The US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) to market Quidel’s Sofia SARS Antigen FIA that delivers results in 15 minutes.
The test can qualitatively detect the nucleocapsid protein antigen of SARS-CoV-2 from anterior nares swab samples from people who are either suspected of Covid-19 by their healthcare provider within first five days of symptom onset.
It can also detect Covid-19 in asymptomatic or other epidemiological reasons to suspect the disease tested twice over two or three days with a gap of at least 24 hours.
Available now without needing a prescription, the simple test demonstrated exceptional performance in five days of symptom onset, with a 96.7% positive result agreement with PCR and 100% negative result agreement.
Quidel noted that routine testing using rapid antigen tests has demonstrated to be effective in Covid-19 diagnosis.
To establish the clinical performance, clinical studies in asymptomatic people undergoing serial testing are progressing.
Quidel president and CEO Douglas Bryant said: “FDA’s authorisation opens the door to true democratisation 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.
“Broadscale application of our Sofia rapid antigen test for covid-19 screening will catch asymptomatic cases early and limit virus spread.”
Testing using the Sofia rapid antigen test is limited to labs which are CLIA- certified and meet the needs to conduct moderate, high or waived complexity tests.
The Sofia SARS Antigen FIA is authorised for Point of Care (POC) usage.
Last week, the US FDA granted an EUA for Quidel’s new QuickVue At-Home OTC COVID-19 Test to be marketed in the country.