Coronavirus

On March 17, 2020, Quidel received FDA Emergency Use Authorization for the Lyra® SARS-CoV-2 assay to detect the virus that causes COVID-19. Hospitals and reference laboratories can run this assay using the bioMérieux NucliSENS® easyMAG® system or EMAG® system for extraction and the ABI 7500 Fast Dx for amplification and detection. Additional validated instruments are further described below. As with our other respiratory assays, the kits can be ordered with swabs/Viral Transport Media (VTM) or with reagents alone.

Update: On March 25, 2020, Quidel received CE Mark for the Lyra® SARS-CoV-2 assay, authorizing Quidel to market and sell the assay in Europe and in countries that accept the CE Mark, and authorization from Health Canada to sell the assay in Canada. Also, on March 25, 2020, the EUA was extended, allowing the assay to run on three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q. Additionally, the Centers for Disease Control and Prevention has expanded the list of acceptable specimens to include nasal and nasal turbinate swabs.

Update: On May 8, 2020, Quidel received FDA Emergency Use Authorization for the Sofia® SARS Antigen FIA for qualitative detection of nucleocapsid protein from SARS-CoV-2 in nasopharyngeal and nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. Physician offices, hospitals and reference laboratories can run this assay using the Sofia 2 immunofluorescence system.

Update: On May 18, 2020, Quidel received Emergency Use Authorization (EUA) and, on May 8th, 2020, CE Mark for the Lyra® Direct SARS-CoV-2 assay, authorizing Quidel to market and sell the assay in the Unites States and Europe and in countries that accept the CE Mark.

Update: On June 23, 2020, Quidel received CE Mark for its Sofia® SARS Antigen FIA to be used with Sofia® or Sofia® 2 instruments.

Update: On July 17, 2020, Quidel amended its EUA performance data for its Sofia® SARS Antigen FIA to 96.7% PPA versus RT-PCR when using nasal swabs within the first 5 days of symptoms.

Update: On October 2, 2020, Quidel received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Sofia® 2 Flu + SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer for the rapid, simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms.


Sofia® SARS Antigen FIA

Sofia® 2 Flu + SARS Antigen FIA

Lyra® SARS-CoV-2

Sofia® SARS Antigen FIA B-Roll

Sofia® 2 FLU + SARS Antigen FIA B-Roll