Celltrion's Covid-19 self-test kit receives U.S. FDA EUA
Celltrion said Monday its Covid-19 diagnostic home-test kit received emergency use authorization (EUA) from the U.S. Food and Drug Administration.
The green light came six months after the point-of-care test (POCT) version, which can only be used in the presence of a medical professional, received approval. Monday’s announcement covered over-the-counter tests that can be administered by the test subject themselves without the help or supervision of a medical professional.
The DiaTrust self-test kit, which was jointly developed by Celltrion and Kosdaq-listed Humasis, produces results within 15 minutes. People 14 and older can purchase them without a medical prescription.
The test kit achieves 86.7 percent sensitivity and 99.8 percent specificity, according to Celltrion. The company conducted clinical trials in United States March through July, and about 490 patients participated in the trials.
The sensitivity of a clinical test refers to the ability to correctly identify subjects with the disease, which means a test with 100 percent sensitivity correctly identifies all those infected who take the test. Specificity is the ability of the test to correctly identify those without the disease.
DiaTrust only requires a single test, while other products retailing in the United States require at least two tests.
Distribution of DiaTrust test kits in the United States will be handled by Celltrion USA. Humasis is manufacturing the kits.
Celltrion aims to “expand its presence in the U.S. market.” In September, the company signed a 738.2-billion-won ($630-million-won) deal with the U.S. government to supply its POCT test kits to around 25,000 locations in the United States.
“The EUA was available based on the high reliability of Celltrion’s test kits,” said a spokesperson for Celltrion. “We will endeavor to supply the products quickly so that they can contribute to halt the spread of Covid-19.”
BY SARAH CHEA [email@example.com]