South Korea's Covid self-test kit gets FDA emergency approval

South Korean biopharmaceutical company Celltrion announced on Monday that its self-diagnostic kit for Covid-19 has been granted emergency approval from US drug authorities.

Celltrion DiaTrust Covid-19 Ag Home Test, co-developed by local healthcare business Humasis, received the US Food and Drug Administration's emergency use authorisation approval, according to a company statement, Yonhap News Agency reported.

The product uses an antibody that specifically binds to the Covid-19 virus and detects infection within 15 minutes, Celltrion said.

It is most suitable for identifying acute or early infection of the Covid-19 virus.


Celltrion USA, which handles Celltrion's overseas business, will be responsible for the sales.

The self-test kit has also been granted approval for emergency use by other countries, including South Korea.

It is also used in several European countries,the report said - IANS