OHC COVID-19 Antigen Self Test Instruction Manual

OHC COVID-19 Antigen Self Test

Product Information

Specifications

• Product Name: OHC COVID-19 Antigen Self Test
• Intended Use: For Emergency Use Authorization (EUA) Only. For In vitro diagnostic use.
• Age Requirement: Individuals aged 14 years or older can self-collect nasal swab samples. Children aged 2-13 years should be tested by an adult.
• Manufacturer: OSANG Healthcare Co., Ltd.
• Website: www.osanghc.com

Product Usage Instructions

Prepare to Perform the Test

1. Before washing your hands, please prepare by blowing your nose.
2. Wash your hands with soap and water or use hand sanitiser before performing the test. Ensure thorough rinsing and dry hands before starting.
3. Check the test expiration date on the back of the foil. Do not use if the expiry date has passed. Test immediately after opening the sealed pouches.
4. Open the pouch and remove the test device from the foil pouch. Ensure the desiccant contains only white and yellow beads. If green beads are present, use a new test device.
5. Place the test device on a flat surface.

Test Procedure

1. Open the pouch that contains the extraction buffer tube & filter cap.
2. Open the seal of the tube carefully without spilling the liquid inside. Place the tube securely in a box to prevent spills.
3. Remove the swab from the packaging, ensuring only the handle is touched.
4. Gently insert the swab into each nostril, rotating it as instructed for proper collection.

FAQ

What should I do if I encounter resistance while inserting the swab?

Do not insert the swab any further if you feel resistance. Swab both nostrils gently without forcing it.

How do I ensure accurate test results?

Properly follow all instructions for sample collection to avoid inaccurate test results. Refer to the user manual for detailed guidance.

Can children perform this test on their own?

Children aged 2-13 years should be tested by an adult. Individuals aged 14 years or older can self-collect nasal swab samples.

WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND 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 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.

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.

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

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/

INSTRUCTION

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-test.

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

1. Bring test kit to room temperature (15-30ºC / 59-86ºF).
   Before washing your hands, please prepare by blowing your nose.

2. 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.

3. 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.

4. 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.

5. Place the test device on a flat surface.

Test Procedure

1. Open the pouch that contains the extraction buffer tube & filter cap.

   • Open the seal of the tube carefully without spilling the liquid inside the tube.
   • Punch a hole in the box to hold the tube.
   • If any liquid spills, do not use the tube.

2. Remove the swab from the packaging.
   Ensure that you only touch the handle of the swab and NOT the soft pad on the tip.

3. Holding the stick end of the swab, gently insert the foam end of the swab into the nostril approximately 1/2 to 3/4 of an inch.
   Do not insert the swab any further if you feel resistance. Swab Both Nostrils

4. Firmly and slowly rotate the swab at least 5 times, brushing against the inside walls of the nostril at least 5 times for a total of 15 seconds.
   Do not just spin the swab.

5. Gently remove the swab, and using the same swab, repeat in the second nostril with the same end of the swab.
   NOTE: When swabbing others, please wear a face mask. With children, the maximum depth of insertion into the nostril may be less than 3/4 of an inch, and you may need to have a second person to hold the child’s head while swabbing.
   WARNING! Inaccurate test results may occur if the nasal swab specimen is not properly collected.

6. Directly insert the swab taken from the nostril into the extraction buffer tube and stir in more than 10 times. Take out the swab from the extraction buffer tube by squeezing and applying pressure on both sides of the tube.
   WARNING! Failure to squeeze the tube can lead to incorrect results due to excess buffer in the swab.
   WARNING! The sample should be mixed into the buffer immediately, but no more than an 1 hour after collecting the sample.

7. Dispose of the swab and seal the tube securely with the nozzle cap.

8. Hold the tube upright above the sample well. Drop 4 drops onto the sample well. Do not apply the liquid in the rectangular result window.
   WARNING! Adding more or less than 4 drops of solution into the sample well may result in incorrect results.

9. Set the timer and read the test result at 15 minutes. Do not read the result after 20 minutes. Read test result at 15 minutes. DO NOT read after 20 minutes.
   WARNING! Do not move or lift the test device during this time.
   After the test is completed, dispose of used materials in household trash. Do not flush or pour test liquids down a drain.

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
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 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.

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 thepresence 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 federalrequirements 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 least48 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 a 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 colour-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.

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.

Please refer to the 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: [email protected]

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

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

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