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. Based on the current knowledge, the incubation period is 1 to 14 days, mostly 4-5 days. 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
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. How accurate is this test?
The performance of the Speedy Swab Rapid COVID-19 Antigen Self-Test was established in a prospective clinical study using an EUA authorized molecular test as a comparator method (PPA XXX% and NPA XXX %). You can find further information by visiting www.Speedy-Swab.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.
8. Do I always need to perform two tests?
The SpeedySwab OTC COVID-19 Test is intended to be used for serial testing of asymptomatic individuals or used twice by the same individual over two or three days with at least 24 hours (and no more than 48 hours) between tests or once by symptomatic individuals within the first six days of symptom onset. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.
9. What is the age range for this test?
The SpeedySwab Home 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.
10. 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
1. My SpeedySwab test did not include any English instructions, what should I do?
Instructions are available on our website (www.watmindusa.com) under the “SpeedySwap Instructions” tab. There are instructions available in both English and Spanish. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Do I need any additional supplies to conduct the test at home?
You should wear a face mask if you are swabbing others.
7. Are tests returnable?
Unfortunately, tests are not returnable. All sales are final.
Questions about Testing Protocols
1. What is the difference between an antigen and molecular test?
There are different kinds of tests for the 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. Antigen tests are very specific for the SARS-CoV-2 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 test is necessary and if you should continue isolating at home. 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.
2. 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, especially when you do not have any symptoms. Testing for asymptomatic individuals 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.
3. Does this test detect the new COVID variants?
This product has been authorized only for detection of proteins from SARS-CoV-2, and does not differentiate between SARS-CoV and SARS-CoV-2.
4. Should I take the test as soon as my symptoms start?
The Speedy Swab Rapid COVI-19 Antigen Self-Test is authorized for samples collected within the first 7 days of symptom onset.
5. Can I swab my throat/ear instead of my nose?
The test is intended for non-prescription home use with adult-collected anterior nasal (nares) swab samples only. Please do not swab your ear or throat.
6. Will this test hurt?
No, the swab is not sharp, and it should not hurt.
7. Do I have to swab both nostrils?
Swab both nostrils carefully with the soft tip of the enclosed swab.
8. If I get the solution on my skin or in my eye, what do i do?
If the reagent solution contacts the skin or eye, flush with plenty of water. If irritation persists, seek medical advice.
9. How do I dispose of the materials when a test is completed?
After test is completed, dispose of used materials in household trash.
Test Results
1. How long does it take to obtain results?
The test is intended to be read at 15 minutes. If the test is read before 15 minutes or after 30 minutes, false negative or false positive results may occur, and the test should be repeated with a new test device.
2. What do the two pink lines on the card mean after I complete the test?
If the test line (T) is visible together with the control line (C), this means that the test was positive. This means the virus that causes COVID-19 was detected. Look carefully! If two lines are visible, even if they are faint, the test is positive for COVID-19.
3. What if you test positive?
A positive test result means that antigens from the virus that causes COVID-19 were detected in your sample and it is very likely you currently have COVID-19. 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 you should self-isolate at home per CDC recommendations to stop spreading the virus to others. Please consult the CDC recommendations regarding self-isolation at www.cdc.gov/coronavirus. Seek follow-up care with your healthcare provider immediately. Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms.
4. If this test is positive, do I need a PCR test?
A positive test result means 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 could give a positive result that is incorrect (false positive).
5. What if you test negative?
A negative test result indicates antigens from the virus that causes COVID-19 were not detected in your sample. If you have symptoms, you likely do not have COVID-19. If you do not have symptoms and you receive a second negative result 24 to 48 hours after your first negative result, then you are likely not infected with COVID-19. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19, and negative results are presumptive and may need to be confirmed with a molecular test. This means that you could possibly still have COVID-19 even though the test is negative. 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 immediately. 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. It is important that you work with your healthcare provider to help you understand the next steps you should take.
6. What if my result is negative, but i still feel really sick? Should I test again and if so when?
If you suspect you have an infection (i.e. if you have prolonged symptoms or if your symptoms worsen) contact your doctor/primary care physician. You may have another infection or your test result may be false.
7. What does an invalid test result mean?
If no control line shows up on the test, the result is invalid (even if any test line shows up). 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.
8. Will this test work if I do not have COVID-19 symptoms?
This test is intended for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. Testing for asymptomatic should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests.
9. Will this test tell me if I have been infected with COVID-19 in the past?
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasal samples during the acute phase of infection.
Privacy
1. 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.
2. 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.
3. 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.