COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card | FDA

COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card | FDA

COVID-19 Update: FDA Issues Emergency Use Authorization to Abbott Diagnostics Scarborough Inc. for its BinaxNOW COVID-19 Ag Card Diagnostic Test

Today, the U.S. Food and Drug Administration (FDA) issued Abbott Diagnostics Scarborough, Inc. an emergency use authorization (EUA) for its BinaxNOW COVID-19 Ag Card antigen test. This is the first COVID-19 diagnostic test that a health care provider can perform without an analyzer. This means test results can be read directly from the testing card. This rapid COVID-19 antigen test detects fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs from individuals suspected of COVID-19 by their health care provider within the first seven days of symptom onset. The test is authorized for point-of-care settings, like a doctor’s office, emergency room, or some schools, operating under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.

Read More Questions? If you have questions, contact COVID19DX@fda.hhs.gov