Federal research centre “fundamentals of biotechnology” RAS is developing tests for the rapid diagnosis of coronavirus infection. Created sets represent an immunochromatographic test strip for detection of antibodies to SARS-CoV-2 in blood, plasma or human serum. These tests allow to separately detect antibodies IgM and IgG – the presence of IgM indicates active phase of the disease, and IgG in a person without symptoms may indicate that he has chickenpox and has immunity.
Design tests within 10-15 minutes, provide a result in the form of painted lines on the test strip and can be used in field-conditions without the involvement of medical personnel.
The development is conducted with the participation of leading Russian research centers, including the SMRC Hematology Ministry of health of Russia, Institute of molecular biology. V. A. Engelgardt of RAS, Institute of Bioorganic chemistry. M. M. Shemyakin and Y. A. Ovchinnikov Russian Academy of Sciences and Biological faculty, Moscow state University. M. V. Lomonosov.
At the moment, in FITS of Biotechnology RAS developed a prototype immunoassay system. In cooperation with the company “Genetic”, conducted testing of prototypes in the serum of the patients. Shows a successful detection of antibodies to SARS-CoV-2.
In the next month after the confirmation of the analytical characteristics of the test system is planned to carry out extended trials for registration in Roszdravnadzor, as well as the start of serial production. Available in FITZ Biotechnology RAS infrastructure will allow to produce up to 100 thousand tests per month.