The company “System-biotech” (part of AFK “System”) received a registration certificate of Roszdravnadzor for a test system for the diagnosis of coronavirus infection COVID-19. Industrial production of new tests will take the Group of companies “nearmedic”.
The new test system has been successfully tested on real biological material, laboratory clinical research and technical testing, based on the Institute of epidemiology and Microbiology them. N. F. Gamalei, and the all-Russian research and test Institute of medical equipment (fsbi “VNIIIMT”).
The sensitivity of the test is confirmed at 100% in the studied samples. The system provides high accuracy of diagnosis of coronavirus by the laboratory analysis of biological material of Roto – and nasopharynx, including those people who suffers from COVID-19 in the light, almost asymptomatic form.
Test system is a standardized reagents for 100 or 400 reactions each. It does not require specific equipment, sophisticated training and allows you to get a response within hours, excluding sample preparation analysis in the laboratory. Thus is minimized the risk of infection of laboratory workers who have been working with neutralized after collection of the biomaterial with the virus.