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

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PCR-Quality Accuracy*

LUCIRA® by Pfizer COVID-19 & Flu Test performance was comparable to highly sensitive lab-based PCR tests in a head-to-head clinical trial and a surrogate study1

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Surrogate Study

ABOUT THE SURROGATE STUDY

SURROGATE SAMPLE TESTING STUDY RESULTS

Prospective Study

ABOUT THE PROSPECTIVE STUDY

PROSPECTIVE STUDY RESULTS

†No positive samples for influenza B were collected during the study due to low levels of influenza B in circulation at the time.

Positive Percent Agreement
Negative Percent Agreement

COVID-19

(Total=406)

97.3%

(n=107/110;

95% CI: 92.3%-99.1%)

99.7%

(n=295/296;

95% CI: 98.1%-99.9%)

Influenza A

(Total=408)

98.4%

(n=60/61;

95% CI: 91.3%-99.7%)

100%

(n=347/347;

95% Cl: 98.9%-100%)

Influenza B

(Total=407)

95.3%

(n=41/43;

95% Cl: 84.5%-98.7%)

99.7%

(n=363/364;

95% Cl: 98.5%-100%)

Compared LUCIRA® by Pfizer COVID-19 & Flu Test performance to that of FDA-cleared (flu) and FDA-authorized (COVID-19) comparator methods.
Samples were collected in viral transport medium and used to prepare contrived specimens for testing.
A total of 425 samples were evaluated, and the comparator assays were performed as per the cleared or authorized Instructions for Use (IFU).
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The Surrogate Study found

>95%

positive agreement for COVID-19, influenza A, and influenza B

Close to 100%

negative agreement for all viruses

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Surveillance of emerging strains of viruses1,2

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

CI, confidence interval; PCR, polymerase chain reaction.

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Positive Percent Agreement
Negative Percent Agreement

COVID-19

(Total=952)

88.3%

(n=83/94;

95% CI: 80.2%-93.3%)

100%

(n=858/858;

95% CI: 99.6%-100%)

Influenza A

(Total=1066)

90.1%

(n=109/121;

95% CI: 83.5%-94.2%)

99.3%

(n=938/945;

95% Cl: 98.5%-99.6%)

Influenza B

(Total=1065)

N/A†

(n=0/0)

99.9%

(n=1064/1065;

95% Cl: 99.5%-100%)

Evaluated clinical performance of the LUCIRA® by Pfizer COVID-19 & Flu Test at 7 U.S. study sites during the 2022-2023 flu season.
1161 anterior nasal swab samples were evaluated after collection from subjects with signs and symptoms consistent with respiratory infection. LUCIRA® by Pfizer COVID-19 & Flu Test performance was evaluated using samples collected by participants.
Comparator assay test (FDA EUA SARS-CoV-2 molecular assay and FDA-cleared influenza A and B molecular assay) samples were collected by a healthcare professional as indicated in the Instructions for Use (IFU).
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The Prospective Study found

>88%

positive agreement for COVID-19 and influenza A

Close to 100%

negative agreement for COVID-19, influenza A, and influenza B

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Surveillance of emerging strains of viruses1,2

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

CI, confidence interval; EUA, emergency use authorization; PCR, polymerase chain reaction.

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Ready the moment you need it

Intentionally designed for the point of care, this portable device allows for PCR-quality* results and untethered convenience.

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LUCIRA® by Pfizer COVID-19 & Flu Test capabilities infographic

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Offer PCR-quality accuracy*

Provides a level of accuracy comparable to highly sensitive lab-based PCR tests.

Multiplex testing for 3 viruses with a single swab

Detect and differentiate COVID-19, Flu A, and Flu B.

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Shallow nasal swab

Test patients 2 years and up using a shallow anterior nasal swab for ease of administration.

Address care or treatment, if clinically warranted, during the visit

A positive result may show in as few as 11 minutes, while a negative or invalid result will display in 30 minutes.†

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Seamless start

Everything you need to perform the test is included in the box, with no extensive training or maintenance required.

Expand capabilities

Run multiple single-use devices simultaneously to meet the demands of your practice.

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The shelf life of LUCIRA® by Pfizer COVID-19 & Flu Test is 18 months, allowing it to be stored for multiple respiratory illness seasons.3

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

See FAQs

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*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.1

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

References: 1. LUCIRA® by Pfizer COVID-19 & Flu Test. Instructions for Use. Pfizer Inc; 2023. 2. LUCIRA® by Pfizer COVID-19 & Flu Test. Package Insert. Pfizer Inc; 2023. 3. LUCIRA® by Pfizer COVID-19 & Flu Test letter of authorization. U.S. Food & Drug Administration. Published September 6, 2023. Accessed August 25, 2023. https://www.fda.gov/media/171937/download

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