MFDS Approves One More COVID-19 Self-Test Kit Product

SD Biosensor 'Standard i-Q COVID19 Ag Home Test'

Citizens visiting the COVID-19 screening clinic at the Jongno-gu Public Health Center in Seoul are conducting rapid antigen tests using self-test kits. Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Kim Heung-soon] The Ministry of Food and Drug Safety announced on the 11th that it has additionally approved one COVID-19 self-test kit product using the antigen test method, which allows individuals to collect samples from the nasal cavity to check for virus infection.

The product approved by the Ministry of Food and Drug Safety on this day is SD Biosensor's 'Standard i-Q COVID-19 Ag Home Test.' This is the second product from SD Biosensor to receive domestic approval, meeting the approval criteria of sensitivity above 90% and specificity above 99%.

Accordingly, the number of self-test kits approved by the Ministry of Food and Drug Safety has increased to six products produced by five companies: Humasis, SD Biosensor, Rapigen, GenBody, and Sugentech.

The Ministry of Food and Drug Safety stated, "We are closely coordinating with self-test kit manufacturers to ensure sufficient quantities are supplied domestically, and we will continue to secure and supply adequate amounts of self-test kits, so individuals do not need to purchase excessively in advance."

They added, "We expect that the newly approved self-test kit will help facilitate the smooth supply of domestic self-test kits. We will actively support the rapid development and approval of self-test kits based on regulatory science."

This content was produced with the assistance of AI translation services.