In the study there are simultaneously involved four groups of biologists from the Institute of Molecular Biology V.A. Engelhardt RAS, National Medical Research Center of Hematology of the Ministry of Health of Russia, the company "Genetico" and the Institute of Bioengineering RAS. TDuring the last day scientists do not get in touch on their social networks where they made a statement about the detection of antibodies to COVID-19.
In the press releases a few hours before they asked not to distract them, because in the cases with severe patients every minute counts.
At this stage the researchers are improving the sensitivity and specificity of the prototype antibody test for the new coronavirus. Keeping registries and studying people with developed immunity to COVID-2019 will also help to create a more detailed picture of the spread of infection in the population, which will significantly increase the effectiveness of measures to combat the epidemic.
Tests that our doctors work with today allow us to identify only infected people, but not who have been ill. The testing system under development will detect not the virus itself, but antibodies and immunity to it. With its help, it will be possible to identify people who have already been ill, including in an erased or asymptomatic form, and at the same time people who have not yet encountered the virus and do not have immunity to it.
The detection of antibodies to COVID-19 on April 4 was reported by the head of the laboratory, leading researcher at the Institute of Molecular Biology named after Engelhardt RAS (Moscow) Alexander Ivanov.
- Yesterday, for the first time, we managed to make and test the serological system on COVID-19. It is designed to identify ill people, including in an erased or asymptomatic form. We were able to generate a fragment of the Spike protein of the new coronavirus, isolate it, sorb it on a special plate and see that antibodies to the virus (IgG) appeared in the cells with the blood of the sick people, he said on his Facebook page.
In a 96-cell plate, there were serum from sick and not sick people, respectively, samples from sick people showed the presence of antibodies, they turned blue.
In the near future, scientists will have to scale the production of antigens to obtain the final version of the test for antibodies to COVID-2019.
The group of Grigory Efimov, the head of the laboratory of the Scientific Research Center for Hematology of the Ministry of Health of Russia, following the Ivanov group, managed to get another working immunity test prototype on April 6.
- Like colleagues, we do not determine the virus itself, but the presence of antibodies in the patient’s blood sample that bind to virus fragments and the amount of these antibodies. Why is it important? Because our test or the like helps to answer a very important question: was COVID-19 sick? Ill patients will have many virus-specific antibodies in their blood. In addition, a serological test is also useful for therapy. Firstly, treatment tactics may depend on the level of antibodies in the blood during an illness. Secondly, the blood plasma of recovered patients with a high level of antiviral antibodies can be used as a medicine for severe patients, ”says Grigory Efimov.
“New test systems can also help Hematology Center specialists conduct research and, if successful, find donors from among people who have already had coronavirus. As well as donors with antibodies, whose serum can be used to treat some patients, ”confirm the value of the development in the press service of the company“ Genetico ”.
The prototype is not yet a ready-made test for clinical use, and in order to bring the work to the end, you have to:
- To study the specificity and sensitivity of this test (the ratio of false positive and false negative results);
- If necessary, modify the test so as to increase sensitivity and specificity;
- Establish large-scale production of viral protein and ready-made diagnostic tests; “Register a test for clinical diagnosis,” Yefimov explains.
Scientists said that a highly specific antigen in the form of DNA in a plasmid for protein production was provided to Russia by the American laboratory of Professor Florian Kramer from Mont Sinai Hospital. Along with Russia, America provided samples to other countries, so similar studies are now underway in several laboratories in the world, including Europe and South Korea.
- The idea of looking at antibodies to find people who have been ill is quite reasonable. Of course, we must wait for measurements of the sensitivity and specificity of such a test. But it is clear that this will help to get a more detailed picture of the number of patients. Indeed, someone may become ill with the virus and not even know about it, ”says Alexander Panchin, candidate of biological sciences, laureate of the“ Enlightener ”Prize .
Can antibodies cure severe patients with coronavirus? Until the invention of the vaccine, the search for effective therapy remains relevant for the entire planet.
- This approach is already used to treat certain diseases. But unlike the immunity obtained as a result of vaccination, such passive immunity is rather short-term, nevertheless, this may be quite enough. Studies show how the antibodies obtained will be applicable in specific situations with coronavirus, ”the scientist notes.
In many respects, the success of antibody therapy is also determined by how long they have been in the patient’s status in the current status. Science has no exact answer to this question yet. There are hypotheses that the immune responses for the current coronavirus should be similar in duration to SARS SARS, outbreaks of which date back to 2002-2003.
Another difficulty in using antibody therapy is the need for careful and long-term monitoring of donor material before the possibility of its use:
- In simple terms, with donated blood plasma, you can enter not only antibodies, but also, for example, HIV, hepatitis C, syphilis. For minimum guarantees, therefore, the donor should not only be tested for infections, but also wait for the incubation period for them. In the case of HIV, this takes at least 120 days, after which you need to re-test for HIV and only then its biomaterial can be used. But whether antibodies to COVID-19 from the donor will remain active during this period is a good question. In addition, we still do not know how fast the coronavirus mutates. And we still don’t remember the problem of the availability of donor material, the compatibility of the material with the recipient by blood groups and many other parameters, ”says biotechnologist Alexei Petrov.
The virus is new, and, unfortunately, without extensive research, there will still be many unknown variables. How resistant is this passive immunity introduced to recipients (patients)? At what point is a recovered person absolutely not dangerous for others (was there a hypothesis that a cured person can infect others for another week)? Is it possible to hang on the ill tag “100% Immunity”, let go for walks or send to help the sick, or can he still be infected again? Answers to these questions are literally vital for doctors and doctors who are now at the forefront. To all of these questions, humanity has yet to answer, scientists say.
Nevertheless, the identification of hidden ills is an indisputable achievement in a global pandemic.
The more people we can test with the new system, test them for a transmitted infection (for contact with SARS-CoV-2), the more accurately we can predict the rate of infection, new “waves” of outbreak. In addition, having studied and counted people who have recovered, we can more clearly define risk groups and, on the contrary, remove those who do not need isolation from quarantine into active life.
The creators of the test plan to register the first Russian test system for antibodies to COVID-19 in the coming days. First of all, the tests will go to the laboratory, and after that they will be available for personal use.
“Our plans are to produce as much antigen to make this test system available in Russia. We have already begun work on the production of antigen, but we are also looking for new partners to speed up the process and reduce risks if something goes wrong during the complex process of biotechnological production in such a short time. Our task is to make it possible to produce a test system at several production sites at once, ”says Artur Isaev, Director of Genetico . - Estimated time to market the test system - 6 weeks. Now everyone is working 24/7, and every hour is important. I wish we were less distracted by the interview. ”
Grigory Efimov, head of the Hematology Research Center of the Russian Research Center for Hematology, publicly announced the search and involvement in research of recovered people with a confirmed diagnosis of COVID-2019 in the past . Scientists are asking such people to respond and donate blood. Fences are planned to be used to improve antibody tests.