labcorp COVID-19 + Flu + RSV Test Home Collection Kit Instructions
- June 5, 2024
- labcorp
Table of Contents
labcorp COVID-19 + Flu + RSV Test Home Collection
INTRODUCTION
- This product (collection kit in combination with the authorized test) has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an 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, influenza B and/or respiratory syncytial virus, 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 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.
Kit includes
Intended use: to collect an anterior nasal swab for the purpose of in vitro diagnostic testing in a CLIA laboratory. Rx only The Labcorp COVID-19 + Flu + RSV Test Home Collection Kit is intended for collection of 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 a HCP.
Important Instruction
- 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
- 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 drop box 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.
- Wash and dry hands before opening the kit. Open the kit and place all the contents on a clean, dry surface.
- Take 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.
- 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.
- Insert the tip of the swab into one nostril. Insert just until the tip of the swab is no longer visible.
- Rotate in a circle around the entire inside edge of the nostril at least 3 times.
- Take the swab out of the nostril. Using the same end of the swab, repeat steps 6 and 7 in the other nostril.
- 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.
- Wash and dry hands thoroughly again. Insert tube into the biohazard specimen bag. Seal the biohazard specimen bag. Fold the specimen bag in half.
- Fill out the Specimen Confirmation Form. Provide the date and time of collection in the Patient Section.
- 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.
- 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.
- Results 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 also delivered to the ordering healthcare provider. To view a dependent or child’s results, add them to your account.
