Step-by-step Instructions
Before you start
During the test After the test
When to use this kit
PRODUCT
INFORMATION
LEAFLET
Refer to the Quick Start Guide
for a summary of the key
information of this leaet.
General Information
Please read this leaet before using
the test. You should follow the Ellume
COVID-19 Home Test App when
performing the test. The test is
intended to be used as an aid in the
diagnosis of a current COVID-19
infection. Please consult a healthcare
professional to discuss your results
and if additional testing is necessary.
Use this test:
As an aid in the diagnosis of current COVID-19
infection AND;
If you are concerned that you have COVID-19.
Do not use this test:
On anyone under 2 years of age;
If you are prone to nosebleeds, OR;
If you have had a facial or head injury/
surgery in the last 6 months.
COVID-19 Home Test –
What is included in the Box
Nasal Swab with
Child Adapter
Product Information Leaet and
Quick Start Guide are also included.
Flip-top
Lid
Child
Adapter
Tab
Processing
Fluid
1
2 3
Swab
Tip
Dropper
www.ellumecovidtest.com
Preparing to do the test
Ensure you have an internet connection
to download the App. Features like emailing
of test result record and result sharing
also require an internet connection.
Ensure you are using a compatible smartphone.
For a full list of compatible devices visit:
www.ellumecovidtest.com
Ensure your phone is charged
(at least 20% battery) or is charging.
Ensure your test is at room temperature
59-77°F (15-25°C).
Ensure all packaging is intact.
Do not use the test if there is visible damage
to the foil packaging.
Only open the foil packaging when you
are ready to do the test.
Use test within 1 hour after opening.
Wash your hands with soap and water
or use hand sanitizer before using the test.
Keep the Swab clean.
Avoid touching the Swab Tip and ensure
it does not touch any surfaces before use.
Step-By-Step Instructions
This leaet only describes the key steps of the
test. Step-by-step instructions on how to
perform this test are in the Ellume COVID-19
Home Test App.
1
Unbox components
Only open foil packaging when you are ready
to do the test. Use within 1 hour after opening.
2
Download and open App
Find the free Ellume COVID-19 Home Test App
on the Google Play Store, the App Store or use
your smartphone’s browser to visit:
www.ellumecovidtest.com
3
Answer a few questions in the App
This will select the right video and instructions
for you and enable health authorities to monitor
COVID-19 infection and test positivity rates.
4
Watch info video
The video will provide an overview of what
to expect. There will be separate step-by-step
instructions later in the App.
5
Follow instructions
Separate step-by-step
instructions will be
available within the
App after the video.
6
Your test result
After nishing the testing
process wait 15 minutes
for your result to appear
on your phone screen.
The App will store your
result and if selected a
test result record will be
sent to your email.
Button Sample Port
Analyzer
Do’s and don’ts Correct swabbing
A positive test result indicates that you very
likely currently have COVID-19 disease.
COVID-19 is a viral illness that causes multiple
symptoms including fever, a cough, sore
throat and shortness of breath (refer to
COVID-19 information section).
What you need to do:
1. Consult a healthcare professional as soon
as possible. Please tell them that you
tested positive for COVID-19.
Provide your healthcare professional with:
‒
Your Test Result Record (sent to you
via email and in your COVID-19 Home
Test App)
‒ The Product Overview for Healthcare
Professionals (in your COVID-19 Home
Test App)
‒ The Fact Sheet for Healthcare
Professionals (in your COVID-19 Home
Test App)
If you have no symptoms, particularly
if you live in an area with low numbers
of COVID-19 infections and have had
no exposure to anyone diagnosed with
COVID-19, additional molecular testing
to conrm your result may be required.
Please advise the healthcare professional
you have tested positive and have no
symptoms. See FAQ ‘Can I have a false
positive test result’ on our website http://
ellumecovidtest.com/FAQ.
2. You should self-isolate at home as per
CDC recommendations to stop spreading
the virus to others.
Please consult the CDC recommendations
regarding self-isolation www.cdc.gov/
coronavirus.
Press the YOUR RESULT & WHAT IT MEANS
button on the result screen in the App to nd
out more about your result and when you can
be with others again.
A negative test result indicates that you are
unlikely to currently have COVID-19 disease.
A negative test result means that proteins,
small parts of the virus that causes COVID-19,
were not found in your sample. However,
you may have had COVID-19 previously.
To conrm a previous infection, you will need
to take a different type of test (antibody test).
What you need to do:
Please consult a healthcare professional
if you develop symptoms, symptoms persist
or become more severe.
Negative results, particularly if you have no
symptoms of COVID-19, may require additional
molecular testing to conrm your result.
Please see FAQ ‘Can I have a false negative test
result’ on our website http://ellumecovidtest.
com/FAQ.
So, what is making you sick? There are many
other viruses that cause similar symptoms to
COVID-19 and these may be the cause of your
symptoms. Regardless of the test result, it is
important that while you are sick you should
practice social distancing and good hygiene
and should not attend work.
If you develop symptoms or your symptoms
persist or become more severe, if you are
concerned about your health or you develop
one of the emergency warning signs
(see COVID-19 information section) then you
should seek medical attention immediately.
Your test has experienced an error.
You will need to retest with a new test
or consult a healthcare professional.
Self-isolate at home.
Call the Ellume toll free helpline 1-888-885-6121
and have your test result and test packaging
handy. We will need the Error Code, Lot
Number and Analyzer ID on the result screen.
Follow the App’s instructions carefully.
Incorrect use or use in the wrong order may
result in a test failure or an incorrect result.
Children aged 2-15 years should be tested
by an adult (18+ years old).
Children aged 2-12 years should be swabbed
with the Child Adapter in place.
Keep out of reach of children.
Small kit parts may be a choking hazard.
Only use the test components provided.
Do not replace the Processing Fluid with
any other uid.
Keep the Swab clean. Avoid touching the
Swab Tip and ensure it does not touch any
surfaces before use. a contaminated swab
is a health hazard.
Immediately after taking the sample,
screw the Swab into the Dropper.
Keep your phone within 3 inches of the
Analyzer until the test result is available.
If you receive a call, answer on speaker.
Keep the Analyzer on a at surface until
the result is available.
Tilting the Analyzer could result in a test error.
Keep foreign substances away from the test
during the testing process. Contact with
foreign substances, specically bleach,
may result in an incorrect test result.
Do not use this test on anyone under
2 years of age.
Do not drop the Analyzer. Handle with care.
Do not perform the test in direct sunlight.
Avoid contact with Processing Fluid.
Do not insert Swab into your nose once it has
been in contact with Processing Fluid and do
not ingest Processing Fluid. Only a clean Swab
should be inserted into your nose.
Do not perform your test within 30 feet
of another person using an Ellume COVID-19
Home Test.
Do not close the Ellume COVID-19 Home Test
App during processing as it will cause an error
and you will need a new test kit.
YOUR TEST IS POSITIVE
FOR COVID-19
YOUR TEST IS NEGATIVE
FOR COVID-19
A TEST ERROR
HAS OCCURRED
Disposal
Before disposal of the Analyzer, we recommend
removing the battery using the following steps:
• Locate the gap at the end (short side) close
to power button of the Analyzer
• Place a coin in the gap
• Twist the coin to break off the bottom end of
the Analyzer along the perforation in the plastic
• Remove the battery from the plastic clips
of the Analyzer
• Dispose of the battery according
to local regulations
• Keep the battery out of reach of children
• Do not incinerate
Dispose the remainder of the test in general waste.
Test results recordYour result and what it means for you
The Ellume COVID-19 Home Test App will show one of the following results on your phone’s screen: A record of your test result and detailed information
regarding your result will be emailed to you
if selected in the App. If you choose not to have
the results sent to your email, your results will
remain accessible within the App.
This record can be used as a proof of test result for
your healthcare professional, employer, or educator.
Once you have your result, you can use the
Menu icon to start a new test and to access
past test results.
Attention all users
If you are not recovering, feeling worse,
or are concerned about your health,
please consult a healthcare professional.
In USA - This product has not been FDA
cleared or approved but has been authorized
by FDA under an Emergency Use
Authorization (EUA). This product has been
authorized only for the detection of proteins
from SARS- CoV-2, not for any other viruses or
pathogens. 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.
D1013763A
This test involves taking a sample from
deep inside your nose. When doing the test, pay
particular attention to the instructions on how
to swab your nose. Incorrect swabbing may lead
to an inaccurate test result. This is particularly
important if you do not have symptoms.
Swabbing a small child.
We recommend swabbing small children with
the help of a second adult. One adult should
hold and reassure the child while the other
takes the swab.
Important
This test is intended to be used as an aid in
the clinical diagnosis of a current COVID-19
infection. Do not use this test as the only
guide to manage your illness. Please consult
a healthcare professional if your symptoms
persist or become more severe, or if you
are concerned at any time.
D1013763 COVID-19 Home Test Product Information Leaflet - EUA FDA Authorised.indd 1D1013763 COVID-19 Home Test Product Information Leaflet - EUA FDA Authorised.indd 1 19/1/21 9:18 am19/1/21 9:18 am