Celltrion Receives US FDA Emergency Use Authorization for COVID-19 Rapid Antigen Test Kit

[Asia Economy Reporter Seo So-jung] Celltrion announced on the 26th that its rapid diagnostic antigen kit for COVID-19, 'Sampinut,' developed in collaboration with domestic diagnostic device specialist BBB, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Sampinut is a rapid point-of-care testing (POCT) antigen kit that combines COVID-19 antibody-antigen technology to enhance sensitivity and uses portable specialized equipment to deliver results within 10 minutes.

This product features fast measurement time by enabling specimen testing and result confirmation within 10 minutes using portable equipment at medical sites, and it shows sensitivity over 94% higher compared to the conventional RT-PCR (reverse transcription polymerase chain reaction) method.

Celltrion recently launched Sampinut in the U.S. in August, recognizing the high market demand amid the rapid increase of new COVID-19 cases in the country. With the acquisition of this EUA, the company expects strong demand for rapid diagnostic antigen kits mainly from large U.S. corporations and government agencies preparing for employees' return to work after remote work, and plans to supply Sampinut nationwide through local specialized wholesalers.

A Celltrion official stated, "We analyze that the demand for rapid diagnostic antigen kits is high in workplaces, schools, and institutions across the U.S.," adding, "Through this EUA for Sampinut, we will do our best to maximize COVID-19 prevention effects in the U.S. and contribute to the global end of COVID-19."

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