Read the Emergency Use Authorization for LUCIRA® by Pfizer COVID-19 & Flu Test

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Molecular testing in the palm of your hand

Get fast, accurate,* in-office results in 30 minutes or less1

LUCIRA® by Pfizer COVID-19 & Flu Test is the first 3-in-1, single-use, molecular test for COVID-19, Flu A, and Flu B that uses the power of nucleic acid amplification testing (NAAT) to deliver results in 30 minutes or less.1,2 LUCIRA® by Pfizer uses reverse transcription loop-mediated isothermal amplification (RT-LAMP) to detect 3 respiratory infections with molecular accuracy.1*

*The LUCIRA® by Pfizer COVID-19 & Flu Test provides a level of accuracy comparable to highly sensitive lab-based polymerase chain reaction (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.

A hand holds up the the LUCIRA® by Pfizer COVID-19 & Flu Test, a small white device. A hand holds up the the LUCIRA® by Pfizer COVID-19 & Flu Test, a small white device.

3 easy steps: Swab, Stir, and Detect.

No extensive training required.1

With speedy, accurate results for COVID-19, Flu A, and/or Flu B, you can assess which respiratory pathogen may be to blame for COVID-19- and flu-like symptoms with molecular accuracy and shift your focus toward care or treatment options.

RT-LAMP: a modern amplification technology

LUCIRA® by Pfizer uses reverse transcription loop-mediated isothermal amplification (RT-LAMP), a modern molecular technology that detects target viral genetic sequences and uses reverse transcription and cDNA amplification to detect the presence of viruses in a sample.1

  • A key aspect of RT-LAMP is its ability to run at a consistent temperature (without thermocycling) compared to that required for traditional PCR methods. The fact that RT-LAMP allows the LUCIRA® by Pfizer COVID-19 & Flu Test to run at one consistent temperature enables this nucleic acid amplification process to occur in a palm-sized device powered with just 2 AA batteries1,3,4

How the device works:

  • Pushing the vial containing the patient’s sample into the test unit fills up internal reaction chambers and turns on a heating element that kick-starts the RT-LAMP amplification1
  • If amplification occurs, the process changes the pH of the solution, allowing a light on the inside of the test unit to shine through the sample, indicating that viral RNA was in the patient's sample

Molecular made easy—without extensive training or capital investment.1

Offer your patients molecular testing without the need for capital investment, complex equipment, or long wait times. Enhance your practice offerings with modern molecular technology by stocking your shelves, especially in preparation for respiratory illness season.

LUCIRA® by Pfizer may also be covered by patients’ insurance plans and be eligible for reimbursement under CPT code 87636.1,5-8

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An image of the The LUCIRA® by Pfizer COVID-19 & Flu Test sitting on the right and the packaging sitting on the left. An image of the The LUCIRA® by Pfizer COVID-19 & Flu Test sitting on the right and the packaging sitting on the left.

As a molecular, multiplex respiratory diagnostic test, LUCIRA® by Pfizer falls under CPT code 87636: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique, as defined by the American Medical Association.1,5

CPT, Current Procedural Terminology; DNA, deoxyribonucleic acid; RNA, ribonucleic acid.

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References: 1. LUCIRA® by Pfizer COVID-19 & Flu Test. Instructions for Use. Pfizer Inc; 2023. 2. US Food and Drug Administration, Center for Devices and Radiological Health. LUCIRA® by Pfizer COVID-19 & Flu authorization letter. June 15, 2023. Retrieved October 16, 2023, from https://www.fda.gov/media/163455/download. 3. Chen X, Xia S. Sensitive methods for detection of SARS-CoV-2 RNA. Methods in Microbiology. 2022;50:1-26. doi:10.1016/bs.mim.2021.06.001 4. Augustine R, Hasan A, Das S, et al. Loop-mediated isothermal amplification (LAMP): a rapid, sensitive, specific, and cost-effective point-of-care test for coronaviruses in the context of COVID-19 pandemic. Biology (Basel). 2020;9(8):182. doi:10.3390/biology9080182 5. American Medical Association. New CPT codes published for SARS-CoV-2 multiplex assays. https://www.ama-assn.org/practice-management/cpt/new-cpt-codes-published-sars-cov-2-multiplex-assays. Accessed September 5, 2023. 6. Diagnostic Laboratory tests. Diagnostic lab test coverage. Medicare.gov. https://www.medicare.gov/coverage/diagnostic-laboratory-tests. Accessed October 9, 2023. 7. Diagnostic Testing of Influenza – Lab Benefit Program (LBM) Reimbursement Policy. EmblemHealth ConnectiCare. 2023. https://www.emblemhealth.com/content/dam/global/pdfs/provider/reimbursement-policies/influenza.pdf. Accessed October 9, 2023. 8. Coronavirus (COVID-19). EmblemHealth. https://www.emblemhealth.com/covid19. Accessed October 9, 2023.