Covid self-test kit from SD Biosensor receives U.S. FDA EUA

Home > Business > Industry

Covid self-test kit from SD Biosensor receives U.S. FDA EUA

Published: 27 Dec. 2021, 13:57

SD Biosensor's Covid-19 self-test kits are displayed at a GS25 convenience store in May. [NEWS1]

SD Biosensor's Covid-19 self-test kit received an emergency use authorization from the U.S. Food and Drug Administration, the company said Monday.

The at-home test kit can be used by anyone 14 or older without a prescription. It produces results within 20 minutes, according to the test-kit maker.

The test kit achieves 95.3 percent sensitivity and 100 percent specificity. The sensitivity of a clinical test refers to the ability to correctly identify those patients with the disease, which means a test with 100 percent sensitivity correctly identifies all patients with the disease. Specificity is the ability of the test to correctly identify those patients without the disease.

“Demand for self-test kits is surging lately in the United States as the number of people infected with Covid-19 is on the rise due to the spread of the Omicron variant,” Heo Tae-young, CEO of SD Biosensor, said. “We will prove our competitiveness based on the high quality of our products.”

BY SARAH CHEA [chea.sarah@joongang.co.kr]