AmazonBasics AVLN1 Amazon COVID-19 Test Collection Kit DTC — FDA Authorized PCR Test Collection Kit — Results in 24 hours from lab receipt — Ages 18+

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User Manual

This is the main product document for model AVLN1.

The file format is pdf, 5 pages, you can download this manual here .

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Amazon COVID-19 Test Collection Kit Instructions for Use
COVID-19 Test
Collection Kit DTC
Instructions
For Use
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 box for 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
(above left to right) Instructions for use, Nasal swab, Collection tube
with saline, Biohazard plastic bag with absorbent pad, Return box with
shipping label, Tape
Fact sheet for individuals (not pictured)
Before you start
Components:
Page 1 of 5
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Amazon COVID-19 Test Collection Kit Instructions for Use
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.
1
2
Collect your sample
Register your kit
Enter the collection tube ID
Confirm your personal information online.
Then enter the collection tube ID, found on
the side of your collection tube.
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.
Register kit
Press “Register kit
Collect your sample immediately after
registering.
!
You must register your kit to get results.
Watch the overview video during the
kit registration process. Rewatch the
video at: AmazonDx.com/FAQs
Page 2 of 5
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Amazon COVID-19 Test Collection Kit Instructions for Use
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.
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.
Repeat in other nostril
In your other nostril using the same swab,
rub the swab slowly at least 4 times
taking about 15 seconds.
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.
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.
½” - ¾”
½” - ¾”
!
Do not touch the soft tip of the swab
to any surface other than inside your
nostrils.
!
 Do not spill the fluid in the collection
tube! If you spill the fluid, clean the area
and discard your kit components.
Page 3 of 5
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Amazon COVID-19 Test Collection Kit Instructions for Use
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.
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.
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 sides have no
tears or holes.
Put your sealed plastic bag with your
collection tube in the box. Close box
and seal with tape.
!
 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.
Before sending your sample to the lab
If you cannot check all of the boxes below, your sample
cannot be processed.
4
Send sample to lab
3
Checklist
!
 Discardtheouterboxthatyoureceived
your kit in.
!
 Donotremovetheabsorbentpadfrom
the plastic bag.
Page 4 of 5
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Amazon COVID-19 Test Collection Kit Instructions for Use
24h
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 Drop Box
or UPS Customer Center locations can
accept samples.
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
!
 Expiredsamplescannotbeprocessed.If
your sample is expired you will receive a
notification of error.
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 an 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 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
Page 5 of 5

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