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The Lucira by Pfizer COVID-19 & Flu Home Test is 

for FDA Emergency Use Authorization (EUA) only

For Over-The-Counter (OTC) Use

For In Vitro Diagnostic (IVD) Use 

• This product has not been FDA cleared or approved, 

but has been authorized for emergency use by FDA 

under an EUA;

• This product has been authorized only for the 

detection and differentiation of nucleic acid from 

SARS-CoV-2, Influenza A, and Influenza B, not for any 

other viruses or pathogens; and

• The emergency use of this product is only authorized 

for the duration of the declaration that circumstances 

exist justifying the authorization of emergency use of 

in vitro diagnostics for detection and/or diagnosis of 

COVID-19 under Section 564(b)(1) of the Federal Food, 

Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), 

unless the declaration is terminated or authorization is 

revoked sooner.

• For more information on EUAs go here:

https://www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization

For the most up to date information on COVID-19, 

please visit: www.cdc.gov/COVID19 

Detailed instructions for (IFU) may be obtained at no 

additional cost at:

www.lucirahealth.com/IFU 

or by calling Pfizer at 1-888-LUCIRA-4 (582-4724) 

Package Insert (PI) INST094 Rev. D

SWAB STIR DETECT

What tips will help me use the nasal swab correctly? 

How do I make sure I am getting a good sample?

It is important to roll the swab around the inside walls 

of both nostrils. You want the swab to be touching and 

rubbing around the inside walls as you rotate.

What is Influenza A & B?

The two most common types of influenza are Influenza 

A & B. This test tests for both of these types of flu. If the 

test is positive for either Influenza A (Flu A) or Influenza 

B (Flu B), the tested individual has the flu.

While seasonal influenza viruses are detected yearround in the United States, flu viruses typically circulate 

during the fall and winter during what’s known as the 

flu season.

How accurate is this test?

The Lucira by Pfizer COVID-19 & Flu Home Test 

was compared to an FDA-authorized known high 

sensitivity SARS-CoV-2 PCR test and an FDA-cleared 

known high sensitivity Influenza A and B PCR test. 

Please refer to the IFU at www.lucirahealth.com/IFU

for complete data.

Can this test detect new SARS-CoV-2 variants and 

Flu strains?

Pfizer performs routine surveillance of emerging 

SARS-CoV-2 and Influenza strains and

will continue to monitor the situation with emerging 

variants. A technical brief that lists SARS-CoV-2 

variants and flu strains to which the Lucira test is 

reactive is available at lucirahealth.com

What are the known and potential risks and benefits 

of this test?

Potential risks include:

• Possible discomfort during sample collection.

• Possible incorrect test results.

Potential benefits include:

• The results, along with other information, can help the 

healthcare provider make informed recommendations 

about your care.

• The results of this test may help limit the spread of 

COVID-19 and flu to the family of the tested individual 

and others in your community.

What if the display shows an invalid test result?

This means something with the test did not work 

properly. If the test has any invalids, the Positive and 

Negative lights will be blinking when the test is done 

in 30 minutes. If the test shows an invalid result, please 

retest or contact Pfizer at 1-888-LUCIRA-4 (582-4724). 

Contact Pfizer if result is invalid upon retesting.

5x Intended Use

The Lucira by Pfizer COVID-19 & Flu Home Test is a single use (disposable) home test 

kit intended for simultaneous rapid in vitro qualitative detection and differentiation of 

SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized for 

non-prescription home use with anterior nasal swab samples from individuals 14 years or 

older (self-collected) or individuals 2 years or older (collected by an adult) with signs and 

symptoms consistent with a respiratory tract infection, including COVID-19. Clinical signs 

and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

The Lucira by Pfizer COVID-19 & Flu Home Test is intended for use in the differential 

diagnosis of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not 

intended to detect influenza C. SARS-CoV-2, influenza A, and influenza B viral nucleic acid 

is generally detectable in anterior nasal swab samples during the acute phase of infection.

Positive results indicate the presence of viral nucleic acid, but clinical correlation with past 

medical history and other diagnostic information is necessary to determine infection status. 

Positive results do not rule out bacterial infection or co-infection with other pathogens 

not detected by the test. The agent detected may not be the definitive cause of disease. 

Individuals who test positive with the Lucira by Pfizer COVID-19 & Flu Home Test should 

self-isolate and seek follow up care with their physician or healthcare provider as additional 

testing may be necessary.

Negative results for SARS-CoV-2 and influenza B are presumptive, meaning that they should 

be confirmed, if necessary for patient management, with an authorized or cleared molecular 

test performed in a CLIA-certified laboratory that meets requirements to perform high or 

moderate complexity tests.

Negative results do not rule out SARS-CoV-2, influenza A, and/or influenza B infection and 

should not be used as the sole basis for treatment or other management decisions, including 

infection control decisions. Negative results should be considered in the context of current 

prevalence of infection, an individual’s recent exposures, history and the presence of clinical 

signs and symptoms consistent with respiratory infection.

Individuals who test negative and continue to experience symptoms of fever, cough and/

or shortness of breath may still have a respiratory infection and should seek follow up care 

with their healthcare provider.

Individuals should report all results obtained with this product to their healthcare provider 

for public health reporting and to receive appropriate medical care. All healthcare providers 

will report all test results they receive from individuals who use the authorized product to 

relevant public health authorities in accordance with local, state, and federal requirements 

using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro 

Diagnostics (LIVD) Test Code Mapping for SARS- CoV-2 Tests provided by CDC.

The Lucira by Pfizer COVID-19 & Flu Home Test is authorized for non-prescription self-use by 

individuals aged 14 years or older and/or, as applicable, for an adult lay user testing another 

person aged 2 years or older in a non-laboratory setting. The Lucira by Pfizer COVID-19 & 

Flu Home Test is only for use under the Food and Drug Administration’s Emergency Use 

Authorization.

Description

This Lucira by Pfizer COVID-19 & Flu Home Test contains everything needed to perform 

one (1) Lucira by Pfizer COVID-19 & Flu Home Test: 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.

Frequently Asked Questions

Please Read Instructions On Reverse

Rotating the swab 5 times 

around the inside walls

of both nostrils is very 

important for the test to 

work properly.

COVID-19 & Flu Home Test

Nucleic Acid Amplification Test (NAAT)

For Individuals with signs and symptoms of 

Respiratory Tract Infection including COVID-19

COVID-19 & Flu

Home Test

Nucleic Acid Amplification Test (NAAT)

Test only works if you follow each step.

Open for instructions.

INST094 Rev D.indd 1 12/7/23 4:33 PM
CYAN MAGENTA YELLOW BLACK PMS 361

• Choose a location to do this test where 

it can sit UNDISTURBED for 30 minutes.

• Please read all instructions carefully before 

you begin.

• Do not insert batteries into test unit until 

ready to perform test.

• Keep test box to use for Lucira Connect. 

• Make sure your test kit contains: 2 AA 

batteries, test unit (pouch 1), sample vial 

(pouch 2), swab (labeled 3), 

and plastic disposal bag.

• Wash and dry hands.

• When ready to begin test, open test unit 

pouch 1.

• Remove swab and hold with handle end. 

Do not set swab down.

• Tilt head back and gently insert swab tip 

until it is fully inside your nostril and you 

meet resistance.

o For adults - insert less than one inch.

o For younger children - insert less than 

1/2 inch

• Once swab tip is fully inside nostril, roll the 

swab 5 times around the inside walls of 

your nostril. The swab should be touching 

the walls of the nostril as you rotate.

• Repeat swab step in other nostril.

• Insert swab into the 

sample vial until it 

touches the bottom.

• Mix sample by stirring 

around the sample vial 

15 times.

• Discard swab. 

• Immediately snap cap 

closed and press vial down 

into test unit until it clicks.

• Ready light will continue blinking while the test 

is running.

• Positive results may display before the test is 

done running.

• Results may be positive for more than one virus.

• Ready light will turn off and all results for 

COVID-19, Flu A, and Flu B will display in 30 

minutes when test is done.

Example Result: Positive for 

COVID-19 & Flu A; Negative for Flu B. 

You must wait until the Ready light 

has stopped blinking, indicating the 

test is complete, to interpret results.

• Ready light will 

start blinking 

when test 

is running.

• Do not move test unit once the test has 

started running.

Wait 30 minutes.

2 3 4

5

Swab Both Nostrils Stir Swab and 

Run Test 

Read Result

Dispose of Test Kit READY

If Ready light is not blinking within 5 seconds, 

use palm of your hand to press down more 

firmly to start test.

For this test to work properly, it is 

important to swab BOTH nostrils.

Adults must swab children 2 years or older.

Rotate5x in BOTH nostrils.

Make sure to roll

around inside walls

to collect a good 

sample.

Ready

Pos

+

Neg

- Flu B

Flu A

COVID

15x

CLICK

READY

Ready

Pos

+

Neg

- Flu B

Flu A

COVID

If you test POSITIVE

If you test NEGATIVE

If the test is INVALID

It is very likely you have COVID-19 (if the test result is positive for 

COVID-19) or flu (if the test result is positive for Flu A or Flu B) 

and it is important to be under the care of a healthcare provider. 

It is likely you will be asked to isolate yourself at home to avoid 

spreading the virus to others. There is a very small chance that 

this test can give a positive result that is wrong (a false positive). 

Your healthcare provider will work with you to determine how 

best to care for you based on your test results along with 

medical history and your symptoms.

Use your smartphone camera to scan the QR code on 

the top of the test unit or on the sticker on the back of 

the box to begin at luciraconnect.com

Lucira Connect is a website that helps you:

• Create a shareable digital record of your test result

A negative result means the virus that causes COVID-19 (if you 

test negative for COVID-19) or flu (if you test negative for Flu A 

& Flu B) was not found in your sample. However, it is possible 

for this test to give a negative result that is incorrect (a false 

negative) in some people with COVID-19 or flu. This means 

you could possibly still have COVID-19 or flu even though the 

test is negative. If this is the case, your healthcare provider will 

consider the test result with all other aspects of your history 

such as symptoms and possible exposures to decide how 

to care for you. It is important you work with your healthcare 

provider to help you understand the next steps you should take.

An invalid result means something with the test did not work 

properly. If the test result is invalid, the positive and negative 

lights on the device will be blinking/flashing. If your test shows 

an invalid result, retest or contact Pfizer at 1-888-LUCIRA-4 to 

obtain a free replacement test.

After use remove the batteries, place the test 

unit in plastic disposal bag and dispose all test 

kit materials in trash. 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.

Invalid results may occur for one, two or all 

three viruses. If an invalid result is observed 

for any of the viruses the entire test is 

considered invalid. Retest with a new test 

and use the retest results as final.

If you receive any invalid results, retest or contact Pfizer 

at 1-888-LUCIRA-4 to obtain a free replacement test.

Set Up Test

then GENTLY set 

in test unit but

do NOT push 

the vial down.

Instructions - Start Here

Open battery door and insert batteries.

Check that Ready light is on.

• Open sample vial pouch 2.

REMOVE sample vial seal

Note: Keep vial away from children. Avoid contact with eyes and 

skin. If contact occurs, rinse with water. If irritation persists, seek 

medical attention.

1 COVID-19 Positive Flu A Positive Flu B Positive

Positive results light up on the right

POSITIVE Results

COVID-19 Negative Flu A Negative Flu B Negative

Negative results light up on the left

NEGATIVE Results

Positive and Negative lights flash if result is Invalid

INVALID Results

Ready

Pos

+

Neg

- Flu B

Flu A

COVID

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8 97014 10055 8

Pfizer Inc.

181 Oyster Point Blvd.

South San Francisco, CA 94080

United States

PACK 115 Rev. G

00810055970148

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