labcorp Pixel COVID-19 Test Home Collection Kit Instruction Manual
- June 6, 2024
- labcorp
Table of Contents
labcorp Pixel COVID-19 Test Home Collection Kit
COVID-19 Test Home Collection Kit
If you are a parent or guardian collecting a sample for a child ages 2–13, please read instructions carefully and follow directions step by step. If you are under 18 years old, please ask your parent or guardian to review the instructions and provide assistance with scheduling a FedEx pickup or confirming FedEx drop box locations and pickup times.
Kit Includes
Intended use: to collect a nasal swab for purpose of in vitro diagnostic testing in a CLIA laboratory. The Pixel by Labcorp COVID-19 Test Home Collection Kit is intended for use with individual anterior nasal swab specimens from individuals age 18 years and older (self-collected), 14 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance), including for use by such individuals without symptoms or other reasons to suspect COVID-19.
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 detection of nucleic acid from
SARS-CoV-2, not for any other viruses or pathogens; and
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 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.
Distributed by Pixel by Labcorp 531 South Spring Street Burlington, NC 27215
Self-collection kit instructions
For In Vitro Diagnostic Use Please read all of the instructions before
beginning collection. If you are a parent or guardian collecting a sample for
a child ages 2–13, please read instructions carefully and follow directions
step by step. If you are under 18, ask your parent or guardian for help with
these instructions.
When you are ready to collect your
sample, register your kit online at
www.pixel.labcorp.com/register and type in the 12-digit registration code that
is located on your collection tube and registration card. If you are under 18,
ask your parent or guardian for help with registering your kit.
Visit https://bit.ly/fedexdropbox to
view FedEx drop box locations and pickup schedules. It’s important to bring
your sample to a drop box on the same day you collect it before the last
Express pickup. Or refer to the flyer in your kit to schedule a FedEx pickup
on the day of collection. If you are under 18, ask your parent or guardian to
assist with scheduling a pickup or confirming drop box locations and pickup
times.
Wash and dry hands before opening the kit. Open your kit and place all the
contents on a clean, dry surface.
Take the foam swab out of its package.
Do not touch the tip of the swab with your hands.
Unscrew the top of the collection tube.
Hold swab in one hand and collection tube in the other being careful not to
spill the liquid. Do not drink the liquid.
Insert the tip of the foam swab into one
nostril. The foam swab does not need to be inserted far – insert just until
the foam tip of the swab is no longer visible. Rotate the swab in a circle
around the entire inside edge of your nostril at least 3 times. When
collecting a sample for a child, be careful not to insert the swab too far
into the nostril.
Take the foam swab out of your nostril. Using the same end of the foam swab,
repeat step 7 in your other nostril.
Remove the foam swab from your second
nostril and place in the collection tube. The end of the foam swab that went
into your nose should be placed into the tube first so that it sits down in
the liquid. Screw the top of the collection tube back on.
Wash and dry hands thoroughly again. Insert collection tube into the biohazard specimen bag. Seal the biohazard specimen bag by closing the zip lock seal.
Place the specimen bag back into your purple Pixel kit box and close the lid (if applicable slide the sleeve over the tray). Place the purple kit box into the FedEx Pak. Remove the adhesive cover strip and seal the return pack closed.
Deliver the postage paid, pre-addressed FedEx Pak to a FedEx drop box. It’s important to bring your sample to a drop box on the same day you collect it before the last Express pickup. Or refer to the flyer in your kit to schedule a FedEx pickup on the day of collection.
