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

style
Banner-top
Blue diamond gradient banner

FAQs

Frequently asked questions

style
Head-section

Expand All

Collapse All

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 For the information on our surveillance of emerging variants of concern, please see our linked Technical Briefs for COVID-19 and Influenza here.

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.
Style
hcpfaq, newtab-pdf

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

style
references-content