Frequently Asked Questions
Questions About Our Kits and Test
Your kit will arrive in 5-7 business days from when you ordered your kit. Your kit will come via FedEx to your home.
As soon as our lab receives your sample, it will be processed in 24-48 hours.
You will receive your results via email with a link to login to view your results.
After we receive your sample, our lab will run your test using Real-Time PCR to identify if your sample contains SARS-CoV-2. By using this process our lab can determine quickly and accurately if the infectious pathogen that causes SARS-CoV-2 is present in your samples. Learn more about pathogen detection HERE.
You do not have to use your test kit as soon as you receive it, but please be aware that your test kit does expire. You can use your kit any time between the date you ordered your kit and before it expires. You can find your kit’s expiration date on the outside of the testing kit box or on the collection tube.
Before taking your sample, be sure to read through each one of the steps on the COVID-19 Home Collection Kit Instruction Sheet that was included in your kit. It’s important that you register your kit before taking your sample, ship your sample on the same day as you collected your sample, and keep your hands and collection space clean during the collection process.
To collect your sample from home by using your collection kit, locate your COVID-19 Home Collection Kit Instruction Sheet that was included in your kit. If you do not have an instruction sheet you can download it to view or print the instructions HERE. Remember to follow all the steps, but for collection instructions specifically, read step #5. You can also view our informational video HERE.
Yes, Simplicity by Assurance Scientific Laboratories offers this product with a FDA Emergency Use Authorization (EUA). This means that this product has not been FDA cleared or approved, but has been approved for emergency use by the FDA under an EUA. This product has only been authorized by the FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Simplicity by Assurance Scientific Laboratories was created to provide our clients and patients with a simple way to do at-home testing. We are a team of medical doctors and scientists who believe in using the best data available to help make an accurate and timely diagnosis. Learn more about Assurance Scientific Laboratories HERE.
Our lab is a CLIA and COLA accredited lab specializing in molecular and toxicology testing. We also do proficiency testing through the College of American Pathologists (CAP) which proves our testing is proficient based on their standards.
You can only order a test kit for a child of whom you are the legal guardian/parent. For legal and privacy reasons, all adults ages 18+ are required to order their own kit through their own account.
Your test results will confirm if you are positive or negative for COVID-19. If positive, it means you have the pathogen SARS-CoV-2, you will need to isolate immediately, and monitor your symptoms. If negative, you do not have the pathogen SARS-CoV-2 and you are free to safely continue your normal routine, though further isolation and quarantining may be recommended if you have been in close contact with a confirmed or suspected case of COVID-19. We recommend you follow any applicable CDC quarantining guidelines and state or local public health laws.
The limitations of this test include the following:
- If there was a problem with your sample (ex. Sample collected incorrectly, tube leakage, etc.), we will not be able to process your test because your results will be inaccurate.
- If you are in the early stages of infection, testing may not be able to detect the virus.
- False positives and negatives are highly unlikely, but possible, meaning that if you test positive or negative there is the possibility that the test result was inaccurate. If you are experiencing or begin to develop symptoms of COVID-19 despite a negative test result, a re-test may be recommended by your doctor to confirm a diagnosis.
You will have access to your test results. Your personal information will not be shared with any third party except for PWNHealth, which provides the necessary independent clinical oversight services for Simplicity by Assurance Scientific Laboratories. Results will not be shared with insurance companies or other healthcare companies unless you personally choose to do so. This will all be covered in the consent documents for your review, prior to making your purchase.
Simplicity by Assurance Scientific Laboratories is cooperating with the Alabama Department of Public Health, as well as other federal and state public health reporting agencies as appropriate, regarding reportable COVID-19 cases. We are required to report COVID-19 results (particularly positive results) to the proper channels. The COVID-19 pandemic requires all of our cooperation to track infections and support public health response and communication.
Assurance Scientific Laboratories is a CLIA and COLA accredited laboratory. We also do proficiency testing through the College of American Pathologists (CAP), which proves our testing as proficient based on their standards. We understand that the privacy and security of your data are extremely important and protecting your information is our number one priority.
The samples we receive for COVID-19 testing are only processed for RNA extraction and RT-PCR for viral RNA detection. No DNA is extracted from any of our COVID-19 samples. Samples are discarded immediately after the clinical reports are issues and are not used for anything other than viral detection. As a clinical laboratory, all of our patient’s records are protected under HIPAA. No genetic material, nor any patient data, is sold or otherwise used except to provide a COVID-19 diagnosis.
We limit the number of test kits sold per day to be able to ensure that our lab is able to process the number of samples we receive in the time period we promise our customers. As our lab and business continue to grow, we have expanded the number of tests we are able to run in a day and we are continuing to expand.
Questions About COVID-19
According to the CDC, you should consider being tested for COVID-19 if you fall under any of these categories:
- You are experiencing symptoms of COVID-19.
- You have been in closed contact (within 6 feet for a total of 15 minutes or more) with someone with confirmed COVID-19.
- You have been asked or referred to get tested by your healthcare provider, local or state health department.
If you do get tested, you should self-quarantine/isolate pending test results and following the advice of your healthcare provider or a public health professional. To learn more, visit the CDC website on COVID-19 HERE.
If you are having a medical emergency, call 9-1-1 immediately. If you are experiencing severe difficulty breathing, continuous pain or pressure in your chest, feeling confused or having difficulty waking up, blue-colored lips or face, or any other emergency signs or symptoms, please seek immediate medical care.
If you have tested positive for COVID-19 in the last 3 months. Speak with your healthcare provider prior to getting tested.
According to the CDC, the risk of contracting COVID-19 is very high for many people. It depends on many factors, including underlying conditions, pregnancy, smoking, and more. To see if you are at high risk for contracting COVID-19, visit the CDC’s webpage HERE.
The CDC states that the COVID-19 virus spreads through respiratory droplets or small particles produced when an infected person coughs, sneezes, sings, talks, or breathes. The virus can also be spread by touching surfaces and objects that infected droplets have landed on. A person can contract COVID-19 this way by touching the infected surface/object and then touching their mouth, nose, or eyes. Learn more by visiting the CDC website HERE.
According to the CDC, individuals that have contracted COVID-19 have a wide variety of symptoms including fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea. This list of symptoms continues to update as we learn more about the COVID-19 virus. Learn more by visiting the CDC website HERE.
If you are having trouble breathing, persistent pain or pressure in your chest, new confusion, trouble staying awake or waking up, bluish lips or face, or any other emergency signs or symptoms, please seek medical care immediately.
There is currently no treatment for COVID-19. Most people recover in about 2 weeks and will not require medical attention. Hospitalization may be required for severe patients.
If you are sick with COVID-19 or believe you may be infected, the CDC recommends you should self-quarantine/isolate by staying home, monitoring your symptoms, wearing a mask if you have to be around people or animals, and keeping yourself and your living area clean. To learn more about what to do if you are sick, visit the CDC’s website HERE.
If you are having a medical emergency, call 9-1-1 immediately. If you are experiencing severe difficulty breathing, continuous pain or pressure in your chest, feeling confused or having difficulty waking up, blue-colored lips or face, or any other emergency signs or symptoms, please seek immediate medical care.
For more information on COVID-19, visit your state’s department of health website and/or the CDC website on Coronavirus (COVID-19) HERE.
Questions About Testing for Minors
Yes, we are able to process COVID-19 tests for children ages 2 years or older. To order a test for a child, you must be the legal guardian/parent of the child you are ordering the test for.
If your child is experiencing severe symptoms including pain or pressure in the chest, trouble breathing, confusion, difficulty staying awake or waking up, blue lips or face, or any other emergency symptoms, call 9-1-1 immediately.
You should consider testing your child for COVID-19 if any of the following are true:
- They are experiencing symptoms of COVID-19.
- They have been in close contact with someone with confirmed COVID-19 in the past 14 days.
- You have been asked or referred for your child to get tested by your healthcare provider, local or state health department.
There are multiple things that you can do to prepare your child for COVID-19 testing. Visit the CDC’s website HERE to learn how to have a safe and reassuring conversation with children about COVID-19.
To learn more about COVID-19, visit the CDC website on Coronavirus (COVID-19) HERE.
To learn more about Simplicity or ask us questions about our test kits, email us at customerservice@simplicityhometest.com.
