The test systems of SARS-CoV-2 Antibodies of the Institute of Bioorganic Chemistry, RAS, are capable of detecting with high accuracy antiviral serum antibodies of three different classes (IgM, IgG, IgA) and can be used to identify patients with a potentially severe form of the disease.
Scientists from the IBCh RAS based on the Competence Center of the NTI IBCh RAS have found a way to identify contact with SARS-CoV-2 even in patients with an asymptomatic or mild form of the disease. New complex test systems almost eliminate the possibility of a false-positive test result due to cross-reaction with other common human coronavirus types. At the same time, they can detect not only antibodies of the IgM and IgG classes but also IgA antibodies to SARS-CoV-2 in human serum or plasma, which, in the conditions of clinical centers dealing with the treatment of coronavirus infection, can help in time to identify patients with a probability of severe course of the disease. The analysis time takes only 90 minutes. The kits are easy to use and safe for personnel.
Test systems for COVID19, created by specialists of the Competence Center of the NTI IBCh RAS based on the Institute of Bioorganic Chemistry. Academicians Shemyakin and Ovchinnikov, in cooperation with the Central Design Bureau of the Russian Academy of Sciences with the Russian Academy of Sciences and the Ministry of Science and Higher Education, have been certified by the Russian Federal Service for Surveillance in Healthcare and are now put into production.
The test systems are intended only for professional use in in vitro clinical laboratory diagnostics. Therefore, organizations can be provided with a comprehensive service for blood sampling and antibody analysis carried out by specialists from the Central Clinical Hospital of the Russian Academy of Sciences. Mobile laboratories have already begun work in Moscow and the Moscow Region and provide logistics for screening employees at workplaces (50–100 blood samples at a time). Any organization, including individual entrepreneurs, can purchase test systems.
Test systems are presented in four versions: general screening test (total determination of three antibodies at once: IgA, IgG, IgM) and three systems for determining a specific class of antibodies (IgA-, IgG- or IgM-antibodies).
The method of enzyme-linked immunosorbent assay (ELISA) is widely used in laboratories. It is the “gold standard” in the diagnosis of anti-infectious immunity. The technique gives the most accurate result and shows the number of immunoglobulins (antibodies) to coronavirus infection in human blood. Solid-phase ELISA is a variant of the test when the antigen is sorbed on a reliable carrier, for example, in the wells of a polystyrene plate. Unlike existing similar tests, which currently only allow the presence of IgG/IgM antibodies in human blood, the developed test systems show IgA antibodies' presence. Therefore, they make it possible to more accurately determine the quality of the immune response to the virus's effect and the stage of the disease.
Clinical studies of test systems were carried out at the Russian Academy of Sciences' Central Clinical Hospital. All four test systems were approved for circulation on the Russian Federation's territory by order of Roszdravnadzor. Manufacturing is carried out in a licensed pharmaceutical manufacturing facility.
The developed system can be used in clinical laboratory practice as an aid for the diagnosis of coronavirus infection, for screening blood tests of patients who seek medical help more than seven days after the onset of ARVI symptoms or have been in contact with COVID-19 patients, as well as for monitoring the epidemiological the situation among the population and assessing the extent of the spread of infection.
RVC is a governmental fund of funds, the Institute of Development of the Russian Federation. The main objectives of RVC to stimulate the creation of Russia's own venture capital industry and execute functions of the Project Office of the National Technology Initiative (NTI). The authorized capital of RVC is more than 30 billion roubles. One hundred percent of the RVC capital belongs to the Russian Federation represented by the Federal Agency for Management of State Property of the Russian Federation (Federal Property Management Agency). The total number of funds formed by RVC has reached 29. Their full size is 64.4 billion rubles. The share of RVC is 38 billion rubles. Funds with capital participation of RVC JSC invested more than 290 portfolio companies for a total amount of 23 billion rubles.
The NTI Competence Centres are units created based on educational or scientific organizations. The centres conduct research and educational activities in consortium with leading technology companies to develop “end-to-end technologies”. There are big data, artificial intelligence, quantum technologies, new and portable energy sources, wireless communication technologies, virtual and augmented reality technologies, etc. A total of 14 such centres have been created. The operator of the NTI Competence Centre project is RVC.