LUCIRA® by Pfizer COVID-19 & Flu Home Test
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Meet the 1st and only at-home molecular test to quickly tell you if it is COVID-19 or the flu—in just 30 minutes.
LUCIRA® by Pfizer COVID-19 & Flu Home Test is the only over-the-counter product that puts 2-in-1 molecular testing for both COVID-19 and Flu A/B in the palm of your hand. With LUCIRA® by Pfizer, you and your family can determine if your viral respiratory symptoms are caused by COVID-19 and/or the flu. After testing, always contact your healthcare provider about care or treatment.The LUCIRA® by Pfizer COVID-19 & Flu Home Test and lab-based PCR tests are both molecular tests. These tests detect genetic material called RNA from target viruses. However, molecular tests can do this in different ways. LUCIRA® by Pfizer COVID-19 & Flu Home Test uses a technology called RT-LAMP, or reverse transcription loop-mediated isothermal amplification. If COVID-19 and/or Flu A/B is present in your sample, the test identifies and copies, or amplifies, the virus’s genetic material millions of times. This is all done at one consistent temperature, allowing it to be done at home. The fact that the LUCIRA® by Pfizer COVID-19 & Flu Home Test can run at one consistent temperature is a main reason why the diagnostic amplification ability normally associated with lab-based PCR machines can now be found in a convenient, at-home test that is powered by 2 AA batteries.
- Quickly test, with results in only 30 minutes.
- Convenient 2-in-1 Testing: LUCIRA® by Pfizer is the first and only molecular test for both COVID-19 and Flu A/B authorized for use in the comfort of your own home.
- Easy-to-Use Lab Testing at Home: LUCIRA® by Pfizer is powered by modern lab technology available at home in 3 simple steps: Swab, Stir, and Detect.
- Modern testing technology in 3 easy steps.
- Lucira™ by Pfizer COVID-19 & Flu Home Test contents:
- Package Insert
- Nasal Swab: One sterile flocked nasal swab in a peel-pouch
- Sample Vial: A single-use, disposable vial containing an elution buffer to release and lyse virions from a nasal swab sample.
- Test Unit: A single-use, disposable unit with lyophilized reagents for multiplexed amplification and electronic readout for detection of SARS-CoV-2, Flu A, and Flu B RNA.
- Batteries: (2) AA batteries for the Test Unit
- Plastic disposal bag to dispose of the test after use.
LUCIRA® by Pfizer COVID-19 & Flu Home Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA). It has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. The authorization is 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
The LUCIRA® by Pfizer COVID-19 & Flu Home Test is authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection including COVID-19.
The LUCIRA® by Pfizer COVID-19 & Flu Home Test is authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection including COVID-19.
Product Documentation:
Emergency Use Authorization
Instructions for Use
Package Insert
Patient Fact Sheet
HCP Fact Sheet
About Pfizer
Breakthroughs that change patients' lives.
Pfizer Inc. is a leading global pharmaceutical and biotechnology company dedicated to developing innovative medicines and vaccines that improve health and well-being. Known for groundbreaking research, including the development of the first mRNA COVID-19 vaccine, Pfizer addresses some of the world’s most challenging health issues. With a commitment to scientific excellence and patient care, the company continues to deliver life-changing treatments across various therapeutic areas.