Frequently Asked Questions
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.).
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
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
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.
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.
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.
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.
InteliSwab® is authorized for over-the-counter use in individuals age 2 and older with or without symptoms when tested twice over 3 days with at least 24 hours, but not more than 48 hours, between tests.
InteliSwab® is authorized for professional point-of-care use in individuals age 2 and older who are within 7 days of symptom onset, or in individuals without symptoms when tested twice over two to three days with at least 24 hours, but not more than 48 hours, between tests.
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
Serial testing is when one person is tested for COVID-19 more than once. Repeat testing is needed to improve test accuracy.
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 second test is also negative, a third time 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.
By repeating testing, it may be possible to more quickly identify cases of COVID-19 infection and reduce spread of infection.
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
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 Services’ (HHS’) 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).
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:
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
InteliSwab® is offered in a variety of package sizes. Refer to the outside of the carton for how many tests are included.
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.
InteliSwab® is designed and developed in Bethlehem, Pennsylvania by OraSure Technologies, a leading innovator in diagnostic testing for infectious disease.
For questions about the InteliSwab® COVID-19 Rapid Test, you can reach OraSure through the Customer Care phone number (1-833-601-0127) or email ([email protected]).
To best assist you, please have the product carton and purchase receipt ready when contacting our Customer Care team. Requests for product replacement that are lacking proof of purchase may be limited or denied.
In a clinical study of 165 individuals, the overall accuracy of InteliSwab® was 93%.
The accuracy of any COVID-19 test is dependent on factors, including when you test, relative to when you were exposed; how accurately you perform the test; and whether you collect a good sample.
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
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
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.
Here are the links to the instructions in both English and Spanish. These come included in your kit.
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.
Yes. InteliSwab® provides test results in minutes without the need for sending your test sample out to a laboratory.
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).
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. To increase the chance that the negative result for COVID-19 is accurate, you should:
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Test again in 48 hours if you have symptoms on the first day of testing.
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Test 2 more times, at least 48 hours apart, if you do not have symptoms on the first day of testing.
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.
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.
InteliSwab® is authorized for over-the-counter use in individuals age 2 and older with or without symptoms. An adult must perform this test on children between the ages of 2 and 17.
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 second test is also negative, a third time after an additional 48 hours. You may need to purchase additional tests to perform this serial (repeat) testing.
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.
Please contact us here so that we can help.
InteliSwab® COVID-19 Rapid Test is designed for over-the counter use in individuals age 2 and older, while InteliSwab® COVID-19 Rapid Test Pro is designed for point-of-care use by healthcare professionals in CLIA-waived facilities. InteliSwab® COVID-19 Rapid Test Pro comes in kits with 25 tests, including 5 stands, each with three vial slots, that allow professionals to run 15 tests concurrently – ideal for batch testing. Kit controls and a visual reference panel are also available and sold separately for InteliSwab® COVID-19 Rapid Test Pro.
InteliSwab® COVID-19 Rapid Test Pro is authorized for professional point-of-care use in individuals age 2 and older who are within 7 days of symptom onset, or in individuals without symptoms when tested twice over two to three days with at least 24 hours, but not more than 48 hours, between tests.
For questions about the InteliSwab® COVID-19 Rapid Test Pro, you can reach OraSure through the Customer Care phone number (1-800-672-7873) or email ([email protected])
InteliSwab® may be eligible for FSA/HSA reimbursement. Contact your health insurance provider to determine reimbursement eligibility.
The InteliSwab® Connect app is a free web application that can be accessed from your laptop, tablet or phone. The app can be used to self-report results to public health authorities. The app allows you to store a record of your test results that you can access at any time. All information collected and stored is encrypted, and your privacy is always maintained.
Compatible smartphones include:
•iPhones running iOS 13 or higher OR
•Android phones running Android 5.1 (Lollipop) or higher
Since this is a web application, it can be accessed via any computer or tablet with appropriate browsers. While we recommend the Chrome browser, the web app has also been tested on Edge, Firefox, Safari and DuckDuckGo
We take your data privacy and security seriously. All data is secured using encryption during storage and transmission. We implement security procedures that include industry standard security systems.
Since this is a web application, the free InteliSwab® Connect app can be accessed through this link- InteliSwab® Connect
Please see our Quick Start Guide here for more information on creating an account.
The InteliSwab® Connect app is not required in order to see your test result. The app is for self-reporting to public health authorities. If you decide not to use the app, you should contact your healthcare provider with your results.
The information you provide is for reporting to public health authorities. Per CDC guidelines, certain federal and state regulations mandate reporting of test results to appropriate agencies. Privacy is of high importance to us. All data is encrypted and not shared with any other third parties.
After you have created your account and are ready to record the result for your child, be sure to create an account for them. You can use one email to create multiple accounts. For more information on account creation please see our Quick Start Guide here.
On the login screen, please select “Forgot password?” Enter your email address and you will receive a password reset link via email.
When you are in the app, you will see a log of all your test results where you would enter your test result. Simply click on the result you would like to see for more details.
To create an account you will need to share:
Full Name, Address, Email Address, Cell Phone Number, Date of Birth, Gender and Ethnicity
Password is case sensitive and requires between 8-32 or more characters, and 3 of the following: Upper case letters, Lower case letters, Special Characters and numbers
Should you not receive an email, please verify that the email is not in your Junk or Spam folder and that your email provider is not automatically blocking messages. If you continue to experience problems, please return to the InteliSwab Connect page and try again.
Please send an email to [email protected]