The Ministry of Food and Drug Safety today (23rd) conditionally approved two types of COVID-19 self-test kits, emphasizing that "it should be used as an auxiliary means, not as a confirmation of infection."



The product approved today is an antigen-based self-test kit of SD Biosensor and Humasis. When you put a cotton swab in your nose and take a sample, you can check the result within about 15 to 20 minutes.



It should be used when genetic testing is difficult for people with symptoms or epidemiological associations, rather than asymptomatic due to inaccurate product limitations.



The following is a summary of the contents announced today by the Ministry of Food and Drug Safety and explanations of related parties in a question-and-answer format.



Q. How does this conditionally licensed self-test kit work?



▲ This product is used by individuals directly collecting a sample from the inside of the nose with the enclosed cotton swab in the self-test kit without the help of an expert.



It is an antigen test method that uses the immunological principle of antigen-antibody binding to detect specific proteins of the Corona 19 virus.



The test result can be checked visually within 15 to 20 minutes.



Q. What is the difference from the previously licensed rapid antigen test for experts?



▲ Both products are antigen-based products, but the expert rapid diagnosis kit collects a sample from the nasopharynx deep in the nose and reads the result, while the self-test kit collects a nasal sample from the nasal cavity by an individual and checks the result.



Q. How does the self-test kit screen for COVID-19 infection?



▲ SD Biosensor products have been approved in Germany, Portugal, the Netherlands, Denmark, Switzerland, Luxembourg, and the Czech Republic.



The sensitivity to recognize a positive patient as positive is 82.5%, and the specificity to confirm a normal person without virus as normal is 100%.



Humasis has been approved in the Czech Republic, Austria and Denmark, with a sensitivity of 92.9% and a specificity of 99.0%.



Q. Who should use the COVID-19 self-test kit?



▲ This target is for people with symptoms from corona 19 virus infection.



Due to the limitations of the product, it is difficult to confirm the results for asymptomatic patients, so it should be used when a person with symptoms or epidemiological associations has difficulty performing a gene amplification (PCR) test.



Q. How do I read the test results?



▲ If two red lines (control line C, test line T) appear on the test, corona 19 infection is suspected, so you must undergo a gene amplification (PCR) test for confirmation.



Even if a single red line (control line C) appears, you should have a PCR test if you have symptoms or suspect infection.



Q. If only one red line appears in the self-test kit and it is presumed to be'negative', can I not take the diagnostic test?



▲ Regardless of the results from the self-test kit, if you have COVID-19 symptoms, you must undergo a gene amplification (PCR) test.



As an auxiliary aspect of genetic testing, it should only be used for screening.



Regardless of the results of the test, you must comply with the KCDC's quarantine regulations, such as wearing a mask.



Q. From when and where can I purchase the COVID-19 self-test kit?



▲ Today, 7-10 days after approval, it is expected to be available through pharmacies and internet.



(Photo = Yonhap News)