It has been confirmed that the Ministry of Food and Drug Safety’s self-test kit approval standards are higher than those of foreign regulatory agencies except the United States.
According to the Ministry of Food and Drug Safety, the Ministry of Food and Drug Safety requires the approval standards for domestic COVID-19 self-test kits to have a sensitivity of 90% or more and a specificity of 99% or more. On the other hand, regulatory agencies in foreign countries such as Germany and the Czech Republic, excluding the United States, which are identical to Korean standards, apply lower standards.
The Ministry of Food and Drug Safety explained, “It is approved by presenting clinical trial standards to prove higher level of performance than overseas regulatory agencies.”
Among the performance measures of self-test kits, sensitivity refers to the probability that a patient with a disease will have a positive test result, and specificity refers to the probability that a test result will be negative among patients without disease.
It is confirmed that the clinical trial scale of the domestic COVID-19 self-test kit approval standard is equivalent to or requiring more clinical trial subjects compared to overseas regulatory agencies.
The Ministry of Food and Drug Safety (MFDS) said, “The self-test kits approved in Korea are designed to have a ratio of confirmed and non-confirmed cases of approximately 1:2 among clinical trial subjects. “he said.
He continued, “In the actual test site, the test is conducted on people who do not know whether or not they are infected, and the positive predictive value (the ratio of true infection confirmed by PCR among positive self-test kits) may vary depending on the infection situation, which is different from clinical trials. point,” he added.
Some of the self-test kits approved in Korea have been recognized for their performance in the international community, such as emergency use approval by foreign regulatory agencies such as the United States and Canada.
According to the Ministry of Food and Drug Safety, SD Biosensor and Humasys’ products are currently approved for long-term use in the United States and Sugentech’s products are used in Canada.
Meanwhile, the Ministry of Food and Drug Safety said, “In order to improve the accuracy of the self-test kit, it is important to carefully read the instruction manual attached to the product and use the kit correctly.” A detailed explanation can be found on the Ministry of Food and Drug Safety’s blog (blog.naver.com/kfdazzang/222640236513).”
