At the Research Institute named after Pasteur spoke about the features of the test for cellular immunity

Russia has developed the world's first test to determine cellular immunity to COVID-19. Academician of the Russian Academy of Sciences, Director of the St. Petersburg Research Institute of Epidemiology and Microbiology named after V.I. Pasteur, Doctor of Medical Sciences, Professor Areg Totolyan.

– What is cellular immunity and how does it differ from the immunity that occurs after an illness?

Areg Totolyan: Almost everyone already knows that it is necessary to control the immunity to coronavirus, but today the most common indicator is the level of antibodies, which reflects the state of humoral immunity. There is also cellular immunity – this is a different population of cells – T-lymphocytes, B-lymphocytes, killer cells, memory cells and others – everything cannot be enumerated, for this you need to read the course of immunology, which is now impossible, but has already been established both in the experiment and by the results of scientific research a very important role of cellular immunity. There is no such universal test, which would be adapted specifically for diagnostics, for routine studies to assess specific cellular immunity.

At the Research Institute named after Pasteur spoke about the features of the test for cellular immunity

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FOLLOWING

We spent the first half of this year developing such a test. As they say, everything new is well forgotten old. I think everyone knows what the Mantoux reaction, the tuberculin test, is. This is the same, only instead of tuberculin, instead of the antigen for mycobacterium tuberculosis, another antigen is introduced, which is characteristic of the current strain of coronavirus. It is not the coronavirus itself, not its fragments, that are being introduced, but a hybrid protein is made, from the most important areas of the coronavirus that are most interesting for the immune system. Such a protein is found intradermally, a skin test is performed. After 72 hours, an assessment is made – this is the period of the maximum response of cells to a similar antigen.

– Why do you need a rapid test for cellular immunity?

Areg Totolyan: We are now moving on to the stage of testing the test. If he gets a start in life, we will have a convenient tool for selecting people who are indicated for either vaccination or revaccination. If we proceed from the assumption that the acquired immunity as a result of the transferred disease is not lifelong, but it will need to be restored periodically, then revaccination will be required, and the skin test will work to accomplish this task.

– Where are you planning to use it?

Areg Totolyan: It's very simple. If you remember the Mantoux reaction, this is put in a regular treatment or vaccination room. For the statement, there is enough nursing staff, and registration and registration after three days is more correct for a doctor, because it is important not only to register a positive or negative reaction, it is necessary to draw the correct conclusions – what follows: vaccination is indicated or not necessary.

– How safe is it?

Areg Totolyan: So far, he is absolutely safe. The tests, which had already been partially carried out, were limited. It is so established in science that the one who has developed something experiences, first of all, on himself. The developers of this test decided to follow scientific traditions, in March we conducted such limited tests on volunteers, and the developers volunteered. We made sure that it is absolutely safe, but theoretically we cannot exclude the limitation of the use of this test in case of systemic allergic reactions, in the acute phase of infectious diseases, allergic, autoimmune. These are all potential contraindications.

The nuance is to finally formulate them. This is why it is necessary to conduct full-scale tests that will precede the registration of the test.

– Are foreign colleagues interested in this development?

Areg Totolyan: No. I have no such information, but it is too early to talk about it. We will be ready to discuss this only after the test is registered in the Russian Federation.

– Are there similar developments in the world? How similar are they to yours?

Areg Totolyan: As for the skin test, I have not seen or heard. As for the assessment of cellular immunity, the development of simpler methods for assessing cellular immunity, yes, such studies are being carried out, including in our country. There are test systems at the development stage, but so far I have not seen registered test systems.

– At what stage of testing is the test now? What else are coming?

Areg Totolyan: These are full-scale tests. The test is developed, the developers are convinced that it works, it is informative. When we tried it on ourselves, we operated with the resource that our employees have. Some were sick, some were vaccinated with EpiVacCorona, some were not sick or vaccinated. We had all the three groups we needed. Such limited tests have already been carried out, this gives us confidence in the correctness of the path that we have chosen – we have proved to ourselves. Now it remains for us to prove to the rest. For this, it is necessary to conduct large-scale biosafety trials, including trials on experimental animals, and then clinical trials. Only after that it will be possible to apply for registration.

– When will the world's first test for cellular immunity be used everywhere?

Areg Totolyan: The answer is clear – at least registration is required. When it is registered, this is a fortune-telling on the coffee grounds, because it is much easier to develop than to register, and rightly so. The main requirement is safety. All these conditions are not accidental. If everything develops as we planned, I hope that such registration is quite possible in the fall.