AVAILABLE SOON
3-in-1 molecular testing—no lab required1
PCR-quality accuracy* in a single-use test with results in 30 minutes or less
The LUCIRA® by Pfizer COVID-19 & Flu Test provides a level of accuracy comparable to highly sensitive lab-based PCR tests. Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for patient management decisions.
Fast 3-in-1 results1
Lab-quality results* in 30 mins or less
- LUCIRA® by Pfizer is the first 3-in-1 single-use molecular test for COVID-19, influenza A, and influenza B that brings the power of NAAT with results in 30 minutes or less1,2
Harness accurate, molecular technology* in-office1
PCR-quality accuracy* delivers reliable results you can act on while patients are in-office
- LUCIRA® by Pfizer is an isothermal molecular test that uses RT-LAMP amplification technology to provide test results for 3 viruses with molecular accuracy.*
- RT-LAMP utilizes a 1-step RNA sequence amplification method to target and amplify specific RNA signatures of SARS-CoV-2, influenza A, and influenza B viruses using reverse transcription and amplification of viral cDNA. Unlike PCR, RT-LAMP does not require thermocycling1,3
Easy to use, easy to onboard to your practice
Efficient, multiplex testing with 1 shallow nasal swab needed1
- LUCIRA® by Pfizer is designed for easy in-office use: just 3 easy steps of Swab, Stir, and Detect. And with just one shallow nasal swab for 3 viruses, it is easy on your patients as well
- As a single-use test, LUCIRA® by Pfizer makes it easy to onboard molecular testing technology: no calibration, no on-going maintenance, and no extensive training needed for your staff.
cDNA, complementary deoxyribonucleic acid; NAAT, nucleic acid amplification testing; PCR, polymerase chain reaction;
RNA, ribonucleic acid; RT-LAMP, reverse transcription loop-mediated isothermal amplification.
References:
- LUCIRA® by Pfizer COVID-19 & Flu Test. Instructions for Use. Pfizer Inc; 2023.
- U.S. Food and Drug Administration, Center for Devices and Radiological Health. LUCIRA® by Pfizer COVID-19 & Flu authorization letter. June 15, 2023. Retrieved September 14, 2023, from https://www.fda.gov/media/163455/download.
- Wong YP, Othman S, Lau YL, et al. Loop-mediated isothermal amplification (LAMP): a versatile technique for detection of micro-organisms. J Appl Microbiol. 2017;124(3):626-643. doi:10.1111/jam.13647
**Emergency Use Authorization
The LUCIRA® by Pfizer COVID-19 & Flu Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product 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 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.
Indication For Use
The LUCIRA® by Pfizer COVID-19 & Flu Test is authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens collected from individuals (2 years of age or older) who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
