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Celltrion test kit wins emergency use authorization from FDA

Celltrion test kit wins emergency use authorization from FDA

Posted April. 20, 2021 07:48,   

Updated April. 20, 2021 07:48


A COVID-19 test kit developed by a South Korean biopharmaceutical company has acquired the FDA’s authorization for use. Celltrion announced Monday that the DiaTrust, a rapid test kit for the coronavirus jointly developed with Humasis, has earned emergency use authorization from the Food and Drug Administration (FDA).

The Celltrion DiaTrust is an expert test kit capable of verifying infection in 15 minutes by detecting the COVID-19 antigen. Unlike other test kits that can only detect either N antigen or S antigen, DiaTrust has improved both the speed and accuracy by employing a “dual detection” method.

“We conducted tests for the early-phase patients of COVID-19 in the U.S.,” said an official from Celltrion. “The sensitivity of verifying positive patients was 93.3%, and the specificity of detecting those unaffected by the virus stood at 99.1%.”

Though it wasn’t a human test, it has been partly verified through a cell experiment that DiaTrust can also detect the variants of the coronavirus in the U.K. and South Africa.

Seong-Mo Kim mo@donga.com