COVID-19 Updates: FDA

May 11, 2020 | COVID-19

The Food and Drug Administration (FDA) recently announced these coronavirus (COVID-19) updates:

FDA Authorizes First Antigen Test for COVID-19

On May 9, 2020, the FDA issued the first emergency use authorization (EUA) for a COVID-19 antigen test. Antigen tests detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The EUA was granted to Quidel Corporation for the Sofia 2 SARS Antigen FIA. This test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver. More Information.

FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

On May 8, 2020, the FDA issued the first EUA for a diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. The FDA issued the EUA to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory-developed test to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. More Information.

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