Manufacturers claim that testing takes only ten minutes and does not require the use of additional laboratory equipment.
Testing takes only ten minutes and does not require the use of additional laboratory equipment.
The registration certificate of Roszdravnadzor for the use of tests was received by the Avivir company of the ChemRar group, the official exclusive distributor of the SGTi-flex COVID-19 IgM / IgG test system of the Korean company Sugentech. According to the KhimRar press service, these tests passed clinical laboratory tests in Russia and are successfully used in public and private hospitals, as well as in enterprises that need to quickly test employees and maintain their production capacities.
“SGTi-flex COVID-19 IgM / IgG is a gold nanoparticle-based IHA test kit for the qualitative determination of antibodies to IgM and IgG to SARS-CoV-2 in human whole blood (from a finger or from a vein), serum or plasma . Analysis execution time takes only 10 minutes, without additional laboratory equipment. The test is specific to SARS-CoV-2 and is highly sensitive. The aggregate indicator of the accuracy of the determination results was 94.4%, ”the KhimRar report said.
In the near future Avivir plans to expand cooperation with Korean manufacturers and introduce several more diagnostic test systems to the Russian market. In addition, the company is negotiating with Sugentech on the localization of the production of these test systems in Russia.
“Korean SGTi-flex test systems demonstrate consistent quality from series to series, this is due to the regulatory system and stringent requirements for production in the country of origin, unlike analogues from other countries,” the company's press service said.