GenBody COVID-19 Ag Home Test Instruction Manual
- June 9, 2024
- GenBody
Table of Contents
COVID-19 Ag Home Test
Date of last Revision 2023.02 (Rev.0)
COVID-19 Ag Home Test
SARS-CoV-2 Antigen For Self-testing For use under Emergency Use Authorization
(EUA) Only For In vitro diagnostic use
03 Sample Collection
1. Peel off the foil cover from the pre-filled tube. 2. Insert the tube upright into the tray hole.
Cat# U-02
Cat# U-01, 05, 25
Carefully read the instructions before performing the test. Failure to follow
the instructions may produce inaccurate test results.
STORAGE & EXPIRATION 1. GenBody COVID-19 Ag kit should be stored between 35.6
to 86 °F
(2 to 30 °C). Ensure all test components are at room temperature before use.
2. Check the expiration date listed on test device pouch. 3. For the most
current expiration dates of this test, please refer to: http://www.fda.gov
/covid-tests.
DISPOSAL
Place all used kit components and the swab samples back in the pouch and
dispose the pouch in household waste.
The type of the tray differs depending on the product catalog.
Avoid exposure of your skin, eyes, nose or mouth to the solution in the tube.
3. Blow your nose thoroughly and clear the nasal passage.
01 Precautions Before the Test
· Wash hands with soap or hand sanitizer and dry thoroughly. · Using the
enclosed tube holder is optional. When testing
with the holder, please beware of buffer spillage. · Test Device should be
used within 60 minutes after opening
the pouch.
4. Remove the swab from the packaging
02 Preparation
1. Check all components before testing.
2. Open the pouch and lay the test device on a flat surface.
Do not touch swab head or lay the swab on any surface.
5. Collect the nasal swab sample
- Self-collection A nasal swab sample can be self-collected by an individual
aged 14 years and older. For self-collection, insert the swab about a half inch deep into the nostril and slowly rub along the inside wall five times for 15 seconds with medium pressure. Repeat the process in the other nostril. - Child specimen collection Children aged 2 to 13 years should be tested by
an
adult. Gently insert the entire tip of the swab head into the child’s nostril (½ to ¾ of an inch). With children , the maximum depth of insertion may be less than ¾ of an inch and you may need a second person to hold the child’s head while swabbing. Slowly rub along the inside wall five times for 15 seconds and repeat the process in the other nostril.
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Do not touch the result window or the sample well of the test device.
For test accuracy, make sure to collect sample from both nostrils.
A false negative result may occur if the nasal swab specimen is not properly
collected.
Wear a face mask if swabbing others.
DO NOT insert the swab any deeper if you feel resistance or pain.
04 Test Procedure
1. After collecting the sample with the swab, insert the swab into the pre-
filled tube.
2. Using both hands, carefully remove the tube and swab together.
3. Squeeze the sides of the tube and twirl the swab in the liquid at least 10
times. (A false negative result may occur if the swab is not twirled at least
10 times). Inadequate sample extraction can result in incorrect results.
4. While slowly removing the swab, continue squeezing the tube to make sure
all the liquid is extracted from the swab. Discard the swab.
False negative results can occur if the specimen is not properly mixed or too
vigorously mixed. 5. Attach the filter cap by firmly pushing it vertically
onto the tube and place the tube back into the tray.
6. Invert the tube and hold the sample vertically above the sample well.
Carefully squeeze 4 drops of the solution into the sample well.
COAVIgD-19
COAVIgD-19
COAVIgD-19
Adding other than recommended number of drops may result in incorrect results.
Do not touch the result window or the sample well of the test device.
Do not add sample to the rectangular result window.
7. Wait 15 minutes and read the result. Do not read the result after 20
minutes. Inaccurate results may occur if the test result is read before 15
minutes or after 20 minutes.
15 – 20 MIN
Wait until 15 minutes Read the result at 15 – 20 minutes
False positive or false negative results can occur if test device is read before 15 minutes or after 20 minutes.
05 Test Interpretation
Report your test result(s) at https://makemytestcount.org/ -this voluntary and
anonymous reporting helps public health teams understand COVID-19 spread in
your area and across the country and informs public health decisions.
Serial (Repeat) testing
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
With symptoms
Without symptoms
First Result Day 1
Positive Negative Negative Positive Negative Negative Negative
Second Result Day 3
N/A Positive Negative
N/A Positive Negative Negative
Third Result Day 5
N/A N/A N/A N/A N/A Positive Negative
Interpretation
Positive for COVID-19 Positive for COVID-19 Negative for COVID-19 Positive for
COVID-19 Positive for COVID-19 Positive for COVID-19 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.
COVID-19 Positive(+)
Positive
If a Control (C) line and the Test (T) line are visible, the test is positive.
Any faint visible reddish purple test (T) line with the control line (C)
should be read as positive.
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).
COVID-19 Negative(-)
Negative
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 or 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.
Invalid
Invalid
If the control (C) line is not visible, the test is invalid. Re-test with a
new device and new swab.
GenBody COVID-19 Ag Home Test
for FDA Emergency Use Authorization (EUA) Only
INTENDED USE
The GenBody COVID-19 Ag Home Test is a lateral flow chromatographic
immunoassay 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 5 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 GenBody COVID-19 Ag Home Test does not differentiate between SARS-CoV and
SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid
protein antigen, which is generally detectable in anterior nasal (nares) swab
samples during the acute phase of infection. Positive results indicate the
presence of viral antigens, 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 and the agent detected may not be the definitive cause of
disease. Individuals who test positive with the GenBody COVID-19 Ag Home Test
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 con firmation 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-like symptoms
of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection
and should seek follow up care from 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 GenBody COVID-19 Ag Home Test is intended for non-prescription self-use
and/or, as applicable, an adult lay user testing another person aged 2 years
or older in a non-laboratory setting. The GenBody COVID-19 Ag Home Test is
only for use under the Food and Drug Administration’s Emergency Use
Authorization. This product has not been FDA cleared or approved.
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.
Frequently Asked Questions
WHAT IS THE DIFFERENCE BETWEEN A COVID-19 ANTIGEN TEST AND A MOLECULAR TEST?
There are different kinds of tests for the SARS-CoV-2 virus that causes
COVID-19. Molecular tests detect genetic material from the virus. Antigen
tests, such as the GenBody COVID-19 Ag Home Test, 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.
WHAT IS SERIAL TESTING?
COVID-19 serial testing is when one person tests themselves multiple times for
COVID-19 on a routine basis, such as every other day. By testing more
frequently, you may detect COVID-19 more quickly and reduce spread of
infection. For the serial testing procedure, please refer to the `How to Use
This Test’ section. You may need to purchase additional tests to perform this
serial (repeat) testing.
HOW ACCURATE IS THIS TEST?
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.genbodyhometest.com.
WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE TEST?
Potential risks include: · Possible discomfort or other complications that can
happen during sample collection. · Possible incorrect test result (see
Warnings and Result Interpretation sections for more information).
Potential benefits include: · The results, along with other information, can
help you and your healthcare provider make informed recommenda-
tions about your care. · The results of this test may help limit the potential
spread of COVID-19 to your family and others in your community.
For more information on EUAs please visit: https://www.fda.gov/emergency-
preparedness-andresponse/mcm-legalregulatory-and-policy-framework/emergency-
use-authorization
WHAT IF I HAVE A POSITIVE TEST RESULT?
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.
WHAT IF I HAVE A NEGATIVE TEST RESULT?
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.
WHAT DOES AN INVALID TEST RESULT MEAN?
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 you should test again with a new test.
IMPORTANT
Do not use this test as the only guide to manage your illness. Consult your
healthcare provider if your symptoms persist or become more severe.
Individuals should provide all results obtained with this product to their
healthcare provider.
Warnings, Precautions, and Safety Information
1. Read all instructions carefully before performing the test. Failure to
follow the instruction may result in inaccurate test results.
2. In the USA, this product has not been FDA cleared or approved, but has
been authorized by FDA under an Emergency Use Authorization. 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.
3. 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.
4. If you have had symptoms longer than 5 days, you should consider testing
at least three times over five days with at least 48 hours between tests.
5. Do not use on anyone under 2 years of age. 6. An anterior nasal swab
sample can be self-collected by an individual age 14 years and older. Children
aged 2 to
13 years of age should be tested by an adult. 7. Do not use kit past its
expiration date. 8. Do not use if any of the test kit contents or packaging is
damaged. 9. Test components are single use only and should be discarded after
use. Do not re-use. 10. Once opened, the test device should be used within 60
minutes. 11. Do not read test results before 15 minutes or after 20 minutes.
Results read before 15 minutes or after 20
minutes may lead to a false positive, false negative, or invalid result. 12.
Wear a safety mask or other face covering when collecting a specimen from a
child or another individual. 13. Do not use nasal sprays for at least 30
minutes before collecting a nasal sample. 14. Do not touch the swab tip at any
time during the test process. 15. Do not use the test device if the desiccant
included in the foil pouch has changed from yellow to green. 16. Swabs
included in the kit are approved for use with the GenBody COVID-19 Ag Home
Test. Do not use other swabs.
17. For additional information on safety, handling, please email or call
Technical Support at ts@genbodyamerica. com or (888)-552-5204
18. Keep testing kit and kit components away from children and pets before
and after use. Avoid contact with your skin or eyes. Do not ingest any kit
components . The reagent solution contains harmful chemicals (see table
below). If the solution contacts your skin or eyes, flush with large amounts
of water. If irritation persists, seek medical advice:
https://www.poisonhelp.org or
1-800-222-1222.
Chemical Name
GHS Code for each Ingredient
Concentration
Sodium azide
H302+H312, Harmful if swallowed or in contact with skin
0.09%
19. For more information on EUAs please visit: https://www.fda.gov/emergency-
preparedness-andresponse/mcm- legal -regulatory-and-policy-framework
/emergency-use-authorization
20. For the most up to date information on COVID-19, please visit:
www.cdc.gov/COVID19
Limitations
1. There is a higher chance of false negative results with antigen tests than
with laboratory-based molecular tests due to the sensitivity of the test
technology . This means that there is a higher chance this test will give a
false negative result in an individual with COVID-19 as compared to a
molecular test, especially in samples with low viral load.
2. This device is only used for testing direct human anterior nasal swab
specimens. Viral transport media (VTM) should not be used with this test.
3. Incorrect test results may occur if a specimen is incorrectly collected or
handled. 4. The performance of the GenBody COVID-19 Ag Home Test was evaluated
using the procedures provided in these
Instructions for Use (IFU) only. Modifications to these procedures may alter
the performance of the test. 5. This test detects both viable (live) and
nonviable SARS-CoV-2. Test performance depends on the amount of virus
(antigens) in the sample and may or may not correlate with viral culture
results performed on the same sample. 6. If the patient continues to have
symptoms of COVID-19, and both the patient’s first and second tests are
negative,
the patient may not have COVID-19, however additional follow-up may be needed.
7. Failure to follow the Test Procedure may adversely affect test performance
and/or invalidate the test result. 8. Positive test results do not rule out
co-infections with other pathogens. 9. All COVID-19 antigen test negative
results are presumptive and confirmation with a molecular assay may
be necessary. 10. This test is read visually and has not been validated for
use by those with impaired vision or color-impaired vision. 11. 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. 12. The performance of this test was established based
on the evaluation of a limited number of clinical specimens
collected between November 2021 – September 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.
INTERNATIONAL SYMBOL USAGE
You may see one or more of these symbols on the labeling/packaging of this
product.
Use-by date
Batch code
In vitro diagnostic device
Catalogue number
Consult instructions for use
Manufacturer
Contains sufficient for
Temperature limit
Do not re-use
Test Device
For Technical Help, please contact:
Technical Support (US) Tel:
888-552-5204 Email:
ts@genbodyamerica.com Web: www.genbodyhometest.com
Manufacturer GenBody Inc. 3-18, Eopseong 2-gil, Seobuk-gu, Cheonan-si,
Chungcheongnam-do, 31077, Republic of Korea Tel: +82-41-523-8993
(International) Email: contact@genbody.co.kr Website: http://www.genbody.co.kr
US Distributor / US Agent Kwell Laboratories, LLC 3420 De Forest Circle Jurupa Valley, CA 91752 USA Tel: 949-561-0664 Email: inquire@kwellabs.com Website: www.kwellabs.com
COVAGHT2-U-01, COVAGHT2-U-02, COVAGHT2-U-05, COVAGHT2-U-25.
Doc. No.: I-164-EN-R0-202302-US
· 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 Emergency Use Authorization (EUA) only
· For in vitro diagnostic use
· For the most current expiration dates of this test, please refer to:
https://www.fda.gov/covid-tests.
1 test kit box 122 x 83 x 30 mm
Ag
1
2
3
1 Test
4
5
6
Questions?
4 Drops
Go to www.genbodyhometest.com or call 888-552-5204 Email: ts@genbodyamerica.com
The GenBody COVID-19 Ag Home Test is lateral flow immunoassay that uses antibodies to detect nucleocapsid protein from SARS-CoV-2. The GenBody COVID-19 Ag Home Test is a non-prescription home test intended for the qualitative detection of SARS-CoV-2 in anterior nasal swab samples self collected from individuals aged 14 years or older or adult-collected from individuals aged 2 years or older. This test is authorized for individuals within the first 5 days symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms when tested at least three times over fi ve days with at least 48 hours between tests.
Blank for UDI Barcode
3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, Chungcheongnam-do 31077, Republic
of Korea Tel: +82-41-523-8993
US Distributor Kwell Laboratories 3420 De Forest Circle Jurupa Valley, CA
91752 USA Tel: 949-561-1664
Store between 35.6-86 (2~30) until use www.genbodyhometest.com
C T
In the USA, this product has not been FDA cleared or approved, but has been
authorized by FDA under an Emergency Use Authorization. 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.
COVID-19 Antigen Home Test 1 Test
COVID-19 Antigen Home Test
COVID-19 Ag
S
Comfortable nasal swab
Results in 15 min
Contents
· 1 Test Device · 1 Extraction Tube · 1 Filter Tip · 1 Nasal Swab · 1
Instruction Sheet · Needed but not provided:
Timer, Tissue
OTC 1
86°F 35.6°F
COVAGHT2-U-01
COVID-19 Antigen
Home Test
B-164(01)-EN-202302-US
B-164(02)-EN-202302-US
Blank for UDI barcode
Questions? Go to www.genbodyhometest.com or call
888-552-5204 Email:
ts@genbodyamerica.com
COVAGHT2-U-02
· 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 Emergency Use Authorization (EUA) only
· For in vitro diagnostic use
· For the most current expiration dates of this test, please refer to:
https://www.fda.gov/covid-tests.
86°F 35.6°F
Contents
· 2 Test Device · 2 Extraction Tube · 2 Filter Tip · 2 Nasal Swab · 2
Instruction Sheet · Needed but not provided:
Timer, Tissue
Results in 15 min
Comfortable nasal swab
OTC
COVID-19 Antigen Home Test Tests 2
COVID-19 Antigen Home Test
COVID-19 Antigen Home Test
COVID-19 Ag
S
CT
3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, Chungcheongnamdo 31077, Republic
of Korea Tel: +82-41-523-8993
US Distributor Kwell Laboratories 3420 De Forest Circle Jurupa Valley, CA
91752 USA Tel: 949-561-1664
The GenBody COVID-19 Ag Home Test is lateral flow immunoassay that uses
antibodies to detect nucleocapsid protein from SARS-CoV-2.
The GenBody COVID-19 Ag Home Test is a non-prescription home test intended for
the qualitative detection of SARS-CoV-2 in anterior nasal swab samples self
collected from individuals aged 14 years or older or adult -collected from
individuals aged 2 years or older . This test is authorized for individuals
within the first 5 days symptom onset when tested at least twice over three
days with at least 48 hours between tests, and for individuals without
symptoms when tested at least three times over five days with at least 48
hours between tests.
Rev.0
In the USA, this product has not been FDA cleared or approved, but has been
authorized by FDA under an Emergency Use Authorization. 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.
Store between 35.6-86 (2~30) until use www.genbodyhometest.com
4 Drops
2 test kit box 156.4 x 93 x 43.8 mm
Tests 2
5 test kit box 170 x 124 x 61 mm
86°F 35.6°F
Contents
· 5 Test Device · 5 Extraction Tube · 5 Filter Tip · 5 Nasal Swab · 5
Instruction Sheet · Needed but not provided:
Timer, Tissue
Results in 15 min
Comfortable nasal swab
OTC 5
Tests 5
COVID-19 Antigen Home Test
COVID-19 Ag
S
CT
Questions?
Go to www.genbodyhometest.com or call
888-552-5204 Email:
ts@genbodyamerica.com
3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, Chungcheongnam-do 31077, Republic
of Korea Tel: +82-41-523-8993
US Distributor Kwell Laboratories 3420 De Forest Circle Jurupa Valley, CA
91752 USA Tel: 949-561-1664
The GenBody COVID-19 Ag Home Test is lateral flow immunoassay that uses
antibodies to detect nucleocapsid protein from SARS-CoV-2.
The GenBody COVID-19 Ag Home Test is a non-prescription home test intended for
the qualitative detection of SARS-CoV-2 in anterior nasal swab samples self
collected from individuals aged 14 years or older or adult- collected from
individuals aged 2 years or older. This test is authorized for individuals
within the first 5 days symptom onset when tested at least twice over three
days with at least 48 hours between tests, and for individuals without
symptoms when tested at least three times over five days with at least 48
hours between tests.
COVAGHT2-U-05
Rev.0
1
2
3
4
Blank for UDI barcode
Store between 35.6-86 (2~30) until use www.genbodyhometest.com
5
6
4 Drops
In the USA, this product has not been FDA cleared or approved, but has been
authorized by FDA under an Emergency Use Authorization. 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.
· 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 tests.
· For Emergency Use Authorization (EUA) only
· For in vitro diagnostic use
· For the most current expiration dates of this test, please refer to:
http://www.fda.gov/covid-tests.
B-164(05)-EN-202302-US
25 test kit box 300 x 125 x 90 mm
3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, Chungcheongnam-do, 31077, Republic of Korea Tel: +82-41-523-8993, Fax: +82-41-523-8991, Email: contact@genbody.co.kr, Website: http://genbody.co.kr US Distributor Kwell Laboratories 3420 De Forest Circle, Jurupa Valley, CA 91752, USA Tel: 949-561-0664
Timer, Tissue
· Needed but not provided:
· 5 Instruction Sheet
S
· 25 Nasal Swab
· 25 Filter Tip
· 25 Extraction Tube
· 25 Test Device
CT
OTC
35.6°F
Contents
86°F
Results in 15 min
Detection of SARS-CoV-2 Antigen
Store between 35.6-86 (2~30) until use www.genbodyhometest.com
Comfortable nasal swab
COVID-19 Ag
COVID-19 Ag Home Test
Rev.0
In the USA, this product has not been FDA cleared or approved, but has
COVID-19 Ag Home Test
Questions?
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been authorized by FDA under an Emergency Use Authorization. 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
· 25 Test Device · 25 Extraction Tube · 25 Filter Tip
Detection of SARS-CoV-2 Antigen
Go to www.genbodyhometest.
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. §
· 25 Nasal Swab · 5 Instruction Sheet
COVAGHT2-U-25
Store between 35.6-86 (2~30) until use
Results in 15 ~
Store at 35.6-86
com or call 888-552-5204
360bbb-3(b)(1), unless the declaration is terminated or authorization is · Needed but not provided:
Blank for UDI
www.genbodyhometest.com
20 minutes
(2~30)
Email: ts@genbodyamerica.com
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revoked sooner.
Timer, Tissue
barcode
· Determining a negative result requires multiple tests. You may need to
The GenBody COVID -19 Ag Home Test is lateral flow immunoassay that uses antibodies to detect nucleocapsid protein from SARS-CoV-2.
4 Drops
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
3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si, Chungcheongnam-do, 31077, Republic of Korea Tel: +82-41-523-8993, Fax: +82-41-523-8991, Email: contact@genbody.co.kr, Website: http://genbody.co.kr
Read the instructions
DO NOT Use after
The GenBody COVID-19 Ag Home Test is a non-prescription home test intended for the qualitative detection of SARS-CoV-2 in anterior nasal swab samples self collected from individuals aged 14 years or older or adult-collected from individuals aged 2 years or older. This test is authorized
a lab-based molecular tests. · For Emergency Use Authorization (EUA) only
For the most current expiration dates of this test, please refer to: http://www.fda.gov/covid-tests.
US Distributor Kwell Laboratories 3420 De Forest Circle, Jurupa Valley, CA 91752, USA Tel: 949-561-0664
carefully before testing
Expiration date
for individuals within the first 5 days symptom onset when tested at least
twice over three days with at least 48 hours between tests , and for
individuals without symptoms when tested at least
three times over five days with at least 48 hours between tests.
· For in vitro diagnostic use · For the most current expiration dates of this
test, please refer to:
http://www.fda.gov/covid-tests.
OTC
86°F 35.6°F
B-164(25)-EN-202302-US
References
- GenBody
- Coronavirus Disease 2019 (COVID-19) | CDC
- GenBody
- MakeMyTestCount
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