Research & Development
US FDA Grants Emergency Use Authorization to Quidel's Sofia SARS Antigen Test for Screening Use with Serial Testing
5 April 2021 - - The US Food and Drug Administration has granted an Emergency Use Authorization allowing US-based Quidel Corp. (NASDAQ: QDEL) to market its Sofia SARS Antigen FIA for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from anterior nares swab specimens directly from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or are individuals without symptoms or other epidemiological reasons to suspect COVID-19 tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests, the company said.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 USC. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care, i.e., in patient care settings operating under a CLIA certificate of Waiver, certificate of Compliance, or certificate of Accreditation.

The Sofia SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, delivering confidence to physicians, healthcare workers and other customers within the professional segment.

This new intended use allows the Sofia SARS Antigen FIA to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours.

Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.1 As with all antigen tests, performance may decrease as days since symptom onset increases due to lower viral loads later in the patient's disease course.

Similarly, the inability to synchronize asymptomatic individuals with onset of infection may impact performance as specimens may be tested when viral loads are below the assay's limit of detection. Clinical studies in asymptomatic patients undergoing serial testing are ongoing to establish the clinical performance.

The Sofia SARS Antigen FIA is only for use under the Food and Drug Administration's Emergency Use Authorization.

The Sofia SARS Antigen FIA has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Federal Food, Drug and Cosmetic Act, 21 USC. § 360bbb-3(b) (1), unless the declaration is terminated or authorization is revoked sooner.

Quidel Corp. (NASDAQ: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe.

An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the US Under trusted brand names Sofia, Solana, Lyra, Triage and QuickVue, Quidel's comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.

With products made in America, Quidel's mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.