How accurate is this test?

The Lucira CHECKIT COVID-19 Test Kit is a molecular 

in vitro diagnostic test that has an analytical sensitivity, 

or ability to detect the SARS-CoV-2 virus, that is 

comparable to some of the best molecular PCR tests 

performed in clinical settings and high complexity labs.

In two Community Testing Studies which included 404 

individuals with and without COVID-19 symptoms, the 

Lucira test achieved 98% (267/272) negative percent 

agreement (NPA) when compared to a FDA authorized 

known high sensitivity SARS-CoV-2 PCR test. Positive 

percent agreement (PPA) among symptomatic 

individuals was 94% and 90% in asymptomatic. Total 

PPA was 92% (121/132) across all samples and included 

10 samples with very low levels of virus >37.5 Ct as 

shown below.

The above graph shows the Lucira CHECKIT COVID-19 

Test Kit positive percent agreement in Lucira’s two 

Community Testing Studies. BLUE bars represent 

samples where the Lucira positive test result matched 

the comparison test result. GREY bars represent the 

Lucira test results that were negative and did not match 

the comparison test positive result. Nearly all of the 

GREY bars occurred in samples where there were very 

low levels of virus that possibly no longer reflected active 

infection1

 that were detected by the comparison test.

1. La Scola B., Clinical Infectious Diseases, September 2020 

Swab Stir Detect

The Lucira CHECKIT COVID-19 Test Kit 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 testing of nasal 

swabs for detection of nucleic acid from SARS-CoV-2, not for 

any other viruses or pathogens.

• 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-preparedness-and-response/

mcm-legal-regulatory-and-policy-framework/emergencyuse-authorization

For the most up to date information on 

COVID-19, please visit: www.cdc.gov/COVID19 

For detailed instructions for point of care use, visit: 

www.lucirahealth.com/IFU 

Package Insert (PI) INST017 Rev. D

Will this test hurt? No, the nasal swab is not sharp and 

it should not hurt. Sometimes the swab can feel slightly 

uncomfortable or tickly.

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.

5x

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 your 

healthcare provider make informed recommendations 

about your care.

• The results of this test may help limit the spread 

of COVID-19 to your family 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 your test is invalid, all the lights will be 

blinking when the test is done in 30 minutes. If your 

test shows an invalid result, please contact us at 

1-888-582-4724 and we will assist you.

What is PCR quality molecular accuracy? 

Lucira CHECKIT COVID-19 Test Kit is a molecular test 

that amplifies the virus’s genetic material while the 

test is running just like PCR lab tests. The amplification 

method provides a level of accuracy comparable to one 

of the highest sensitivity lab PCR tests.

Positive

Negative

Ready Done

COVID-19

COVID-19 Test Kit

Intended Use

The Lucira CHECKIT COVID-19 Test Kit is a single-use test 

kit intended to detect the novel coronavirus SARS-CoV-2 that 

causes COVID-19. This test is for nonprescription home use 

with self-collected anterior nasal swab samples from individuals 

aged 14 years and older (self-collected) or individuals 2 years or 

older (collected by an adult) with or without symptoms or other 

epidemiological reasons to suspect COVID-19.

This test is similar to a PCR test in that it utilizes a molecular 

amplification technology for the detection of SARS-CoV-2 viral 

RNA. SARS-CoV-2 viral RNA is generally detectable in anterior 

nasal swab samples during the acute phase of infection. Positive 

results indicate the presence of viral RNA, 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 viruses. The agent 

detected may not be the definitive cause of disease. Individuals 

who test positive should self-isolate and seek additional care from 

their healthcare provider.

Negative results are presumptive and confirmation with a 

molecular assay performed in a laboratory, if necessary for patient 

management, may be performed. Negative results do not preclude 

SARS-CoV-2 infection and should not be used as the sole basis for 

treatment or management decisions for the individual, including 

infection control decisions. Negative results should be considered 

in the context of an individual’s recent exposures, history and the 

presence of clinical signs and symptoms consistent with COVID-19. 

Individuals who test negative and continue to experience 

COVID-like symptoms of fever, cough, and/or shortness of breath 

may still have SARS-CoV-2 infection should seek follow up care 

from their physician or healthcare provider.

The Lucira CHECKIT COVID-19 Test Kit is for use only under the 

Food and Drug Administration’s Emergency Use Authorization.

Test results can be reported through the LUCI secure web portal, 

to relevant public health authorities in accordance with local, state 

and federal requirements.

Description

This Lucira CHECKIT COVID-19 Test Kit contains everything 

needed to perform one (1) Lucira COVID-19 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.

10 20 30 40 50 60 70 80 90 100 110 120 130

10

0

20

30

40 37.5 CT

CT Value

The # of cycles (CTs) required to detect virus increases when the 

amount of virus in the sample is low

Samples shown by decreasing amount of virus 

Lucira Community Testing Study 

Positive Percent Agreement (PPA) Summary

For more clinical data, visit www.lucirahealth.com/data

Test only works if you follow each step

Open for instructions 

COVID-19 Test Kit

PMS 

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PMS 361 PMS 2194 PMS 4276

INST017 Rev D.indd 1 6/8/23 10:48 AM
• 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.

• Do not discard box so it can be used for 

LUCI reporting. 

• 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.

• 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. 

• Snap cap closed and press 

vial down into test unit 

until it clicks. 

• Ready light will 

start blinking 

when test 

is running.

• Do not move test unit once the test has 

started running.

Wait 30 minutes.

1

2 3 4

5

Swab Both Nostrils Stir Swab and Run

Test 

Read and Report 

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 you swab BOTH nostrils.

Adults must swab children ages 2-13.

Rotate 5x in BOTH nostrils.

Make sure to roll

around inside walls

to collect a good 

sample.

Positive

Negative

Ready Done

COVID-19

15x

Positive

Negative

Ready Done

COVID-19

CLICK

READY

COVID-19

Ready Done

Positive

Negative

COVID-19

Ready Done

Positive

Negative

COVID-19

Ready Done

Positive 

Negative

Positive Result

Positive light 

displays

Negative Result

Negative light 

displays

Invalid Result

All lights 

flashing

If you test POSITIVE

If you test NEGATIVE

It is very likely you have COVID-19 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.

A negative result means the virus that causes COVID-19 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. This means you could possibly 

still have COVID-19 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.

After test is completed, place the test unit in plastic disposal 

bag and dispose all test kit materials in trash.

Done light will display when test is ready in 30 minutes.

Set Up Your 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

Next, please use Pfizer’s secure LUCI portal (Lucira 

Connect) to receive a verified test result on your phone 

and transmit your result to public health agencies. To get 

started, go to luciraconnect.com from your smartphone.

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

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

seek medical attention.

INST017 Rev D.indd 2 6/8/23 10:48 AM
CYAN MAGENTA YELLOW BLACK LUCIRA

LIGHT BLUE

LUCIRA

BLUE

PMS 360

TM

TM

OPEN OTHER 

END

OPEN THIS END

Please read instructions

Por favor de leer las instrucciones

PACK038 Rev. A

CHECK IT

Keep this box. Your unique test kit number is stickered above.

What is PCR quality molecular accuracy? Lucira CHECK-IT COVID-19 test result reporting portal.To receive a verified test result, Pfizer maintains LUCI, a securesensitivity PCR tests.provides a level of accuracy comparable to one of the highest while the test is running just like PCR tests. The amplification method Test Kit is a molecular test that amplifies the virus’s genetic material 

 You will use the QR code at left to register 

this test:This kit contains everything you need to run 

authorization is revoked sooner.and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, circumstances exist justifying the authorization of emergency use of in vitro diagnostics for The emergency use of this product is only authorized for the duration of the declaration that for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. authorized for emergency use by FDA under an EUA. This product has been authorized only The Lucira Check It COVID-19 test kit has not been FDA cleared or approved, but has been instructions.your test result. To get started, see Read Results section in enclosed 

 instructions, 2 AA batteries, 1 test 

For In Vitro Diagnostic Use(EUA) onlyFor use under Emergency Use Authorization unit, sample vial, nasal swab and disposal bag.

8 9 10055 97004

Use this photo guide if 

healthcare provider. After 

sharing your results with a 

test is finished, place test 

unit here and take photo that 

includes your test result

 alongside sticker with your

 unique test kit number.

PCR quality molecular accuracy in 30 minutes or less

before usingRead instructions SWAB STIR DETECT

molecular test kit1 Single-use 

PCR quality molecular accuracyin 30 minutes or less

before usingRead instructions 

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PCR quality molecular accuracy in 30 minutes or less

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before usingRead instructions SWAB STIR DETECT

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SWAB STIR DETECT

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