MFDS approves 2 additional self-test kits... Total 8 products from 7 companies authorized

Addition of Products from Median Diagnostic and Osang Healthcare

[Asia Economy Reporter Ki Ha-young] The Ministry of Food and Drug Safety has approved two additional COVID-19 self-test kit products. As a result, a total of eight products from seven companies?Humasis, SD Biosensor, Rapigen, GenBody, Suzen Tech, Median Diagnostics, and Osang Healthcare?are now available for use.

On the 15th, the Ministry announced that it had approved two additional COVID-19 self-test kits, which allow individuals to collect samples from their nasal cavity to check for virus infection. The newly approved self-test kits are products from Median Diagnostics and Osang Healthcare.

The Ministry explained that the self-test kits from Median Diagnostics and Osang Healthcare met the approval criteria of at least 90% sensitivity and 99% specificity. Sensitivity refers to the probability that an infected person tests positive, while specificity refers to the probability that a non-infected person tests negative.

COVID-19 self-test kits are rapid antigen test products that allow individuals to collect samples from their nasal cavity to determine virus infection. Users must thoroughly read the instructions and use the kits accurately according to the approved methods.

A Ministry official stated, "We are closely coordinating with self-test kit manufacturers to ensure sufficient supply within the country," adding, "We plan to continue supplying adequate quantities, so individuals do not need to purchase excessively in advance."

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