The company “System-biotech” (part of AFK “Sistema”) signed a contract with “nearmedic” the launch of contract manufacturing of Russian of a diagnostic kit for detecting coronavirus infection. Industrial production of new tests COVID-19 will begin soon after receipt of the registration certificate of Roszdravnadzor. Completion of registration procedures is expected before the end of this week.
Test system created a “System-biotech” on the basis of domestic developments and reagents, includes everything needed to perform the analysis using the PCR method in terms of virtually any clinical laboratory with standard equipment.
In the course of studies on the negative and the positive and biomaterial reference groups patients, as well as the clean strains of the virus test system demonstrated high specificity to different serotypes of coronavirus, high accuracy and speed of obtaining results. The analysis takes about an hour excluding sample preparation. According to test results diagnostic sensitivity of the test approaches 100%, it does not give false positive responses to other viruses.
“Plant Ledger “nearmedic” in the Kaluga region, the country’s only certified for compliance with ISO 18385:2016 9001:2015, expands the industrial production of new diagnostic kits certified for compliance with GOST 9001:2015. Technological capacities of the plant allow to produce 50 thousand tests a week. Capacity of the site allow you to further increase production to 200 thousand tests per week,” – said General Director of “nearmedic Pharma” Alexander Mickle.