PREVENTING the H5N1 False Positive Pandemic: The Urgent Need for Negative Controls, ΔΔCt, and Scientific Integrity NOT ARBITRARILY HIGH CYCLE THESHOLD CUT-OFFS in RT-PCR Testing
We have seen this before, it was called COVID-19 and the last time it led to lockdowns and millions of deaths of untreated bacterial pneumonia. We can stop this pandemic of false positives of H5N1.
HHS must convene an emergency re-assessment of the practice of the use PCR this way without back-up, sequence-based estimation of false positives and false negatives.
A pandemic of false positives looms on the horizon. H5N1, a virus with legitimate clinical concern, is being detected using RT-PCR tests in animals that rely on arbitrarily high cycle thresholds (Ct), EVEN THOUGH THEY ARE EMPRICALLY BASED, they are used PER SAMPLE without negative controls or verification through sequencing. If left uncorrected, the flawed methodologies that led to massive false positive COVID-19 diagnoses could now result in an equally devastating—yet entirely preventable—culling of livestock, economic collapse, and global panic.
We have seen this before. The misuse of non-quantitative RT-PCR (nonQ-RT-PCR) testing in COVID-19 led to mass quarantines, economic disruption, and policy failures based on inflated case counts. Now, the same high Ct values are being used in H5N1 testing, despite overwhelming evidence that non-specific amplification at these levels produces vast numbers of false positives. Worse still, the absence of rigorous negative controls and reliance on fixed Ct thresholds means that entire industries—including poultry, dairy, and livestock—could be decimated unnecessarily.
We are on the precipice of a crisis that is not virological but methodological. We must act now to prevent the H5N1 pandemic of false positives by enforcing scientific best practices: mandating negative controls, implementing the ΔΔCt method, and requiring Sanger sequencing confirmation for all positive cases.
Understanding Sensitivity (SN), Specificity (SP), False Positive Rate (FPR), and False Discovery Rate (FDR)
Scientific integrity in diagnostic testing depends on correctly interpreting Sensitivity (SN), Specificity (SP), False Positive Rate (FPR), and False Discovery Rate (FDR). These measures dictate how effective a test is at distinguishing actual infections from false positives.
Sensitivity (SN): The ability of a test to correctly identify those with the virus. High sensitivity ensures minimal false negatives but does not prevent false positives.
Specificity (SP): The ability of a test to correctly identify those without the virus. High specificity ensures minimal false positives.
False Positive Rate (FPR): The proportion of uninfected individuals incorrectly classified as positive. High Ct values increase the FPR by detecting non-specific amplification.
False Discovery Rate (FDR): The proportion of all positive results that are actually false positives. Studies have shown that at high Ct values (above 35), FDR can exceed 50%, meaning that more than half of reported "cases" may not be actual infections.
Why We Don't Use Overly Sensitive Tests in Other Fields: The CT Scan Analogy
To illustrate the dangers of excessive sensitivity and high false positive rates, consider CT scans for cancer. If doctors lowered the detection threshold too far, they would flag benign growths as cancerous, leading to far more deaths from infections from biospies than saved from the treatment of the cancers they detected. Not to mention th unnecessary treatments, surgeries, and psychological distress for patients. We do not diagnose cancer based solely on an overly sensitive test; we confirm with biopsies.
The same logic must apply to infectious disease diagnostics. Using RT-PCR with high Ct values without confirmatory sequencing is equivalent to diagnosing every shadow on a CT scan as cancer. This is not science; it is reckless misdiagnosis - and will lead to deaths due to mistreatment or lack of treatment.
The Flawed Science Behind RT-PCR Testing for H5N1
RT-PCR is a powerful molecular tool when used correctly, but its misuse as a diagnostic tool has already wreaked havoc during the COVID-19 pandemic. Instead of measuring viral load in a clinically meaningful way, RT-PCR tests have been AND ARE BEING misapplied with arbitrary Ct cutoffs as high as 37–40, leading to the detection of non-viable viral fragments and massive over-diagnosis.
The science is clear: beyond Ct 30, the probability of detecting infectious virus drops dramatically. By Ct 35, up to 91% of samples detected are non-culturable, meaning they do not contain viable virus. Studies, including those by Singanayagam et al. (2020), confirm that FDR (false discovery rate) increases exponentially at high Ct values. And yet, the FDA continues to approve tests that set Ct thresholds up to 38 for H5N1 detection.
High Ct values create a domino effect of misdiagnosis. The presence of non-viable RNA fragments is reported as a "positive" case, triggering containment measures, mass animal culling, and economic devastation. Every unnecessary culling of animals not only cripples food security but also increases selective pressure for viral mutations, heightening the actual pandemic risk.
The Role of False Positives in Policy Disasters
False positives in RT-PCR testing create an illusion of viral spread where none exists. The consequences are far-reaching:
Mass Culling of Healthy Animals: False positives in livestock surveillance programs lead to the unnecessary slaughter of millions of animals. This has already happened in past outbreaks, leading to severe economic and environmental consequences.
Collapse of Food Supply Chains: The destruction of poultry and livestock industries due to false positives can create artificial shortages, driving up food prices and leading to economic instability.
Public Distrust in Science and Public Health: As seen during COVID-19, when false positives lead to unnecessary restrictions, public trust in testing and public health erodes, reducing compliance when real threats emerge.
Diversion of Resources from Real Threats: Public health efforts must be directed towards actual infections, not statistical noise from improperly applied tests.
If this trajectory is not corrected, we will see an avoidable crisis unfold—one where testing policies, not viral spread, dictate public health disaster.
The Urgent Need for Negative Controls
One of the most egregious failures in RT-PCR testing for H5N1 is the absence of negative controls in routine testing. Negative controls are essential to detect contamination and non-specific amplification, ensuring that a reported positive result is truly due to the presence of the target viral RNA.
Without negative controls:
Laboratories cannot distinguish between true positives and background noise.
Cross-contamination between samples can inflate positive case numbers.
Laboratories are left guessing about the reliability of their results.
In stark contrast, best practices in molecular diagnostics—including forensic science and microbiological research—always use negative controls to ensure result validity. It is unacceptable that RT-PCR for H5N1, a virus with profound economic and public health implications, is being conducted without this fundamental safeguard.
Conclusion: A Call for Immediate Action
The world is on the brink of another diagnostic failure—one that could decimate livestock industries, destabilize economies, and create unwarranted public fear. We must act now to correct course.
Mandate Negative Controls in All H5N1 RT-PCR Testing: Every test run must include verified negative controls to eliminate contamination and non-specific amplification.
Implement ΔΔCt as a Standard for Viral Load Quantification: Abandon arbitrary Ct thresholds in favor of a scientifically validated approach.
Require Sanger Sequencing for All Positive Cases: No sample should be classified as "H5N1 positive" without confirmatory sequencing.
Re-Evaluate Past H5N1 Surveillance Data: Public health agencies must reanalyze past results, adjusting for false positives and correcting policy missteps.
End the Automatic Culling of Animals Based on NonQ-RT-PCR Alone: The economic and ecological consequences are too great to allow this reckless policy to continue.
The scientific community must stand against the misuse of molecular testing for H5N1 before false positives lead to a self-inflicted pandemic of fear and destruction.\
HHS must convene an emergency re-assessment of the practice of the use PCR this way without back-up, sequence-based estimation of false positives and false negatives.
We have the tools to prevent this. Now, we must have the will.
Missed Bacterial Pneumonia Cases Left Untreated Were the Majority of COVID-19 Hospital Deaths. In April 2020, I Warned About that the False Positive-Prone Non-Quantitative RT-PCR Was Deadly
Hospital protocolists sticking to the strict hand-me-down highly profitable “COVID protocol” may have doomed a majority of admitted COVID-19 patients to death due to a perfect storm of institutional failure.
What Would Happen if the PCR Test Were Disproven?
A blog article from 10/2020 was an early rational voice on False Positives. We are about to suffer badly due to OSHA's testing requirements due to work loss.
Lee S H. Evidence-Based Evaluation of PCR Diagnostics for SARS-CoV-2 and the Omicron Variants by Gold Standard Sanger Sequencing. Science, Public Health Policy and the Law. 2022 Nov 01; v4.2019-2024
Follow the Science, Not Mere “Authority”, on COVID19 PCR False Positive Rates https://jameslyonsweiler.com/2021/01/31/follow-the-science-not-mere-authority-on-covid19-pcr-false-positive-rates/
MORE:
Editorial
https://ipaknowledge.org/naat-evaluation-consortium.php
PCR COVID-19 False Positives Will Continue in 2022 - Unless We Act Now
https://popularrationalism.substack.com/p/pcr-covid-19-false-positives-will
https://www.researchgate.net/scientific-contributions/Sin-Hang-Lee-2150895983
We separated moms and babies at birth for 10 days for a positive PCR on mom, no symptoms. Yep, we failed.
"H5N1, a virus with legitimate clinical concern" ... Stop right there!
The few cases in humans for the last 5 years were not serious at all, just a bit of redeye and fatigue.
This looks like the best time to let H5N1 spread like chickenpox and generate herd immunity among fowl and make it endemic but also so humans are exposed casually and often at low doses. Why wait for the biowarfare labs to make an actual "Highly Pathogenic" strain or worse the BigPharma to gain momentum to jab everyone with their toxic and ineffective products?