Self-Test Kit Sales Start Next Month... "Auxiliary Measure, Please Get PCR Test If Suspected"

An SD Biosensor official is demonstrating a test using the COVID-19 'self-diagnostic kit.' [Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Starting next month, COVID-19 self-test kits that allow individuals who are not medical personnel to check their infection status at home will be sold at pharmacies and online.

Yoo Cheon-gwon, head of the Diagnostic Analysis Management Division at the Central Disease Control Headquarters, stated at the briefing that "Today, the Ministry of Food and Drug Safety granted conditional approval for self-test kits that individuals can use by themselves." The Ministry of Food and Drug Safety conditionally approved two types of self-test kits from two manufacturers, SD Biosensor and Humasis. Under the conditional approval, these kits can be used temporarily for three months before the official products are released.

These products allow individuals to collect specimens from their nasal cavity themselves and visually check the results within 15 to 20 minutes. A Ministry of Food and Drug Safety official explained, "The two products submitted clinical performance data for self-testing conducted abroad and have been approved for use in European countries."

However, Director Yoo emphasized, "Although the conditionally approved products are convenient to use, they also have the drawback of lower performance," adding, "It is necessary to carefully read the instructions and use them cautiously, assuming strict compliance with quarantine rules during personal use." He also added, "Those suspected of having COVID-19 or with epidemiological links should visit screening clinics for polymerase chain reaction (PCR) testing regardless of the self-test results, which is the most important." The Ministry of Food and Drug Safety also explained that the two products should be used only as auxiliary tools, not for COVID-19 diagnosis.

The actual distribution of the self-test kits is expected to take place about a week later. The Ministry of Food and Drug Safety anticipates that "the kits will be available for purchase at pharmacies and online approximately 7 to 10 days after approval."

Regarding supply volume, Lee Sang-won, head of the Epidemiological Investigation and Analysis Division at the Central Disease Control Headquarters, said, "Since production volume is considerable, we do not think there will be major concerns about supply," adding, "Because the kits are used for limited purposes, if used appropriately, excessive quantities are not expected to be required."

There are no plans for separate government or health insurance support for the cost of purchasing the kits. Director Lee stated, "So far, considering cost and effectiveness, it is judged that individuals will decide whether to purchase," and "There is no plan to consider health insurance support." He further explained, "However, when institutions or organizations conduct projects, partial coverage by the institution may be possible."

On the 23rd, when the number of new COVID-19 cases reached 797, close to 800, citizens visiting the screening clinic set up at Songpa-gu Public Health Center in Seoul are waiting to get tested. Photo by Jinhyung Kang aymsdream@

Opinions from the medical community regarding the use of self-test kits are divided. As the number of new COVID-19 cases reached 797 on the day, marking the highest in 106 days and raising concerns about a 'fourth wave,' the improved accessibility to testing is expected to help identify 'asymptomatic transmitters.' Director Yoo also stated, "In areas such as nursing hospitals and facilities where the test subjects are consistent and periodic testing is possible, and follow-up management can be conducted based on test results, self-test kits could serve as an auxiliary tool."

However, there are significant counterarguments. Accuracy is the biggest issue. Most self-test kits use antigen testing methods to quickly provide results, but their sensitivity is lower than that of PCR tests, resulting in significantly reduced accuracy.

Earlier this year, Professor Kim Nam-joong's research team at Seoul National University Hospital's Infectious Diseases Department published findings showing that the accuracy of antigen test products was only 17.5% compared to PCR tests. False positives could lead to unnecessary isolation and work disruption, while false negatives could result in virus spreaders, potentially causing a backlash against quarantine efforts.

This content was produced with the assistance of AI translation services.