OHC COVID-19
Antigen Self Test

Home Test for Your Safe Home

The OHC COVID-19 Antigen Self Test, a high quality test you can trust.

91% relative sensitivity and 99% relative specificity*

Prevent your loved ones from exposure to the virus with the accuracy of the OHC COVID-19 Antigen Self Test.

OHC continues to conduct studies for SARS-CoV-2 as new variants continue to emerge so that we can provide high-quality testing for you and your family.

Using the easy nasal swab test, you can self-collect samples with highly accurate and reliable results you can expect in just 15 minutes.

Children starting at the age of 14 can self test. Children from ages 2 to 13 require the help of an adult.

Feel safe and confident whether or not you have symptoms of COVID-19.

The OHC COVID-19 Antigen Self Test detects both Omicron and Delta variants.

*Clinical Data shows, OHC COVID-19 Antigen Self Test showed a relative sensitivity of 91% ( 95% CI: 82.8 to 95.6%) at high viral loads (less than a cycle threshold (Ct)-value of 30) and relative specificity of 99% (95% CI: 95.2 to 99.6%).

Kit Contents

Here's what you will find inside your kit.

  • Cassette image

    Cassette

  • Sterile nasal swab image

    Sterile
    nasal swab

  • Extraction buffer tube image

    Extraction
    buffer tube

  • Tube Filter Cap image

    Tube
    Filter Cap

  • User Manual Quick guide image

    User Manual
    Quick guide

  • Box (Tube holder) image

    Box
    (Tube holder)

INSTRUCTIONS FOR USE (IFU)

Seven Easy Steps to Run a Test

STEP 1: OPEN TUBE &
PLACE TUBE IN TUBE HOLDER
01.

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.
OPEN TUBE & PLACE TUBE IN TUBE HOLDER
STEP 2: OPEN SWAB
02.

Remove the swab from the packaging.

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

OPEN SWAB
STEP 3: COLLECTION THE SAMPLE
03.

Holding the stick end of the swab, gently insert the foam end of the swab into the nostril approximately ½ to ¾ of an inch.

Do not insert the swab any further if you feel resistance.

**Swab Both Nostrils**

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.**

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.
SWAB BOTH NOSTRILS
STEP 4: REMOVE THE SWAB &
PLACE IT INTO THE TUBE & MIX
04.

Directly Insert the sterile swab taken from the nostril into the extraction buffer tube and stir it 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.
PLACE SWAB IN TUBE & REMOVE SWAB FROM THE TUBE
STEP 5: DISPOSE THE SWAB & SEAL THE TUBE
05.

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

INSERT CAP
STEP 6: ADD 4 DROPS
INTO THE CASSETTE SAMPLE WELLDROPS INTO THE CASSETTE SAMPLE WELL
06.

Hold the tube uprights 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.
PLACE CASSETTE & ADD 4 DROPS
STEP 7:

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.

START TIMER & READ TEST RESULT

READ & 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.

POSITIVE RESULT

If a test line (T) is visible together with a control line (C), this means that the result is positive. Look carefully at the result: The test should be considered positive if two lines are visible - even if they are faint. A positive test result means that the virus that causes COVID-19 was detected in your sample, and it is very likely that you have COVID-19. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self-isolation. Your doctor may require you to undergo a molecular PCR test to confirm the result. There is a very small chance that this test can give a positive result that is incorrect (a false positive).

PLACE TUBE IN TUBE HOLDER
NEGATIVE RESULT

If a control line (C) is visible and a test line (T) is not visible, this means that the result is negative. It is unlikely that you have COVID-19. However, even if your test is negative, continue to observe all hygiene and safety measures.


If you suspect that you have an infection, contact your doctor/primary care physician. You may have another infection, or your test result may be false. Negative results do not rule out COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If you do not have COVID-19 symptoms and your result is negative, you should test again with at least 24 hours and no more than 48 hours between tests.

PLACE TUBE IN TUBE HOLDER
INVALID RESULT

If a control line (C) is not visible, the result must be considered invalid. The test is not working correctly and you should perform another test using a different test kit. You may have performed the test incorrectly. Carefully read the Quick Reference Instructions and repeat the test. If your test result is still invalid, please contact your doctor or a COVID-19 test center.

PLACE TUBE IN TUBE HOLDER

FAQ

Frequently Asked Questions.

  • WHAT IS COVID-19?

    COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.

  • WHAT ARE THE KNOWN POTENTIAL RISKS AND BENEFITS OF THIS TEST?

    • 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.
  • WILL THIS TEST HURT?

    No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from your healthcare provider.

  • WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?

    There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests, such as the OHC COVID-19 Antigen Self Test detect proteins from the virus. Antigen tests are very specific for the COVID-19 virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. There is a higher chance of false negative results with antigen tests than with laboratory based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test is necessary and if you should continue isolating at home.

  • HOW ACCURATE IS THIS TEST?

    The performance of the OHC COVID-19 Antigen Self Test was established in a prospective clinical study using an EUA authorized molecular test as a comparator method (PPA 64.2% and NPA 98.6%). COVID-19 antigen tests are less sensitive than molecular (PCR) tests, and the performance of antigen tests can vary with the amount of COVID-19 protein in your sample. This means that the test may miss as many as 36 cases of COVID-19 out of 100. For more information about the Osang clinical performance, please see the Healthcare provider instructions for use. It is not possible to determine how much virus is in your sample prior to testing and a negative test does not rule out COVID-19 infection. A negative test also does not mean that you are not infectious. You can still have COVID-19 with a negative result from this test and infect other people. For this reason, it is recommended that you test at least twice (serial testing) when using this test. You should contact your healthcare provider to determine if additional testing with a highly sensitive COVID-19 molecular test is recommended. You can find further information by visiting http://www.osanghc.com/en/ifu/hometest. 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.

  • WHAT IS SERIAL TESTING?

    Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every 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. 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.

  • WHAT IF YOU TEST POSITIVE?

    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.

  • WHAT IF YOU TEST NEGATIVE?

    A negative test result indicates that antigens from the virus that causes COVID-19 were not found in your sample. You should test again in 24 to 48 hours. If you receive a second negative result 24 to 48 hours after your first negative result, then you are likely not infected with COVID-19. However, negative results do not rule out SARS-CoV-2 infection. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. For example, you may get a false negative result if you did not perform the test correctly or if the level of antigen from the virus causing COVID-19 was below the test limits. The amount of antigen in a sample may decrease the longer you have symptoms of infection. If you test negative and continue to experience symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. 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 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 the test should be run again, using all new test components.

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Distributed by Osang LLC.

Please follow local government and health regulations and guidance with respect to COVID-19 health and safety.