Seodongyong "Domestically Approved Self-Test Kits?"... Kwon Deokcheol "None" · Yoo Eunhye "Effectiveness in Question"

Oh expresses concern over the proposal to pilot disposable self-test kits

[Asia Economy Reporter Oh Ju-yeon] On the afternoon of the 21st, Minister of Health and Welfare Kwon Deok-cheol responded "No" to the question from Seo Dong-yong, a member of the Democratic Party of Korea, during the National Assembly's government questioning session, asking whether there are any self-test kits approved for use domestically. This drew attention as it was a question aimed at verifying safety and other aspects related to Seoul Mayor Oh Se-hoon's policy advocating the use of rapid antigen test-based 'self-test kits' targeting schools in the Seoul area. Deputy Prime Minister and Minister of Education Yoo Eun-hye also expressed concerns, saying "I am worried" in her response that day.

Deputy Prime Minister and Minister of Education Yoo Eun-hye and Minister of Health and Welfare Kwon Deok-cheol are attending and conversing at the Central Disaster and Safety Countermeasure Headquarters meeting for COVID-19 response held on the 16th at the Government Seoul Office in Jongno-gu, Seoul. Photo by Kim Hyun-min kimhyun81@

On the same day, Representative Seo said, "Right after taking office, Mayor Oh actively considered the pilot introduction of disposable self-diagnostic kits at karaoke rooms and other places, and later stated his intention to use them in schools and religious facilities," and requested Minister Kwon to clarify, "I hope the concepts of 'self-diagnostic kits' and 'self-test kits' are clearly distinguished."

Minister Kwon replied, "Diagnosis is when medical professionals such as doctors comprehensively assess test results and symptoms to determine the presence of disease, whereas self-testing is something individuals can perform on their own without such expert judgment." He added that what Mayor Oh referred to should be called a 'self-test kit.'

When Representative Seo asked again, "Is it not possible to diagnose COVID-19 using the kits Mayor Oh mentioned?" Minister Kwon said, "That is correct. If a positive result comes from self-testing, it must be confirmed again through a PCR (polymerase chain reaction) test."

Regarding whether there are any self-test kits approved for use domestically, Minister Kwon said, "There are none."

Minister Kwon further explained, "I heard that there are kits exported from Korea and used abroad as professional-use kits, and that applications for approval as self-test kits domestically have been submitted to the Ministry of Food and Drug Safety."

Deputy Prime Minister and Minister of Education Yoo Eun-hye, who spoke shortly afterward, also stated, "There are no self-test kits approved by the Ministry of Food and Drug Safety yet," and added, "According to experts' opinions, self-test kits still lack sensitivity, accuracy, and reliability in determining positive and negative results."

Minister Yoo continued, "Questions have been raised about whether they would be effective for infection control in schools," and added, "If a positive result is obtained through a diagnostic test kit but the accuracy is not high, there is concern that many cases will test negative upon follow-up PCR testing."