Gov't gives conditional approval to two self-test kits

The government on Friday gave conditional approvals to two over-the-counter Covid-19 self-test kits.

This file photo shows a Covid-19 self-test kit developed by SD Biosensor. [YONHAP]

The government on Friday gave conditional approvals to two over-the-counter Covid-19 self-test kits.

The Ministry of Food and Drug Safety said conditional approvals were given to self-test kits produced by SD Biosensor and Humasis. With the conditional approvals, the products will be allowed for temporary use in Korea until the two biotechnology firms roll out formally approved products.

According to the ministry, the over-the-counter self-test kits are expected to be available at pharmacies and online in about a week to 10 days.

Both products are rapid antigen test kits, and both require the subject to collect a sample from inside his or her nose, without needing a medical professional’s help. The test result is available within 15 to 20 minutes.

The ministry had already approved the two products for domestic use by medical and health experts. In some other countries, they had already won emergency approvals for at-home tests.

To obtain formal approvals, the manufacturers must submit additional data including clinical test outcomes within three months.

Because the at-home test products are not as accurate as the polymerase chain reaction (PCR) equivalents or antigen tests conducted by medical experts, the ministry stressed Friday that the over-the-counter products must be used only as supplementary tools.

“The accuracy of a self-test is far lower than a test conducted by a medical professional,” said Yoon Tae-ho, a senior Health Ministry official, during a regular briefing on Friday. “It cannot replace the PCR tests intended for diagnosis. Self-test kits will be used only as supplementation."

If a self-test comes out positive, the test-taker must take a PCR test.

SD Biosensor’s self-test kits are used in seven European countries including Germany. Humasis products are being used in three European countries.

In a clinical test conducted in Germany, SD Biosensor’s product showed 82.5 percent sensitivity and 100 percent specificity. The sensitivity of a clinical test refers to the ability to correctly identify those patients with the disease. A test with 100 percent sensitivity correctly identifies all patients with the disease. The specificity is the ability of the test to correctly identify those patients without the disease.

Humasis conducted clinical tests in the Czech Republic and Brazil, and its product showed 92.9 percent sensitivity and 99 percent specificity.

The conditional approvals of the over-the-counter test kits were granted as the country is experiencing increasing numbers in its daily new cases.

Earlier this month, newly elected Seoul Mayor Oh Se-hoon requested the government to approve self-test kits to be used at schools and commercial establishments in order to help normalize people's lives in the capital city.

Ki Mo-ran, a preventive medicine expert appointed last week to a newly created post of presidential secretary for disease control and prevention affairs, has repeatedly promoted the importance of allowing self-tests.

BY SER MYO-JA [ser.myoja@joongang.co.kr]