The large pharmaceutical factory that is in Nearmedic ownership and that FormaPharm Engineering Group had constructed as a turnkey project, is located in the city of Obninsk in the Kaluga region, Russian Federation. Within this factory, a laboratory, intended for the production of reagents for human genetic and relatedness identification was built in 2018. Due to new and current circumstances caused by the coronavirus/ COVID-19 pandemic, it has been decided to expand the scope of testing in this laboratory. Therefore, Nearmedic has started the production of Russian diagnostic testing sets for detection of the coronavirus/COVID-19.
The project design for the construction of the entire factory, including the laboratory as well as equipment erection and commissioning, was completed by FormaPharm Engineering Group an expert in pharmaceutical engineering.
The highly precise test-system includes all that is necessary for PCR analysis, according to clinical laboratory standards.
During the researches, conducted on real positive and negative biomaterial of the reference group of patients, as well as on the clean virus strains, test-system showed high specificity towards different coronavirus serotypes, high precision and high speed in results generation. The analysis takes about an hour, excluding the probe preparation time. Research results show that the diagnostic sensitivity is approaching 100%, whereby there is no false positive reaction to other viruses shown.
The Nearmedic production plant realized by FormaPharm Engineering Group is unique in the Russian Federation. It has obtained the certificate of compliance to the ISO 18385:2016 and 9001:2015 standards, and is the only one that has developed the industrial production of diagnostic sets (tests), which comply to the Russian standard GOST 9001:2015.