amazon COVID-19 Test Collection Kit DTC Instruction Manual
- June 6, 2024
- Amazon
Table of Contents
Amazon COVID-19 Test
Collection Kit DTC
FDA Authorized
APPLY UPC CODE HERE
Before you start
Carefully read all instructions before you begin.
Sample collection takes less than 10 minutes.
The return box must be used to ship your sample to the lab. Check the box for
the pre-applied shipping label. Make sure corners are not damaged and sides
have no tears or holes. If damaged, discard and get a new kit by visiting
AmazonDx.com/FAQs
Drop your sample off at UPS within 24 hours. Expired samples cannot be
processed. Due to weekend shipping schedules, we recommend collecting and
shipping your sample Monday Friday. Before collecting your sample, confirm the
last air drop off time at www.ups.com/dropoff
For frequently asked questions, visit
AmazonDx.com/FAQs
Components:
(above left to right) Instructions for use, Nasal swab, Collection tube with
saline, Biohazard plastic bag with an absorbent pad, Return box with a
shipping label, Tape
Fact sheet for individuals (not pictured)
Register your kit
Watch the overview video during the kit registration process. Rewatch the
video at: AmazonDx.com/FAQs
Visit AmazonDx.com
Using your personal device, visit AmazonDx.com or view
the QR code with your camera app. Sign in or create an account.
Enter the collection tube ID
Confirm your personal information online. Then enter the collection tube ID,
found on the side of your collection tube.
Press “Register kit”
Collect your sample immediately after registering.
You must register your kit to get results.
Collect your sample
We recommend testing while seated.
Do not touch the soft tip of the swab.
Do not touch or drink the fluid in the collection tube.
If the fluid touches eyes or skin, rinse with water.
If you spill the fluid or the swab touches any surface other than inside your
nostrils discard your kit components. Clean the area with your routine
household surface disinfectant, and get a new kit by visiting
AmazonDx.com/FAQs
Wash and dry your hands
Wash your hands with soap and warm water for 20 seconds.
Use hand sanitizer if there is no sink.
Clean the surface of the area where you will collect your sample.
Remove the lid from the collection tube
Put the tube lid on a clean surface nearby, with the lid top facing down.
Put the collection tube in the tube holder provided in the box to avoid
spilling fluid.
Open the swab pouch
Peel back the tab on the handle end to remove the nasal swab from the pouch.
Hold by the handle, do not touch the soft tip. Discard the swab pouch.
Do not touch the soft tip of the swab to any surface other than inside your
nostrils.
Swab first nostril
Insert the soft tip of the swab ½ – ¾ inch inside your nostril. Rub the swab
in a slow circular motion against the inside walls of your nostril at least 4
times.
This should take about 15 seconds.
Repeat in another nostril
In your other nostril using the same swab, rub the swab slowly at least 4
times taking about 15 seconds.
Put swab in collection tube soft tip down
To break off the swab handle, hold the tube firmly. Bend the swab handle at
the indicator line back and forth against the collection tube until it breaks.
Discard the handle.
Do not spill the fluid in the collection tube! If you spill the fluid, clean
the area and discard your kit components.
Recap the collection tube
Make sure the lid is on tight, so no fluid can spill out. If the collection
tube leaks your sample cannot be processed.
Wash your hands or use hand sanitizer if there is no sink.
Checklist
If you cannot check all of the boxes below, your sample cannot be processed.
Before sending your sample to the lab
- I registered my kit. If you have not registered your kit please go back to section 1.
- I collected a sample from both nostrils.
- The nasal swab only touched my nostrils.
- I did not spill the fluid in the collection tube.
If you miss any testing steps your results may be inaccurate or result in an error. If you have missed steps please discard kit components and clean your area. Get a new kit at your earliest convenience by visiting AmazonDx.com/FAQs.
Send sample to the lab
Put tube inside the plastic bag
Put the capped collection tube inside the plastic bag with the absorbent pad.
Release excess air from the bag and seal it shut. Clean the sample collection
surface area with a disinfectant.
Do not remove the absorbent pad from the plastic bag.
Prepare your box for return shipping
The return box must be used to ship your sample to the lab. Check your box to
make sure corners are not damaged and the sides have no tears or holes.
Put your sealed plastic bag with your collection tube in the box. Close box
and seal with tape.
Discard the outer box that you received your kit in.
Drop the box with your sample off at a UPS location within 24 hours
Drop your sample off at UPS within 24 hours. Before collecting your sample,
confirm the last air drop-off time at http://www.ups.com/dropoff. Please
note only The UPS Store®, UPS DropBox, or UPS Customer Center locations can
accept samples.
Expired samples cannot be processed. If your sample is expired you will
receive a notification of error.
Questions?
For frequently asked questions and support:
AmazonDx.com/FAQs
For In Vitro Diagnostic Use Only
For Use Under Emergency Use Authorization Only
For Use by Individuals 18 Years or Older
STS Lab Holdco LLC (a subsidiary of Amazon.com Services
LLC) 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 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 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. 410 Terry Ave N, Seattle, WA 98109, USA
How it works
Purchase your kit. Register the kit at amazondx.com by entering your personal
information and collection tube ID. Follow the instructions found in your kit
to collect your anterior nasal sample and ship it to the lab via UPS. Once
your test is processed you will receive an email and SMS with a link to your
results.
As needed, follow up with your healthcare provider.
For frequently asked questions and support:
AmazonDx.com/FAQs
Components
Instructions for use, Nasal swab, Collection tube with saline, Biohazard
plastic bag with an absorbent pad, Return box with a shipping label, Tape,
Fact sheet for individuals. Shipping to lab included. Requires access to a
computer or smartphone with internet, E-mail, and SMS to register kit and
receive results online, and disinfectant to clean your test area. Disinfectant
and device not included. For use by individuals 18 years or older.
For Use Under Emergency Use Authorization Only.
STS Lab Holdco LLC (a subsidiary of Amazon.com Services LLC) 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 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 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.
410 Terry Ave N, Seattle, WA 98109, USA
STORE KIT AT ROOM TEMPERATURE (430 C) KEEP OUT OF REACH OF CHILDREN
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