Celltrion announced on the 25th that the COVID-19 antigen rapid self-test kit DiaTrust COVID-19 Ag Home Test, jointly developed with Humasis recently acquired Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).

Celltrion received the EUA of Celltrion DiaTrust™ COVID-19 Ag Rapid Test for Professionals from the FDA in April, and the rapid self-test kit was also approved this time.

The DiaTrust Home Test conducted clinical trials on 490 patients with COVID-19 symptoms in the United States from March to July, and showed 86.7% and 99.8% accuracy in sensitivity and specificity, respectively.

Third-party products that have already been approved by the FD