OHC COVID-19 Antigen Self Test User Manual
- May 15, 2024
- OHC
Table of Contents
OHC COVID-19 Antigen Self Test User Manual
User Instructions For Emergency Use Authorization (EUA) Only. For In vitro diagnostic use.
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.
Carefully read the instructions before performing the test. Failure to follow the instructions may result in inaccurate test results.
An anterior nasal swab sample can be self-collected by an individual aged 14 years or older. Children aged 2-13 years should be tested by an adult.
For the most current expiration dates of this test, please refer to: https://www.fda.gov/covid-testhttp://osanghc.com/en/ifu/hometest/
Please refer to the Healthcare Provider (HCP) IFU online for specifics about materials provided in the kit: http://www.osanghc.com/en/ifu/hometest/
Prepare to Perform the Test
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Bring test kit to room temperature (15-30ºC / 59-86ºF).
Before washing your hands, please prepare by blowing your nose. -
Wash your hands with soap and water, or use hand sanitizer before performing the test. Make sure your rinse thoroughly and your hands are dry before starting.
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Check test expiration date on the back of the foil. Do not use if the expiry date has passed NOTE: Testing should commence immediately after opening the sealed pouches.
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Open the pouch and remove the test device from the foil pouch. Ensure the desiccant contains only white and yellow beads. NOTE: If green beads are present use a new test device.
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Place the test device on a flat surface.
Test Procedure
Read and Interpret the Results
WARNING! Inaccurate test interpretations may occur if results are read before
15 minutes or after 20 minutes.
Look at the result window and locate the letters C and T on the side of the
window. A pink/purple line should always appear at the C position; this is a
control line and signals that the test is working properly.
Repeat testing is needed to improve test accuracy. Please follow the table
below when interpreting test results 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.
Negative result
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
healthcare provider.
Positive result
If a Control (C) line and the Test (T) line are visible, the test is positive.
Any faint visible pink/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 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).
Invalid result
If a control (C) line is not visible, the test is invalid. Re-test with a new
swab and new test device.
Report your test result(s) at Make My Test Count. 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.
Intended Use
The OHC COVID-19 Antigen Self Test 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 two
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 OHC COVID-19 Antigen Self 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 specimens 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. The agent detected may not be the definite cause of disease.
Individuals who test positive with the OHC COVID-19 Antigen Self 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 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 OHC COVID-19 Antigen Self Test is intended for non-prescription self-use
and/or as applicable an adult lay user testing another person 2 years of age
or older in a non-laboratory setting. The OHC COVID-19 Antigen Self Test is
only for use under the Food and Drug Administration’s Emergency Use
Authorization. This product has not been FDA cleared or approved.
Warnings, Precautions, and Safety Information
Read instructions carefully before performing a test. Failure to follow may
produce inaccurate test results. – 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. – 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.
– 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.
– Do not use on anyone under 2 years of age.
– Wear a safety mask or other face-covering when collecting a specimen from a
child or another individual.
– Do not use if any of the test kit contents or packaging is damaged.
– Test components are single-use. Do not re-use.
– Do not use kit past its expiration date.
– Do not touch the swab tip.
– Once opened, the test card should be used within 60 minutes.
– 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.
– Keep testing kit and kit components away from children and pets before and
after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest
any kit components. The reagent solution contains harmful chemicals (see table
below). 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/mcmlegalregulatory-and-policy-framework/emergency-
use-authorization
– For most up to date information on COVID-19, please visit:
www.cdc.gov/COVID19
– Use of personal protection materials such as gloves is recommended. – Do not
use nasal sprays for at least 30 minutes before collecting a nasal sample.
– Remove any piercings from nose before starting the test.
– Do not use on anyone who is prone to nosebleeds or has had facial injuries
or head injuries/surgery in the past six months.
– Make sure there is sufficient light for testing. For best results, read test
in a well-lit area.
– The test should be performed at ambient temperature (i.e., 15-30oC).
– Use only components of this test kit.
– In the event of spillage, ensure that it is cleaned thoroughly using
suitable disinfectant.
– The control line may show up within a few minutes of starting the test.
It may take up to 15 minutes for the test line to show up.
LIMITATIONS
– 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.
– The performance of this test was established based on the evaluation of a
limited number of clinical specimens collected between January February 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.
– All COVID-19 antigen test negative results are presumptive and confirmation
with a molecular assay may be necessary. If you 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 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.
– This test is read visually and has not been validated for use by those with
impaired vision or color-impaired vision.
– Incorrect test results may occur if a specimen is incorrectly collected or
handled.
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 test 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 (FAQ)
Q: WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE TEST?
A: Potential risks include:
– Possible discomfort 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 recommendations 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 go here: https://www.fda.gov/emergency-
preparedness-and-response/mcmlegalregulatory-and-policy-framework/emergency-
use-authorization
Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?
A: 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 OHC COVID-19 Antigen Self 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.
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
http://www.osanghc.com/en/ifu/hometest/
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.
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: 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 test results obtained with this product to their healthcare provider.
Storage and Stability
Store the OHC COVID-19 Antigen Self Test at 2-30 / 36-86 and protect from direct sunlight. Ensure 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. Do not freeze the kit.
Symbols
Please refer to Healthcare Provider (HCP) IFU online for specifics regarding the Symbols glossary. If you have any questions about using the test or reading the results, please call our customer care hotline. Telephone: 844-760-0556 Email: covidhometest@osangllc.com
Manufactured for OSANG LLC. 215 N Marengo Ave. 3rd Fl. Pasadena CA 91101
OSANG Healthcare Co., Ltd.
132, Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, Korea (14040)
www.osanghc.com
ISC02945 Rev.2023-05-03
References
- MakeMyTestCount
- Coronavirus Disease 2019 (COVID-19) | CDC
- OSANG Healthcare
- 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222