott Panbio LFT by comparing it against PCR finding test sensitivity of between 95% and 98% (when Ct-values were less than 32). They reported a specificity of 100%, but solely based on comparing against PCR without any evaluation of pathogenic cross reactivity.
If we look back even earlier in time to 2020 this study reveals that one kit, the Biocredit LFT, when compared against in-house PCR performed abysmally with between 28% and 81% sensitivity on high viral load SARS-CoV-2 samples.
A Cochrane study was done to assess the diagnostic accuracy of LFTs using data accumulated up to November 2020 and concluded that:
“Some antigen tests are accurate enough to replace RT‐PCR when used in people with symptoms. This would be most useful when quick decisions are needed about patient care, or if RT‐PCR is not available. Antigen tests may be most useful to identify outbreaks, or to select people with symptoms for further testing with PCR, allowing self‐isolation or contact tracing and reducing the burden on laboratory services. People who receive a negative antigen test result may still be infected.”
Hardly a ringing endorsement. Also, note that they say nothing about how these studies were conducted and simply assume comparison against PCR is sufficient and rigorous.
In the UK LFTs were deployed as part of operation moonshot on 23 December 2020, shortly after the vaccination programme rolled out on 8 December 2020. The operation was expected to cost £100bn but (thankfully) before it really got going it was subsumed in the test and trace programme run by Dido Harding. Despite the eye watering cost it was hailed as a game changer by the press.
The choice of LFT for operation moonshot was the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, shown below.
The Innova LFT was down selected from a list of 130 suppliers after desktop review, and 40 of these were referred to Oxford University/Public Health England Porton Down for review (Porton Down is also the location for the UK Ministry of Defence chemical and biological weapons research centre). The resulting report recommended the Innova LFT:
“Due to the rapid implementation of Innova for mass testing in the United Kingdom, the purchasing and roll-out decisions which have been made by DHSC, we have focussed on the performance characteristics (kit failure rate, specificity and viral antigen detection) of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.”
The reported false positive rate of the Innova LFT was 0.32%, though, again, all evaluations were done against PCR only. The joint (preliminary) report from Porton Down and the University of Oxford can be accessed here. The report is very hard to follow as none of the quoted test accuracy statistics can be deduced from the tables contained therein. The specific claims made in the report include:
Sensitivity 76.8% - in phase 3b 248/323 of the PCR positives were antigen positive.
Specificity 99.68% (one minus false positive rate of 0.32%)
Although the claimed specificity is very high, clearly the sensitivity is surprisingly poor. Despite this, the UK selected the Innova LFT alone.
In their report, published July 2021, on asymptomatic testing for SARS-CoV-2 using antigen detecting lateral flow devices the UK Health Secuity Agency (HSA) and the Department for Health and Social Care (DHSC) admitted that:
"There is currently no gold standard test for transmissible virus "
"As PCR is an imperfect gold standard"
The manufacturer documented that the kit was never designed for use on asymptomatic individuals (despite this fact it was rolled for regular testing of precisely this cohort)
Innova document many limitations of the procedure, including clinical history and infection prevalence, that end users would have been ignorant of.
One of UKHSA’s justifications for ‘test and trace’ was that frequency of testing was more important than accuracy. This paper simulated the test and trace approach using estimated test sensitivity values for PCR and LFT tests but it failed to formally consider the effects of test specificity, thus rending the simulation results moot. Despite this they still recommended regular testing with those suffering from the consequences of false positives as a mere side effect:
Isolating this second group of patients will have no impact on viral spread but will incur costs of isolation, as would the isolation of individuals who received a false-positive test result due to imperfect test specificity ….
The Innova LFTs were removed from emergency use authorisation by the medicines and healthcare products regulatory agency (MHRA) and replaced by a device ‘manufactured’ by DHSC. However, the test kits were the same kits manufactured in the same way by the same Chinese company!
In summary, what is clear is that up to the middle of 2021 the only independent verification of the specificity of LFTs looks to have been done via PCR. There don’t appear to be any reports on specificity testing for cross reactivity of the earlier test kits so we have little idea whether and how they might have cross reacted with other pathogens during this earlier phase of the ‘pandemic’.
Empirical experience of LFTs in the UK
It is important to note that the false positive rate tells us nothing about the proportion of positive tests that are false (defined as the “negative predictive value”) unless we know the underlying infection rate. Suppose, for example, that a test has a false positive rate of 1%. Then if the infection rate was 0.1% (1 in 1000) imagine testing 10,000 people. Only about 10 of these would be infected but, because of the 1% false positive rate, about 100 of the remaining 9,990 uninfected would wrongly test positive. That means only 10 out of 110 testing positives are infected, yielding a 91% negative predictive value.
This explains why, in the Cambridge asymptomatic testing study, although the false positive rate for the PCR test used was only 0.35% almost all those testing positive (87%) were false positives based on confirmatory testing.
Similarly, this BMJ article described the evaluation of the Innova LFT in mass test scenarios, including at the University of Birmingham with these results:
“We found two positives in 7189 students, which scales up to 30 per 100 000 and was shocking in itself, as Birmingham has a rate of 250 cases per 100 000…..Using PCR testing, the team retested 10% of the samples that had been negative with the Innova LFT and found six false negative cases, raising the rate to 60 per 100 000.”
The BMJ article quotes a tweet by Professor John Deeks saying:
“We thus estimate that we found 2 cases and will have missed 60 (because we only double tested 10%). We estimate the true prevalence to be 0.86% (95% [confidence interval] 0.40% to 1.86%) which is much more credible than the 0.03% test positive rate. Our estimate of overall sensitivity is 3.2%.”
Thus, by this calculation the Innova LFT had a sensitivity of just over 3%. Again, all verification was done using PCR as the gold standard (a very telling and implicit assumption).
In December of 2020 Public Health Scotland performed testing across universities and colleges showing only 0.2% positives in 43925 tests between 30th November and 12th December 2020 and of 31 LFT positives subject to confirmatory testing only 13 were confirmed by PCR as positive (42%).
In Wales the pilot project reported an LFT positivity rate that was below 0.7% from 2nd November to 13th December 2020, a period when PCR positivity was high.
The Covid-19 surveillance report from Public Health England in February 2021 compares LFT and PCR positivity nationally. From this we can see the positivity rate using the Innova LFT only starts to rise from week 50 of 2020 and then declines to false positive levels, of less than 1%, by week 4 of 2021, a period of only 6 weeks. What’s more it never exceeds 4% positivity in week 53 compared to a peak 18% PCR positivity that same week.
This difference in positivity between PCR and LFTs is remarkable and calls into question the assumption that PCR can be used as the gold standard validation test for LFTs under any circumstances. What is clear from the comments by Professor Deeks about the mass trials is that the very low positivity results shown by LFTs were unwelcome. And rather than abandon the trials and look afresh at both PCR and LFT tests they simply presumed the PCR tests were better oracles than LFTs and stuck with them.
However, rather than examine sensitivity we should instead focus on specificity, since our thesis majors on the fact that we have been over diagnosing a range of other respiratory infections as “covid”. What the empirical evidence shows is that the Innova LFT was likely much more specific than PCR and given this it was not cross reacting with other pathogens such as the common cold or influenza in the way that PCR tests maybe were. How so? Well during this period, the UK were running PCR testing using single gene positives rather than the two from three genes required by the WHO, as reported here.
These abuses of PCR testing help explain the large gap between PCR positivity and LFT positivity in the UK data: a difference of up to 14%, occurring when the peak (in week 53 2020) LFT positivity was approximately 4% whilst the PCR positivity was approximately 18%.
What is the explanation for this difference? Well, there are several explanations for why we would see inflated positivity in the PCR test: it was picking up false positives from competing winter cold or influenza viruses; it wrongly classifying tests as positive based on the single gene positive fraud; and there was well-known Ct threshold manipulation in which thresholds Ct well above 30 were used which are known to produce false positives. When we compare less specific PCR test kits with more specific LFT kits, which did not cross react with common colds etc. and did not suffer from the single gene positive or Ct threshold manipulation, were not ramped up for use in hastily constructed labs, we can only conclude the LFTs gave more accurate results. If we can safely assume that the LFTs are giving accurate results for SARS-CoV-2 then what does the UK LFT data tell us? Well, perhaps, by comparison, the LFT sensitivity looked low because PCR was ‘over calling’? If so, this tells us the positivity numbers derived from LFTs were more trustworthy and furthermore confirms that there was no pandemic.
The FDA Intervention
Given the UK went ‘all in’ with the Innova LFT, to the tune of £100bn, a test which supposedly has high accuracy, it should come as great surprise that on 10 June 2021 the FDA warned the public to stop using the test and demanded its withdrawal from the market.
“The test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it has been recalled by Innova Medical Group, Inc. “
The FDA go on to say:
“…..labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.”
Innova Medical Group recalled their test on April 23 2021 and received an official warning letter from the FDA which goes into specifics:
“More specifically, the labeling distributed for your 25T Configuration devices included a ‘Clinical Performance’ section, which claimed a Relative Sensitivity of 96% (88.75-99.17% CI); a Relative Specificity of 100% (98.34-100% CI); and an Accuracy of 98.98% (97.06-99.79% CI). This level of clinical performance for the 25T Configuration devices appears unsupported by any clinical data including both clinical performance data submitted to FDA in your Emergency Use Authorization (EUA) request…..”
“Similarly, the labeling distributed for your 7T Configuration devices included a Performance of Prospective Clinical Study” section based on a prospective clinical study conducted by third-party investigators in UK in September and October 2020” which claimed a Positive Percent Agreement of 81.4% (74.3-88.4% CI). This PPA for the 7T Configuration devices does not appear to align with the PPA observed in the phase 3b prospective clinical study conducted in the United Kingdom. Accordingly, the clinical performance estimates reported in the labeling of the 25T Configuration and 7T Configurations devices are false or misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices.”
The UK study it is referring to is, of course, the Porton Down and Oxford University study discussed earlier in this article. That report concludes the sensitivity was 76.8% and specificity was 99.68% yet the FDA are quoting Innova as claiming a sensitivity of 96% and a specificity of 100%. A remarkable difference between claim and reality.
The FDA letter goes onto state that:
“Separate and apart from the foregoing issues, FDA further notes that the clinical study data you submitted in your EUA request for the SARS-CoV-2 Antigen Rapid Qualitative Test was identical to data previously provided by other manufacturers in their separate EUA requests.”
The FDA also raise issues relating to procedures for control and distribution to ensure only approved devices are distributed and that kits manufactured in China are inspected, tested, or verified.
The Chinese connection is interesting. Innova looks to be a brand name listed along with Xiamen Biotime as the producers of the Innova LFT here. Notice it is odd that their test passed on September 11th 2020 two months before the Porton Down University of Oxford evaluation.
So not only were Innova found to be making inaccurate claims about their LFTs, but numerous issues were found in the submitted data and quality control procedures. And this is for a test that the UK adopted for operation moonshot to the tune of £100bn.
To date Innova still do not appear on the FDA approved list of suppliers.
The big question is: why did the FDA force the withdrawal of the Innova LFT from the market? Plainly the product description was inaccurate and there appear to be other issues serious enough to warrant withdrawal, but we can speculate that there was maybe some other motive.
Assuming the Innova LFT was not sensitive but was specific, meaning that it did not cross react with competing pathogens but did not perform well in detecting SARS-CoV-2, did the FDA reject it because it was ‘too good’ compared to PCR? This is a highly speculative question of course, but if the aim of testing was to maximise positivity to deliver a pseudo-pandemic, then a test that minimised false positives whilst maximising false negatives would not meet requirements. on the other hand, if we give the benefit of the doubt and assume the authorities genuinely believed false positives to be a lesser health risk than false negatives, because SRS-CoV-2 is so deadly, then the Innova LFT test would not fit the bill. Either way the Innova LFT would need to go.
By 18 June 2021 the UK DHSC were distributing DHSC self-branded tests within the UK. Photographs of box labels show these tests were clearly Innova LFT tests, manufactured by Xiamen Biotime. Is it a coincidence that the UK DHSC were claiming to be the manufacturer, rather than Innova, and were distributing them as NHS Covid-19 tests shortly after the FDA decision?
Have LFTs improved since 2020/21?
Even though LFT kits in 2020 and into 2021 had a shaky provenance given the untrustworthy studies that evaluated accuracy against PCR alone, by 2023 LFTs were being reported as being very specific and sensitive.
Instand produced a report in 2023 based on three quality assurance surveys they undertook in 2021, the first one taking place in March 2021. In total 168 participating laboratories were sent a very small number of SARS-CoV-2 samples along with negative lysate and alpha (hCoV 229E and hCoV NL63) coronaviruses as controls. For LFTs the specificity on NL63 was 98.7% and for 229E was 99.3%. They concluded that the sensitivity for SARS-CoV-2 is at least 94% for LFTs. Note that Instand did not test rhinoviruses (HRV), which cause over 50% of all common colds or hCoV OC43.
In August 2023 the Lancet published a study comparing seven commercial LFTs finding there was no cross reactivity with a comprehensive list of respiratory pathogens. They tested the four endemic human coronaviruses (HCoV‑229E, HCoV‑NL63, HCoV‑OC43, or HCoV‑HKU1), enterovirus, rhinovirus, influenza, HPIV, RSV, mycoplasma pneumonia, adenovirus, bocavirus, influenza A and B, legionella pneumophila or MERS-CoV and SARS-CoV. All manufacturer products (Abbott, RapiGen, Coris Bioconcept, nal von minden, Roche Biosensor) performed well on the tests except for Healgen, which suffered a catastrophic failure cross reacting with HPIV, influenza, adenovirus, and rhinovirus.
So, by 2023 LFT sensitivity is at least 94% according to Instand. Furthermore, these studies were done by challenging LFTs using actual pathogens rather than us PCR as the gold standard. This therefore presents a significant difference in accuracy, and a step up in trustworthiness, compared to LFTs in 2020 and 2021. It looks like LFTs were always quite specific and did not cross react and this capability was maintained between 2020 and 2023, but over that time period the sensitivity improved considerably.
This latest data available suggest LFTs are highly specific and reasonably sensitive and as such ‘better’ than PCR. Given this the motivation for the FDA decision is puzzling at best.
Conclusion and discussion
The efficacy of mass population testing for SARS-COV-2 virus is critically dependent on the reliability of the test applied, whether it be a PCR or lateral flow test (LFT). Our view is that PCR tests and lateral flow tests (LFTs) were adopted to enable mass testing with associated high SARS-Cov-2 positivity to enhance the public perception of a pandemic. The £200bn UK moonshot programme selected the Innova LFT. Unlike PCR this test did not inflate SARS-CoV-2 positives and thus revealed that 2020 through to 2021 was a pseudo-pandemic. At the time few noticed how important this gap between LFT and PCR positivity was, or commentators still wrongly believed that PCR could be trusted in the right hands and simply ignored the low SARS-CoV-2 from LFT tests. The deployment of the Innova LFT may have inconveniently highlighted how bad the PCR testing was and how inflated the positive numbers were. ‘Coincidentally’, the FDA demanded it be withdrawn from the US market in 2021, despite it being the largest investment in a single medical test from a single manufacturer in human history. It is conceivable that the FDA may have withdrawn the product simply because it exposed the inaccuracy of PCR, and this was an undesired outcome. Furthermore, why were the UK DHSC distributing ‘re badged’ Innova FTAs as DHSC manufactured NHS Covid-19 tests, rather than Innova tests, shortly after the FDA decision?
Some open questions remain about that has happened over the three years of the ‘pandemic’:
Why was LFT technology tested in 2020 against PCR rather than by being challenged by potentially cross-reacting pathogens?
Why did we have to wait for cross reactive pathogenic testing until later in the pandemic and not report this until 2023?
Was ‘better’ LFT technology delayed until after the vaccine roll out, and if so, what was the reason?
Also, it might be claimed that PCR wasn't the only gold standard available. Perhaps watching to see who developed symptoms and antibodies would have been the most clinically meaningful alternative and provided a truer gold standard?
In the absence of open, transparent evaluation there remains the possibility that neither test should have been trusted. Some commentators have adopted this position and with some justification especially given the virus was not risk-additive. Consequently, all covid-19 statistics would then be tainted, all clinical trials voided, and many death certificates rendered meaningless. Even if tests were 100% sensitive and specific there could have been multiple viruses causing the same symptomatic illness, where the real danger is pneumonia, so the value of any test is questionable.
Note that this article has only discussed events up to the winter 2020/21. We have deliberately avoided discussion of LFT or PCR accuracy after the vaccination programmes were launched. We have avoided discussion of this later period because we believe the situation became more complex given the potential interplay between the evolution of the virus and those vaccinated. The potential for viral shedding post vaccination massively complicates any assessment of viral prevalence because it would be hard to disentangle natural infection and infection related to vaccination, either by vaccination enhancing vulnerability to infection or via vaccine shedding giving the impression of infection.
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Also known as rapid antigen test (RAT) and rapid antigen detection test (RADT), lateral flow device (LFD), antigen-detecting rapid diagnostic test (Ag-RDT), antigen rapid diagnostic test (Antigen-RDT), point of care (POC) test, rapid test.
Note that even if the tests had had excellent specificity and sensitivity, the fatality rates still were not high enough for the ‘event’ to have justified being labelled a pandemic.