pixel COVID-19 PCR Test Home Collection Kit User Guide
- June 6, 2024
- PIXEL
Table of Contents
Let’s get Started.
COVID-19 PCR 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.
IVD
Distributed by Pixel by Labcorp
531 South Spring Street
Burlington, NC 27215
This product has not been FDA cleared or approved, but has been authorized for
emergency use by FDA under a 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 the 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.
PXCIFU050321.2
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 dropbox on the same day you collect it before the last Xpress 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 dropbox. It’s important to bring your sample to a dropbox 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.
Covid-19-Test-At-Home-Box-Design-BOX_POTC1521_5-R15 [Edits] R7.pdf 1 1/8/21 3:15 PM
A safe and trusted way to get tested for COVID-19
Trusted by experts
This PCR test is the same test used by doctors. PCR tests are considered the
gold standard by the CDC for COVID-19 testing.
Short nasal swab collection
Our kit uses a short nasal swab making self-collection easy and painless.
No additional fees
The price of kit includes all contents, FedEx Express’ overnight shipping to
lab, and lab fee. Includes consultation with an independent physician network
for users with a positive or indeterminate result.
**Average result in 1-2 days***
The average time to receive results is 1-2 days from when your sample is
received at the lab.
‘Average based on data from August-December 2020. Individual result timelines
may vary.
About This Test
This RT-PCR test detects the presence or absence of SARS-CoV-2, the virus that
causes COVID-19
Contents
Considerations
Require access to the Internet and an email account. Not for resale. Intended
for sale and use in the U.S only. Store kit at room temperature until sample
collection.
Pixel by Labcorp offers this product with an FDA Emergency Use Authorization (EUA). This means that this product has not been FDA cleared or approved but has been authorized for emergency use by FDA under a EUA. This product has been authorized only for the home collection and maintenance of anterior nasal swab specimens as an aid in the 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 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.