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People wait to receive a flu vaccination in Seoul on Oct. 27. (Yonhap News)

Amid intense fears of a flu outbreak also taking place amid the COVID-19 pandemic, a reagent capable of diagnosing both respiratory ailments simultaneously has received its first official permit in South Korea.

The Ministry of Food and Drug Safety (MFDS) announced on Nov. 3 that it had “granted an official permit for a simultaneous COVID-19 and influenza diagnosis reagent product.”

“The simultaneous diagnosis reagent that received the permit is a reverse transcription polymerase chain reaction (RT-PCR) product that is capable of simultaneously diagnosing COVID-19 and influenza, which are difficult to distinguish because of similar symptoms such as coughing, sore throat, and fever,” it explained.

The Korea Disease Control and Prevention Agency (KDCA) has determined that three instances of individuals being simultaneously infected with COVID-19 and the flu occurred in Daegu and North Gyeongsang Province in February.

The company responsible for making the product approved for domestic use is Kogene Biotech. The MFDS explained that the product can be used to make a determination about whether a suspected patient has COVID-19 and/or the flu within three to six hours based on testing of samples such as bodily secretions. The MFDS called the product “highly significant in that it substantially reduces the testing time, increasing the convenience for patients and lessening the burden on healthcare professionals.”

In a regular briefing the day before, KDCA Director Jung Eun-kyeong said, “We believe that if a simultaneous diagnosis kit is approved by the MFDS, it will be used mainly by screening centers, and we are in discussions with the Ministry of Health and Welfare (MOHW) regarding how to handle the insurance coverage aspect.” In connection with this, Yang Jin-young, a deputy department director with the MFDS, said on Nov. 3 that “because it also diagnoses influenza in contrast with the existing COVID-19 diagnosis reagent, I imagine that it will be set at a higher price than the existing diagnostic kit.”

Previously, reagents for diagnosing COVID-19 and the flu simultaneously had only been produced for exportation. As of Nov. 3, a total of 197 COVID-19 diagnosis reagent products had been exported with permission from the MFDS, with 13 of them exported as simultaneous COVID-19 and flu diagnosis reagents.

“Exported products are subject to approval by the country in question, so the domestic licensing procedures are simple,” explained Jeong Hyeon-cheol, director of the MFDS medical product review department. “Reagents for the domestic market must receive MFDS approval for clinical trials, so it will take some time for a permit to be granted.”

By Choi Ha-yan, staff reporter

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