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

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FAQs

Frequently asked questions

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What can a molecular test detect?

Molecular tests or nucleic acid amplification tests (NAATs) are designed to detect the genetic material (RNA) from viruses in a sample. This is a different approach from antigen tests, which aim to identify specific viral proteins.1,2

Does LUCIRA® by Pfizer COVID-19 & Flu Test monitor for new SARS-CoV-2 variants and flu strains?

Pfizer performs routine surveillance of emerging SARS-CoV-2 and flu strains and will continue to monitor the situation with emerging variants.3,4

How many times can I use the test?

Once. LUCIRA® by Pfizer COVID-19 & Flu Test is a single-use test only.4

What is the shelf life of the test?

The shelf life of LUCIRA® by Pfizer COVID-19 & Flu Test is 18 months.5

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 1 or 2 viruses are invalid.4 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 is reimbursable. 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.4,6-9

QW modifier must be used when billing for tests performed in facilities with a CLIA certificate of waiver.

The QW modifier must be added to 87636 to denote that the LUCIRA® by Pfizer COVID-19 & Flu Test diagnostic test is being conducted in your office setting and not in a traditional lab setting. Please ensure that when billing for LUCIRA® by Pfizer COVID-19 & Flu Test, the code 87636QW is used.

Have questions about LUCIRA® by Pfizer COVID-19 & Flu Test?

Call Customer Support at 1-888-LUCIRA-4 (582-4724). Available Monday-Sunday, 8 AM-8 PM ET.

CLIA, Clinical Laboratory Improvement Amendments of 1988.

*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.4

References: 1. COVID-19 test basics. US Food and Drug Administration. Accessed April 16, 2024. https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics#:~:text=Molecular 2. Hayden MK, Hanson KE, Englund JA, et al. The Infectious Diseases Society of America guidelines on the diagnosis of COVID-19: antigen testing. Clin Infect Dis. Published online January 26, 2023. doi:10.1093/cid/ciad032 3. LUCIRA® by Pfizer COVID-19 & Flu Test. Package Insert. Pfizer Inc; 2023. 4. LUCIRA® by Pfizer COVID-19 & Flu Test. Instructions for Use. Pfizer Inc; 2023. 5. LUCIRA® by Pfizer COVID-19 & Flu Test letter of authorization. US Food and Drug Administration. Published June 15, 2023. Accessed September 14, 2023. https://www.fda.gov/media/163455/download 6. New CPT codes for multi-virus tests detect COVID-19 and flu. American Medical Association. Published October 7, 2020. Accessed February 28, 2024. https://www.ama-assn.org/press-center/press-releases/new-cpt-codes-multi-virus-tests-detect-covid-19-and-flu 7. Diagnostic laboratory tests. Medicare.gov. Accessed October 9, 2023. https://www.medicare.gov/coverage/diagnostic-laboratory-tests 8. Reimbursement policy: diagnostic testing of influenza - lab benefit program. EmblemHealth ConnectiCare. https://www.emblemhealth.com/content/dam/global/pdfs/provider/reimbursement-policies/influenza.pdf 9. Coronavirus (COVID-19) coverage and benefits. EmblemHealth. https://www.emblemhealth.com/covid19