ECL COVID-19 AtHome Collection Kit Instruction Manual

: June 6, 2024
: ECL

Table of Contents

Welcome to Self-Collection!
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Download This Manual (PDF format)

EMPIRE CITY LABORATORIES

ECL COVID-19 At Home Collection Kit
instructions for use

Please read all of the instructions before beginning collection. Failure to follow the instructions may lead to the test not being performed. You MUST activate your kit before sending back the specimen. Only 1 specimen is to be shipped back per Home test box. Plan accordingly to ensure that your Home test will make that day’s FedEx express pickup.

Welcome to Self-Collection!

This kit is for use by individuals 18 years of age or older.
Do not use it if you are on blood thinners or have had previous trauma to your nose.
Do not drink or wash your nose with the liquid found in the tube.
Do not touch the swab tip with your ﬁnger, or with anything else except inside your nose and the tube liquid. If the swab tip touches anything, then contact us for another swab.
Do not use the swab on more than one person. Sharing a swab with someone else can cause an infection.
Follow directions for use.
Avoid contact with eyes.
Keep out of reach of children.
This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under a EUA for use by the authorized laboratory;
This product has been authorized only for the detection of nucleic acid fron 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 in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and
Cosmetic Art, 21 U.S, C. & 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

This kit includes a patient information card, activation card, IFU brochure, swab, collection tube, specimen bag, and FedEx envelope. Please make sure to activate your kit at my.wellcom.us/hometest
Apply hand sanitizer or wash and dry your hands thoroughly before opening the kit. Place all contents on a clean, dry surface.
Remove the swab from the container, being careful not to touch the soft end, which is the absorbent tip.
Insert the entire absorbent tip of the swab into your nostril, but do not insert the swab more than 3/4 of an inch into your nose.
Slowly rotate the swab in a circular path against the inside of your nostril at least 4 times for a total of 15 seconds. Be sure to collect any nasal drainage that may be present on the swab.
Gently remove the swab.
Using the same swab, repeat steps 4-6 in your other nostril.
Place the swab in the sterile tube and snap off the end of the swab at the break line. Place the cap on the tube.
Re-apply hand sanitizer or wash your hands thoroughly. Place the tube containing the swab in the biohazard bag provided and seal. Do not remove the absorbent material in the bag.
Make sure to write the collection date and time on the provided patient’s Infocard. Place the specimen bag and paperwork back into your Home test shipping box and close the lid.
Place the box into the FedEx return pack. Remove the adhesive cover strip and seal the return pack closed.
Deliver the postage-paid, pre-addressed FedEx return pack to a FedEx dropbox. It’s important to bring your sample to a dropbox on the same day you collect it and before the last Express pickup. Visit https://bit.ly/fedexdropbox to view FedEx drop box locations and pickup schedules.