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

Molecular technology in your hands

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See LUCIRA® by Pfizer COVID-19 & Flu Test in action

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A pair of hands hold a vial with purple solution while the white device with a green Ready light sits on a surface.
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Harness the power of molecular amplification

LUCIRA® by Pfizer COVID-19 & Flu Test harnesses the efficient power of RT-LAMP.1

Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a modern nucleic acid amplification technology that delivers the accuracy of polymerase chain reaction (PCR)* without thermocycling.2,3

LUCIRA® by Pfizer performs nucleic acid amplification at one consistent temperature, enabling testing to be performed on a palm-sized unit powered by 2 AA batteries.1,4

RT-LAMP detects pathogen-specific, target viral RNA and creates cDNA via reverse transcription, then amplifies the resulting cDNA millions of times. The amplification process changes the pH of the reaction, resulting in a colorimetric change and subsequent detection of the target organism.1,3

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

cDNA, complementary deoxyribonucleic acid; RNA, ribonucleic acid.

A graphic that demonstrates the RT-LAMP process from the swab sample to the cDNA amplification. A graphic that demonstrates the RT-LAMP process from the swab sample to the cDNA amplification. A graphic that demonstrates the RT-LAMP process from the swab sample to the cDNA amplification.
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Proven high-accuracy* COVID-19 and Flu detection in head-to-head performance studies1

The LUCIRA® by Pfizer COVID-19 & Flu Test performed comparably in a head-to-head clinical trial and a surrogate study compared to highly sensitive lab-based PCR tests.1,6

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Surrogate Sample Study1

The Surrogate Sample Testing Study compared LUCIRA® by Pfizer COVID-19 & Flu Test performance to that of FDA-cleared or authorized 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

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

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LUCIRA® by Pfizer COVID-19 & Flu Test

Surrogate Sample Testing Study Results

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Positive Percent

Agreement

Negative Percent

Agreement

COVID-19

(Total=406)

97.3%

(n=107/110;

95% Cl: 92.3%-99.1%)

99.7%

(n=295/296;

95% Cl: 98.1%-99.9%)

Influenza A

(Total=408)

98.4%

(n=60/61;

95% Cl: 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%)
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Prospective Sample Study1

The Prospective Sample Study evaluated clinical performance of the LUCIRA® by Pfizer COVID-19 & Flu Test at 7 US study sites during the 2022–2023 flu season. 1161 anterior nasal swab samples were collected from subjects with signs and symptoms consistent with respiratory infection.

  • LUCIRA® by Pfizer 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 IFUs
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LUCIRA® by Pfizer COVID-19 & Flu Test

Prospective Study Results

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Positive Percent

Agreement

Negative Percent

Agreement

COVID-19

(Total=952)

88.3%

(n=83/94;

95% Cl: 80.2%-93.3%)

100%

(n=858/858;

95% Cl: 99.6%-100%)

Influenza A

(Total=1066)

90.1%

(n=109/121;

95% Cl: 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%)
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†No samples positive for influenza B were collected during the study due to low levels of influenza B in circulation at the time.1

Surveillance of emerging strains of viruses1,6

Pfizer performs routine surveillance of emerging SARS-CoV-2 and Influenza strains and will continue to monitor the situation with emerging variants. This includes the SARS-CoV-2 strains known as Omicron (and its BA subvariants), Eris, and Pirola.

Technical briefs that list SARS-CoV-2 variants and influenza strains to which the LUCIRA® by Pfizer COVID-19 & Flu Test is reactive are available here.

CI, confidence interval; EUA, emergency use authorization; FDA, US Food & Drug Administration; IFU, instructions for use.

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References: 1. LUCIRA® by Pfizer COVID-19 & Flu Test. Instructions for Use. Pfizer Inc; 2023. 2. Notomi T, Okayama H, Masubuchi H, et al. Loop-mediated isothermal amplification of DNA. Nucleic Acids Res. 2000;28(12):E63. doi:10.1093/nar/28.12.e63 3. Chen X, Xia S. Sensitive methods for detection of SARS-CoV-2 RNA. Methods Microbiol. 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. Kellner J, Ross JJ, Schnabl J, et al. A rapid, highly sensitive and open-access SARS-CoV-2 detection assay for laboratory and home testing. Front Mol Biosci. 2002;9:801309. doi:10.3389/fmolb.2022.801309 6. LUCIRA® by Pfizer COVID-19 & Flu Test. Package Insert. Pfizer Inc; 2023.
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