SpeedySwab Covid-19 FAQs
Questions About COVID-19
What is COVID-19?
COVID-19 is an acute respiratory infectious disease caused by the SARS-CoV-2 virus, a novel Betacoronavirus. SARS-CoV-2 is mostly spread person-to-person, both by individuals with symptoms of COVID-19 infection and by infected people without symptoms. Symptoms include fever, fatigue, and cough. For a full list of symptoms, see: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
Product Questions
Is this COVID-19 Antigen Self-Test Kit FDA approved or cleared?
This product has NOT been FDA cleared or approved; but has been authorized by the 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.
What is Emergency Use Authorization (EUA)?
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical counter measures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.
Can this test be used as proof of a negative COVID-19 test for travel?
The type of testing and documentation required for international/air travel may be different based on the travel destination, airline, and state requirements. Therefore, we recommend that you contact your airline carrier, visit the CDC/TSA website, and view your local health department’s website for the latest requirements on the type of acceptable testing and documentation for your travel destination.
What are the known potential risks and benefits of this test?
Potential risks include:
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.
Does the product expire? How long is it good for?
The SpeedySwab Rapid COVID-19 Antigen Self Test is stable until the expiration date marked on the outer packaging and container.
How many times can I use this test?
All kit components are intended for single-use. Do not reuse. Do not use with multiple specimens.
How accurate is this test?
The performance of the SpeedySwab™ Rapid COVID-19 Antigen Self-Test was established in a prospective clinical study using a EUA-authorized molecular test as a comparator method. You can find further information by visiting www.SpeedySwab.com . 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.
Do I always need to perform multiple tests?
The SpeedySwab OTC COVID-19 Test is intended to be used for serial testing of symptomatic and asymptomatic individuals or when tested twice over three days with at least 48 hours between tests within the first six days of symptom onset as show below.
Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results.
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.
What is the age range for this test?
The SpeedySwab Home is approved for ages 2 and up. This test should not be used in children under the age of two. The test has not been validated for use in this age group and if you are concerned that your under two year-old has COVID -19 you should see a healthcare care professional for advice and further management. Children age 2 to 13 should be tested by an adult.
Will my insurance reimburse the cost of purchasing this test? Can people use HSA/FSA accounts to purchase this test?
Please reach out to your health insurance provider to determine purchase or reimbursement eligibility through your health insurance provider or your HSA/FSA account.
Missing, Damaged or Incomplete Test Components
My SpeedySwab test did not include any English instructions, what should I do?
Instructions are available on our website (www.speedyswab.com) under the "Health Solutions" tab. If you are unable to find this information on the website, please provide us the Lot number of the package you received, and we will mail or email you a new instruction sheet.
I am missing part of my test kit. What should I do?
We will gladly send you another test. Please provide name, address, phone #, where the test was purchased or obtained.
I lost my swab, can I use a Q-tip instead of the swab?
Please only use the swab that is provided with the test. If you need a replacement swab, we will need the LOT number on the box for the test kit.
Should the test be stored and used at a certain temperature?
The kit should be stored in a location between 36 and 86 degrees Farenheit (2-30 degrees Celsius). Ensure all test components are at room temperature before use.
Is it alright if my test kit was exposed to temperatures outside of the storage temperature (extreme heat or extreme cold) range printed on the box during shipping?
Yes. The kit has been tested under extreme heat/ cold temperatures and can be used if the product was exposed to extreme temperatures for a period no longer than 7 calendar days.
Do I need any additional supplies to conduct the test at home?
You should wear a face mask if you are swabbing others.
Are tests returnable?
Unfortunately, tests are not returnable. All sales are final.
Questions about Testing Protocols
What are the known and potential risks and benefits of the test?
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/emergencypreparedness- and-response/mcm-legal-regulatory-and-policy-framework/emergencyuse-authorization
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 Speedy Swab Rapid 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.
How accurate is this test?
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 WWW.SpeedySwab.com.
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 SARSCoV-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.
Test Results
Interpretation of Results
Test results are read and interpreted visually. Read results at 15 minutes with good lighting. WARNING: Do not read the result before 15 minutes or after 30 minutes. Inaccurate test interpretations may occur.
Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results.
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.
Positive Result
Two reddish/pink lines appear in the test window, one on the test line position (T) and the other on the control line position (C).
If the Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible red 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 very 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).
Negative Results
Only one reddish/pink line on the control line (C) position appears with no line on the test line position (T).
If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative.
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 health care provider.
Invalid Result
If a line does not appear on the control line position (C) in 30 minutes, even if a Test line (T) is visible, the test result is invalid. Re-test with a new swab and a new test device.
Privacy
Are you selling my data?
No, we are not selling you data. Protecting your private information is our priority and we do not sell, rent, or lease user information to third parties.
Does the Government have access to these results?
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting. 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 federal requirements.
If this is positive do I have to report it? If yes, then who do I report it to?
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting. 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 federal requirements.