Osang Healthcare Obtains MFDS Export Approval for COVID-19 Antigen Rapid Test Kit and Influenza Simultaneous Diagnostic Kit

[Asia Economy Reporter Oh Ju-yeon] Osang Healthcare, a subsidiary of Osang Jaiel, announced on the 24th that it has obtained export approval from the Ministry of Food and Drug Safety for a rapid antigen diagnostic kit for COVID-19 and a PCR-based simultaneous diagnostic kit capable of diagnosing Influenza A, B, and COVID-19 at the same time.

The COVID-19 rapid antigen diagnostic kit that received export approval this time is a product that can quickly diagnose COVID-19 infection within 10 to 15 minutes by collecting patient specimens from the nasopharynx and nasal cavity using the immunochromatography method.

Clinical results conducted through professional institutions showed the highest level of accuracy (positive agreement rate 96.67%, negative agreement rate 99.00%) and demonstrated almost perfect concordance.

The company stated, "It is expected to respond quickly to the demand in countries where rapid screening tests are needed due to recent large-scale global outbreaks or surges in infections, or where PCR testing is difficult."

Both COVID-19 and influenza are respiratory diseases transmitted through droplets, with very similar symptoms such as fever, cough, and sore throat. It is necessary to confirm diagnostic results through testing with highly sensitive PCR diagnostic kits at the early onset of symptoms. Additionally, demand for the simultaneous diagnostic kit is expected to increase significantly as the flu season approaches.

Osang Healthcare plans to expand exports to Europe, Central and South America, Africa, and Asia after obtaining European (CE-IVD) certification for the antigen rapid diagnostic kit and simultaneous diagnostic kit that received export approval this time, in response to the rapidly increasing demand by country due to the recent resurgence of COVID-19.

Meanwhile, Osang Healthcare was the first in Korea to receive emergency use authorization from the U.S. FDA in April for a PCR-based COVID-19 diagnostic kit, and has also obtained export approval from the Ministry of Food and Drug Safety and European (CE-IVD) certification for PCR rapid diagnostic kits and antibody diagnostic kits.

Through the export approval of this antigen diagnostic kit and simultaneous diagnostic kit, the company has established a full lineup of molecular and immunodiagnostics related to COVID-19, enabling it to meet diverse demands related to COVID-19 diagnostic kits.