Frequently Asked Questions
Why is the label on your website different than the label on the box I received?
We have received an updated EUA (emergency use authorization) from the FDA with new labeling required. Please see the new labels and collection instructions below.
What's the difference between mask testing and nasal swab tests?
Mask testing is a cost-effective and less invasive way of surveilling the local environment of your home or office. It has a lower price point, making it easier to test for the virus more frequently. Results will be available and emailed to you within 48 hours of return shipping to the lab.
Nasal swab testing is a clinical test, which is the best way to diagnose if an individual has COVID-19. Clinical test results are specific to an individual and are therefore protected by patient privacy laws, and results will be available and emailed to you within 48 hours of return shipping to the lab.
Can I order both the worn mask test and a nasal swab test?
There are different federal laws regarding how we process information and results with each test, so you’ll need to purchase a nasal swab test separately.
What's your refund / cancellation / replacement policy?
- For orders that have not shipped, they are eligible for a 100% refund.
- For orders 30 days or less since purchase date, they are eligible for a full refund less $20 USD per test kit to cover shipping, handling, and processing fees. Please include the Kit ID information when you contact us.
- For orders over 30 days old and orders where results have been released, they are not eligible for any refund.
My nasal PCR test is authorized by the FDA under Emergency Use Authorization (EUA) – what does that mean?
Typically, FDA approval takes many years of testing and clinical trials. During a public health emergency (like the COVID-19 pandemic, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.
What should I do if I receive a positive COVID-19 test?
If you test positive for COVID-19, follow the CDC guidelines for steps you should take based on your specific circumstances.
When will my test kit be shipped to me?
Your order will be delivered within 1-2 business days. Kits are shipped Monday – Friday. If you order after 12pm ET on a Friday or over the weekend, the kit will arrive the following Tuesday.
What do I do with a dry saline tube in my kit?
There are two possible causes for a dry saline tube in your kit:
- The liquid provided in the original tube leaked during transportation. Leaking during transportation is usually due to a cracked tube or the cap not being secured after sample collection. If liquid was present when you sent the sample but not present when received by our laboratory, the cap needs to be tightened more securely prior to sending.
- The liquid was spilled during the collection process.
Please contact us if you receive a tube that does not contain liquid upon arrival or if you accidentally spill the liquid during collection of your sample, and we will provide you with a replacement tube in these situations.
How do I ship my kit back to the lab to get tested?
After you collect your sample, return your kit in the provided FedEx envelope and drop off in the nearest FedEx drop box. FedEx drop boxes do NOT pick up on Saturday or Sunday. If you use a drop box on a Friday, please make sure it’s before the end-of-day pickup.
When will I get my results back?
You’ll get test results in our secure, online portal 48 hours from when you return your test to the lab. Tests cannot be shipped back to the lab on Saturday or Sunday, and turnaround time does not include the weekend.
How accurate is my nasal RT-PCR test?
RT-PCR is the gold standard for SARS-CoV-2 testing. Our validation study showed 100% sensitivity (accuracy) and 100% specificity (no false positives from cold causing coronaviruses and common respiratory viruses). These values were from an analytical validation, not a clinical validation.* Read more about the different kinds of tests on our blog.
*For EUA approval, the FDA recommends analytical validations for most applications. Analytical validations use precise virus additions to negative residual clinical samples, and thus do not have the variables of virus shedding and the quality/accuracy of sample collection. An analytical validation approach provides an objective assessment of test performance but also provides sensitivity and specificity values that are higher than typically seen in clinical studies.
Why does a licensed ordering physician approve orders and medical history?
This is part of the normal ordering process for the At Home COVID-19 Nasal PCR Test Kit and has no impact on your shipping turnaround time.
Can I pay with insurance?
Your empowerDX At Home COVID-19 Nasal PCR Test Kit may be covered by insurance, and your HSA + FSA are gladly accepted.
How sensitive is the Nasal PCR Test?
As of December 2020, our lab’s SARS-CoV-2 assay offers the best sensitivity of the 118 laboratories that have submitted results to FDA’s SARS-CoV-2 Reference Panel, with a limit of detection (LoD) of 180 NAAT Detectable Units/mL1.
Can I be cleared for airline travel with this test?
Yes – this test is a molecular nasal PCR test, and it’s the test most airlines require to be cleared before you fly.
Can I order a test for someone else?
The person ordering and activating this test MUST be the individual who collects the nasal sample and views the test results. This product cannot be gifted to someone else, and our lab will not deliver results in this case.
How can I order multiple tests?
You can order multiple test kits for yourself by repeating the entire ordering process. Do not order for another person using your personal account.
If more than one person needs a test kit, please order each kit with a separate name and email address.
Why mask testing?
Mask testing is a method of environmental surveillance for local environments like homes and offices. The masks are worn by individuals in small group environments, and the results help others understand potential exposure within the local environment. Mask testing is also less invasive than nasal PCR tests, and provides a more cost-effective way to monitor potential exposure in these environments.
What is your mask being tested for?
We’ll use an RT-PCR test to determine if SARS-CoV-2, the virus that causes COVID-19 is present on the mask.
What should I do if one of the masks in my kit tests positive?
Detection of the COVID-19 virus on the surface of the submitted mask is a strong indication that someone in your home or office is either shedding virus or have been intimately exposed to COVID-19. We recommend that you and your recent close contacts seek clinical testing and consult your primary care physician for treatment options.
Please contact your healthcare provider if you think you’ve been exposed to COVID-19, and follow CDC guidelines based on your specific circumstances.
How does the mask test work?
Multiple masks (our kits include four masks) are worn and pooled together for testing. The empowerDX worn mask test uses PCR technology to detect the RNA of the SARS-CoV-2 virus. A positive result means that the virus was detected on the worn mask sample. Negative results reveal that the virus was not detected on the mask sample.