Step-by-step Instructions

• «I) GENERAL TEST INFORMATION
Please read this leaflet before using the test.
You must follow the Theraflu App when
performing the test.
fluTEST
HOME DIAGNOSTIC KIT
PRODUCT
INFORMATION
LEAFLET
Refer to the Quick Start Guide
for a summary of the key
information of this leaflet.
AT All TIMES
This test is intended to be used as an aid in
the diagnosis of flu (influenza). If your test
detects flu please consult a healthcare
professional. If your test does not detect flu
but you are becoming increasingly unwell,
are not recovering, or if you are concerned
about your health, please see a
healthcare professional.
Home diagnostic kit:
rnasal swab
L with child adapter
-[FLIP-TOP
>----4 LID
I ' -[CHILD
..J .i... ADAPTER
~[SWAB
TIP
[analyzer
© -[BUTTON
c!) -[SAMPLE
PORT
r processing
Lt1u1d
[dropper
When to use this test:
! Use this test if you have all 3
of the below:
• You have had a fever or have felt feverish
within the last 24 hours, AND;
• You have a runny or blocked nose, AND;
• You have had flu-like symptoms for 3 days
or less.
x Do not use this test:
• On anyone under 2 years of age;
• If you have been unwell for 4 days or more;
• If you are prone to nose bleeds;
• If you have had a flu nasal spray mist
vaccine in the last 7 days, OR;
• If you have had a facial or head injury or
surgery in the last 6 months.
Flu safety
High Risk Groups
Users who fall into one of the following
groups are at high risk of complications
from the flu and are recommended to
see a healthcare professional regardless
of their test result:
• Children under the age of 5 and
especially under 2 years of age
• Adults 65 years and older
• People under 19 years of age who are
on long-term aspirin or salicylate
containing medications
• Pregnant women
• American Indians and Alaska Natives
• People who live in nursing homes and
other long-term care facilities
Or individuals who suffer from:
• Asthma
• Neurologic and neurodevelopment
conditions
• Blood disorders
• Chronic lung disease
• Endocrine disorders
• Heart disease
• Kidney disorders
• Liver disorders
• Metabolic disorders
• Weakened immune system due to disease
or medication
• Obesity (with a body mass index [BMIJ of
40 or more)
For most current information on high risk
groups refer to:
https://www.cdc.gov/features/fluhighrisk/index.html
8 ATTENTION ALL USERS
If you are not recovering, feeling worse, or
are concerned about your health, please
consult a healthcare professional.
Warning Signs
The following are signs of severe flu
(influenza) infection. Please seek medical
attention if any of these apply to you at
anytime:
Adults
• Difficulty breathing or shortness of breath
• Persistent pain or pressure in the chest
or abdomen
• Persistent dizziness, confusion, inability
to arouse
• Seizures
• Not urinating
• Severe muscle pain
• Severe weakness or unsteadiness
• Fever or cough that improve but then
return or worsen
• Worsening of chronic medical condition
Children
• Fast breathing or trouble breathing
• Bluish lips or face
• Ribs pulling in with each breath
• Chest pain
• Severe muscle pain (child refuses to walk)
• Dehydration (no urine for 8 hours, dry
mouth, no tears when crying)
• Not alert or interacting when awake
• Seizures
• Fever above 104° F (40°C)
• In children less than 12 weeks, any fever
• Fever or cough that improve but then
return or worsen
• Worsening of chronic medical conditions
For most current information on warning
signs refer to:
https://www.cdc.gov/flu/consumer/symptoms.html
BEFORE THE TEST
Preparing to do the test
~ Ensure you have an Internet connection.
You will need to download the Theraflu App.
The app will require an Internet connection
to email you your test result record.
~ Ensure YoU are using a compatible
smartphone. For a full list visit:
www.theraflu.com
~ Ensure your phone Is charged (at least
20% battery) or is charging.
~ Ensure your test Is at room temperature.
59-77°F C15-25°C).
~ Ensure all packaging Is Intact. Do not use
the test if there is visible damage to the
foil packaging.
~ Only open the loll packaging when you
are ready to do the test. Use test within
1 hour after opening.
~ Wash your hands before using the test.
~ Keep the swab clean. Avoid touching the
swab tip and ensure it does not touch any
surfaces before use .
9 STEP-BY-STEP INSTRUCTIONS
This leaflet only describes the key steps
of the test. Step-by-step instructions on
how to perform this test are in the
Theraflu App.
6 key steps of the test
2
4
UNBOX COMPONENTS
Only open foil packaging when you are
ready to do the test. Use within 1 hour.
DOWNLOAD AND OPEN THE APP
Find the free Theraflu App on the
Google Play Store, the App store,
or use your smartphone's web browser
to visit: www.theraflu . com
ANSWER QUESTIONS
This will select the right video and
instructions for you.
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
6
FOLLOW
INSTRUCTIONS
Separate
step-by-step
instructions will be
available within the
app after the video.
YOUR TEST
RESULT
After finishing the
testing process wait
12 minutes for your
result to appear on
your phone screen .
Once you have your result, you can
use the Menu icon to start a new test,
access past test results or use the
talamedicina consultation (refer to
Post Result Service section).
Frequently asked questions (FAQs)
0 How does the Theraflu Home Flu Test
work? When you have flu, the virus
causing your symptoms is present in your
nasal secretions. The Theraflu Home Flu
Test can detect small amounts of flu
(influenza) virus in your nasal secretions.
0 How accurate Is the Theraflu Home Flu
Test? No rapid flu test is 100% accurate.
The Theraflu Home Flu Test has an overall
accuracy of 95% for Flu A and 89% for
Flu 8.
0 What should I do if my phone cannot
connect with the analyzer? Contact
Theraflu's toll free customer helpline
for assistance.
r O Why Is the app asking me for my name
and email address? The app will
automatically email you a record of
your test result. You can share this
record as a proof of influenza testing
with your doctor, pharmacist or employer.
For the app to be able to generate this
record and email it to you it requires the
patient's name and an email address.
0 Whats should I do if my phone runs out
of charge during the test? It is ok to
charge your phone while performing the
test. Make sure to keep the analyzer
within 3 inches (7 centimeters) of
your phone.
0 The analyzer light is flashing red.
What does this mean? A flashing red
analyzer light indicates that the battery
of the analyzer is too low to perform
the test.
0 The analyzer light Is solid red.
What does this mean? A solid red
analyzer light indicates that the analyzer
is faulty.
0 I have a nose bleed after swabbing my
nose. What should I do? In the unlikely
event your nose starts bleeding, apply
pressure to your nose and consult a
healthcare professional. Do not insert
the swab again.
0 I am trying to squeeze the fluid into the
sample port but no fluid is coming out.
What should I do? Ensure the swab is
screwed into the dropper as tightly as
possible. Some force will be required to
do this. Then try again holding the
dropper completely vertical. If this does
not solve the problem, call Theraflu's toll
free customer helpline for assistance.
For further FAQs visit www.tharallu.com
Clinical performance
The performance of the Theraflu Home Flu
Test was determined in a clinical study
conducted from December 2018 to April 2019
at geographically diverse sites throughout
the USA. According to the CDC, influenza A
viruses predominated during the 2018/2019
influenza season with influenza A(HlNl)
pdm09 viruses and influenza A(H3N2)
viruses mainly represented. Influenza B
activity was very low. The overall accuracy of
the test for the detection of influenza A when
compared to the reference result, as
determined by the concordance between
viral culture and two FDA cleared molecular
test kits, was 95%, with positive percent
agreement (PPA) of 88% and negative
percent agreement (NPA) of 98%. The overall
accuracy of the test for detection of influenza B
was 98% with a PPA of 83% and NPA of 98%.
Due to the very small number of influenza B
cases seen during the season, additional
bench testing was conducted using stored
clinical samples. The overall accuracy of the
test for detection of influenza B when using
these samples was 91% with 86% PPA and
97% NPA. The results for the annual reactivity
panel provided by the CDC can be found on
our website www.theraflu.com
If you or your healthcare professional would
like to know more about how the test works
you will find more details in the Test Result
Record that was emailed to you. Alternatively
you or a healthc are professional can contact
Theraflu's toll free customer helpline at
anytime.
a DURING THE TES _T ..1
Do's and don'ts
~ Follow the app's Instructions carefully.
Incorrect use or use in the wrong order may
result in a test failure or an incorrect result.
~ For children under the age ol 16 years,
the test must be performed by an adult.
~ Children aged 2-12 years must 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 fluid.
~ 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.
~ Screw the swab Into the dropper
immediately after taking the sample.
~ Keep your phone within 3 Inches or the
analyzer until the test result is available.
Answer calls on speaker.
~ Keep the analyzer on a flat 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 may result in an
incorrect test result.
X Do not drop the analyzer. Handle with care.
X Do not perform the test In direct sunlight.
X Avoid contact with processing fluld . Do
not insert swab into your nose once it has
been in contact with processing fluid and
do not ingest processing fluid.
X Do not perform your test within 30 feet
ol another Theraflu test.
X Do not close the Theraflu App during
processing as It wlll cause an error and
you wlll need a new test kit.
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.
SWABBING A SMALL CHILD. We recommend
swabbing small children with the help of a
second adult. One adult should hold & reassure
the child while the other takes the swab.
Warnings and precautions
~ Store in a dry location between 36-86°F
(2-30°C)
~ Keep out of direct sunlight
~ Use at room temperature 59-77°F (15-25°()
~ Keep out of reach of children
X Do not use after expiry date
X Do not use if any of the packaging is opened
or damaged
X Do not re-use; this is a single use test
X Do not use this test as the only guide to
manage your illness, particularly if your test
has not detected flu. Please consult a
h ealthcare professional if symptoms
persist or become more severe
! Avoid performing the test in a very dry
environment (very low humidity) to prevent a
build up of static electricity that could
damage the electronics of the test
! A test result will be less reliable when there is
very little flu in the community (outside flu
season , and in the very early and very late
stages of the flu season). Please consult a
healthcare professional if you are concerned
about your health, if your symptoms persist,
or if symptoms become more severe
! No test components to be used inside the
body except the nasal swab
! High levels of blood in your nasal swab
sample may interfere with the test
! Individuals who received nasally administered
flu vaccine may test positively for the virus
for up to seven days after vaccination
Test 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
• Lift up the little metal battery holder and
turn the analyzer so the battery can slide out
• Dispose of the battery according to local
regulations
• Keep the battery out of reach of children
• Dispose the remainder of the test in
general waste
• Do not incinerate
AFTER THE TEST
Your result and what it means for you
I
The Therallu App wlll show one ol the IQllowlng results on your phone's screen:
_i:\ YOUR TEST
,::!:) DETECTED FLU
Your test Is positive for flu (Influenza)
AorB.
Flu is a viral infection of the nose, mouth,
throat and sometimes lungs.
It is treatable with antiviral medicines if
treated within the treatment window of
48 hours after onset of symptoms. The
antiviral treatment is more effective the
earlier it is initiated.
You are contagious and can give the flu
to other people - please read about
stopping the spread of influenza in the
Flu and You section.
We recommend consultlng a healthcare
professional as soon as possible. This is
particularly important if:
•You are In a high-risk group (refer to
the User Safety section), OR;
•You are in the treatment window, OR;
•You are concerned about your health.
Please tell the healthcare professional
that you have had a positive flu test.
Press the YOUR RESULT & WHAT IT
MEANS button in the app to find out
more about your result.
8 IMPORTANT
This test is intended to be used to aid a
dinical diagnosis. 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
anytime.
~ YOUR TEST DID NOT
0 DETECT FLU
Your test Is negative for flu (Influenza).
So what could be making you sick? Other
viruses cause flu-like symptoms. These
illnesses typically resolve by themselves
within 2-4 days, but sometimes they can
cause more severe illness, especially in
children or people at high risk (refer to
User Safety section).
Sometimes more serious conditions can
cause flu-like symptoms. These include
bacterial infections of the throat, sinuses
and lungs.
If you feel worse, you don't get better,
or you are concerned about your health,
please consult a healthcare professlonal.
i\ A TEST ERROR HAS
0_) OCCURRED
Your test has experienced an error.
Please call the Theraflu's toll free
customer helpline and have your test
result and the test packaging handy. We
will need the Error Code under the circle
on the result screen as well as the Lot
Number and Analyzer ID of your test.
You will need to test again with a new
test or consult a healthcare professional
for further care .
Testing outside the flu season
As with all flu tests, test results are slightly
less reliable when there are very few flu
cases in the community (outside the flu
season). Please consult a healthcare
professional if you are concerned about
your health, if your symptoms persist,
or if symptoms become more severe .
Post result services
Telemedlclne Service
The Theraflu Home Flu Test enables you to
connect to a telemedicine consultation
directly through the app. This allows you to
discuss your illness with a healthcare
professional. If the healthcare professional
believes a prescription medication is needed,
this will be sent electronically to you or your
pharmacy. The healthcare professional may
also write a flu certificate for your employer
if appropriate. To arrange a telemedicine
consultation simply press the VIDEO CALL A
DOCTOR button on the result screen and
follow the prompts. The telemedicine
consultation has an extra fee, some or all of
which may be covered by your health
insurance.
Test Results Record
A record of your test result and detailed
information regarding your result will be
emailed to you automatically. This record
can be used as a proof of test result for your
doctor, pharmacist or employer. If required,
your employer can log on to verify the
record's authenticity. Acceptance is at your
employer's discretion.
Buy over the counter medicine in app
When you are sick, the last thing you want to
do is drag yourself out of the house to buy
more medicine. The Theraflu App works with
retailers to deliver to you the
over-the-counter medication you need,
when you need it, all from the comfort of
your home. Simply press the BUY OVER THE
COUNTER MEDICINE button on the result
screen, and follow the prompts to get
medication delivered to your door in as little
as a few hours. Additional charges for
delivery may apply. Theraflu over the
counter medicine are not antiviral.
8 ATTENTION ALL USERS
If you are not recovering, feeling worse,
or are concerned about your health,
please consult a healthcare professional.
More about the test Flu and you
• Some technologies inside the test are
licensed from Thermo Fisher.
• This product contains small amounts of
animal sourced materials.
• This device complies with the emission
and immunity requirements described in
EN61326-2 -6. Interference from other
electronically driven equipment is not
expected.
This equipment has been tested and found
to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide
reasonable protection against harmful
interference in a residential installation.
This equipment generates, uses and can
radiate radio frequency energy and, if not
installed and used in accordance with the
instructions, may cause harmful interference
to radio communications. However, there is
no guarantee that interference will not occur
in a particular installation. If this equipment
does cause harmful interference to radio or
television reception, which can be
determined by turning the equipment
off and on, the user is encouraged to try to
correct the interference by one or more
of the following measures :
• Reorient or relocate the receiving antenna
• Increase the separation between the
equipment and receiver
• Connect the equipment into an outlet on a
circuit different from that to which the
receiver is connected
• Consult the dealer or an experienced
radio/TV technician for help
Warning: Any changes or modifications not
expressively approved by GSK could void the
user's authority to operate this equipment
For a Glossary of Symbols please refer to
www.theraflu.com
0 What Is flu? Flu is a serious and common
contagious illness caused by a viral
infection of the nose, throat and lungs.
0 How does flu spread? Flu viruses are
mainly spread by tiny droplets made
when people with flu cough, sneeze,
blow their nose and talk. A person might
also get flu by touching a surface or
object that has flu virus on it and then
touching their own eyes, mouth or nose .
0 How long can a sick person spread
flu to others for? People infected with
flu may infect others from about 1 day
before feeling sick to 5-7 days after
symptoms appear. Some people are
infectious for longer, including children
and people with weakened immune
systems.
0 How severe is illness caused by flu?
Different flu viruses affect people
differently. Even healthy children and
adults can get very sick or even die
from flu.
0 Does flu have compllcatlons? Sometimes
people who have flu get a delayed
bacterial infection, usually of the lungs.
This usually occurs within 5 days of
symptoms and is caused by the flu virus
making the person more susceptible to
infection. Antibiotics are likely to help
these people and it is recommended that
you consult a healthcare professional if
you think your flu infection has led to a
subsequent bacterial lung infection.
0 How can I avoid catching flu? Try to
avoid close contact with sick people.
Wash your hands often and avoid
touching your mouth, nose and eyes.
Face masks help reduce the spread of flu.
Clean and disinfect surfaces and objects
that may be contaminated with germs
like the flu.
Customer helpline
If you have any questions about this flu test,
please contact Theraflu toll free customer
helpline on
1-855-328-5259
0 I had flu last year, why have I got It
again? Each year, the flu virus changes
slightly. This means that you are not
protected from getting influenza this
year just because you had it last year.
0 I got the flu vaccine this year, why do
I have a positive flu test? You may have
been exposed to a flu virus shortly
before or after getting vaccinated. Or
you may have been exposed to a flu
virus that is not included in the seasonal
flu vaccine. There is also a small chance
of becoming infected with a flu virus the
flu vaccine is designed to protect
against, despite getting vaccinated.
0 How can I protect myself from flu?
Vaccination is widely regarded as the
best method of preventing flu
(influenza) infection. Each year, flu
viruses change a little, so flu experts
change the flu vaccine to match the new
viruses. It is important to get vaccinated
every year, especially if you are in a high
risk group, or you live and work with
people in high risk groups.
al) Will antiviral drugs make me better?
If started within 2 days (48 hours)
antiviral drugs may help you get better
sooner and make your illness less severe.
Antiviral medicines also decrease the
chance you will have complications of flu
(influenza). For people in high risk
groups, there might be benefits in
treatment even if you have been sick for
longer than 2 days. Antiviral medicines
are not a replacement for vaccination -
prevention is better than treatment.
m Will antibiotics make me better?
If you have flu, antibiotics will not make
you better because flu (influenza)
is a virus.
Manufacturer
Distributed by: CiSK Consumer Healthcare
Warren, NJ 07059
<02019 GSK or licensor. Trademarks are
owned by or licensed to the GSK group
of companies.
l"ii"iftl No test components to be used inside the body
l.!!.!!J except the nasal swab as directed.
10035E-OB-1119
2019-11-04
1059865PIL