FDA COVID-19 Test Home Collection Kit DTC Instructions
- June 6, 2024
- FDA
Table of Contents
FDA COVID-19 Test Home Collection Kit DTC
Email: [email protected]
Toll Free: +1 855-463-1670
CLIA-Certified
Lab Partners
FDA AUTHORIZED
Physician-reviewed test results, fast and easy-to-read results, all from the comfort of your home.
IVD For Use Under Emergency Use Authorization
Register
Register your kit online at everlywell.com/register by entering the unique kit
ID found within this package.
Collect
You will collect your sample at home using the collection instructions
included in this package and then mail your sample directly to our CLIA-
certified lab partner.
Review
If positive results are shown, you will be contacted by our independent
physician network for next steps.
Your Sample Will Be Tested For:
The presence or absence of RNA from SARS-CoV-2 virus
Why EverlyWell?
Warnings and Limitations
*Indicated for use in individuals age 18+ (self-collected), 16+ (self-collected under adult supervision), or 2+ (collected with adult assistance). Check everlywell.com/states to check what states this test is valid in. Requires access to the internet and an email account. Store kit at room temperature (4-30°C) until sample collection.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. This product has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices 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.
Return Instructions
Double-check that the sample is registered at everlywell.com/register and that the completed ID sticker is affixed to the sample tube. If you are under 18, please ask your parent or guardian for assistance with the packaging and return shipment of your specimen.
Wash your hands
Wash your hands thoroughly with soap and water for 20 seconds.
Get return box ready
Assemble the box (insert flaps or pop open) and close one end. Prepare
sample
Place the biohazard bag inside the box. The box provides extra protection
during transit. Put box in mailer
With clean hands, place the shipping box into the prepaid mailer. Apply the
shipping label to the front of the mailer.
Do not cover the UN3373 label. Disinfect the mailer
Use the provided alcohol prep pad to disinfect the mailer, avoiding the
address label, before completing the final shipping step. 
Ship
Deliver the pre-paid, pre-addressed return pack to a UPS drop box. It’s
important to drop off the sample on the same day the sample is collected and
before the last pickup for overnight shipping. Do not deliver your sample to a
drop box on the weekend.
What’s next?
-
Once the sample arrives at the lab, it will pass a quality check before processing begins. We’ll contact you if there are any issues.
Keep kit ID for reference. -
A board-certified physician will review the test taker’s results and securely transmit them to us.
-
We’ll email you as soon as the results arrive.
Check the order status any time by going to everlywell.com/orders
- For Use by individuals 18 years of age and older when self-collected
- For Use by individuals 16 years of age and older when self-collected under adult supervision
- For Use by individuals 2 years of age and older when collected with adult assistance
*This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA. This product has been authorized only for the home collection and maintenance of anterior nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
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 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.
Questions?
Instructions
The kit includes:
Important Reminder
Be sure to complete these 3 steps before mailing the kit.
Visit www.everlywell.com/register and complete registration.
The lab can only process the sample if you:
- Register the test taker’s sample at everlywell.com/register
- Fill out ID sticker with test taker’s information and affix to the sample tube
- Ship sample the same day of collection (Monday-Friday)
Sample Collection Instructions
Please read all instructions fully prior to collecting the specimen. Follow all instructions closely to ensure the collected specimen is acceptable for processing. Failure to follow all instructions may lead to the specimen being rejected or to incorrect results. Make sure you can ship the same day the sample is collected (Monday-Friday).
Register
Register the kit at everlywell.com/register using the test taker’s information
before collecting the sample. Do not register until you are ready to collect
the sample because you will be asked to enter the time of collection. Collect
Monday-Friday as samples cannot be shipped on the weekend. The lab cannot
process the sample if this step is missed.
Watch video
For best results, watch our collection video at
everlywell.com/collect before you start. If
you are under 18, please ask your parent or guardian for assistance with the
packaging and return shipment of your specimen. Locate UPS drop box
Visit the UPS website to view drop box locations and pick up schedules. Your
sample must be dropped off at the drop box before the last pickup on the day
it is collected. Only collect samples on Monday-Friday as samples cannot be
shipped on the weekend. Fill out kit ID sticker
Using a ballpoint pen or fine tip permanent marker, write the test taker’s full
name, date of birth, and collection date on the ID sticker before placing it
on the collection tube. Do not cover the barcode sticker already on the tube.
The information must match what you used to register the kit. Do not pour the
liquid out of the tube. Prep space and wash hands
Disinfect surfaces where the specimen will be collected. The test taker should
blow their nose. The person collecting the sample should thoroughly wash their
hands with soap and water for 20 seconds prior to collection. Prepare to
collect
Before inserting the swab, locate the perforation on the swab (near the tip),
as this will be needed after the sample is collected. The test taker should
tilt their head back slightly. Insert nasal swab
Hold the swab below the perforation line. Insert the soft tip of the swab into
the nostril. That’s usually 1/2 to 3/4 of an inch for an adult and less than
1/2 an inch for younger children.
DO NOT go beyond this depth. If you are collecting a specimen from a child, be
careful not to insert the swab too far into the child’s nostril. Collect
swab sample
Rotate the swab 4 times all the way around the nasal wall, applying slight
pressure and taking approximately 15 seconds to collect the sample. Remove
swab. Repeat this process in the other nostril using the same swab. Place
the swab sample in the tube
Place the swab sample (tip down) in the tube without spilling the liquid.
Break the swab at the perforated line (near the tip) and leave in tube.
Tightly seal cap. Liquid volume may not completely cover the swab tip. Place
tube into bag
Place tube into protective biohazard bag with the absorbent sheet. Follow
return instructions on the reverse.