EN
GENABIO
User Instructions
Genabio COVID-19 R
apid Self-Test Kit
A rapid test for the detection of SARS-CoV-2 antigens in
anterior nasal swab specimens. For self-testing use. For
use under an Emergency Use Authorization (EUA) only.
Carefully read the instructions before performing the test.
Failure to follow the instructions may result in inaccurate
test results.
If you have any questions regarding the use of this
product or if you want to report a test system problem,
please contact Genabio Diagnostics Inc. (via Email:
system problems may also be reported to the FDA
through the MedWatch medical products reporting
program (Phone: 800.FDA.1088; Fax: 800.FDA.0178;
http://www.fda.gov/medwatch).
How to Use This Test
• Serial testing should be performed in all individuals
with negative results; individuals with symptoms of
COVID-19 and initial negative results should be tested
again after 48 hours. Individuals without symptoms of
COVID-19, and with initial negative results, should be
tested again after 48 hours and, if the 2nd test is also
negative, a 3rd time after an additional 48 hours. You
may need to purchase additional tests to perform this
serial (repeat) testing.
• If you test negative but continue to have symptoms
of COVID-19, and both your first and second tests are
negative, you may not have COVID-19, however you
should follow-up with your healthcare provider.
• If your test is positive, then proteins from the virus
that causes COVID-19 have been found in your sample
and you likely have COVID-19.
Step by Step Instructions
Prepare Materials
Open the package and take out the COVID-19 Test Pouch,
Pre-filled Tube, Anterior Nasal Swab, and the Instruction
for Use.
If stored refrigerated, allow test components
(COVID-19 Test Pouch and Pre-Filled Tube) to equilibrate to
room temperature (15‒30°C or 59-86°F ) before starting
the Test Procedure.
CO
VID-19 Test Pouch
Genabio Rapid Test
Pre-Filled Tube
Anterior Nasal Swab
Instruction for Use
Note: This product comes in a 1-test, 2-test, 5-test, or 25-test
configuration.
The number of items supplied in the kit will vary depending on
which kit was purchased.
A
timer is required to perform the test and is not included in
the test kit. Do not begin if you do not have at least 25 minutes
available to focus on performing the test. Before you begin,
wash your hands for at least 20 seconds and then dry your
hands. Perform the test indoors, at room temperature on a
clean, flat surface.
Preparation
Clean your hands thoroughly with hand sanitizer or
soap for at least 20 seconds and make sure they are dry
before you start the test.
Read the instructions.
.
.
Check the kit's contents and the expiration date.
Genabio Rapid Test
Open the foil pouch and put the COVID-19 test cassette on a flat
surface. Once opened, use the test cassette within 1 hour.
Specimen Collection
An anterior nasal swab sample can be self-collected by
adults. Children 2-13 years old should be tested by an
adult.
Remove the swab from the package.
Note: Do not touch the soft end with your hands or
anything else.
Insert the entire soft end of the swab into your nostril
no more than ¾ of an inch (1.5 cm) into your nose.
For children the maximum depth of insertion of swabs
into the nostril may be less than ¾ of an inch. You may
need additional help from the other person to hold the
child’s head for swab sampling.
Slowly rotate the swab, gently pressing against the
inside of your nostril 10 times for a total of 15 seconds.
Get as much nasal discharge as possible on the soft end
of the swab.
Gently remove the swab, use the SAME SWAB and
repeat steps in your other nostril with the SAME end of
the swab.
Be sure to collect nasal drainage on the swab.
Note: Failure to swab properly may cause a false
negative result.
Test Procedure
Tear off the seal on top of the collection tube.
Place the swab into the collection tube
immediately and stir for 30 seconds.
Note: If the swab is not stirred at least 30 seconds, a
false negative result may occur.
Rotate the swab at least 5 times
while squeezing the tube.
Note: If the swab is not rotated at
least 5 times, a false negative result
may occur.
Remove the swab while
squeezing the tube.
Attach the dropper tip firmly onto the tube.
3 drops
Invert the collection tube with sample, squeeze and
add 3 drops to the sample well of the test cassette.
RESULTS
Start the timer for 15 minutes. Do not move the cassette.
Warning: Do not read the result before 15 minutes or after 30
minutes. Inaccurate test results may occur if not interpreted in
this time frame.
Result Interpretation
Repeat testing is needed to improve test accuracy. Please follow
the table below when interpreting test results for COVID-19.
Status on First
Day of Testing
First Result
Day 1
Second Result
Day 3
Third Result
Day 5
Interpretation
Positive N/A N/A Positive for COVID-19
With
Symptoms
Negative Positive N/A Positive for COVID-19
Negative Negative N/A Negative for COVID-19
Positive N/A N/A Positive for COVID-19
Without
Symptoms
Negative Positive N/A Positive for COVID-19
Negative Negative Positive Positive for COVID-19
Negative Negative Negative Negative for COVID-19
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.
Control (C) line and Test (T) line both appear as pink-colored lines in the
show window.
Note: Any faint visible pink color Test (T) line should be interpreted as
positive, when the Control (C) line is also present. The Test (T) line may
vary in shade an intensity (light or dark, weak or strong) depending on the
concentration of antigen present in the sample. The intensity of the
Control (C) line should not be compared to that of the Test (T) line for
interpretation of the test result.
You do not need to perform repeat testing if you have a positive result at
any time.
A positive test result means that the virus that causes COVID-19 was
detected in your sample and it is very likely you have COVID-19 and are
contagious. Please contact your doctor/primary care physician or your local
health authority immediately and adhere to the local guidelines regarding
self-isolation. There is a very small chance that this test can give a positive
result that is incorrect (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 the Control (C) line is visible, but the Test (T) line is not visible, the test is
negative.
To increase the chance that the negative result for COVID-19 is accurate,
you should:
• Test again in 48 hours if you have symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if you do not have symptoms
on the first day of testing.
A negative test result indicates that the virus that causes COVID-19 was not
detected in your sample. A negative result is presumptive, meaning it is not
certain that you do not have COVID-19. You may still have COVID-19 and you
may still be contagious. There is a higher chance of false negative results
with antigen tests compared to laboratory-based tests such as PCR. If you
test negative and continue to experience COVID-19-like symptoms, (e.g.,
fever, cough, and/or shortness of breath) you should seek follow up care
with your health care provider.
If no line appears in the Control (C) area, the test results are invalid
regardless of the presence or absence of a line in the Test (T) area. An invalid
result means the test was not able to tell if you have COVID-19 or not. If the
test is invalid, re-test with a new swab and new test device.
Repo
rt your test result(s) at Genabio.com/covid
under "Report Test Results" –
this voluntary
reporting helps public health teams understand COVID-19
spread in your area and across the country and informs public health decisions.
EN
GENABIO
For Emergency Use Authorization (EUA) Only
For In Vitro Diagnostic Use
This product has not been FDA cleared or approved but has been
authorized by FDA under an EUA.
• This product has been authorized only for the detection of
proteins from SARS-CoV-2, not for any other viruses or
pathogens.
• An anterior nasal swab sample can be self-collected by an
individual age 14 years and older. Children age 2 to 13 years
should be tested by an adult.
• 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 IVDs 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 detailed instructions, please visit:
https://www.genabio.com
Intended Use
The Genabio COVID-19 Rapid Self-Test Kit is a lateral flow
immunoassay device intended for the qualitative detection of
nucleocapsid protein antigen from the SARS-CoV-2 virus.
This test is authorized for non-prescription home use with self-
collected anterior nasal (nares) swab samples from individuals
aged 14 years or older or adult-collected anterior nasal (nares)
swab samples from individuals aged 2 years or older. This test is
authorized for individuals with symptoms of COVID-19 within the
first 7 days of symptom onset when tested at least twice over
three days with at least 48 hours between tests, and for
individuals without symptoms or other epidemiological reasons to
suspect COVID-19, when tested at least three times over five days
with at least 48 hours between tests.
The Genabio COVID-19 Rapid Self-Test Kit does not differentiate
between SARS-CoV or SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid
protein antigen, which is generally detectable in anterior nasal
(nares) samples during the acute phase of infection. Positive
results indicate the presence of viral antigens, but clinical
correlation with patient 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 and
the agent detected may not be the definitive cause of disease.
Individuals who test positive with the Genabio COVID-19 Rapid
Self-Test Kit should self-isolate and seek follow-up care with their
physician or healthcare provider as additional testing may be
necessary.
All negative results are presumptive and confirmation with a
molecular assay, if necessary for patient management, may be
performed. Negative results do not rule out SARS-CoV-2 infection
and should not be used as the sole basis for treatment or patient
management decisions, including infection control measures such
as isolating from others and wearing masks. 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-19 like symptoms of fever, cough and/or shortness of
breath may still have SARS-CoV-2 infection and should seek follow up care with
their physician or healthcare provider. Individuals should provide 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 Genabio COVID-19 Rapid Self-Test Kit is intended for non-prescription self-
use and/or, as applicable, for an adult lay user testing another person aged 2
years or older in a non-laboratory setting.
The Genabio COVID-19 Rapid Self-Test Kit is only for in vitro diagnostic use
under the Food and Drug Administration's Emergency Use Authorization. This
product has not been FDA cleared or approved.
Warning and Precaution
• In the USA, this product has not been FDA cleared or
approved but, has been authorized by FDA under an EUA.
• This product has been authorized only for the detection of
proteins 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.
• Read all instructions carefully before performing the test. Failure
to follow directions may product inaccurate test results.
• Serial testing should be performed in individuals with negative
results at least twice over three days (with 48 hours between tests) for
symptomatic individuals and three times over five days (with at least
48 hours between tests) for asymptomatic individuals. You may need
to purchase additional tests to perform this serial (repeat) testing.
• If you have had symptoms longer than 7 days you should consider
testing at least three times over five days with at least 48 hours between
tests.
• Do not touch swab tip.
• Testing should occur immediately after opening the pouch.
• To ensure correct results, you must follow the instructions for use
• Use only the contents provided in the test kit.
• Test components are single use. Do not re-use.
• Do not use this test kit beyond its expiration date.
• Do not use if any of the test kit contents or packaging is damaged
or open.
• Do not use the test on children under 2 years of age.
• An anterior nasal swab sample can be self-collected by an
individual age 14 years and children aged 2 to 13 years of age should be
tested by an adult.
• Wear a face mask or other face covering when collecting
specimen from a child or another individual.
• False negative test results may occur if a specimen is incorrectly
collected or handled.
• Do not read the test result before 15 minutes or after 30
minutes. Results read before 15 minutes or after 30 minutes may lead
to a false positive, false negative, or invalid result.
• Once opened, the test card should be used with 30 minutes.
• Keep testing kit and kit components away from children and
pets before and after use. The chemicals in the reagent solution may be
hazardous to the skin, eyes, nose, or mouth. Do not ingest any kit
components. The reagent solution contains harmful chemicals (see
table blow). If the solution contacts your skin, eyes, nose, or mouth,
flush with large amounts of water. If irritation persists, seek medical
advice: https://www.poisonhelp.org or 1-800-222-1222.
• For more information on EUAs please visit:
https://www.fda.gov/emergency-preparedness-and-response/mcm-
legal-regulatory-and-policy-framework/emergency-use-authorization
• For the most up to date information on COVID- 19, please visit
https://www.cdc.gov/COVID-19
• Ensure that there is sufficient lighting for testing and interpretation.
Chemical
Concentrations
GHS Code for applicable Ingredient
Name
W/W %
Harmful if swallowed(H302)
Triton X-100
Cause skin irritation(H315)
0.10%
Cause serious eye damage(H318)
Harmful if swallowed (H302)
Harmful if inhaled (H332)
ProClin®300 0.05%
Causes severe skin burns and eye damage (H314)
May cause an allergic skin reaction(H317)
Limitation
• Incorrect test results may occur if a specimen is incorrectly
collected or handled.
• There is a higher chance of false negative results with home use
tests than with laboratory-based molecular tests due to the sensitivity o
the test technology. This means that there is a higher chance this test
will give you a negative result when you have COVID-19 as compared to
molecular test, especially in samples with low viral load.
• All COVID-19 antigen test negative results are presumptive and
confirmation with a molecular assay may be necessary. If you continue t
have symptoms of COVID-19, and both your first and second tests are
negative, you may not have COVID-19, however you should follow-up
with a healthcare provider.
• If the test is positive, then proteins from the virus that causes
COVID-19 have been found in the sample and you likely have COVID-19.
• These test results are shown as lines of color. Because these lines
can be very faint, users with vision impairment - such as far-sightedness
or glaucoma - are encouraged to seek assistance to interpret results
accurately (e.g., reading glasses, additional light source, or another
person with no vision impairment).
f
a
o
• The performance of this test was established based on the
evaluation of a limited number of clinical specimens collected between
January 2022 and June 2022. The clinical performance has not been
established for all circulating variants but is anticipated to be reflective
of the prevalent variants in circulation at the time and location of the
clinical evaluation. Performance at the time of testing may vary
depending on the variants circulating, including newly emerging
strains of SARS-CoV-2 and their prevalence, which change over time.
Frequently Asked Questions
Q: WHAT IS COVID-19?
A: COVID-19 is an acute respiratory infectious disease caused by the
SARS-CoV-2 virus, a novel Betacoronavirus. SARS-CoV-2 is mostly
spread person-to-person, both by individuals with symptoms of
COVID-19 infection and by infected people without symptoms. Based
on the current knowledge, the incubation period is 1 to 14 days,
mostly 4-5 days. Symptoms include fever, fatigue, and cough. For a full
list of symptoms, see:
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
Q: WHAT ARE THE KNOWN AND POTENTIAL RISKS BENEFITS OF THIS
TEST?
A: Potential risks include:
•Possible discomfort during sample collection.
•Possible incorrect test results (see Result Interpretation Section)
Potential benefits include:
•The results, along with other information, can help you and your
healthcare provider make informed decisions about your care.
•The results of this test may help limit the spread of COVID-19 to your
family and others in your community.
Q
: WILL THIS TEST HURT?
A: No, the nasal swab is not sharp and it should not hurt. Sometimes the
swab can feel slightly uncomfortable or tickly. If you feel pain, please stop
t
h
e test and see
k advice from
a healthcare provider.
Q: WHAT IS SERIAL TESTING?
A: Serial testi
ng is when one person test
s themselves
multiple ti
mes
for
COVID-19 on a routine basi
s, such as e
very day or every
other day. By
.
testing more frequently, you may detect COVID-19 more quickly and
reduce spread of infection. Serial testing (i.e. testing every day or
every other day) is more likely to detect COVID-19. If you do not have
any symptoms, testing should be performed at least twice over three
days, with at least 24 hours and no more than 48 hours between tests.
You may need to purchase additional tests to perform this serial
(repeat) testing.
Q: HOW ACCURATE IS THIS TEST?
A: Clinical studies have shown that antigen tests more accurately
determine whether you are infected with the virus that causes
COVID-19 when taken multiple times across several days. Repeat
testing improves test accuracy. This serial testing approach is
recommended to minimize the risk of incorrect results. For more
information on the performance of the test and how the performance
may apply to you, please refer to the performance data in the
Healthcare Provider Instructions for Use (IFU), available at
https://www.genabio.com.
Q: WHAT IF I HAVE A POSITIVE TEST RESULT?
A: A positive result means that it is very likely you have
COVID-19 because proteins from the virus that causes COVID-19 were
found in your sample. You should self-isolate from others and contact
a healthcare provider for medical advice about your positive result.
Your healthcare provider will work with you to determine how best to
care for you based on your test result, medical history, and symptoms.
Q: WHAT IF I HAVE A NEGATIVE TEST RESULT?
A: A negative test result indicates that antigens from the virus that
causes COVID-19 were not detected in your sample. However, if you
have symptoms of COVID-19, and your first test is negative, you
should test again in 48 hours since antigen tests are not as sensitive as
molecular tests. If you do not have symptoms, and received a negative
result, you should test at least two more times with 48 hours in
between tests for a total of three tests. If you have a negative result, it
does not rule out SARS-CoV-2 infection; you may still be infected and
you may still infect others.
It is important that you work with your healthcare provider to help
you understand the next steps you should take.
Q:WHAT DOES AN INVALID TEST RESULT MEAN?
A: If no control line shows up on the test, the result is invalid (even if
any test line shows up). An invalid result means the test was not able
to tell if you have COVID-19 or not. If the test is invalid, a new swab
should be used to collect a new nasal specimen and the test should be
run again, using all new test components.
Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND
MOLECULAR TEST?
A: There are different kinds of tests for the SARS-CoV-2virus that
causes COVID-19. Molecular tests detect genetic material from the
virus. Antigen tests such as the Genabio COVID-19 Rapid Self-Test Kit,
detect proteins from the virus. Due to the lower sensitivity of antigen
tests, there is a higher chance this test will give you a false negative
result when you have COVID-19 than a molecular test would.
Q: IS THERE OTHER INFORMATION AVAILABLE DESCRIBING THE
PERFORMANCE OF THIS TEST?
A: Yes. Please see the Healthcare Provider Instructions for Use
available at https://www.genabio.com for additional information. The
performance of this test is still being studied in patients without signs
and symptoms of respiratory infection and for serial screening.
Performance may differ in these populations.
Important
Do not use this test as the only guide to manage your illness. Please
consult your healthcare provider if your symptoms persist
or become
more
severe,
or
i
f
you
are
concerned
at
any time.Indivi
duals should
provide all results obtained with this product to their healthcare provider
for public health reporting.
Healthcare
Providers
Please visit https://www.genabio.com to obtain the complete instructions for
use and fact sheet for healthcare providers.
Storage and Stability
Store the Genabio COVID-19 Rapid Self-Test Kit between 2-30 ° C
(36-86 °F). Ensure that all kit contents are at room temperature
before use. Kit contents are stable until the expiration date printed
on the outer packaging. Do not use beyond the expiration date.
The Test Cassette must remain in the sealed pouch until use.
For the most current expiration dates of this test, please refer to:
https://www.fda.gov/covid-tests
Symbols
Catalogue number
In vitro diagnostic
use only
Lot Number (Batch Code)
Tests Per Kit
Use by (Expiration Date)
Manufacturer
Temperature
Limitations (Storage
Temperature)
Date of Manufacture
One Time Use
(Single Use Only)
Consult Instructions
for Use
The extraction buffer solution in the extraction buffer tube contains a
hazardous ingredient as shown in above
ta
ble. If
the extraction
buff
er
solution cont
acts the skin
or eye, i
mmediately wash wi
th plenty of
running
water. In case the irritation persists, please seek medical advice at:
https://www.poison.org/contact-us or 1-800-222-1222.
In the USA
1. This test is intended
to be used as an aid
to clinical diagnosis of a current
COVID-19 infection.
Do not use this test
as the only guide to manage your
illness.
2.
In USA - This
product has
not been FDA cleared or approved but
has been
authorized by FDA under an Emergency Use Authorization (EUA). This
product has
been
authorized
only for
the detection
of
proteins
from
SARS-
CoV-2,
not for any
other virus 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
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.
Manufactured for Genabio Diagnostics Inc.
Add:
19B Crosby D
r
. Ste
220,Be
dford,
MA 01730,
USA
Tel: 1-800-614-3365
Email: [email protected] https://www.genabio.com
More Information:
All rights reserved.
All trademarks referenced are trademarks of either
the Genabio of companies or their respective
owners. GBD210613 Rev 7, Effective April 2023
The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic
immunoassay device intended for the qualitative detection of the nucleocapsid protein
antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals
with or without symptoms or other epidemiological reasons to suspect COVID-19.
Determining a negative result requires multiple tests. You may need to purchase
additional tests to perform serial (repeat) testing. This test is more likely to give you a
false negative result when you have COVID-19 than a lab-based molecular test.
For more information on expiration dating for COVID-19 antigen tests, please refer to
http://www.fda.gov/covid-tests
x For in vitro diagnostic use.
• For Emergency Use Authorization (EUA) only.
• For ages 2 through 13, an adult must collect and test the anterior nares specimen.
• This test does NOT determine if you had COVID-19 in the past or if you have immunity.
• For symptomatic individuals, the test is for serial testing at least twice over three days
with at least 48 hours between tests.
• For asymptomatic individuals,the test is for serial testing at least three times over five
days with at least 48 hours between tests.
• In the USA, this product has not been FDA cleared or approved, but has been
authorized by FDA under an EUA. This product has been authorized only for the
detection of proteins 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.
In vitro diagnostic medical device
• For in vitro diagnostic use.
• For Emergency Use Authorization (EUA) only.
• For ages 2 through 13, an adult must collect and test the anterior nares specimen.
• This test does NOT determine if you had COVID-19 in the past or if you have immunity.
• For symptomatic individuals, the test is for serial testing at least twice over three days with at
least 48 hours between tests.
• For asymptomatic individuals,the test is for serial testing at least three times over five days
with at least 48 hours between tests.
• In the USA, this product has not been FDA cleared or approved, but has been
authorized by FDA under an EUA. This product has been authorized only for the
detection of proteins 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.
The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic immunoassay
device intended for the qualitative detection of the nucleocapsid protein antigen from
SARS-CoV-2 in anterior nasal swab specimens directly from individuals with or without
symptoms or other epidemiological reasons to suspect COVID-19. Determining a negative
result requires multiple tests. You may need to purchase additional tests to perform serial
(repeat) testing. This test is more likely to give you a false negative result when you have
COVID-19 than a lab-based molecular test.
For more information on expiration dating for COVID-19 antigen tests, please refer to
http://www.fda.gov/covid-tests
The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic immunoassay
device intended for the qualitative detection of the nucleocapsid protein antigen from
SARS-CoV-2 in anterior nasal swab specimens directly from individuals with or without
symptoms or other epidemiological reasons to suspect COVID-19. Determining a negative
result requires multiple tests. You may need to purchase additional tests to perform serial
(repeat) testing. This test is more likely to give you a false negative result when you have
COVID-19 than a lab-based molecular test.
For more information on expiration dating for COVID-19 antigen tests, please refer to
http://www.fda.gov/covid-tests
• For in vitro diagnostic use.
• For Emergency Use Authorization (EUA) only.
• For ages 2 through 13, an adult must collect and test the anterior nares specimen.
• This test does NOT determine if you had COVID-19 in the past or if you have immunity.
• For symptomatic individuals, the test is for serial testing at least twice over three days with at
least 48 hours between tests.
• For asymptomatic individuals,the test is for serial testing at least three times over five days with
at least 48 hours between tests.
• In the USA, this product has not been FDA cleared or approved, but has been
authorized by FDA under an EUA. This product has been authorized only for the
detection of proteins 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.
1 896852 19500
The Genabio COVID-19 Rapid Self Test Kit is a lateral flow chromatographic immunoassay device
intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
anterior nasal swab specimens directly from individuals with or without symptoms or other
epidemiological reasons to suspect COVID-19. Determining a negative result requires multiple
tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more
likely to give you a false negative result when you have COVID-19 than a lab-based molecular test.
For more information on expiration dating for COVID-19 antigen tests, please refer to
http://www.fda.gov/covid-tests
• For in vitro diagnostic use.
• For Emergency Use Authorization (EUA) only.
• For ages 2 through 13, an adult must collect and test the anterior nares specimen.
• This test does NOT determine if you had COVID-19 in the past or if you have immunity.
• For symptomatic individuals, the test is for serial testing at least twice over three days with at least 48 hours between tests.
• For asymptomatic individuals,the test is for serial testing at least three times over five days with at least 48 hours between tests.
• In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This
product has been authorized only for the detection of proteins 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.
