(COVID-19) IGM/IGG RAPID TEST KIT OR WHAT IS STATED IN THE PERMIT FROM THE U.S. FOOD AND DRUG ADMINISTRATION?

Following the reaction of the Minister of Health, Venko Filipce, regarding over 50 positive cases diagnosed in the private hospital “Sistina”, which he said were not credible, “Sistina” also reacted.

The hospital’s response said their tests were being used in many developed countries and were a key tool in detecting the virus. They say the tests were purchased in the Netherlands, whose government approved the tests. They have filed criminal charges against anyone who publicly dissuaded citizens from testing in Sistina for “endangering public health through untrue information they place in the general public and spreading panic by spreading false news.”

Sistina also announced that “regarding the misinformation spread in the general public, which is related to these tests that are produced in the Netherlands and used by KB Acibadem Sistina, “The hospital will also inform the Dutch Embassy in our country.”

However, the Dutch embassy, ​​regardless of this debate in the society, addressed the general public with great news announcing a donation of new, quality molecular tests for North Macedonia.

“The Netherlands will support North Macedonia in the procurement of tests for the Coronavirus based on nuclear technology and developed by the International Atomic Energy Agency and the World Health Organization. The tests are expected to arrive in the country in a few days,” was said the statement from the Dutch Embassy in North Macedonia.

The tests that Sistina promoted

The tests used by Sistina, if researched online, it can be easily concluded that those who offer such tests on the market are very careful about the facts associated with this product. Among other things, there’s information about how the tests work, how they are used, but also how well tested and safe they are. Here is an example of a company that sells the same type of test as the one from Sistina, which has been the subject of a heated debate and even threats of criminal charges lately. The subject is about the company RayBiotech, which on its official website states that “antibody test results should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or ascertaining the status of the infection.” Just as a fact, this company has its offices in 41 countries around the world.

Additionally, if we try to find out whether other companies follow this example when it comes to Coronavirus (COVID-19) IgM/IgG Rapid Test Kit, we will notice that the company CellexCovid also uses identical text on its official website.

As stated: “qSARS-CoV-2 IgG/IgM Rapid Test is an aid in diagnosing patients suspected of having SARS-CoV-2 infection in relation to the clinical picture and the results of other laboratory tests. The results of the qSARS-CoV-2 IgG/IgM Rapid Test cannot be used as the sole basis for diagnosis.”

Why do most companies actually write this?

If you go to the official website of the U.S. Food and Drug Administration, it is easy to see that the specific test is permitted for use, but not because of meeting the standards and completed clinical trials, but because we’re talking about a pandemic and as indicated in the decision to issue a license for its use, at the given moment on April 1, it refers to the so-called “Emergency Use Authorization (EUA)” act – “Permission to use in emergencies.” In the permission of any company that will manufacture, pack and distribute this kit they are instructed to clearly state the facts as written in it. Among the facts already mentioned above, is that it cannot be used as the sole basis for diagnosis. The Federal Agency instructs patients to indicate the following:

– This test has not been tested and approved by the FDA

– This test is permitted for use by the FDA under the EUA – Permission to use in emergencies by authorized laboratories…

Finally, they emphasize that: No description or written material for any kind of promotion for the use of this test must not indicate or point out that this test is safe and effective in determining SARS-CoV-2.

We hope that with this text we have managed to clarify things at least a little bit, and to contribute to this debate from a slightly different angle.