First “ABC”—Flu A/B + COVID-19—Rapid Antigen Test Authorized by FDA

You are here

First “ABC”—Flu A/B + COVID-19—Rapid Antigen Test Authorized by FDA

October 3, 2020

“Game-changing” testing innovation from Quidel will save lives heading into flu season

WASHINGTON, D.C. – AdvaMed released the following statements on the announcement last night that Quidel Corporation, a member company of AdvaMed and AdvaMedDx, received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration of “a rapid point-of-care test to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer for the rapid, simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms.”

AdvaMed president and CEO Scott Whitaker said: “This is yet another game-changing innovation out of the medtech community that has been so committed since Day One to saving lives throughout this pandemic. As we head into flu season and are simultaneously working furiously to contain the novel and deadly COVID-19, the ability to distinguish between those suffering from potentially confusing symptoms of the flu and the Coronavirus can be a matter of life and death, and will allow our frontline health care workers to immediately distinguish between the two diseases and act quickly to save lives.”

Quidel Corporation’s president and CEO Doug Bryant is chairman of the AdvaMedDx board of directors. AdvaMedDx executive director Susan Van Meter said of the groundbreaking test: “Quidel’s rapid ABC test, which can be deployed nearly anywhere health care providers care for patients, is a critical new tool broadening the ecosystem of the COVID tests commercial manufacturers are delivering at scale to protect patients and public health.”

###

AdvaMed member companies produce the medical devices, diagnostic products and digital health technologies that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

AdvaMedDx member companies produce innovative, safe and effective in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies both in the United States and abroad. For more information, click here.