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.

Update: On December 18, 2020, Quidel received EUA from the FDA to market its QuickVue® SARS Antigen test, a point-of-care assay for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

Update: On December 23, 2020, Quidel received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Solana® SARS-CoV-2 Assay, an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens in viral transport media from patients suspected of COVID-19 by their healthcare provider.

Update: On February 3, 2021, Quidel announced the opening of a new manufacturing facility in Carlsbad, CA that will be dedicated to the production of Quidel’s popular QuickVue® line of products. The 128,000 square-foot facility will be the company’s highest-volume production plant in the world and begins operations in the second half of 2021 with a mission to produce 600 million QuickVue® SARS rapid antigen tests per year for the detection and diagnosis of COVID-19 infections.

Update: On March 1, 2021, Quidel received an Emergency Use Authorization (EUA) from the FDA allowing the company to market its new QuickVue® At-Home COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms. This test is also authorized for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms.

Update: On March 31, 2021, Quidel received an Emergency Use Authorization (EUA) from the FDA allowing the company to market its new QuickVue® At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two (or three days) with at least 24 hours (and no more than 36 hours) between tests. This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nares (NS) specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older.

Update: On April 1, 2021, Quidel received an Emergency Use Authorization (EUA) from the FDA allowing the company to market its Sofia® SARS Antigen FIA for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from anterior nares swab specimens directly from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or are individuals 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.


QUICKVUE® SARS Antigen Test

QuickVue® At-Home OTC COVID-19 Test B-Roll

Sofia® SARS Antigen FIA

Sofia® SARS Antigen FIA B-Roll

Sofia® 2 Flu + SARS Antigen FIA

Sofia® 2 FLU + SARS Antigen FIA B-Roll

Solana® SARS-CoV-2 Assay

Solana® SARS-CoV-2 Assay B-Roll

Lyra® SARS-CoV-2