The claim

The federal government would have banned the Federal Office for Safety in Health Care (BASG) by law from examining the Covid-19 antigen tests for possible toxic ingredients. A privately financed laboratory analysis has now shown that the tests contained extremely toxic substances that would already have an effect on the skin. Since these substances are not declared on the packaging and leaflets in Austria, there would be a risk to physical safety, especially in school areas.

Our conclusion

According to BASG and DGUV, the amounts of toxic chemicals in the buffer solution are so small that no damage can occur even if used incorrectly. However, ideally neither children nor adults should come into contact with the liquid. The BASG has not received a test ban from the federal government. The buffer solution has been tested by other authorities in the European Economic Area and evaluated as harmless.

Who doesn't know the antigen tests that have been with us constantly in recent years. With routine, the utensils almost unpack themselves and for many of us it is hardly necessary to look at the package insert. But what is actually inside? What are these few drops of liquid called buffer solution? Why are these just a few drops and not much more?

The laboratory investigation of the “We-EMUs”:

The corporate alliance “We-EMUs – To Promote Society and Well-Being” examined four of these buffer fluids in a privately financed laboratory analysis. This revealed that sodium azide and also Triton X-100 are in the buffer liquid. These fluids, it is claimed, attack, kill and decompose human cells. They are considered highly toxic.

The press conference on the topic was broadcast on RTV private television and on several social media platforms. In fact, only a single forensic doctor spoke at the conference, alongside the president of the Vienna Animal Welfare Association, a lawyer, a teacher and a journalist.

What is sodium azide and what does it do in the Covid-19 test?

Sodium azide is the sodium salt of hydronitric acid. The University of Münster states that this is a substance with high toxic effects.

“Amounts of 5 to 10 mg can paralyze the optic nerve, cause profound fainting, etc. (effect is due to blockade of the cytochrome oxidase system). Very toxic to aquatic organisms can have long-term harmful effects in water bodies.

University of Münster – Sodium Azide (PDF)

In the Covid-19 antigen tests, this chemical acts as a preservative. It prevents the buffer solution from being contaminated by microorganisms or viruses before use.

Each buffer tube contains 0.1 mg to a maximum of 0.35 mg sodium azide.

What is Triton X-100?

It is a non-ionic surfactant from the group of octylphenol ethoxylates.

It can cause severe eye irritation and allergic skin reactions and therefore eye and face protection and gloves should be worn when handling the chemical.

In the Covid-19 antigen tests, this chemical acts as a solvent that can release the nuclear envelope protein from any virus particles that may be present. Each tube contains a total of approximately 350 μl (0.35 ml) of liquid. Of this total liquid, a maximum of 1.5% Triton X-100 should be present.

Here is the exact information from the studies on the amount of chemicals in the Covid-19 antigen tests

In February 2022, the German Statutory Accident Insurance Association (DGUV) will issue a four-page statement on the topic: “Ingredients of Corona (SARS-CoV-2) antigen rapid tests”.

Here it says in relation to sodium azide in the tests:

“For example, according to the manufacturer’s information, the extraction buffer of an antigen test contains 0.1% sodium azide (this corresponds to 1 mg/ml). The test kit comes with extraction buffer tubes prefilled with 350 µL (0.35 mL) of buffer each, ready for immediate use. Each extraction buffer tube contains 0.35 mg sodium azide . This is a very small amount if you compare it, for example, with a previously described therapeutic use of 0.65 - 3.9 mg, in which no damage to health occurred (for more detailed information see MAK justification paper 20031). However, the instructions for use from different manufacturers often indicate concentrations of sodium azide as “ less than 0.1 mg/ml ”. “There are therefore very low concentrations of sodium azide in these SARS-CoV-2 antigen tests.”

DGUV – Ingredients of Corona (SARS-CoV-2) rapid antigen tests (PDF)

Here it says in relation to Triton-X-100 in the tests:

“However, the concentration of these substances in the buffer solution of the corona antigen tests is very low. According to the manufacturer, the buffer of a product contains the detergent Triton-X-100 in a concentration of 1.5% . The buffer solution is mainly supplied in the test kit in pre-filled and sealed tubes that are ready for use. The liquid volume is very small and is approximately 350 μl (0.35 ml) per tube. If the test is used according to the instructions for use, contact with the buffer solution is extremely unlikely. However, due to the very low concentration of detergent in the buffer solution, there is no health risk even if the buffer is used improperly or accidentally comes into contact with the skin.”

DGUV – Ingredients of Corona (SARS-CoV-2) rapid antigen tests (PDF)

So it turns out that both toxic agents are found in the Covid-19 antigen tests in such small quantities that they cannot be harmful to health even if they are used improperly. Of course, children should only perform the tests under supervision and ideally no one should have contact with the buffer fluid.

Why are chemical substances needed in Covid-19 antigen tests?

The press office of the BASG (Federal Office for Safety in Health Care) argues as follows:

“All corona rapid tests available on the market contain chemical substances. Such a test would not be possible otherwise: they are necessary to get a reliable result. The task of a substance can be: It cracks the pathogen's shell to get to a special viral protein. This ensures that the test shows a positive test result in the event of an infection. The substance is also intended to kill any viruses that may be contained in the samples and ensure that the swab solution is non-infectious.”

Why are these substances not clearly labeled?

The BASG states that this is not legally necessary due to the low concentration.

Who examined the tests?

The accusation that the BASG did not examine the tests is actually true. However, according to BASG, the buffer solution of all tests was examined by another EEA (European Economic Area) authority and no legal deviations were found within the scope of the special approval. The tests were therefore granted temporary special approval.

Conclusion

According to BASG and DGUV (German Social Accident Insurance), the amounts of toxic chemicals in the buffer solution are so small that no damage can occur even if used incorrectly. However, ideally neither children nor adults should come into contact with the liquid.

The BASG has not received a test ban from the federal government. The buffer solution has been tested by other authorities in the European Economic Area and evaluated as harmless.

Update October 13, 2022

Due to several inquiries about this topic, we asked the BASG again. Here are our questions and the respective answers from BASG press management:

All rapid corona tests available on the market contain chemical substances. Otherwise such a test would not be possible. They are necessary to achieve a reliable result. One of the tasks of a substance can be to crack the pathogen's shell to get to a special virus protein. This ensures that the test shows a positive test result in the event of an infection. The substance is also intended to kill any viruses that may be contained in the samples and ensure that the swab solution is non-infectious.

The manufacturer information for all products also stipulates that the test is carried out under supervision or directly by an adult, as is done in schools. Four products from different manufacturers were subjected to analysis. The specific products can be found on the following website [ https://www.testfrei-gesund.at/analyse/ ].

For all products, the buffer solution in question is bottled in a separate container. According to the intended purpose, there is no contact between the user and the buffer solution. There is therefore no potential risk if the product is used compliantly. According to information on the website, tests were carried out using, among other things, the EN ISO 10993 standard. This standard deals with the biocompatibility of medical devices where contact between the product and the body is intended for the intended purpose. However, this does not apply to all products published https://www.testfrei-gesund.at/analyse/

Regardless, it should be noted that the EN ISO 10993 standard is not harmonized for products in accordance with the In Vitro Diagnostics Directive and therefore does not give rise to a presumption of conformity. This means that the legal rules for checking legal conformity for this type of product were not adhered to because an incorrect standard was used.

All buffer solutions consist of chemical substances that help the tests function correctly. To prevent the buffer solution from being contaminated by microorganisms before use, preservatives are included, for example. The need to label substances that can be considered hazardous depends on the type of substance, the amount and its concentration in the buffer solution. If this is below defined limits, no information is required on the label. It is therefore possible that a substance occurs in a buffer solution, but due to the low concentration there is no requirement for labeling.

According to the Federal Office for Safety in Health Care (BASG), the buffer solutions of individual diagnostics (rapid tests) and their labeling requirements were evaluated by an authority in the EEA within the framework of special approvals. According to the information available to the BASG, this evaluation covered over 100 antigen tests from different manufacturers, including products from the manufacturers named on the website. As part of this evaluation, this authority was unable to identify any deviations from the legal requirements. A temporary special approval was therefore granted for these products.

In the case of products for which hazardous substances were not identified on the labeling, this was not necessary in accordance with legal regulations due to the low active ingredient concentrations. Due to the testing activity of the EEA authority and its results, no parallel testing of the same products in Austria was indicated. In addition, it should be mentioned that an identification number is attached next to the CE marking in the images shown on the website.

It can be deduced from this that a so-called “notified body” (independent testing body) was involved in the conformity assessment procedure. In addition, the BASG requested a statement from manufacturers on a random basis as to whether substances subject to declaration were present in the buffer solution and whether the manufacturer was aware of any serious incidents due to the buffer solution. From the answers so far it can be seen that there is no obligation to declare the substances used and that no serious incidents have been recorded to date.

The addition of Section 113a of the Medical Devices Act (MPG) by Section 323 Paragraph 18 of the Federal Tax Code made it possible to use rapid tests for self-use in schools for SARS-Cov-2 diagnostics during the Corona pandemic (from January 23, 2021). The prerequisite for this was that the products had to be registered with the Federal Office for Safety in Health Care (BASG). This option ended in December 2021. However, the affected rapid tests for personal use were always subject to market surveillance for medical devices in accordance with Section 75 MPG. If health risks for the user of such products had been identified at a later date, measures would have been taken by the BASG.

As far as possible wording in the accompanying texts is concerned, the instructions for use for lay users mentioned do not contain any further information regarding the wearing of protective equipment. Such formulations come from a time when tests for professional users were also used by laypeople. However, this is no longer the case. You can easily see this: If there is a four-digit number after the CE mark, you can assume that it is a product for layperson use. Supervision during or implementation of the sample collection by an adult should guarantee proper sample collection and analysis. The BASG cannot assess the implementation of these aspects in the school setting.

Attached you will find an example of the wording of the accompanying text:

“(…) The instructions on handling laboratory reagents and in particular the use of protective equipment primarily refer to the professional use of the test when professional users (e.g. medical professionals) work with this substance with a certain frequency (e.g. several times a day). However, the concentration of these substances in the buffer solution is very low. The surfactant contained in the solution in a very low concentration has the function of deactivating the virus. The buffer solution containing the virus-deactivating surfactant is included in every batch of the SARS-CoV-2 Rapid Antigen test. When using the test according to the instructions for use, users will not have contact with the buffer solution at any time. This is delivered in pre-assembled and sealed tubes that are precisely pre-filled for individual use and ready for immediate use. No further steps are necessary, such as removing partial volumes. The sterile packaged swab itself does not contain any surfactants. Therefore, direct contact of a surfactant with the nasal mucosa is excluded. Due to the very low concentration of the surfactant in the buffer solution, there is no particular health risk even in the event of improper use, such as accidental contact of the buffer with the skin.”

We cannot answer the questions about the laboratory. We have no information about the laboratory, quality system, methods, methodological competence, etc. Therefore, BASG cannot make any statements about the reliability and comparability of any test results. With regard to the EN ISO 10993 standard used, we have already stated above that it is not harmonized for products in accordance with the In Vitro Diagnostics Directive and is therefore not suitable for a conformity assessment.

Author: Elke Haberl, Mimikama

Source:

University of Münster - Sodium azide (PDF) , DGUV - Ingredients of Corona (SARS-CoV-2) rapid antigen tests (PDF)
You might also be interested in: Vaccine mRNA detected in breast milk – experts give the all-clear


If you enjoyed this post and value the importance of well-founded information, become part of the exclusive Mimikama Club! Support our work and help us promote awareness and combat misinformation. As a club member you receive:

📬 Special Weekly Newsletter: Get exclusive content straight to your inbox.
🎥 Exclusive video* “Fact Checker Basic Course”: Learn from Andre Wolf how to recognize and combat misinformation.
📅 Early access to in-depth articles and fact checks: always be one step ahead.
📄 Bonus articles, just for you: Discover content you won't find anywhere else.
📝 Participation in webinars and workshops : Join us live or watch the recordings.
✔️ Quality exchange: Discuss safely in our comment function without trolls and bots.

Join us and become part of a community that stands for truth and clarity. Together we can make the world a little better!

* In this special course, Andre Wolf will teach you how to recognize and effectively combat misinformation. After completing the video, you have the opportunity to join our research team and actively participate in the education - an opportunity that is exclusively reserved for our club members!


Notes:
1) This content reflects the current state of affairs at the time of publication. The reproduction of individual images, screenshots, embeds or video sequences serves to discuss the topic. 2) Individual contributions were created through the use of machine assistance and were carefully checked by the Mimikama editorial team before publication. ( Reason )