Quest Self-Collection Kit for COVID-19 Instruction Manual

: June 6, 2024
: Quest

Table of Contents

Kit contents
Read all instructions before starting.
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

Self-Collection Kit for
COVID-19
Quick Guide

Read all instructions before starting your COVID-19 Self-Collection.
Rx Only, IVD, and For Use Under Emergency Use Authorization
This kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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 authorization is terminated or revoked sooner.

LabOne, Inc. dba Quest Diagnostics, Lenexa KS, Quest Diagnostics Incorporated and its subsidiaries (Quest) complies with applicable federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. ATTENTION: If you speak English, language assistance services, free of charge, are available to you.

QuestDiagnostics.com/home/nondiscrimination/ 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 Quest Diagnostics Incorporated. All rights reserved. 06/2020

Welcome to Self-Collection
Before completing your specimen self-collection, view the selfcollection demo video at bit.ly/COVID19selfcollection.

READ FIRST FOR YOUR SAFETY

Do not use if you are under the age of 18 years old without adult supervision, on blood thinners, or have had a previous trauma to your nose.
Read the instructions carefully before starting.
Once the swab is inserted, your nose may feel very full. If you feel pain at any time during your collection, stop and call your doctor to guide you with your collection.
Do not use the liquid in the tube to wet the swab, or to lubricate your nostrils. Do not drink the liquid.
Do not touch the swab tip with your finger, or with anything else except your 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 your COVID-19 Self-Collection.
Failure to follow instructions may lead to incorrect test results.

Before you begin
Visit fedex.com/labreturns to view drop box locations. Be sure to bring your sample to a drop box on the same day you collect it before 3:00 PM. DO NOT drop sample into a drop box on Saturday or Sunday.

If you have any questions, please call 1.855.332.2533.

Kit contents

Quest Self-Collection Kit for COVID-19 - Kit contents

This self-collection kit has:

not been FDA cleared or approved
been authorized by FDA under an EUA
been authorized only for the unsupervised self-collection and maintenance of nasal specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

Read all instructions before starting.

Open the kit. Lay all the materials on a clean surface.
Locate and sign the test requisition. Verify your name and birthdate are correct, and call 1.855.332.2533 if anything is incorrect.
Complete the Date and Time Collected lines on the test requisition. Your sample may be rejected if you fail to complete date and time on the requisition.
Wash and dry your hands.
Peel off the label with your name and date of birth from the bottom of the test requisition and place it on the tube.
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, about one 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 frst) until it reaches the bottom. Tip of swab will be in the liquid. Break the swab handle against the side of the tube at perforated break point.
Screw the cap onto the tube and place the tube into the bag. Seal the bag. Important: Do not remove the desiccant (white sheet) from the bag.
The test requisition MUST be returned with your specimen in order to be tested. Place the bag and test requisition into the box and close the box. Place the box into the white bag with the pre-applied FedEx return label. Seal the white bag.
Drop the postage paid FedEx return bag at a drop box location the same day you collect it, before 3:00 PM. DO NOT drop your specimen package in a drop box on a Saturday or Sunday.