South Korea grants conditional approval to COVID-19 self-test kits

The Ministry of Food and Drug Safety said Friday that it had granted temporary use approval for two COVID-19 self-test kits, one made by SD Biosensor and the other by Humasis. The move will bring the self-test kits to local pharmacies and online stores by end of April or early May for people to purchase without prescriptions.

The two self-test kits provide results within 15 minutes and have been touted by many, including Seoul Mayor Oh Se-hoon, as a means to bolster Korea’s fight against the pandemic.

The temporary approval is valid for three months, and SD Biosensor and Humasis are required to submit additional clinical trial data during that time to gain official approval.

SD Biosensor’s self-test kit earned expert-use approval in Korea in November and is already in use in seven European countries. Humasis’ self-test kit earned local approval last month and is being used in three European countries.

The Drug Safety Ministry warned that the two approved self-test kits are only “supplementary tools” and that a final diagnosis of COVID-19 must be determined by doctors using preemptive polymerase chain reaction tests.

A person with symptoms of COVID-19 should prioritize receiving a PCR test, the ministry said, adding that self-test kits should only be used when no other means are available. Self-test kits are deemed less accurate than PCR tests and can yield false positive or false negative results.

“The most important thing to note is that people with COVID-19 symptoms must receive PCR tests whether they used the self-test kits or not,” the ministry said in a statement.

“People should also strictly abide by quarantine rules from the Korea Disease Control and Prevention Agency, like wearing face masks, regardless of the results of the self-test kit.”

The introduction of the two self-test kits is in line with the Korean government’s efforts to increase its COVID-19 testing capacity in light of a continued surge in the number of new daily cases.

The country on Friday announced 797 new COVID-19 cases confirmed the previous day -- 758 locally transmitted and 39 imported from overseas -- raising the cumulative total to 117,458 cases. Korea also added three more deaths, raising the total number of deaths from COVID-19 to 1,811.

“The curve of daily addition from the third virus wave is a little different from the curve we see today,” said senior Health Ministry official Yoon Tae-ho in a daily press briefing Friday.

The average number of daily new cases per week has risen steadily over the past three weeks, from 559 cases to 625 cases and 640 cases. A continued rise in these numbers could eventually burden medical workers and institutions, Yoon said.

The daily case counts have risen along with the continued discovery of infection clusters and untraceable cases. In response, the authorities have decided to maintain the current social distancing rules until May 2, while placing more restrictions on entertainment establishments.

At the moment, the Greater Seoul communities of Seoul, Incheon and Gyeonggi Province are under Level 2 social distancing rules and the rest of the country is under Level 1.5 rules, although some municipalities are enforcing Level 2 rules on their own. Private gatherings of five or more people are prohibited across the country.

As a large portion of the new cases are occurring in the capital region, the authorities announced Friday that they would allow new social distancing rules to be applied in North Gyeongsang Province for two weeks starting Monday, ahead of their official nationwide launch on an unspecified date.

The new system is a four-tier social distancing plan with more detailed virus control guidelines, as opposed to the current one with five levels.

Korea has also continued its vaccination efforts, with the total number of people vaccinated surpassing 2 million Thursday, about two months after the nationwide campaign kicked off in late February.

The KDCA said Friday that 2,035,549 people, or 3.91 percent of the total population, had received their first COVID-19 shots, with 130,615 people having done so in the past 24 hours.

Of those people, 1,194,718 have received shots of the AstraZeneca vaccine, while the other 840,831 people have received jabs from Pfizer. Close to 80,000 people have received two doses thus far, up 18,528 from a day earlier.

The authorities are looking to inoculate 3 million people by the end of April and 12 million by the end of June, with the goal of achieving herd immunity by November. The country now runs 204 injection centers across the country but is looking to raise the figure to 264 by next week.

The Korean government previously told its people that the country had secured enough vaccines for 79 million people this year, but global vaccine shortage woes have placed that schedule in doubt.

The government had sought to sign a “vaccine swap” agreement with the United States, but US President Joe Biden said Wednesday that “we don’t have enough to be confident to send it abroad now.” The US Department of State stressed that Washington would prioritize vaccination efforts in the US.

Korea is also looking into possibly bringing over the Sputnik V vaccine from Russia to increase the supply here. But safety concerns surround Sputnik V, and President Moon Jae-in has ordered a review of the data.