FDA detected Endotoxin by Mass Spectrometry

The US FDA accepts Horseshoe Blood Limulus Amoebocyte Lysate (LAL) tests for Endotoxin in lieu of the Rabbit Pyrogens Test. Why don't they use reliable tests?

As mentioned in earlier posts Gram Negative Bacterial Cell fragments known as Endotoxin and its supertoxin Lipid A are deliberately¹ incorporated into the Pfizer Covid19 and Novavax jabs and are also present in AstraZeneca, Janssen, Moderna jabs because no technology was applied to remove them.

Endotoxin varies with species of Bacteria

A nice cryoelectron tomography image of a single E. coli bacterial cell showing the location of the toxin was published in 2019.²

Note the Inner Membrane (IM) and Outer Membrane (OM) (scale bar 200 nm), PeptidoGlycan (PG), LipoPolySaccharide (LPS), anchored to the membrane by the LPS Lipid A which consists of a β-1′,6-linked disaccharide of Glucosamine that is both phosphorylated and fatty acylated. The inner core (Kdo (3-deoxy-D-manno-octulosonic acid). (d) shows LPS modifications that occur in Salmonella.

Ingredients in the jabs can hide or mask the actual Endotoxin levels, as mentioned with EDTA and Polysorbate 80 in the case of AstraZeneca.

Here I expand on the False low Endotoxin measurements, which will have Legal implications because accurate reliable tests are available to quantify the toxic load.³

Crazy Variation in FDA Endotoxin Limits

Before getting into details of why you can’t trust any limits imposed on medical “devices” which includes jabs, here are a few limits in Endotoxin Units that have been found, largely not updated for decades and all based on the Horseshoe Crab LAL test.

Products that directly or indirectly contact the Cardiovascular system and Lymphatic system.

0.5 EU/mL or 20 EU/device

Devices in contact with Cerebrospinal fluid (e.g. Epidural), the limit is

0.06 EU/mL or 2.15 EU/device.

There is evidence that the FDA accepted an arbitrary limit of 5 EU/ml for Covid19 jabs and the European Union allowed 12.5 EU/ml.

FDA Mass Spectrometry Endotoxin Measurement

I used Mass Spectrometry⁴ to help identify new molecules I made starting in 1974.

In 1990 researchers in Sweden pointed to the inadequacy of the LAL test and reported a faster, more sensitive method based on gas chromatography and Mass Spectrometry.⁵

In 2004, chemical derivatization of the Lipid A fraction of Endotoxin was used to detect as little as 7 picogram per sample using Gas Chromatography combined with Mass Spectrometry.⁶

In 2012 Mass Spectrometry was used to identify a strain of Shigella that causes dysentery responsible annually for one million fatalities mostly among infants.⁷

In 2015 researchers in France⁸ proved that Mass Spectrometry could be used to detect Endotoxin where LAL tests failed.

The Eyes are especially sensitive to Endotoxin as mentioned in an earlier article.

In 2016 a rapid test using Mass Spectrometry was reported by researchers at the FDA in collaboration with Nanjing Normal University that could detect 30 picograms/ml Endotoxin in aqueous solution.⁹

Notice the very large molecular mass Endotoxin they were interested in, ranging from 10 to 40,000 Daltons. The technique relies on recognition of a series of fragments derived by smashing the larger molecule and can detect both positively and negatively charged ions, measuring the mass to charge ratio (m/z).

MALDI-TOF

Advanced technology called Matrix Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry allows the very accurate measurement of large molecules and their fragments.

Dangers of Undetected Endotoxin

Low Endotoxin Recovery (LER) is the most commonly used term to describe the failure to detect the actual toxin level in a jab of interest and has led to FDA and other regulatory authorities holding workshops on the hazardous implications.¹⁰¹¹

The hidden Endotoxin is also called “Masked”.¹²

Schwartz et al. demonstrated in 2017 that Citrate and detergents like Polysorbates can render the LAL test essentially useless as explained in their Figure 1.

Endotoxin Free E. Coli available but won’t be used

As discussed above, Pfizer wants the toxic Endotoxin, and especially its deadliest component in its jabs Lipid A to act as “Adjuvant” that they don’t have to pay for.

Genetic manipulation of E. coli to make a modified Lipid A, Lipid IV_A that does not trigger an endotoxic response in humans was published in 2015.¹³

But other scientists are so concerned, they developed Entoxin free E. coli for the purpose of safer drug self-assembling nanoparticle protein manufacture.¹⁴

False Spikeopathy experiments

Failure to measure Endotoxin in commercial Spike Protein has led to many False conclusions in studies of Spikeopathy which in turn misdirects attempts to ameliorate Jab Damage.

Call to Action

We need politicians and lawyers to apply the necessary levers to get the hidden Endotoxin measurements and the analytical methods used from the regulatory authorities who have caused deliberate Septic Shock in the global mass jabbing tragedy. Revealed measurements will be shown to underestimate the poison.

My next Substack will cover another highly reliable Endotoxin test based on Monocyte Cytokine storm.

1. Production of the Pfizer BioNTech mRNA jabs

2. Needham BD and Trent MS. 2019. Fortifying the barrier: the impact of lipid A remodelling on bacterial pathogenesis. https://www.nature.com/articles/nrmicro3047

3. Paid Subscriber Only Discussion Post

4. https://en.wikipedia.org/wiki/Mass_spectrometry

5. Sonesson A, et al. 1990. Comparison of the limulus amebocyte lysate test and gas chromatography-mass spectrometry for measuring lipopolysaccharides (endotoxins) in airborne dust from poultry-processing industries. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC184394/

6. Binding N, et al. 2004. Quantification of bacterial lipopolysaccharides (endotoxin) by GC–MS determination of 3-hydroxy fatty acids. https://pubs.rsc.org/en/content/articlelanding/2004/em/b309237b/

7. Casabuono AC, et al. 2012. Characterization of lipid A profiles from Shigella flexneri variant X lipopolysaccharide. https://www.infona.pl/resource/bwmeta1.element.wiley-rcm-v-26-i-17-rcm6306.

8. Pais de Barros J-P, et al. 2015. Quantitative lipopolysaccharide analysis using HPLC/MS/MS and its combination with the limulus amebocyte lysate assay. https://www.jlr.org/article/S0022-2275(20)35555-3/fulltext

9. Li H, et al. 2016. Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry.https://www.sciencedirect.com/science/article/abs/pii/S0003267016311333

10. FDA 2012. Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers

11. https://www.pda.org/pda-europe/news-archive/full-story/2016/08/29/pda-s-ler-task-force-holds-its-first-workshop

12. Schwartz H, et al. 2017. Biological Activity of Masked Endotoxin. https://www.nature.com/articles/srep44750

13. Mamat U, et al. 2015. Detoxifying Escherichia coli for endotoxin-free production of recombinant proteins. https://microbialcellfactories.biomedcentral.com/articles/10.1186/s12934-015-0241-5

14. Rueda F, et al. Structural and functional features of self-assembling protein nanoparticles produced in endotoxin-free Escherichia coli. https://link.springer.com/article/10.1186/s12934-016-0457-z