FAQ | Osang LLC

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COVID-19 SELF TESTING FAQ

Welcome to Osang's FAQ for Covid-19 Self Testing.

If you do not see your question answered answer here, please feel free to contact us anytime.

Q: WHAT IS COVID-19?

A: 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.

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

A: Potential risks include:

- Possible discomfort during sample collection.

- Possible incorrect test result .See 'Warnings and Result Interpretation' section of Quick Reference Instructions (QRI) for more information.

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.

For more information on EUAs, click the following link:

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-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 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.

Q: HOW ACCURATE IS THIS TEST?

A: 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.

Q: WHAT IS SERIAL TESTING?

A: 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. 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.

Q: WHAT IF YOU TEST NEGATIVE?

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.

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