Quest Diagnostics COVID-19 PCR Test Home Collection Kit Instruction Manual

: June 5, 2024
: Quest Diagnostics

Table of Contents

Quest Diagnostics COVID-19 PCR Test Home Collection Kit
READ FIRST FOR YOUR SAFETY
Materials
Read all instructions before starting.
COVID-19 PCR Test Home Collection Kit
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Quest Diagnostics COVID-19 PCR Test Home Collection Kit

Quest-Diagnostics-COVID-19-PCR Test-Home-Collection-
Kit

Welcome to Specimen Collection
Before starting to collect a specimen, view the specimen collection demo video at

READ FIRST FOR YOUR SAFETY

Do not use the Materials if the tube is leaking or the swab packaging is damaged. Call for a replacement.
Do not use if the individual being swabbed is on blood thinners or had a recent nose injury.
Read the instructions carefully before starting.
Once the swab is inserted, the nose may feel very full. If there is pain at any time during the collection, stop and call the doctor to guide the specimen collection.
Do not use the liquid in the tube to wet the swab, or to lubricate the nostrils. Do not drink the liquid. Do not touch the swab tip with anything except the inside of the nose and the tube liquid. If the swab tip touches anything, then contact Quest Diagnostics at 1.855.332.2533 for another swab.
Do not use the swab on more than one person. Sharing a swab with someone else can cause an infection.

Read all instructions before starting specimen collection.
Failure to follow instructions may lead to incorrect test results.

Before you begin
Visit fedex.com/labreturns to view dropbox locations. Be sure to bring the specimen to a dropbox on the same day the specimen is collected and before 3:00 PM. DO NOT drop the specimen into a drop box on Saturday or Sunday.
If you have any questions, please call 1.855.332.2533.

Materials

This product has:

not been FDA cleared or approved, but has been authorized for emergency use by FDA under a EUA.
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-CoV2, not for any other viruses or pathogens.

Read all instructions before starting.

Open the materials, and lay all the materials on a clean surface.
Locate the Activation Card and follow the instructions on the Activation card to activate your materials the day the specimen is collected. Make sure the code on the Activation Card and the Tube are the same, and call 1.855.332.2533 if the codes are not the same.
IMPORTANT: You must activate the Materials on-line or the lab cannot test the specimen.
Wash and dry your hands.
Remove the swab from the package and do not touch the tip of the swab! Open the specimen tube, holding it in one hand and the swab in the other hand. Do not spill or drink the liquid.
Insert the swab into one nostril.
- For adults – insert less than one inch.
- For younger children – insert less than 1/2 inch.
  Rotate the swab in a circular motion around the entire inside edge of the nostril. Do this 2 times and then keep it in place for 15 seconds.
  Repeat the same process in the other nostril using the same swab.
Insert the swab into the tube (tip first) until it reaches the bottom. The tip of the swab will be in the liquid. Break the swab handle against the side of the tube at the perforated breakpoint.
Screw the cap onto the tube and place the tube into the bag. Important: Do not remove the desiccant (white sheet) from the bag. Seal the bag.
Place the bag into the box and close the box. Place the box into the Return UN3373 Shipping Bag with the pre-applied FedEx return label. Seal the Shipping Bag. If you are under 18 years of age, have an adult help you with packaging and sending the specimen.
Drop off the postage-paid FedEx Return Shipping Bag at a dropbox location the same the specimen is collected, and before 3:00 PM. DO NOT drop off the specimen in a drop box on a Saturday or Sunday or holiday.

COVID-19 PCR Test Home Collection Kit

Read all instructions before starting to collect a specimen!

For In Vitro Diagnostic Use
For Use Under Emergency Use Authorization
The Quest COVID-19 PCR Test Home Collection Kit is intended for use by any individuals, 18 years and older (self-collected), 16 years and older (self- collected under adult supervision), or 2 years & older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. Testing is limited to laboratories designated by Quest Diagnostics that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC 263a, & meet the requirements to perform high complexity tests. This kit requires access to the Internet and a free MyQuest patient portal account (myquest.questdiagnostics.com/web/home).
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 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 USC 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
LabOne, Inc. dba Quest Diagnostics, Lenexa KS. Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third-party marks–® and ™– are the property of their respective owners. ©2020-2022 Quest
Diagnostics Incorporated. All rights reserved. INS0020 3/16/2022

Important! Do this first.
This is your activation card.

Before you collect your sample, you are required to activate your collection materials. Specimens returned without activation will not be tested or resulted.