LUCIRA COVID-19 Test Kit Instruction Manual
- June 9, 2024
- Lucira
Table of Contents
LUCIRA COVID-19 Test Kit
COVID-19 Test Kit
Para instrucciones en español:
www.lucirahealth.com/espanol
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 OTC test kit has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA.
- This OTC test kit 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 OTC test kit 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-F1 Rev. C
Frequently Asked Questions
Please Read Instructions On Reverse
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.
Rotating the swab 5 times around the inside walls of both nostrils is very important for the test to work properly.
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 is a molecular test that amplifies the virus’s genetic material while
the test is running just like PCR lab tests. Lucira’s amplification method
provides a level of accuracy comparable to one of the highest sensitivity lab
PCR tests.
How accurate is this test?
Lucira’s CHECKIT 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.
Lucira Community Testing Study
Positive Percent Agreement (PPA) Summary
The # of cycles (CTs) required to detect virus increases when the amount of virus in the sample is low
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.
- La Scola B., Clinical Infectious Diseases, September 2020
For more clinical data, visit www.lucirahealth.com/data
Test only works if you follow each step Open for instructions
Indication
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
authorized for nonprescription over-the-counter (OTC) use with self-collected
nasal swab samples in individuals 14 years and older (self-collected) or
individuals ≥2 years (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 SARSCoV- 2 RNA.
Positive results are indicative of the presence of SARS-CoV-2.
Individuals who test positive should self-isolate and seek additional care
from their healthcare provider. Positive results do not rule out bacterial
infection or coinfection with other viruses.
Negative results do not preclude SARS-CoV-2 infection.
Individuals who test negative and continue to experience COVID-like symptoms
should seek follow up care from a healthcare provider. Negative results in an
asymptomatic individual are presumptive and confirmation with a molecular
assay performed in a laboratory, if necessary for patient management, may be
performed.
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 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.
Instructions – Start Here
- 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 box to use 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.
Set Up Test
- When ready to begin test, open test unit pouch 1.
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.
Swab Both Nostrils
For this test to work properly, it is important you swab BOTH nostrils.
-
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.
Rotate 5x in BOTH nostrils.
Make sure to roll around inside walls to collect a good sample.
Adults must swab children ages 2-13.
Stir Swab and Run Test
-
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 push vial down into test unit to start test until it clicks.
-
Ready light will start blinking when test is running.
If Ready light is not blinking within 5 seconds, use palm of your hand to push down more firmly to start test.
- Do not move test unit once the test has started running.
Wait 30 minutes.
Read and Report Result
Done light will display when test is ready in 30 minutes.
Next, please use Lucira’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.
If you test POSITIVE
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.
If you test NEGATIVE
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.
Dispose of Test Kit
After test is completed, place the test unit in plastic disposal bag and dispose all test kit materials in trash.
What is PCR quality molecular accuracy?
Lucira is a molecular test that amplifies the virus’s genetic material while
the test is running just like PCR tests. Lucira’s amplification method
provides a level of accuracy comparable to one of the highest-sensitivity PCR
tests.
To receive a verified test result, Lucira has developed LUCI, a secure test
result reporting portal. You will use the QR code at left to register your
test result. To get started, see Read Results section in enclosed
instructions.
The Lucira Check It COVID-19 test kit 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 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.
Para instrucciones en español:
www.lucirahealth.com/espanol
This kit contains everything you need to run this test: instructions, 2 AA
batteries, 1 test unit, sample vial, nasal swab and disposal bag.
For use under Emergency Use Authorization
(EUA) only
For In Vitro Diagnostic Use
Patents: www.lucirahealth.com/patents
References
- LUCI
- Coronavirus Disease 2019 (COVID-19) | CDC
- COVID-19 Single-Use Molecular Tests | Lucira Pfizer
- COVID-19 PCR quality at-home test | Lucira Pfizer
- COVID-19 Single-Use Molecular Tests | Lucira Pfizer
- Emergency Preparedness and Response | FDA