BD has entered into a partnership USA Swimming, the national governing body for swimming in the US, to conduct Covid-19 screening tests for US Olympic team trials and other USA Swimming events. Rapid antigen tests using the BD Veritor Plus System will be carried out as an additional safety measure beyond the PCR testing at all Olympic trials, as well as at all 2021-2022 USA Swimming events where testing is required.
Quidel Corporation has received an amended Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its Sofia Q, the latest addition to the Sofia and Sofia 2 line of fluorescent immunoassay analysers. Sofia Q is a smaller test device using fluorescent technology to provide accurate and automated results in just 15 minutes. The sale of the device will initially be limited to use with the Sofia SARS Antigen FIA in the clinical laboratory improvement amendments (CLIA) and CLIA-waived professional setups.
Avacta Group, a biotechnology company developing diagnostics and cancer therapies, announced that the company’s AffiDX SARS-CoV-2 antigen lateral flow test has been registered in the EU. The notification of registration allows the company to market its products across all 27 EU member countries for professional use. Clinical data of Avacta’s lateral flow test showed 100% sensitivity in identifying individuals with viral loads measured by PCR of Ct less than 27.