CTK Biotech Gets FDA Emergency Use Authorization for At-Home COVID Antigen Test

Original from: 360DX

CTK Biotech said on Tuesday that its ImmuView COVID-19 Antigen Home Test has received Emergency Use Authorization from the US Food and Drug Administration.

The over-the-counter test is designed to qualitatively detect SARS-CoV-2 nucleocapsid protein in nasal swab specimens collected at home. In symptomatic individuals, the test is authorized for use at least twice over three days and with at least 48 hours between tests, according to the company. In asymptomatic individuals, the test is authorized for use at least three times over five days, with at least 48 hours between tests.

About a year ago, Poway, California-based CTK — a subsidiary of Copenhagen-based SSI Diagnostica — received CE marking for its OnSite COVID-19 Ag Self Test.

Source: CTK Biotech Gets FDA Emergency Use Authorization for At-Home COVID Antigen Test