Quidel Granted EUA to Market COVID-19 Antigen Test
By Michael Barbella, Managing Editor | 05.17.21
Assay provides results in 15 minutes and s now available without a prescription.
Another COVID-19 test is hitting the market.
The U.S. Food and Drug Administration (FDA) has granted Quidel Corporation Emergency Use Authorization to market its Sofia SARS Antigen FIA for detecting SARS-CoV-2. The assay is designed to identify the COVID-19 nucleocapsid protein antigen from anterior nares swab specimens directly from individuals within the first five days of the onset of symptoms, or those 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.
“Quidel’s goal throughout this pandemic has been to develop the most innovative and sensitive testing technologies on the market and to make our COVID-19 tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “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. Broadscale application of our Sofia® rapid antigen test for COVID-19 screening will catch asymptomatic cases early and limit virus spread.”
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), 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 percent of the time, and negative results agreeing 100 percent 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 FDA’s Emergency Use Authorization. The Sofia SARS Antigen FIA has not been FDA cleared or approved.
The U.S. Food and Drug Administration (FDA) has granted Quidel Corporation Emergency Use Authorization to market its Sofia SARS Antigen FIA for detecting SARS-CoV-2. The assay is designed to identify the COVID-19 nucleocapsid protein antigen from anterior nares swab specimens directly from individuals within the first five days of the onset of symptoms, or those 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.
“Quidel’s goal throughout this pandemic has been to develop the most innovative and sensitive testing technologies on the market and to make our COVID-19 tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “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. Broadscale application of our Sofia® rapid antigen test for COVID-19 screening will catch asymptomatic cases early and limit virus spread.”
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), 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 percent of the time, and negative results agreeing 100 percent 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 FDA’s Emergency Use Authorization. The Sofia SARS Antigen FIA has not been FDA cleared or approved.
