EverlyWell COVID-19 Test Home Collection Kit Instruction Manual

: June 6, 2024
: everlywell

Table of Contents

The kit includes
Important Reminder
Sample Collection Instructions
Return Instructions
What’s next?
Questions?
Read User Manual Online (PDF format)
Download This Manual (PDF format)

EverlyWell COVID-19 Test Home Collection Kit

The kit includes

Swab and tube

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Kit ID stickers

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Biohazard bag with Absorbent Sheet

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Return box

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Return envelope

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Return label

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Alcohol prep pad

Rx Only. For Use Under Emergency Use Authorization. For In Vitro Diagnostic Use.

Important Reminder

Be sure to complete these 3 steps before mailing the kit.

Register kit

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Fill out kit ID sticker

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Ship on day of collection

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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.

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 2
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./
A board-certified physician will review the test taker’s results and 2. 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.