UPDATE : Monday, September 7, 2020
Celltrion’s Covid-19 diagnostic kit gets CE certification
  • By Lee Han-soo
  • Published 2020.07.17 15:39
  • Updated 2020.07.17 15:39
  • comments 0

Celltrion said that its Covid-19 antigen diagnostic kit has won EU’s Conformite Europeenne (CE) certification.

Celltrion’s Covid-19 antigen diagnostic kit received CE certification on Friday. (Celltrion)

The kit, co-developed with BBB, a local healthcare venture, is a point-of-care testing (POCT) kit that allows hospitals to check the results immediately after taking a sample directly at the treatment site by using a portable device.

“This product significantly improves accuracy by increasing the sensitivity to diagnose a virus-infected patient positively,” the company said. “The results can be checked within 20 minutes, which helps in rapid diagnosis.”

The kit boasts the speed and the advantages of an antigen diagnostic kit. It can screen patients in the early stages of infection, the company added.

Celltrion USA, its U.S. branch, will be in charge of marketing the diagnostic kit in the United States., while Celltrion Healthcare will sell the equipment elsewhere.

“Now that the company has received CE certification, we are launching it in the local market,” a company official said. “We will proceed as quickly as possible.”


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