The Ministry of Food and Drug Safety is defending the performance of the COVID-19 self-test kits distributed in Korea. It seems that the self-test kit false-positive and false-negative controversy arose in some areas, and they seem to have started to refute it.
In a press release on the 18th, the Ministry of Food and Drug Safety announced that it is presenting clinical trial standards to prove a higher level of performance than overseas regulatory agencies when permitting domestic COVID-19 self-test kits.
The Ministry of Food and Drug Safety only permits self-test kits with a sensitivity of 90% or more and a specificity of 99% or more, and this is the same standard as the US, which requires the highest accuracy abroad.
In addition, he explained that the clinical trial scale of the COVID-19 self-test kit approval standard is equivalent to or requiring more clinical trial subjects compared to overseas regulatory agencies.
In terms of clinical design, the Ministry of Food and Drug Safety explained that the ratio of confirmed and non-confirmed patients among clinical trial subjects was designed to be approximately 1:2, and the performance was evaluated by including 30% of asymptomatic and early infected patients among confirmed patients.
In addition, he emphasized that some of the self-test kits approved in Korea are being used following receiving emergency use approval from foreign regulatory agencies such as the United States and Canada. Currently, SD Biosensor and Humasys have received emergency use approval in the United States, and Sugentech has received emergency use approval in Canada.
Regarding this announcement, an official from the Ministry of Food and Drug Safety said, “There are criticisms that the reliability of the self-test kit is low, but this is due to the inherent limitations of the self-test kit, not a quality problem. The approval standard itself is at a high level,” he explained.
However, the industry’s view of the Ministry of Food and Drug Safety is not pretty. This is because when the Seoul Metropolitan Government first introduced a plan to use the COVID-19 self-test kit in April 2021, the Ministry of Food and Drug Safety and other health authorities showed a lukewarm stance on the use of the COVID-19 self-test kit.
Until the government switched the medical response system due to the spread of Omicron last month, the Ministry of Food and Drug Safety gave official permission to self-test kits for a total of three products from three companies. In addition, no additional approval was granted for the last Rapigen product in July of last year. On the other hand, the Ministry of Food and Drug Safety approved a total of five products this month alone.
An industry insider pointed out, “I wasn’t interested until then, but when the omicron mutation spread rapidly, I started to give permission,” he said.
Meanwhile, the Ministry of Food and Drug Safety announced that it will supply 21 million doses of COVID-19 self-test kits that can be purchased by individuals to regarding 75,000 pharmacies and convenience stores nationwide from the 20th to the 26th.