'Check Results in 15 Minutes' Two COVID-19 Self-Test Kits Approved (Comprehensive)

Available for Purchase at Pharmacies and Online in About Ten Days
Authorities Emphasize "Supplementary Measure" Again

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] Two COVID-19 self-test kits that allow individuals to check for infection within 15 minutes have received official approval from authorities for the first time in South Korea. However, authorities have repeatedly emphasized that self-test kits should only be used as supplementary tools, not for definitive diagnosis.

On the 23rd, the Ministry of Food and Drug Safety announced that it granted product approval for two antigen-based COVID-19 self-test kits on the condition that additional clinical performance data be submitted within three months. This marks the first time COVID-19 self-test kits have been approved for use domestically. These products are expected to be available for purchase at pharmacies and online approximately 7 to 10 days after approval.

The approved products are from SD Biosensor and Humasis. In South Korea, these products have been approved for professional use, while overseas they have undergone clinical trials for self-testing and received emergency use authorization.

SD Biosensor’s product was approved by the Ministry of Food and Drug Safety in November last year with a clinical sensitivity (the probability that the test is positive among patients with the disease) of 90% and specificity (the probability that the test is negative among patients without the disease) of 96% for professional use. It is currently used for self-testing in seven countries including Germany, the Netherlands, Denmark, Switzerland, Portugal, Luxembourg, and the Czech Republic. Clinical sensitivity for self-testing in Germany was 82.5%, with a specificity of 100%.

Humasis’s product received professional use approval from the Ministry in March with a clinical sensitivity of 89.4% and specificity of 100%. It is currently used for self-testing in three countries: the Czech Republic, Denmark, and Austria. Clinical sensitivity for self-testing in the Czech Republic and Brazil was 92.9%, with a specificity of 99%.

These self-test kits provide results within 15 minutes but have the limitation of lower sensitivity. The Ministry of Food and Drug Safety stated, "Both products detect viral antigens from nasal swab specimens of symptomatic COVID-19 patients and provide results in about 15 minutes. However, compared to the existing PCR method and antigen tests performed by medical professionals or experts using deep nasopharyngeal swabs, these kits have lower sensitivity, so they must be used carefully while adhering to quarantine guidelines."

Accordingly, the Ministry reiterated that these two products should only be used as supplementary tools. They were approved as auxiliary means to allow individuals, not experts, to easily perform self-testing amid concerns over COVID-19 spread and a potential pandemic. These products are intended for temporary use until officially approved products become available.

Yoon Tae-ho, head of the Central Disaster and Safety Countermeasure Headquarters’ quarantine team, also stated at a regular briefing that "since self-test kits are used by individuals themselves rather than experts, their accuracy is significantly lower. They are expected to be used as supplementary tools rather than replacing PCR tests for diagnostic purposes."

The target users for self-test kits are symptomatic COVID-19 patients. However, the principle remains that genetic testing should still be conducted for those with symptoms or suspected cases. The Ministry explained, "Due to the nature and limitations of the products, it is difficult to detect results in asymptomatic individuals with low viral loads. Therefore, these kits should be used as supplementary tools mainly for symptomatic individuals or those with epidemiological links who find it difficult to undergo genetic testing." The scope of use may change depending on results when officially approved products with completed clinical trials become available.

If two bright red lines (control line (C) and test line (T)) appear on the self-test kit, a genetic test should be conducted. Even if only one bright red line (control line (C)) appears, genetic testing is recommended if infection is suspected or symptoms are present.

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