Life Sciences Insight

Quidel Sofia SARS Antigen Test Obtains FDA Emergency Use Authorization for Serial Screening

Quidel announced Friday that it has obtained Emergency Use Authorization from the US Food and Drug Administration for the intended use of serial SARS-CoV-2 screening using its Sofia SARS Antigen FIA test.

The Sofia SARS Antigen FIA test is now available without a prescription and can be used in CLIA-waived settings.

Last month, the FDA announced a new pathway to quickly authorize serial testing to screen asymptomatic people, in particular to support screening in schools and workplaces. Quidel’s QuickVue At-Home OTC COVID-19 Test was granted serial testing authorization this week along with assays from Becton Dickinson and Abbott.

“FDA’s authorization opens the door to true democratization of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus,” said Quidel CEO Doug Bryant.

The Quidel Sofia SARS antigen test is a fluorescent immunoassay that runs in approximately 15 minutes using the firm’s Sofia or Sofia 2 immunoassay analyzer instruments. The test detects antigen from the SARS-CoV-2 nucleocapsid protein directly from anterior nares swab specimens.

The Sofia SARS test is now authorized to be used within the first five days of symptom onset as well as in individuals without symptoms, provided they are tested twice over two or three days with at least 24 hours, and no more than 36 hours, between tests.

Quidel noted that the Sofia SARS Antigen FIA shows 97 percent positive agreement and 100 percent negative agreement with PCR within the first five days of symptom onset.

Separately, Quidel announced it has been named the official diagnostics partner of the San Diego Padres baseball team. Terms of the deal were not disclosed. 

The firm will now provide its Sofia 2 instruments and Sofia SARS Antigen tests for use by the San Diego Padres medical staff for use with front office and stadium staff.