On April 16, 2020, the innovative biotechnological company Sistema-Biotech (part of the Sistema Group of companies) received a registration certificate from the Federal Service for Healthcare Supervision (Roszdravnadzor) for a test system designed to diagnose COVID-19 coronavirus infection. Industrial production of new tests for coronavirus will be carried out by the Nearmedic Group of companies.
The registered test system was successfully tested on real biomaterial, and underwent laboratory clinical studies and technical tests on the basis of the
N.F. Gamaleya Research Institute of Epidemiology and Microbiology and the all-Russian Research and Testing Institute of Medical Technology (VNIIIMT), a subordinate expert institution of Roszdravnadzor.
According to the results of control procedures, the sensitivity of the test was confirmed at the level of 100% in the studied random sampling. The system provides high accuracy of diagnosis of coronavirus by laboratory analysis of biological material from the mouth and nasopharynx, including those people who have a mild, almost asymptomatic form of COVID-19.
The test system is a standardized kit of reagents designed for 100 or 400 reactions each. It does not require specific equipment, complex training of personnel and allows one to get the answer within an hour without taking into account the preparation of samples for analysis in the laboratory. At the same time, the risk of infection of laboratory employees, who have to work with the virus that has already been neutralized after the biomaterial had been taken, is minimized.
«Our test system uses components exclusively made in Russia. This allows one to maintain the cost of the system at a competitive level and, along with safety and ease of use, makes it available for widespread introduction. Production of diagnostic kits has already been launched at the Nearmedic Pharma plant in the Kaluga region. At the first stage, we plan to produce up to 50 thousand tests per week, followed by an increase in capacity to 200 thousand tests. We are also negotiating with a number of other manufacturers to scale up the production,» commented Artem Sirazutdinov, the managing partner of AFK Sistema.
«The industrial scale production of tests that allow rapid detection of COVID-19 coronavirus infection is, first of all, a socially significant task for our country, the practical solution of which will help to stop the pandemic. But our cooperation, in my opinion, also demonstrates the high efficiency of Russian science and industry in solving urgent social and economic issues of the country, the ability to quickly find solutions and implement them in difficult conditions, » said Vladimir Nesterenko, head of the Nearmedic Group.
«Our production is focused on the production of forensic kits, which means that maximum attention is paid to the cleanliness of premises and the technological process. We planned the site in such a way that different reagents could be produced here. And in the current difficult situation, we understand the importance of issuing kits for detecting coronavirus infection. We were able to quickly re-orient the production facility and prepare a platform for the production of high quality kits, which are now so needed by medical institutions,» said Natalia Ermakova, head of the production of diagnostic test systems at the Nearmedic Group.
The new test systems will be delivered to institutions that provide laboratory services of testing for coronavirus. Detection of a coronavirus is based on the identification of an unchanged section of its genome. This makes it possible to reliably diagnose any of the existing and potential modifications of the COVID-19 infection pathogen. Reverse transcription analysis followed by real-time polymerase chain reaction (PCR) using fluorescent probes can be performed at virtually any medical laboratory.
In addition, Sistema-Biotech intends to send a registration dossier to Roszdravnadzor in the nearest future for its another product which will enable rapid analysis of saliva for coronavirus in just 30 minutes and can be effectively used for mass population screening, as well as for routing the incoming flow of patients with suspected COVID-19 in hospitals, including the MEDSI clinical hospital in Otradnoye.