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In collaboration with NIH, OraSure confirms that InteliSwab™ detects the Omicron variant. Read More.

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 a 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 not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g. fever, coughing, difficulty breathing, etc.).

Where can I go for updates and more information?

The most up-to-date information on COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19

For additional information about InteliSwab™, visit InteliSwab.com

What are common symptoms of COVID-19?

Symptoms of COVID-19 may appear 2-14 days after exposure and may include fever, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, or a runny nose, nausea or vomiting and diarrhea. It is also possible for someone infected with COVID-19 to have no symptoms.

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

Information about Emergency Use Authorizations and COVID-19

For more information on EUAs go here: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

For the most up to date information on COVID-19, please visit: http://www.cdc.gov/ COVID19

Visit InteliSwab.com to obtain the complete Instructions for Use and Fact Sheets.

What type of test is InteliSwab™?

There are different kinds of tests for diagnosing COVID-19. InteliSwab™ is an antigen test. Antigen tests detect proteins (small parts) from the SARS-CoV-2 virus. Antigen tests are designed to detect virus levels that reflect active infection.

Does this test detect the new SARS-CoV-2 variants?

Viruses constantly change through mutation. With COVID-19, the CDC has identified variants of concern, including Alpha, Beta, Gamma, Delta and most recently the Omicron Variant.

InteliSwab™ has been tested against these variants and successfully detects these strains of the virus. We continually test InteliSwab against variants of concern as they are identified by the CDC.

For more information on variants, click here.

Is the test easy to use?

Using InteliSwab™ is remarkably simple. You just swab your nostrils with the gentle swab, swirl the swab in the tube, and see your test results in minutes. There are no confusing steps, no batteries or plugs needed and no mailing samples to a lab.

Who can use InteliSwab™?

InteliSwab™ is authorized for over-the-counter use in individuals age 15 and older with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests.

InteliSwab™ is authorized for professional point-of-care use in individuals age 15 and older who are within 7 days of symptom onset, or in individuals without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests.

InteliSwab™ is authorized for prescription home use in individuals age 15 years and older who are within 7 days of symptom onset.

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 Instructions for Use for more information)

Potential benefits include:
• The results, along with other information, can help your healthcare provider make informed recommendations about your care
• The results of this test may help limit the spread of COVID-19 to your family and those you come in contact with

What is serial testing?

Serial testing is when one person is tested for COVID-19 more than once. Because antigen tests may be less sensitive than other COVID-19 tests and false results may occur, repeated testing may identify more individuals with COVID-19 infection than a single test.

By repeating testing, it may be possible to more quickly identify cases of COVID-19 infection and reduce spread of infection. Additional testing with molecular COVID-19 test may be necessary, depending on your individual risk factors and test results. It is important that you work with your healthcare provider to help you understand the next steps you should take.

What are the differences between antigen tests and other COVID-19 tests?

There are different kinds of tests for diagnosing COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the 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. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. If you do not have an additional test to determine if you are infected and may spread the infection to others, the CDC currently recommends that you should stay home until three things have happened:
You have had no fever for at least 24 hours (that is three full days of no fever without the use of medicine that reduces fevers).
AND
Other symptoms have improved (for example, when your cough or shortness of breath has improved). Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation.
AND
At least 10 days have passed since your symptoms first appeared. For more information, the CDC has provided guidelines on how to prevent the spread of COVID-19 if you are sick: https://www.cdc.gov/coronavirus/2019-ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf

Is this test FDA-approved or cleared?

No. This test is not yet approved or cleared by the United States FDA. FDA may issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.

This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

What are the approved alternatives?

There are no approved available alternative antigen tests. Any tests that have received full marketing status (e.g. cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases here:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

How many COVID-19 home tests come in a package?

There are two complete test kits included in each InteliSwab™ OTC COVID-19 Rapid Test package. If your first test result is negative, you should test again in 24 to 36 hours. InteliSwab™ COVID-19 Rapid Test is intended to be used for serial testing twice by the same individual.

Is the test reusable?

No. Each test is intended for single use. After the test is completed and the results are read, the test should be disposed of in the trash.

Do not throw away the test stand if you bought a two-test kit until both tests are completed.

Where is the test made?

InteliSwab™ is designed and developed in Bethlehem, Pennsylvania by OraSure Technologies, a leading innovator in diagnostic testing for infectious disease.

How accurate is InteliSwab™?

InteliSwab™ results were compared to highly sensitive molecular FDA Authorized SARS-CoV-2 assays to determine test performance. InteliSwab™ correctly identified 84% of the positive samples with both low levels and high levels of virus.

Additionally, InteliSwab™ correctly identified 98% of negative samples.

InteliSwab™ is a lateral flow in vitro diagnostic antigen test to detect COVID-19. Antigen tests are designed to detect active infection in individuals. A clinical study was conducted during February and April of 2021 to determine the performance of the InteliSwab™ test.

A total of 146 individuals with signs and symptoms of COVID-19 within the first 7 days of symptom onset were enrolled across 5 different locations in the US. Subjects 18 years or older independently collected the lower nasal sample and completed the home use test.

What does it mean if I have a positive test result?

If you have a positive test result, it is very likely that you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). If you test positive with the InteliSwab™ COVID-19 Rapid Test you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary. Your healthcare provider will work with you to determine how best to care for you based on the test result along with other factors of your medical history, and your symptoms. For the most up to date information on COVID-19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage: https://www.cdc.gov/COVID19

What does it mean if I have a negative test result?

A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. 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. The amount of antigen in a sample may decrease the longer you have symptoms of infection. In symptomatic people, specimens collected after you have had symptoms for more than seven days may be more likely to be negative compared to a molecular assay.

If you test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. For example, your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. If you are concerned about your COVID-19 infection status after testing or think you may need follow up testing, please contact your healthcare provider.

For more information about when to test visit: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html

Is the test easy to use?

Using InteliSwab™ is remarkably simple. You just swab your nostrils with the gentle swab, swirl the swab in the tube, and see your test results in minutes. There are no confusing steps, no batteries or plugs needed and no mailing samples to a lab.

Are there videos explaining how InteliSwab™ works and how to use InteliSwab™?

Yes, you can click on these links:

How to use (training video) –
https://inteliswab.com/otcinstructions/

How it works – https://inteliswab.com/wp-content/uploads/2021/05/ANIMATED-FILM_05-14.mp4

Where can I find the instructions for the InteliSwab™ COVID-19 Rapid Test?

Here are the links to the instructions in both English and Spanish. These come included in your kit.

Instructions for Use in English: https://inteliswab.com/wp-content/uploads/2021/08/3001-3570-0621-COVID-19-Rapid-Test-OTC-IFU_2.pdf

 Instructions for Use in Spanish: https://inteliswab.com/wp-content/uploads/2021/08/3001-3571-0621-COVID-19-Rapid-Test-OTC-Spanish-IFU_3.pdf

Who can use InteliSwab™?

InteliSwab™ is authorized for over-the-counter use in individuals age 15 and older with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests.

Will this test hurt?

No. The gentle nasal swab is not sharp and it should not hurt. Only the lower part of the nostril should be swabbed. If you feel pain, please stop the test and seek advice from a healthcare provider.

Does this test provide me with test results?

Yes. InteliSwab™ provides test results in minutes without the need for sending your test sample out to a laboratory.

What if you test positive?

A positive result means that it is very likely you have COVID-19 and it is important to report your results to your healthcare provider. You should isolate yourself at home to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (false positive).

What if you test negative?

If you receive a second negative result 24 to 36 hours after your first negative test, then you are likely not infected with COVID-19. If you have symptoms, you may have a different virus or type of infection. You may have COVID-19 and still get a negative result (false negative) if: You didn’t perform the test correctly, such as not swabbing correctly or not waiting 30 minutes for test results. The level of antigen from the COVID-19 virus was below the test limits. You have had signs and symptoms of COVID-19 for more than 7 days. This means you could still possibly have COVID-19 even though the test is negative. Please see your health care provider. Your healthcare provider will consider the test result along with all other aspects of your medical history, including your symptoms and possible COVID-19 exposures to decide how to care for you. It is important for you to work with your healthcare provider to help you understand the next steps you should take. A different type of test might be necessary to determine whether or not you have COVID-19.

Why do I have a test line and no control line (when reading results of your test)?

If you have a test line and no control line, your test is positive. When the level of virus in the sample is high, the line next to the “C” may not be present or may be very faint. The line next to the “C” must be visible to read a negative test result. If you see both a test line and a control line, your test result is positive.

Please see the Instructions for Use and the reference card to help you understand how to interpret test results.

Is the solution in the tube harmful?

No. The solution in the tube contains potentially harmful chemicals (Triton X-100 and ProClin 950); however, laboratory studies have shown them to be nontoxic at the levels contained in the solution.

The developer solution should only be used as directed; do not ingest; keep out of the reach of children; avoid contact with skin and eyes.

If the solution contacts the skin or eye, flush with copious amounts of water. If irritation persists, seek medical advice: https://www.poison.org/contact-us or 1-800-222-1222.

Who should use this test?

Individuals 15 years and older with or without symptoms can still utilize this test, as needed, regardless of vaccination status.

What is the age range for the test?

InteliSwab™ is authorized for over-the-counter use in individuals age 15 and older with or without symptoms. An adult must perform this test on children between the ages of 15 and 17.

Why is InteliSwab™ only authorized for individuals age 15 and older?

The tests conducted to gain Emergency Use Authorization (EUA) from the FDA included individuals aged 15 and older. An adult must perform this test on children between the ages of 15 and 17. Pediatric studies are underway to expand usage to ages 2 and above.

Do I need to perform two tests?

If your first test result is negative, you should test again in 24 to 36 hours. InteliSwab™ COVID-19 Rapid Test is intended to be used for serial testing twice by the same individual.

Should people who were vaccinated use this test?

Yes. Even vaccinated individuals may carry the virus and could infect others. Testing along with vaccinations are important tools to prevent spread of COVID-19. Frequent testing is another way to reduce further spread.

I am interested in purchasing bulk quantities of InteliSwab™ for my organization. How can I purchase this test?

Please contact us so that we can help. You will find a contact form on the bottom of the InteliSwab.com website.

Who can use InteliSwab™?

InteliSwab™ COVID-19 Rapid Test Pro is authorized for professional point-of-care use in individuals age 15 and older who are within 7 days of symptom onset, or in individuals without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests.

InteliSwab™ COVID-19 Rapid Test Rx is authorized for prescription home use in individuals age 15 years and older who are within 7 days of symptom onset.

How can I contact OraSure, the makers of InteliSwab™?

For questions about the InteliSwab COVID-19 Rapid Test Pro or Rx version, you can reach OraSure through the customer care phone number (1-800-672-7873) or email ([email protected])

For additional questions about the InteliSwab™ COVID-19 Rapid Test, consumers can call 1-833-601-0127