Zenbody and Suzentec Self-Test Kits Approved: "Products from 5 Companies Usable"
[Asia Economy Reporter Lim Chun-han] The Ministry of Food and Drug Safety approved two new COVID-19 self-test kits on the 4th. In South Korea, a total of five types of self-test kits from five companies, including the existing SD Biosensor, Humasis, and Rapigen products, are now available for use.
The newly approved self-test kits are from ZenBody and Sujentech. The Ministry explained that these kits met the approval criteria for self-test kits, with a sensitivity of over 90% and a specificity of over 99%. Sensitivity refers to the probability that the test result is positive for patients who have the disease, while specificity refers to the probability that the test result is negative for people who do not have the disease.
COVID-19 self-test kits are antigen test kits that allow individuals to collect specimens from their noses and check for virus infection themselves. Users must thoroughly read the instructions and use the kits accurately according to the approved methods.
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If the self-test kit result is positive, individuals should visit a screening clinic to undergo a genetic test (PCR). The used test kit should be sealed in the envelope provided with the product and brought to the screening clinic for disposal.
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