August 28, 2020 - Quidel Corporation (San Diego, CA) yesterday announced business updates and reaffirmed that it is “an industry leader in the introduction of FDA-authorized rapid tests for a wide range of diseases and medical conditions, [and] remains in the forefront of the battle against the COVID-19 pandemic.” Competition Was Expected “Abbott’s entry into the SARS … [Read more...]
Quidel to update packaging of POC Sofia SARS Antigen test for COVID-19 to include either nasal or nasopharyngeal swabs
August 20, 2020 - Quidel Corporation announecd that labeling for Quidel’s Emergency Use Authorization (EUA) for the Sofia SARS Antigen FIA has been amended to include either nasal or nasopharyngeal swabs. The new kit labeling, with the addition of a nasopharyngeal swab, allows Quidel to offer a second kit configuration to support the nasopharyngeal sample … [Read more...]
Quidel expands training program; Maryland allows POC testing for COVID-19
August 11, 2020 - Quidel Corporation (San Diego, CA) announced that the State of Maryland has allowed point-of-care testing for COVID-19. Under the new directive, Maryland residents who believe they should be tested can now contact their healthcare provider, who can order a “COVID-19 test for any individual who believes it necessary, regardless of symptoms.” Separately, as … [Read more...]
Quidel’s Sofia SARS Antigen FIA updates EUA performance data to 96.7% PPA vs PCR
July 20, 2020 – Quidel Corporation (San Diego, CA) announced it has updated the performance data for its Sofia SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the U.S. Food and Drug Administration … [Read more...]
Quidel receives BARDA funding to develop point-of-care diagnostic assay that includes COVID-19
Quidel Corporation (San Diego, CA) announced it has received funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to support the development of a point-of-care diagnostic assay that potentially tests for four … [Read more...]
Quidel receives amended Emergency Authorization for rapid antigen COVID-19 diagnostic assay using Sofia 1 instrument
Quidel Corporation (San Diego, CA) announced it has received an amended Emergency Use Authorization (EUA) from the FDA, allowing Quidel to run its Sofia SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the Sofia Fluorescent Immunoassay Analyzer (Sofia 1), Quidel’s first-generation automated immunoassay instrument. Quidel previously received EUA to run the Sofia … [Read more...]