MFDS Grants Domestic Use Approval for Two COVID-19 Self-Test Kits (Update)

Condition for Submission of Additional Clinical Performance Test Data Within 3 Months

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 23rd that it has approved two antigen-based COVID-19 self-test kits on the condition that additional clinical performance test data be submitted within three months.

The newly approved COVID-19 self-test kits are products from SD Biosensor and Humasis. These products have been approved for professional use domestically, and overseas they have undergone clinical trials for self-testing and received emergency use authorization.

First, the SD Biosensor product received approval from the Ministry of Food and Drug Safety in November last year with a clinical sensitivity (the probability that the test result is positive among patients with the disease) of 90% and specificity (the probability that the test result 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. The clinical sensitivity for self-testing conducted in Germany is 82.5%, and specificity is 100%.

In the case of the Humasis product, it received professional use approval from the Ministry of Food and Drug Safety in March with a clinical sensitivity of 89.4% and specificity of 100%. It is used for self-testing in three countries: the Czech Republic, Denmark, and Austria. The clinical sensitivity for self-testing conducted in the Czech Republic and Brazil is 92.9%, and specificity is 99%.

The Ministry of Food and Drug Safety explained, "These two products were approved as supplementary means to allow individuals, not professionals, to easily perform self-testing amid concerns about the spread and pandemic of COVID-19, aiming to reduce infection spread through various testing methods. However, these conditionally approved products are intended for temporary use before formal approval products are available."

While these products have the advantage of providing test results quickly, the Ministry explained that their sensitivity is lower. The Ministry emphasized, "Both products detect viral antigens from nasal swab specimens of symptomatic COVID-19 patients for self-testing and provide results within approximately 15 minutes. Compared to the existing genetic test (PCR) method and antigen tests performed by medical personnel or testing experts collecting specimens from deep nasopharyngeal swabs, these have lower sensitivity, so they must be used carefully with strict adherence to quarantine guidelines."

However, self-test kits should only be used as supplementary tools and not for confirming COVID-19 infection. Confirmation is ultimately determined by a physician considering genetic test results and clinical symptoms. If symptoms are suspected, a genetic test should be conducted first, and if genetic testing is difficult, self-test kits can be used. The Ministry stated, "If two red lines (control line C and test line T) appear on the self-test kit, a genetic test must be performed. Even if only one red line (control line C) appears, if infection is suspected or symptoms are present, a genetic test should be conducted."

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