labcorp COVID-19 + Flu Test Home Collection Kit Instruction Manual

Labcorp COVID-19 + Flu Test
Home Collection Kit
Instruction Manual

1. Read through the instructions completely before collecting the sample. To see an instructional video or report a missing item in the kit, visit Labcorp.com/HomeKit.
   Instructions for parents or guardians collecting a sample for a child ages 2-13.
   If you are under 18, ask your parent or guardian for help with these instructions.

2.  The sample must be shipped Monday through Friday and on the same day that you collect it.
   Do not collect the sample until you or your parent or guardian confirm pickup times of the dropbox or have confirmed your scheduled pickup.
   If you are under 18, please ask your parent or guardian to assist with scheduling a pickup or confirming drop box locations and pickup times.
   Visit https://bit.ly/fedexdropbox to view FedEx drop box locations and pickup schedules. For more information, refer to the back of this instruction card.

3. Wash and dry hands before opening the kit. Open the kit and place all the contents on a clean, dry surface.

4. T ake the swab out of its package. Do not touch the tip of the swab with your hands. Don’t let the swab touch anything else. If the swab touches any other surface, request a new kit.

5. Unscrew the top of the tube. Hold swab in one hand and tube in the other, being careful not to spill the liquid. Do not drink the liquid.

6. Insert the tip of the swab into one nostril. Insert just until the tip of the swab is no longer visible. Insert less than 1 inch into the nostril for adults and less than 1/2 inch for younger children.

7. Rotate in a circle around the entire inside edge of the nostril at least 3 times.

8. Take the swab out of the nostril. Using the same end of the swab, repeat steps 6 and 7 in the other nostril.

9. Remove the swab from the second nostril and place in the tube. The end of the swab that went into the nose should be placed into the tube first so that it sits down in the liquid. Screw the top of the tube back on.

10. Wash and dry hands thoroughly again. Insert the tube into the biohazard specimen bag. Seal the biohazard specimen bag. Fold the specimen bag in half.

11. Fill out the Specimen Confirmation Form. Provide the date and time of collection in the Patient Section.

12. Place the specimen bag and Specimen Confirmation Form into the white shipping box and close the lid. Place the shipping box into the FedEx return pack. Remove the adhesive cover strip and seal the FedEx return pack closed.

13. Return the postage-paid, pre-addressed FedEx return pack to Labcorp. You can deliver it to a FedEx drop box or schedule a pickup. It’s important to ship the specimen Monday through Friday and on the same day you collect it.

14. Results are available in the Labcorp Patient™ portal 1 to 2 days after the specimen arrives at the lab. Visit patient.labcorp.com to set up or access your account. Results were also delivered to the ordering healthcare provider. To view a dependent or child’s results, add them to your account.

Let’s get started.
www.labcorp.com/HomeKit.

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:

Avoid contact with eyes
Keep out of reach of children

Intended use: to collect an anterior nasal swab for purpose of in vitro diagnostic testing in a CLIA laboratory. Rx only The Labcorp COVID-19 + Flu 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) when directly ordered by an HCP.

Distributed 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 for use by authorized laboratories.
• This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and/or influenza B, 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Ship the Specimen to Labcorp via FedEx
The specimen must be shipped Monday through Friday on the same day that you collect it.
You have 2 options for shipping the sample.

FedEx Drop Box
It’s important to bring your specimen to a dropbox on the same day you collect before the last Express pick up. Deliver your specimen to a dropbox Monday through Friday. Do not take it to a FedEx office. Do not place the kit in dropbox on Saturday or Sunday.
Schedule a FedEx Pickup
Schedule your FedEx pickup for a weekday (Monday through Friday).
Call FedEx at 800-463-3339 and answer some questions.
FedEx: “What are you calling about?” You: “FedEx Express® return pickup”
FedEx: “…a pickup request for a return. To arrange a pickup for today or tomorrow, depending on availability, say “pickup.” You: “Pickup”
FedEx: “Is the word “stamp” written anywhere on your return label?” You: “No” FedEx: “What is the tracking number?” You: Provide the tracking number (TRK#) from the return label
FedEx: “What kind of return are you calling about?” You: “FedEx Express”
Provide additional information as requested. You may be asked for the pickup location address, the number of packages to be picked up, day and time window for the pickup, or if your shipment is currently ready.
Note the confirmation pickup number provided. If you are asked for a credit card or account number, state that this is a FedEx Express return pickup and provide the tracking number (TRK#) from the return label.

Do not collect your specimen until you confirm pickup times of the drop box or have confirmed your scheduled pickup.
Visit https://bit.ly/fedexdropbox to view FedEx drop box locations and pickup schedules.

Let’s get started.
WWW.PIXEL.LABCORP.COM
COVID-19 + Flu Test Home Collection Kit

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 an anterior nasal swab for purpose of in vitro diagnostic testing in a CLIA laboratory. Rx only. The Pixel by Labcorp COVID-19 + Flu 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), when determined to be appropriate by the healthcare provider.

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 for use by authorized laboratories. This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and/or influenza B, 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
PXCIFU092221.2

Self-collection kit instructions
For In Vitro Diagnostic Use

1. Please read all instructions carefully before beginning collection and follow directions step by step. If you are under 18, ask your parent or guardian for help with these instructions.

2. 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.

3. 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 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.

4. Wash and dry hands before opening the kit. Open your kit and place all the contents on a clean, dry surface.

5.  Take the foam swab out of its package.
   DO NOT touch the tip of the swab with your hands or touch any other surfaces with the swab tip. If the swab touches any other surface, contact customer support for a replacement kit.

6. 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.

7. 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. Insert the swab less than 1 inch into the nostril for adults and less than 1/2 inch for younger children.

8. Take the foam swab out of your nostril. Using the same end of the foam swab, repeat step 7 in your other nostril.

9. 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.

10. 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.

11. 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.

12. 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.

Customer support can be reached at [email protected] or 800-833-3935

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