About - QuickVue At-Home
image of Quidel building

Testing Technologies
You Can Trust

About Quidel

Manufacturing diagnostic tests for over four decades

Quidel is a California-based leading diagnostic manufacturer focused on improving the quality of healthcare throughout the globe. As a trusted innovator in the medical device industry for over 40 years, Quidel launched the QuickVue brand in 1986 with visually read rapid diagnostics focusing on women’s health and respiratory diseases. In 1999, QuickVue Influenza A+B was the first visually read rapid test cleared by the FDA for professional use. Now, the QuickVue At-Home OTC COVID-19 Test* utilizes the same technology used for decades by healthcare professionals and makes simple, easy-to-use COVID-19 tests accessible for the good of our families, our communities, and the world.

image of Quidel employees and image of Quidel company flag shown next to the U.S. flag
Douglas Bryant - Quidel President and CEO

Meet Douglas Bryant

Quidel President and CEO discusses the company’s ongoing commitment to enhancing the well-being of people worldwide.

Quidel Corporation Timeline

Quidel has been an industry innovator since 1979 with several first‑to‑market products including our Quickvue Flu A/B test in 1999.
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  • 1979

    Quidel founded
    1979 - Quidel founded
  • 1983

    First commercial product introduced: pregnancy test
    1983 - First commercial product introduced: pregnancy test
  • 1985

    FDA-cleared test for Strep A
    1985 - FDA-cleared test for Strep A
  • 1989

    Acquired Bone Health and
    Complement Pathway marker business
    1989 - Acquired Bone Health and
    Complement Pathway marker business
  • 1999

    Launch QuickVue Flu A/B product
    1999 - Launch QuickVue Flu A/B product
  • 2010

    Acquisition of Diagnostics Hybrids Cellular DFA
    2010 - Acquisition of Diagnostics Hybrids Cellular DFA
  • 2011

    Launch of Sofia Automated Analyzer FIA and Sofia Influenza A+B FIA
    2011 - Launch of Sofia Automated Analyzer FIA and Sofia Influenza A+B FIA
  • 2015

    Launch of Solana Molecular Instrument and Solana Group A Strep
    2015 - Launch of Solana Molecular Instrument and Solana Group A Strep
  • 2017

    Acquisition of Alere Triage Cardiac and Toxicology
    2017 - Acquisition of Alere Triage Cardiac and Toxicology
  • 2020

    42,000+ Sofia Placements Worldwide
    2020 - 42,000+ Sofia Placements Worldwide
  • 2020

    SARS-CoV-2 Pandemic and launch of Sofia and QuickVue SARS Antigen rapid tests, Lyra SARS-CoV-2 PCR assays, and Solana SARS-CoV-2 molecular assay
    2020 - SARS-CoV-2 Pandemic and launch of Sofia and QuickVue SARS Antigen rapid tests, Lyra SARS-CoV-2 PCR assays, and Solana SARS-CoV-2 molecular assay
  • 2021

    QuickVue At-Home OTC COVID-19 Test EUA
    2021 - QuickVue At-Home OTC COVID-19 Test EUA
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Quidel COVID-19 Story

Demonstrating
R&D Capability and
Manufacturing Capacity to
Deliver Unique High-Volume
Solutions for COVID Testing
  • CDC Logo

    February 26, 2020

    CDC confirms 1st U.S. case from community spread in CA. White House Task Force created and led by VP Pence.

    The White House logo

    March 4, 2020

    Quidel CEO and CFO invited to meet with White House Task Force to discuss testing. In less than 2 weeks, Quidel begins shipping their 1st EUA test for COVID-19. This was one of the first EUA’s to detect the virus in individuals suspected of having COVID-19.

    Lyra Real-Time Direct SARS-CoV-2 SARS-CoV-2

    March 17, 2020

    EUA

    Quidel receives its 1st EUA on Lyra, a molecular RT-PCR test to detect SARS-CoV-2 RNA in individuals suspected of having COVID-19. Quickly ramps up manufacturing capacity to 1 Million tests per month. A 3rd EUA was issued on May 18 for a direct PCR assay without extraction.

  • Sofia SARS Antigen

    May 8, 2020

    EUA

    Quidel receives its 2nd EUA on the first rapid, 15-minute immuneassay test to detect SARS viral antigen (nucleocapsid protein) in individuals suspected of having COVID-19 on its flagship platform, Sofia 2. Quickly ramps up manufacturing capacity to 1.125 Million tests per week or 4.5 Million tests per month. Quidel receives approval on an EUA amendment on June 9, for the SARS Antigen test on the original Sofia analyzer. On July 17, Sofia SARS Antigen FIA updates performance data.

    Sofia2 - 3-in-1 SARS Antigen Influenza A+B

    October 2, 2020

    EUA

    Quidel receives EUA for another first rapid, 15-minute immunoassay Multi-Antigen Respiratory Panel to differentiate Influenza A+B from COVID-19.

  • QuickVue SARS Antigen

    December 18, 2020

    EUA

    Quidel receives EUA for another rapid immunoassay, QuickVue, to detect SARS viral antigen nucleocapsid proteins using a simple test strip with no instrument. Direct anterior nares swab samples can be used.

    Solana SARS-CoV-2

    December 23, 2020

    EUA

    Quidel receives EUA for a 25-minute molecular test to detect SARS-CoV-2 viral RNA in individuals suspected of having COVID-19 on its Solana platform. Quickly ramps up Solana manufacturing capacity to 750,000 tests per month.

    QuickVue At-Home COVID-19

    March 1, 2021

    EUA

    Quidel receives EUA for QuickVue At-Home COVID-19 Test to detect SARS viral antigen nucleocapsid proteins using a simple strip with no instrument. Prescriptions only.

  • QuickVue At-Home OTC COVID-19

    March 31, 2021

    EUA

    Quidel receives EUA for QuickVue At-Home OTC COVID-19 Test – No Prescription Required.

    Solana SARS-CoV-2

    May 5, 2022

    EUA

    Quidel receives EUA for updated Solana SARS-CoV-2 Assay with Lyophilized Master Mix.

Quidel COVID-19 Story

Demonstrating R&D Capability and Manufacturing Capacity to Deliver Unique High-Volume Solutions for COVID Testing
  • CDC Logo

    February 26, 2020

    CDC confirms 1st U.S. case from community spread in CA. White House Task Force created and led by VP Pence.

    The White House logo

    March 4, 2020

    Quidel CEO and CFO invited to meet with White House Task Force to discuss testing. In less than 2 weeks, Quidel begins shipping their 1st EUA test for COVID-19. This was one of the first EUA’s to detect the virus in individuals suspected of having COVID-19.

  • Lyra Real-Time Direct SARS-CoV-2 SARS-CoV-2

    March 17, 2020

    EUA

    Quidel receives its 1st EUA on Lyra, a molecular RT-PCR test to detect SARS-CoV-2 RNA in individuals suspected of having COVID-19. Quickly ramps up manufacturing capacity to 1 Million tests per month. A 3rd EUA was issued on May 18 for a direct PCR assay without extraction.

    Sofia SARS Antigen

    May 8, 2020

    EUA

    Quidel receives its 2nd EUA on the first rapid, 15-minute immuneassay test to detect SARS viral antigen (nucleocapsid protein) in individuals suspected of having COVID-19 on its flagship platform, Sofia 2. Quickly ramps up manufacturing capacity to 1.125 Million tests per week or 4.5 Million tests per month. Quidel receives approval on an EUA amendment on June 9, for the SARS Antigen test on the original Sofia analyzer. On July 17, Sofia SARS Antigen FIA updates performance data.

  • Sofia2 - 3-in-1 SARS Antigen Influenza A+B

    October 2, 2020

    EUA

    Quidel receives EUA for another first rapid, 15-minute immunoassay Multi-Antigen Respiratory Panel to differentiate Influenza A+B from COVID-19.

    QuickVue SARS Antigen

    December 18, 2020

    EUA

    Quidel receives EUA for another rapid immunoassay, QuickVue, to detect SARS viral antigen nucleocapsid proteins using a simple test strip with no instrument. Direct anterior nares swab samples can be used.

  • Solana SARS-CoV-2

    December 23, 2020

    EUA

    Quidel receives EUA for a 25-minute molecular test to detect SARS-CoV-2 viral RNA in individuals suspected of having COVID-19 on its Solana platform. Quickly ramps up Solana manufacturing capacity to 750,000 tests per month.

    QuickVue At-Home COVID-19

    March 1, 2021

    EUA

    Quidel receives EUA for QuickVue At-Home COVID-19 Test to detect SARS viral antigen nucleocapsid proteins using a simple strip with no instrument. Prescriptions only.

    QuickVue At-Home OTC COVID-19

    March 31, 2021

    EUA

    Quidel receives EUA for QuickVue At-Home OTC COVID-19 Test – No Prescription Required.

    Solana SARS-CoV-2

    May 5, 2022

    EUA

    Quidel receives EUA for updated Solana SARS-CoV-2 Assay with Lyophilized Master Mix.

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    Our QuickVue At-Home OTC COVID-19 Test has received 510(k) clearance by the U.S. FDA under a new name – QuickVue COVID 19-Test.

    The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

    This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first six days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The QuickVue At-Home OTC COVID-19 Test does not differentiate between SARS-CoV and SARS-C0V-2.

    *In the USA, this product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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