The PCR Disaster: On the genesis and evolution of the "Drosten test"

By Illa – 50 Q&As – Unbekoming Book Summary

The test is the key to it all. Without a test, there’s no pandemic. No test means no cases, and no cases mean no pandemic.

It was always about the PCR test. It served as the primary prop in the illusion. The test transformed a healthy person (asymptomatic) into a sick person (a “case”). It was alchemy: turning water into wine.

This book effectively explains how they “reduced the gene targets” (Q7) early on, immediately inflating case numbers. However, the book assumes two key premises: that a new disease called COVID-19 existed and that it was caused by a “novel” virus. Reasonable people can disagree with both assumptions.

I believe the historical documentation of PCR corruption and fraud presented in the book is important and worth examining. What’s unclear to me is exactly what triggered the test to produce positive results. We were told that it “detected genes,” but genes, after all, are merely chemical sequences.

Even if we accept the official narrative, the PCR test never detected the “full virus”—it only detected fragments. As such, the test could never determine whether the detected “virus” in someone was actually infectious. The entire setup is a mess of lies and fraud, and even within their framework, it doesn’t make sense.

But if there was no new disease, as Rancourt and his team prove, and no novel virus, as demonstrated by the lack of a genuinely and properly isolated “virus,” it raises an obvious question: What exactly was the test detecting?

I remain open to the idea that diseases can be artificially triggered in populations—whether through EMFs, toxins, or the spraying of chemical agents. That would be a simple way to ignite public panic, which could then be amplified by the media’s relentless fear campaign. It’s a straightforward formula.

The fact that the test flagged healthy people suggests that the trigger is universal, embedded in everyone. Could fear itself create a chemical reaction that pings the PCR test? Or could it be detecting normal cellular debris caused by EMFs?

What exactly that trigger is, I don’t know—it could be anything. It is alchemy, after all.

The Pcr Disaster Genesis And Evolution Of The Drosten Test

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Deep Dive Conversation Library (Bonus for Paid Subscribers)

This deep dive is based on the book:

Discussion No.43:

23 important insights from “The PCR Disaster”

Thank you for your support.

Analogy

Imagine a highly respected security company develops a new motion detector for homes. The inventor originally designed it to detect large movements, like people walking through rooms. However, the company discovers they can make it much more sensitive - so sensitive it can detect a fly landing on a windowsill or dust floating in the air.

The company rushes this ultra-sensitive detector to market during a crime panic, skipping normal testing procedures. They partner with a global electronics distributor who starts mass-producing and shipping these detectors worldwide before independent testing is complete. The company also modifies the detector to be less discriminating over time - first it required three distinct movements to trigger an alarm, then two, then just one.

Soon, millions of these oversensitive detectors are installed in homes, businesses, and government buildings worldwide. They generate countless alarms, but no one can tell if they're detecting actual intruders or just picking up innocent movement like curtains swaying in the breeze. When homeowners or security experts raise concerns about false alarms, the company and government officials avoid answering direct questions about the detector's accuracy.

Meanwhile, police and policymakers start treating every alarm as a confirmed break-in, implementing curfews and restrictions based purely on alarm statistics, without confirming if actual crimes occurred. The security company and distributor profit enormously, while society bears the cost of responding to an endless stream of unverified alarms.

This mirrors how the PCR test - a tool designed for research - was adapted into an oversensitive diagnostic test, rushed to market through commercial partnerships, progressively simplified, and used to drive policy decisions without proper validation or willingness to address accuracy concerns. Just as an over-sensitive motion detector can't distinguish between an intruder and a floating dust particle, an over-amplified PCR test may not meaningfully distinguish between infectious virus and irrelevant genetic fragments.

With PCR, if you do it well, you can find almost anything in anybody - it starts making you believe in the, sort of, Buddhist notion that everything is contained in everything else. I mean, if you amplify one single molecule up to something you can really measure - which PCR can do—then there’s just very few molecules that you don’t have at least one single one of in your body...

It allows you to take a very minuscule amount of anything and make it measurable and then talk about in meetings and stuff like it is important. See, that’s not a misuse that’s just sort of a misinterpretation...

Those tests are all based on things that are invisible, and the results are inferred, in a sense. PCR is separate from that, it’s just a process that’s used to make a whole lot of something out of something. It doesn’t tell you that you’re sick and it doesn’t tell you that the thing you ended up with was really going to hurt you or anything like that.

Kary Mullis
Inventor of PCR and Nobel Prize laureate (1944–2019)

12-point summary

1. PCR Technology's Fundamental Limitations: The PCR test, while powerful for research, was never designed to diagnose disease. Its inventor Kary Mullis explicitly warned that it could find "almost anything in anybody" if amplified enough cycles, making it misleading when used for mass clinical testing.

2. Speed Over Scientific Process: The development and publication of the Drosten-Landt COVID-19 PCR test protocol occurred at unprecedented speed - going from concept to WHO publication in just days, and achieving journal publication in 27 hours. This pace bypassed normal scientific validation procedures and peer review processes.

3. Commercial Influences: The rapid deployment of tests revealed strong commercial interests. Test kits with Roche order numbers existed before the protocol's scientific publication, suggesting commercial production preceded proper validation. The partnership between TIB Molbiol and Roche demonstrated how business interests shaped the testing response.

4. Evolution of Testing Standards: Testing requirements were progressively simplified, moving from three genes to single-gene testing. This evolution prioritized speed and cost-effectiveness over accuracy, increasing false positive rates and reducing the ability to distinguish between active infections and mere viral fragments.

5. Cycle Threshold Concerns: The protocol specified 45 amplification cycles, exceeding the standard maximum of 40 recommended by experts. This high threshold could detect meaningless amounts of genetic material, creating positive results with questionable clinical significance.

6. Historical Pattern: The COVID-19 testing response followed a pattern established in previous outbreaks like SARS and swine flu, where rapid test deployment and commercial interests shaped the response. However, COVID-19 testing was unique in its scale and its impact on policy decisions.

7. Regulatory Oversight Failure: Government agencies demonstrated reluctance to address concerns about testing accuracy. The German Ministry of Health's non-response to formal inquiries and the Robert Koch Institute's evasive answers suggested systemic avoidance of testing validity questions.

8. Conflicts of Interest: Significant undisclosed conflicts of interest emerged in the test's development and publication. These included the dual roles of key figures as both authors and journal editors, and commercial interests in test production and distribution.

9. Quality Control Issues: Ring tests revealed concerning false positive rates, particularly with common cold coronaviruses. Despite these findings, quality control measures were often reduced rather than strengthened as the pandemic progressed.

10. Case Definition Impact: The reliance on PCR testing alone to define cases marked a significant departure from traditional epidemiology, where clinical symptoms and epidemiological links were previously required. This change fundamentally altered how the pandemic was measured and managed.

11. Global Distribution Network: A sophisticated global distribution system rapidly deployed tests worldwide through commercial channels, development aid, and international organizations. This network demonstrated the integration of scientific, commercial, and political interests in pandemic response.

12. Documentation Discrepancies: Test documentation revealed concerning inconsistencies, particularly in translations and intended use descriptions. The German version notably omitted critical limitations present in other language versions, raising questions about transparency and proper test utilization.

50 Questions & Answers

1. What is PCR technology and how was it originally invented?

PCR (polymerase chain reaction) was invented by Kary Mullis in 1983 through what he described as "an improbable combination of coincidences, naiveté and lucky mistakes" while driving along a moonlit mountain road. The technique allows for the creation of billions of copies of a single DNA molecule within hours using just a test tube, simple reagents, and heat. It can work with pure DNA or complex biological materials from various sources.

The method's power lies in its ability to find and amplify a single molecule in a sample, multiplying it by a factor of 100 billion - specifically, it works with a molecule section from which the presence of the whole molecule is deduced. For this groundbreaking invention, Mullis received the Nobel Prize in 1993.

2. Why is the number of PCR cycles significant in testing?

Each PCR cycle doubles the amount of target DNA present, creating an exponential increase. At 10 cycles, one molecule becomes approximately 1,000 copies; at 20 cycles, it becomes about 1 million; at 30 cycles, about 1 billion; and at 40 cycles, about 1 trillion copies. The inventor Kary Mullis stated that anything over 40 cycles indicated serious problems with the PCR process.

The cycle threshold becomes critical because too many cycles can generate false positives and unreliable results. The MIQE Guidelines (minimum standards for PCR experiments) suggest that values above 40 cycles are suspect due to implied low efficiency and generally should not be reported. Some experts even suggest limiting cycles to 35.

3. What are the basic components needed for PCR testing?

PCR requires a double-stranded DNA sample containing the target sequence to be amplified, along with primers that define the starting points of amplification. The process needs the enzyme polymerase, which duplicates the DNA, and the four nucleotides (A, T, G, C) that serve as building blocks for new DNA strands.

The reaction takes place in a device called a thermocycler, which controls temperature changes needed to separate DNA strands (above 90°C) and allow new strand synthesis (below 60°C). For COVID-19 testing specifically, an additional step is required to convert viral RNA into DNA before PCR can begin.

4. What are the key limitations of PCR as described by its inventor?

Kary Mullis explicitly stated that PCR cannot tell if someone is sick or if what was found would harm them. He emphasized that PCR merely makes many copies of something and that the results are inferred rather than directly observed. According to Mullis, PCR could find "almost anything in anybody" if amplified enough.

Mullis was particularly critical of using PCR for viral diagnosis, noting that finding viral fragments does not prove causation of disease. He emphasized that PCR's ability to amplify tiny amounts of genetic material could lead to misinterpretation when results are discussed as if they were significantly important.

5. How does PCR amplification work mathematically?

PCR amplification follows an exponential pattern where each cycle doubles the amount of target DNA. Starting from a single gene segment, after one cycle there are two copies, and doubling continues with each cycle: 10 cycles produce about 1,000 copies, 20 cycles about 1 million, 30 cycles about 1 billion, 40 cycles about 1 trillion, and 50 cycles about 1 quadrillion.

The mathematical progression demonstrates why the number of cycles is crucial - the difference between 40 and 45 cycles represents a massive increase in amplification, from 1 trillion to 35 trillion copies. This exponential growth also explains why too many cycles can amplify even minimal amounts of target material or contamination into apparently significant results.

6. How did the Drosten-Landt COVID-19 test develop in January 2020?

The test was developed at unprecedented speed in early January 2020, before the virus sequence was even published. Drosten and Landt created their test using SARS and other known coronaviruses as references. By January 9, they had designed their first test kit, and by January 11, Landt sent kits to Taiwan's CDC and Roche in Hong Kong without instructions.

The development process moved from the first WHO protocol on January 13 (testing three genes) to a modified version on January 17 (testing two genes), culminating in the Eurosurveillance publication on January 23. This rapid development occurred before there were even patients to test in Taiwan and Hong Kong, as the first cases weren't reported until January 21 and 22.

7. What was the significance of reducing gene targets from three to one?

The reduction from three genes to one represented a significant lowering of diagnostic standards. Originally, the protocol required testing the E gene, RdRp gene, and N gene, with the E gene serving as an initial screening test and the others as confirmation. The reduction first eliminated the N gene, then made the RdRp gene optional, leaving only the E gene test.

This simplification made testing easier and cheaper but significantly reduced specificity. The E gene test alone cannot distinguish between SARS-CoV-2 and other coronaviruses (sarbecoviruses). Scientists criticized this reduction, noting that testing multiple genes across the viral genome provides better evidence of an intact, infectious virus versus mere fragments.

8. How did WHO's testing recommendations change over time?

WHO's recommendations evolved from requiring multiple gene targets to accepting single-gene testing. In January, their protocols called for testing multiple genes with confirmation steps. By March 2020, WHO published new guidance stating that in areas with established COVID-19 virus circulation, screening by RT-PCR of a single discriminatory target could be considered sufficient.

This change was developed with input from several consultants, including Drosten, Koopmans, and Zambon, who were all co-authors of the original protocols and Eurosurveillance article. The simplified approach made testing easier but compromised accuracy and specificity.

9. Why was the E-gene chosen for single-gene testing?

The E-gene was selected because tests targeting it are inexpensive and have high sensitivity. However, this choice was controversial because the E-gene is not specific to SARS-CoV-2 but is common to other coronaviruses (sarbecoviruses). Originally, E-gene testing was meant only as an initial screening step to be confirmed by more specific tests.

When confirmatory testing was discontinued for endemic areas on WHO's recommendation, many laboratories, particularly smaller ones, began using only E-gene testing from April 2020. This choice prioritized cost and convenience over specificity, leading to false positives from detection of other coronaviruses.

10. What validation procedures were required for the tests?

For commercial tests, validation procedures should have included determination of analytical performance data, collection within assay validation, and verification through manufacturer testing. In-house tests required validation by the performing laboratory itself, following national and international guidelines such as RiliBäK and DIN EN ISO 15189.

However, the rapid deployment of tests, particularly in January 2020, raised questions about whether proper validation procedures were followed. The timeline between test development and distribution, especially for the first TIB Molbiol/Roche tests, suggests that comprehensive validation may have been compromised in favor of speed.

11. What is the historical relationship between Drosten and Landt?

Their collaboration began during the 2003 SARS outbreak, forming a profitable partnership that has lasted through multiple disease outbreaks. After their initial success with SARS PCR testing, they worked together on tests for bird flu, swine flu, MERS, and Zika. The SARS test marked the beginning of Drosten's rise to prominence, earning him his first Federal Cross of Merit.

Their partnership proved particularly lucrative during the 2009 swine flu outbreak, where Landt's company TIB Molbiol doubled its annual turnover. This pattern of collaboration on emerging viral threats established a template that would be repeated with COVID-19, combining Drosten's scientific authority with Landt's commercial test production capabilities.

12. How are TIB Molbiol and Roche connected?

TIB Molbiol and Roche maintain a symbiotic relationship dating back to the introduction of Roche's LightCycler device in 1998. TIB Molbiol designs test kits specifically for Roche's equipment, with their products carrying Roche order numbers and being distributed through Roche's global network. This partnership intensified after Roche acquired Boehringer Mannheim, which had initially collaborated with TIB Molbiol.

The relationship became particularly significant during disease outbreaks, where TIB Molbiol's ability to rapidly develop tests combined with Roche's global distribution network and dominant market position in diagnostics. This arrangement gave both companies a "First Mover Advantage" in responding to new disease outbreaks, as demonstrated with SARS, swine flu, and later COVID-19.

13. What role did WHO play in test protocol development?

WHO served as the primary channel for globally distributing the Drosten-Landt PCR protocol. The organization published their first protocol on January 13, 2020, followed by a modified version on January 17, both written by Drosten. These protocols set the international standard for COVID-19 testing, despite lacking traditional validation procedures.

WHO's involvement gave the protocols immediate global credibility and reach. The organization later modified its recommendations to allow single-gene testing in areas with established COVID-19 circulation, a significant relaxation of testing standards. This decision was made with input from several key figures who were involved in the original protocol development, including Drosten.

14. How was the Charité involved in test development?

The Charité, through its Institute of Virology directed by Drosten, played a central role in developing the COVID-19 PCR test. The institute's involvement extended beyond pure research through its commercial arm, Labor Berlin—Charité Vivantes GmbH, which was tasked with achieving "sustainable growth" through diagnostic services.

This dual role as both developer and commercial provider of testing created potential conflicts of interest that were not initially disclosed. The Charité's prestigious reputation lent credibility to the test, while its commercial laboratory stood to benefit financially from widespread test adoption.

15. What conflicts of interest emerged during test development?

Several significant conflicts of interest surfaced during test development. Drosten and Reusken were co-editors of Eurosurveillance while simultaneously being authors of the paper it rapidly published. Landt's ownership of TIB Molbiol and his commercial interest in test production were not initially disclosed, nor was Marco Kaiser's connection to another Landt company.

The commercial relationship between Labor Berlin (where Drosten and Corman worked) and test implementation was also not disclosed. These conflicts raised questions about the objectivity of the test's development and validation process, particularly given the unprecedented speed of publication and widespread adoption.

16. How quickly was the Drosten protocol published in Eurosurveillance?

The protocol was published with extraordinary speed - submitted on January 21, accepted on January 22, and published on January 23, 2020. This 27-hour turnaround from submission to publication was unprecedented in the journal's history, where even rapid communications typically took 20-30 days and regular articles averaged around 100 days for review and publication.

Statistical analysis of Eurosurveillance's publication timeline showed this paper as a dramatic outlier, being processed roughly 100 times faster than typical papers. This unprecedented speed raised serious questions about the thoroughness of peer review and the potential influence of the authors' editorial positions at the journal.

17. What concerns were raised about the peer review process?

Critics pointed out that proper peer review would have been impossible in the 27-hour window between submission and publication. The presence of ten significant methodological flaws suggested inadequate review. The dual role of Drosten and Reusken as both authors and journal editors raised questions about the integrity of the review process.

Scientists later requesting retraction noted that this expedited publication appeared to bypass normal quality control measures. They argued that the paper's flaws would have been caught by proper peer review, suggesting the speed of publication was prioritized over scientific rigor.

18. How did Eurosurveillance respond to criticism?

Eurosurveillance took over two months to respond to formal criticism of the paper, eventually issuing a defense that critics characterized as dismissive and lacking in scientific substance. Rather than addressing specific technical concerns, the journal offered general statements about emergency circumstances and the paper's utility in responding to the pandemic.

The journal's response focused primarily on defending the rapid publication timeline and addressing conflict of interest issues, while largely avoiding engagement with the technical and methodological criticisms raised. This response was seen by critics as further evidence of compromised scientific standards.

19. What was unusual about the publication timeline?

Beyond the unprecedented 27-hour turnaround, the publication timeline revealed several anomalies. The paper appeared before the virus sequence was publicly available and before there were confirmed cases in many regions where the test was sent. The timeline suggests test production was already underway before formal publication or peer review.

Documentation showed that commercial test kits with Roche order numbers existed before the protocol's publication, indicating parallel commercial development alongside the scientific process. This unusual timeline suggested coordination between commercial and scientific interests that preceded formal scientific validation.

20. What roles did journal editors play in the publication?

Two of the paper's authors, Drosten and Reusken, served as editors of Eurosurveillance, creating a clear conflict of interest in the publication process. Their dual roles as authors and editors raised questions about the independence and objectivity of the review process, particularly given the paper's unprecedented publication speed.

The editors' positions at the journal appeared to facilitate an extremely rapid publication process that bypassed normal review procedures. When criticism emerged, the editorial board's response suggested a protective stance toward the paper rather than an objective evaluation of the scientific concerns raised.

21. What are the three primary gene targets in PCR testing?

The initial PCR protocol focused on three genes: the E gene (encoding the viral envelope protein), the RdRP gene (part of the viral replication complex), and the N gene (producing the nucleocapsid protein). Each gene had specific purposes in virus detection - the E gene served as an initial screening tool, while RdRP and N genes were meant for confirmation of positive results.

The genes were selected based on their different roles in viral structure and function. The E gene is common across coronaviruses, making it useful for broad detection but less specific. The RdRP gene, involved in viral replication, and the N gene, which forms the protein shell around viral genetic material, were chosen for their greater specificity to SARS-CoV-2.

22. How does cycle threshold affect test results?

Cycle threshold represents the number of amplification cycles needed to detect viral genetic material. Each cycle doubles the amount of target DNA, creating an exponential increase. The higher the cycle number, while technically increasing sensitivity, also increases the risk of detecting clinically insignificant amounts of viral material or generating false positives.

The Drosten protocol specified 45 cycles, exceeding the standard maximum of 40 cycles recommended by PCR's inventor and other experts. This higher threshold could detect extremely small amounts of viral material, but raised questions about clinical relevance. As David Crowe noted, "if you cut off at 20, everybody would be negative. If you cut off at 50, you might have everybody positive."

23. What is the significance of primer design?

Primers are short DNA sequences that define where PCR amplification begins and ends on the target genome. The Drosten protocol's primer design was criticized for covering only roughly half of the virus genome, missing important viral regions and increasing false positive rates. Ideal primer design would target both ends of the viral genome to better distinguish between complete, infectious virus and mere fragments.

The placement of primers in highly variable regions of the viral genome created additional problems. This design choice made the test more susceptible to genetic variations and less reliable over time as the virus mutated. Critics argued that more stable regions of the genome would have provided more consistent results.

24. How do different genes indicate virus presence?

Different viral genes serve distinct functions in confirming virus presence. The E gene, while easiest to detect, is least specific as it's common to many coronaviruses. The RdRP gene, specific to viral replication machinery, and the N gene, coding for viral structure, provide more specific evidence of SARS-CoV-2 presence.

Testing multiple genes across the viral genome increases confidence in detecting an intact, infectious virus rather than just fragments. The progressive reduction from three-gene to single-gene testing represented a significant compromise in the ability to distinguish between active infection and mere presence of viral genetic material.

25. What technical flaws were identified in the protocol?

Scientists identified ten major methodological flaws in the Drosten protocol, including problematic primer design, inadequate temperature protocols, and inappropriate cycle thresholds. The protocol's concentration on gene regions subject to variation made it less reliable for long-term use. Additionally, the high cycle threshold of 45 exceeded established maximums.

These technical issues were compounded by the lack of proper validation studies and inadequate specification of positive and negative controls. The protocol's rapid development and implementation meant these flaws were not identified through normal peer review processes, leading to potential worldwide impacts on testing accuracy.

26. How did SARS testing in 2003 compare to COVID-19 testing?

SARS testing in 2003 operated under stricter criteria, requiring both clinical symptoms and epidemiological links before testing. The virus could only be detected in 40% of suspected cases, leading to scientific debate about its role as the causative agent. However, testing was limited to symptomatic cases, preventing the identification of asymptomatic "cases."

In contrast, COVID-19 testing in 2020 was conducted much more broadly, including asymptomatic individuals. The definition of a "case" changed to rely solely on positive PCR results, regardless of symptoms. This fundamental difference in testing strategy and case definition created very different pictures of the two outbreaks.

27. What lessons from the 2009 swine flu influenced testing?

The 2009 swine flu pandemic demonstrated how PCR testing could create a "case" epidemic without corresponding clinical impact. Testing increased dramatically during the normal flu season end, creating an apparent "first wave" in summer and "second wave" in autumn, though fatality rates remained low.

This experience showed how testing patterns could create the appearance of an epidemic through laboratory results alone. The financial success of test manufacturers and pharmaceutical companies during this period established a template that would be repeated with COVID-19, combining rapid test development with global distribution.

28. How did previous virus outbreaks shape test development?

Each major outbreak since SARS in 2003 strengthened the collaboration between Drosten and Landt, establishing a pattern of rapid test development and deployment. Their response to bird flu, swine flu, and MERS created a template for quick test production and distribution through established commercial channels.

This history of collaboration made possible the extremely rapid development of COVID-19 tests in early 2020. The established relationships between scientific authorities, test manufacturers, and global distribution networks enabled unprecedented speed in test deployment, though at the cost of proper validation.

29. What patterns emerged across different viral outbreaks?

A consistent pattern emerged of rapid test development followed by widespread implementation, often before traditional validation procedures were complete. Commercial interests consistently benefited from early market entry, while questions about test accuracy and clinical relevance were raised after implementation.

The financial success of test manufacturers and pharmaceutical companies during each outbreak created incentives for rapid response to new threats. This pattern culminated in the COVID-19 response, where previous relationships and procedures enabled test deployment at unprecedented speed.

30. How did test marketing evolve over different outbreaks?

Test marketing evolved from relatively limited deployment during SARS to increasingly global distribution with each subsequent outbreak. The partnership between TIB Molbiol and Roche became more sophisticated, combining rapid test development with worldwide distribution networks and marketing strategies.

By the time of COVID-19, the system for global test marketing was well-established, allowing immediate worldwide distribution through commercial and aid channels. This evolution reflected growing sophistication in combining scientific authority with commercial interests in response to disease outbreaks.

31. How were the tests commercialized globally?

TIB Molbiol distributed tests worldwide through multiple channels, including direct sales, partnership with Roche, and government aid programs. The German Ministry for Cooperation and Development's Rapid Expert Group on Health helped distribute test kits throughout Africa, Latin America, and Asia. This distribution was supported by workshops organized jointly by Roche and TIB Molbiol in various regions.

The tests reached diverse locations from Moldova to Dubai through WHO channels, and spread to locations like Malta, Puerto Rico, and Iran via the United Arab Emirates. By March 2020, test kits were being prepared for shipment to WHO at approximately 160 euros each, with TIB Molbiol running production continuously, including nights and weekends to meet demand.

32. What was the financial impact of test distribution?

The financial implications were substantial for both TIB Molbiol and Roche. TIB Molbiol had previously doubled its annual turnover during the 2009 swine flu outbreak, and COVID-19 testing represented an even larger opportunity. For Roche, as the world's largest pharmaceutical company with a dominant diagnostics division, the tests provided both direct profit and a means of acquiring new customers.

The business model extended beyond just test sales. Roche provided a complete pandemic supply chain, including PCR tests, antibody tests, and later antigen tests, planning to supply hundreds of millions of rapid tests monthly. This comprehensive approach, combined with their existing market dominance, created significant financial returns.

33. How were tests priced and marketed?

The tests were marketed through multiple channels with varying pricing strategies. TIB Molbiol positioned itself as a modest family business offering reasonable prices, despite being part of a million-dollar company network with substantial real estate holdings. The basic test kits were priced at approximately 160 euros each for WHO distribution.

Marketing emphasized speed and first-mover advantage, with TIB Molbiol and Roche promoting their ability to respond rapidly to emerging threats. The companies leveraged their experience from previous outbreaks, presenting themselves as reliable partners in emergency response while building long-term customer relationships through their testing infrastructure.

34. What role did development aid play in test distribution?

Development aid became a significant channel for test distribution, particularly through the German Ministry for Cooperation and Development. The ministry's Rapid Expert Group on Health, which included the RKI and BNI, was reinforced by staff from Drosten's Virological Institute at Charité to distribute TIB Molbiol test kits globally.

While presented as humanitarian assistance, this aid effectively served as market development for both TIB Molbiol and Roche. The companies conducted workshops in Africa early in the pandemic, combining training with test kit distribution, supported by organizations including the Bill and Melinda Gates Foundation.

35. How did commercial interests influence test development?

Commercial interests shaped test development from the earliest stages. The extraordinarily rapid development and deployment of tests in January 2020, before the virus sequence was publicly available, suggested preparation had begun earlier. Documentation revealed that test kits with Roche order numbers existed before the protocol's publication in Eurosurveillance.

The influence of commercial interests was also evident in the progressive simplification of testing requirements, making tests cheaper and easier to perform but less reliable. The reduction from three genes to one gene testing made the process more commercially viable while reducing its specificity and accuracy.

36. What approval processes were required for the tests?

The approval processes varied significantly between different test versions. The E-gene test received CE marking in February 2020, allowing its use for patient diagnosis in Europe. However, other components of the test system, including the N-gene and RdRP tests, remained classified for "research use only" yet were widely used in diagnostic settings.

This created a complex situation where some tests were being used diagnostically without proper approval. The approval requirements appeared to be circumvented in many cases through emergency authorizations or by simply proceeding without formal approval during the declared emergency.

37. How were emergency authorizations handled?

Emergency authorizations varied by region and created a patchwork of approvals. While Roche received Emergency Use Authorization from the US FDA for their Cobas SARS-CoV-2 test, the TIB Molbiol/Roche Diagnostics LightMix Modular tests did not receive this authorization. Some countries, like India, conducted their own evaluations and declined to approve these tests due to low concordance.

The emergency situation appeared to override normal authorization procedures in many cases. Tests were implemented widely before receiving formal approvals, with the urgency of the situation being used to justify bypassing standard validation requirements.

38. What documentation was required for test approval?

Standard documentation requirements included analytical performance data, validation studies, and specificity testing. However, the rapid deployment of tests, particularly in January 2020, suggested these requirements were not fully met. The timeline between test development and distribution left little time for proper documentation and validation.

The manuals accompanying the tests revealed inconsistencies in their intended use across different languages. For example, the German version omitted critical limitations present in other language versions, particularly regarding the requirement for significant respiratory symptoms in test subjects.

39. How did different countries approach test approval?

Countries varied significantly in their approach to test approval. Some, like India, conducted independent evaluations and rejected tests that didn't meet their standards. Others appeared to accept tests based on WHO recommendations or emergency authorizations from other jurisdictions without additional validation.

The urgency of the situation led many countries to accept tests without their usual approval procedures. This created a situation where tests that might not have been approved under normal circumstances were widely implemented based on emergency provisions or WHO guidance.

40. What standards were applied to test validation?

While standard validation procedures typically required extensive testing for specificity, sensitivity, and cross-reactivity, these requirements appeared to be relaxed during the pandemic. The MIQE Guidelines, which set minimum standards for PCR experiments, were not strictly followed, particularly regarding cycle threshold limits and validation procedures.

The rapid deployment of tests suggested that comprehensive validation standards were compromised in favor of speed. This was particularly evident in the acceptance of high cycle thresholds (45 cycles) that exceeded recommended maximums, and in the reduced requirements for confirmatory testing.

41. What quality control measures were implemented?

Quality control for PCR testing operated through different layers of oversight. Laboratory physicians were required to ensure quality-assured evaluation of tests, and laboratories had to participate in regular interlaboratory comparisons for quality assurance. INSTAND, a society for quality assurance in medical laboratories, conducted ring tests to evaluate test performance.

However, these quality measures revealed concerning results. The INSTAND ring tests showed that virus-free samples and samples containing common cold coronaviruses produced false positives - approximately 1% for some samples and up to 7% for others. These findings suggested that quality control measures were identifying significant problems that weren't being adequately addressed in clinical practice.

42. How were false positives addressed?

False positives received surprisingly little attention despite their potential significance. While the Robert Koch Institute avoided directly addressing questions about false positive rates, some laboratories acknowledged the issue. For example, a major laboratory in Bavaria reported 58 false positives out of 60 positive tests, attributing the errors to reagent shortages and compatibility issues.

Remarkably, rather than increasing scrutiny of positive results, the response to false positives was often to reduce confirmation requirements. The WHO's March 2020 guidance allowing single-gene testing in areas with established COVID-19 circulation effectively lowered the standards for confirming positive results, increasing false positive rates.

43. What cross-reactivity issues were identified?

Cross-reactivity emerged as a significant concern, particularly with the E-gene test. INSTAND's ring tests revealed that the tests could react positively to other coronaviruses, with one common cold coronavirus (HCoV 229E) producing false positives in nearly 7% of cases. This issue became especially relevant since the E-gene test was increasingly used alone without confirmatory testing.

The potential for cross-reactivity raised particular concerns about testing in settings like slaughterhouses, where animal coronaviruses might be present, and about increased false positives during normal cold and flu seasons when other coronaviruses circulate more widely. Despite these concerns, the issue received little attention in testing protocols.

44. How were laboratory standards maintained?

Laboratory standards were theoretically maintained through requirements for qualified personnel, regular participation in quality assurance programs, and adherence to national and international guidelines. However, the pressure of high testing volumes and reagent shortages sometimes forced laboratories to modify their procedures or use alternative detection agents.

The maintenance of standards became particularly challenging as testing expanded rapidly and requirements were simplified. The shift from multiple gene testing to single gene testing, while making the process easier and faster, represented a significant lowering of laboratory standards that had been established through previous experience with PCR diagnostics.

45. What validation procedures were required?

Official validation procedures called for extensive testing of analytical and clinical specificity, including cross-reactivity checks with other pathogens. For commercial tests, manufacturers were supposed to collect performance data and validate their assays. In-house tests required validation by the performing laboratory according to national and international guidelines.

However, the unprecedented speed of test development and deployment in January 2020 made thorough validation impossible. Documents revealed that commercial test kits bearing Roche order numbers existed before the protocol's publication, suggesting that commercial production preceded proper scientific validation.

46. How did test results influence case definitions?

Test results fundamentally changed the definition of COVID-19 cases. Unlike previous outbreaks like SARS, where case definitions required both clinical symptoms and epidemiological links, COVID-19 cases were defined solely by positive PCR results, regardless of symptoms or clinical presentation. This meant that asymptomatic individuals with positive tests were counted as cases.

This shift in case definition had far-reaching implications. The reliance on PCR testing alone meant that the number of "cases" could increase dramatically without corresponding clinical illness. The testing of asymptomatic individuals, combined with potential false positives, created a situation where case numbers might not reflect actual disease burden.

47. What impact did testing have on policy decisions?

Testing became the primary driver of public health responses and policy decisions. Case numbers derived from PCR testing influenced lockdown decisions, social distancing requirements, and other containment measures. However, these decisions were based on raw positive test numbers without consideration of false positive rates or clinical significance.

The focus on test results rather than clinical outcomes represented a significant departure from traditional epidemiological approaches. This testing-centered policy approach continued even as questions emerged about test accuracy and the clinical relevance of positive results at high cycle thresholds.

48. How were asymptomatic cases handled?

The handling of asymptomatic cases marked a major departure from previous outbreak protocols. While earlier outbreaks like SARS focused on symptomatic cases, COVID-19 testing included widespread screening of asymptomatic individuals. Positive tests in these individuals were treated as cases despite the absence of symptoms.

This approach to asymptomatic cases raised questions about the clinical significance of positive test results and the appropriateness of contact tracing and isolation measures for individuals who showed no signs of illness. The practice contradicted earlier statements by experts, including Drosten, who had previously advised against PCR testing of asymptomatic individuals.

49. What role did testing play in pandemic response?

Testing became the cornerstone of the pandemic response, with positive PCR results driving case counts, policy decisions, and public health measures. The ability to conduct mass testing using PCR created a new paradigm where laboratory results, rather than clinical observations, defined the scope and severity of the outbreak.

This testing-centered approach represented a significant shift from traditional epidemic management, where clinical cases and outcomes played a more central role. The reliance on PCR testing, particularly with high cycle thresholds and reduced confirmation requirements, created a situation where the testing response might have amplified the apparent scale of the pandemic.

50. How did government agencies respond to testing concerns?

Government agencies often proved resistant to addressing concerns about testing accuracy and reliability. The German Ministry of Health failed to respond to formal inquiries about false positive rates and test specificity, exceeding legal deadlines for response. The Robert Koch Institute provided evasive answers to similar questions, avoiding direct engagement with concerns about test accuracy.

This pattern of non-response or evasion suggested a reluctance to examine potential problems with the testing regime, even as evidence mounted of significant issues with false positives and test specificity. The lack of transparency from government agencies made it difficult to assess the true impact of testing problems on pandemic response.

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