On October 1, Nearmedic Plus started mass production of the latest test systems designed to test for protective immunity to the SARS-CoV-2 virus, developed by the National Research Center for Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya under the Ministry of Health of the Russian Federation (the Gamaleya National Research Center).
The Gamaleya Center test systems’ principle of operation is based on the immunoenzymometric assay of class G immunoglobulins to the receptor-binding domain (RBD) of the SARS-CoV-2 coronavirus surface glycoprotein S (spike). The tests provide for detection of virus-neutralizing antibodies in the patient’s blood serum with a high degree of specificity, which allows them to be attributed as new, third-generation test systems.
The receptor-binding domain (RBD) is a special protein structure that is specific to the SARS—CoV-2 virus and is located on the «crown spikes». Using RBD, the virus binds to the receptor of a human cell and enters the cell. In this case, the human immune system detects the receptor-binding domains of the virus and produces anti-RBD antibodies in response, blocking the RB domains and thereby preventing the virus from entering cells. Anti-RBD antibodies present virus-neutralizing antibodies.
Thus, the new test systems provide for the detection of not just any antibodies to the virus in the body, but to determine whether a person possesses specific protective immunity to SARS-CoV-2.
The use of the test systems, under the registration name of SARS-CoV-2-RBD-IFA-GAMALEI, is planned for:
- verification of positive results for SARS-CoV-2 antibodies,
- determination of protective antibodies against SARS-CoV-2 in patients who have recovered,
- selection of donors for convalescent plasma used in the treatment of severe patients with coronavirus infection,
- determination of protective antibodies in vaccinated patients.
Nearmedic Plus is the manufacturer of SARS-CoV-2-RBD-IFA-GAMALEI test systems. The first batch has already been produced. In the near future, the company plans to start deliveries to medical institutions in the country.
«The fight against the global COVID-19 pandemic is the main task faced by the medical and pharmaceutical community. We need to understand that, while we are only getting closer to victory, we have not completely defeated the new coronavirus yet. There exists a very realistic threat of a second wave. At the same time, it is now necessary for businesses to have the ability to operate at full rate, and for children to be able to attend schools and kindergartens. Therefore, it is especially important, on the one hand, to identify and isolate infected people in a timely manner, and, on the other, to be able to assess actual risks of infection among other socially active citizens. The third-generation test systems developed by the N.F.Gamaleya National Research Center solve the problem of determining protective immunity, which guarantees protection from COVID-19. I am sure that they will be subject to the highest demand on the market, and I am proud that the N. F. Gamaleya National Research Center chose our site for the production of these unique test systems,» said Vladimir Nesterenko, head of the Nearmedic Group of companies.
Earlier, Alexander Gintzburg, Director of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya under the Ministry of Health of the Russian Federation, explained: «The test system developed by our center is a third-generation test system. Among all class G antibodies, it detects only those that directly neutralize the virus.»
The representatives of the Gamaleya National Research Center for Epidemiology and Microbiology noted that, even if a person had previously had the disease in its asymptomatic or mild form, the person cannot have a diehard warranty against re-infection with coronavirus since anti-RBD antibodies may have not been produced in sufficient quantities. Moreover, over time, the number of such antibodies in all patients tends to decrease. Only a vaccine can provide truly stable and effective immunity to the coronavirus. And before mass vaccination starts, passing an anti-RBD antibody test remains the most reliable way to accurately assess the risks of possible infection."
Nearmedic is a Russian pharmaceutical, biotechnological and medical group of companies specializing, among other things, in the production and introduction into medical practice of diagnostic test systems, other medical products, and medicines. At the company’s plant, a single production framework incorporates all technological processes: from the synthesis of raw materials to the production of ready-made preparations and reagent kits.