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

Using the test-banner

Using the test-banner

USING THE TEST

Lab technology that’s easy to use

In-office molecular accuracy* in 3 simple steps1

LUCIRA® by Pfizer COVID-19 & Flu Test is easy for your staff to learn and use, and requires no extensive training. In just a few steps, you can start testing for COVID-19, Flu A, and Flu B simultaneously using the single-use, 3-in-1, molecular test for these common respiratory pathogens.

Test kits contain everything needed to perform one (1) LUCIRA® by Pfizer COVID-19 & Flu Test, including instructions, 2 AA batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab, and 1 disposal bag. For this test to work properly, it is important to read the instructions and follow each step.

*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.

To begin, set up the test in a suitable location1

  • Choose a location where the test can be left alone for 30 minutes
  • Open Pouch 1 that contains the testing device, insert the batteries (2 AA), and then check that the Ready light is on
  • Open Pouch 2 that contains the sample vial. Remove the sample vial seal and gently set the vial into the test unit (do not push down)

A masked doctor swabs a young patient in the doctor's office with the LUCIRA® by Pfizer COVID-19 & Flu Test sitting on a tray to the left.

1. Swab
  • Both nostrils must be swabbed for the test to work properly. Using sterile technique, remove the swab and hold it by the handle end. Then tilt the patient’s head back and fully insert the swab tip into the nostril until resistance is felt
  • Roll the swab 5 times around the inside of the nostril, making sure the swab touches the walls of the nostril as the swab is rotated. Repeat for the other nostril

A hand comes in and uses the LUCIRA® by Pfizer COVID-19 & Flu Test with the packaging sitting on the right on top of the counter.

2. Stir
  • Insert the swab into the sample vial until it touches the bottom and stir it around the sample vial 15 times. Discard the swab after stirring

A close up shot of the white LUCIRA® by Pfizer device with the green ready light on and the vial with purple liquid sitting in the device.

3. Detect
  • Snap the lid of the sample vial closed and press the vial down into the test unit until it clicks. The test is running when the Ready light is blinking
  • Do not move the test unit while the test is in progress
  • The Ready light will continue blinking while the test is running. A positive result may display while the test is still running. Complete results will display after 30 minutes

Get the results you need, when you need them

  • Get the answer you need in 30 minutes or less1
  • Positive result for COVID-19, Flu A, or Flu B may show in as few as 11 minutes, while a negative or invalid result will display in 30 minutes1†
  • Clear, easy-to-read display lets you know whether a result is positive, negative, or invalid1

How to interpret results

When the test is finished after 30 minutes, the Ready light will turn off and result lights will show for COVID-19, Flu A, and/or Flu B. The behavior of the lights indicates a positive, negative, or invalid result. A positive result may show in as few as 11 minutes, while a negative or invalid result will display in 30 minutes.1†

Reading LUCIRA® by Pfizer Test Results1

Complete results display in 30 minutes

Positive results light up on the right.

An LED display with a test result that is positive for COVID-19, Flu A, and Flu B and has 3 green lights next to the label "Pos +"

Negative results light up on the left.

An LED display with a test result that is negative for COVID-19, Flu A, and Flu B and has 3 green lights next to the label "Neg -"

An LED display with invalid results. It is both positive and negative for Flu A, as shown by a green light for + and a green light for -.

Full results in 30 minutes. Negative results should be confirmed with further testing, if clinically indicated.1

Invalid results may occur for one, two, or all three viruses. Positive or negative results for other viruses are still valid if one or two viruses are invalid. If you receive any invalid results, retest with a new test or contact Pfizer at 1-888-LUCIRA-4 (582-4724). Contact Pfizer if result is invalid upon retesting.1

After the test is complete, dispose of the test and materials.

After use, remove the batteries, place the test unit in the plastic disposal bag, and dispose of all test kit materials in accordance with local regulations. Do not allow the test unit to come into contact or be disposed of with bleach, as harmful gases could be emitted as a result.1

Frequently Asked Questions

Can LUCIRA® by Pfizer COVID-19 & Flu Test detect new SARS-CoV-2 variants and flu strains?
The performance of this LUCIRA® by Pfizer COVID-19 & Flu Test was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants of SARS-CoV-2 but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.1 More information can be found in the Technical Brief.
How many times can I use the test?
Once. LUCIRA® by Pfizer COVID-19 & Flu Test is a single-use test only.1
What is the shelf life of the test?
The shelf life of the LUCIRA® by Pfizer COVID-19 & Flu Test is 18 months.2
What if there is an invalid result for any of the viruses?
If you receive any invalid results, retest with a new test or contact Pfizer at 1-888-LUCIRA-4 (582-4724). Positive or negative results for other viruses are still valid if one or two viruses are invalid.1 Contact Pfizer if a result is invalid upon retesting.
Is LUCIRA® by Pfizer COVID-19 & Flu Test covered by insurance?

LUCIRA® by Pfizer COVID-19 & Flu Test may be reimbursable through insurance. As a molecular, multiplex respiratory diagnostic test, LUCIRA® by Pfizer falls under CPT code 87636, as defined by the American Medical Association:

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.1,3-6

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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 9, 2023, from https://www.fda.gov/media/163455/download. 3. American Medical Association. New CPT codes published for SARS-CoV-2 multiplex assays. https://www.ama-assn.org/practicemanagement/cpt/new-cpt-codes-published-sars-cov-2-multiplex-assays. Accessed October 9, 2023. 4. Diagnostic Laboratory tests. Diagnostic lab test coverage. Medicare.gov. https://www.medicare.gov/coverage/diagnostic-laboratory-tests. Accessed October 9, 2023. 5. Diagnostic Testing of Influenza – Lab Benefit Program (LBM) Reimbursement Policy. EmblemHealth ConnectiCare. https://www.emblemhealth.com/content/dam/global/pdfs/provider/reimbursement-policies/influenza.pdf. Accessed October 9, 2023. 6. Coronavirus (COVID-19). EmblemHealth. https://www.emblemhealth.com/covid19. Accessed October 9, 2023.