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R-FIND IgG/M/A ELISA kit received a domestic license from MFDS

미디어 2021.05.06

SG Medical, a company specializing in the import and manufacture of in vitro diagnostic devices, announced on the 6th that R-FIND COVID-19 IgG, IgM, and IgG/M/A ELISA has receiveda domestic license from the Ministry of Food and Drug Safety. These products measure the formation of Covid-19 antibodies.


Oh Se-moon, CEO of SG Medical said "This is the first time in the industry that we have obtained a domestic license for the Covid-19 antibody diagnostic test ELISA kit” and "We are planning to export it not only to Korea but also to Asia, Latin America and Africa."



These three diagnostic kits are kits that detect IgM, the first antibody produced after viral infection, IgG produced after about 1-2 weeks, and IgG/M/A, all antibodies. It can be useful for diagnosing whether the virus is infected and active stages.



ELISA diagnostic kits have more accurate results because they have higher sensitivity to judge positive patients and specificity to judge negative patients than rapid diagnostic kits. In addition, more than 90 patient samples can be tested simultaneously, making them easier to use in large hospitals with large sample counts.


Three types of SG Medical's R-FIND antibody diagnostic test kits showed sensitivity of 92% or higher and specificity of 96% or higher.


As a result, SG Medical has obtained domestic licenses and established a Covid-19 product line-up such as neutralizing antibodies and sample transport medium, and is currently developing rapid diagnostic kits for antigen experts and home-test.

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