NHS ACON Flowflex SARS-CoV-2 User manual

Read this whole guide carefully before you start the test.
This test may be different from those you have used before.
Your step-by-step guide for
ACON Flowflex™SARS-CoV-2
Antigen Rapid Test (Self-Testing)
ABC12345678
These instructions for use relate to ACON FlowflexTM SARS-CoV-2 Antigen Rapid
Test (Self-Testing), product code: L031-118Y5 only.
The guide explains how to test yourself or another person for COVID-19, and report
the results to the NHS.
Alternative language versions and video demonstrations are available on
gov.uk/covid19-self-test-help
Report all your test results to the NHS

2Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
What you need to do
Your step-by-step guide
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing) is a rapid test for
the detection of COVID-19 where the users take their swab sample from their
nose.
It is for self-testing and in vitro diagnostic use only.
The product has not been made with natural rubber latex however the presence
or traces of natural rubber latex in the product as delivered to the end-user
cannot be excluded completely.
Please carefully read the instructions before performing the test.
1
2
3
4
5
6
7
8
Prepare your test area and check your kit contents page 7
Set up your test page 9
Take your swab sample page 11
Doing a test on someone else page 12
Process the swab sample page 13
Read your result page 15
Report your result page 16
What your results mean page 17
Safely dispose of your test kit page 18
Around 1 in 3 people with COVID-19
do not know they have it.

3
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ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
What you need to do
Advice about taking the test
Precautions
• Do not eat, drink, smoke or vape 30 minutes prior to or during the test.
• Do not use the test if any part is damaged.
• All used test materials should be safely disposed of in the household waste.
• Wash hands thoroughly before and after use.
• Avoid using samples that contain blood.
• Assistance with the swabbing and testing process may be required by those with
hand and vision issues.
• Keep the test kit away from children and animals.
Storage and handling
• The test kit should be stored at temperatures between 2 - 30 °C. DO NOT FREEZE.
• Do not use the test after the expiration date printed on the sealed pouch.
• Test should be performed at temperature range 15 - 30 °C.

4Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
About this test
Why you should self-test?
This COVID-19 self-test kit is a swab test for the nose to check if you are
infectious. It's for people who have symptoms as well as those with no
symptoms. However you should follow national guidelines to check what
type of test is right for you.
If you test positive for COVID-19 you should:
• Help limit the spread of the disease, you and your household should self-isolate
following government guidelines:
nhs.uk/conditions/coronavirus-covid-19/self-isolation-and-treatment/
• Advise people you have been in close contact with and locations you have visited in
the last 48hrs before your symptoms started, or from the day a positive test result is
shown if no symptoms are present, to test for possible COVID-19 infection. Always
follow local and national guidelines.
If you test negative for COVID-19
It is likely that you were not infectious at the time the test was taken. A negative test
result, however, is not a guarantee that you do not have coronavirus.

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ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
About this test
ADVICE
Do not delay getting help if you are worried. Trust your instincts.
If you have COVID-19 symptoms or have contracted COVID-19, please follow NHS
guidance:
nhs.uk/conditions/coronavirus-covid-19
If you have COVID-19 symptoms and your condition worsens, or you do not get
better after seven days, use the NHS 111 online coronavirus service
111.nhs.uk.
If you do not have internet access, call NHS 111.
For a medical emergency dial 999.
You can get more advice about COVID-19 symptoms in children at: nhs.uk/
conditions/coronavirus-covid-19/symptoms/coronavirus-in-children/

6Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
Who this test is suitable for?
Adults aged
18+
Self-test and report,
with assistance if
needed.
Adolescents aged
12 - 17
Self-test and
report with adult
supervision. The adult
may conduct the test,
as necessary.
Children under
12
Should be tested by an
adult. Do not conduct
this test if you do not
feel confident testing
a child.
How often to test
How often you should test may vary depending on your circumstances and
current national or local guidelines.
Where to find extra support
Get more self-test information at: gov.uk/covid19-self-test-help
This instructions booklet only refers to ACON FlowflexTM SARS-CoV-2 Antigen Rapid
Test (Self-Testing), Product code: L031-118Y5.

7
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ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
1. Prepare your test area
TIP
Do not eat, drink, smoke or vape 30
minutes prior to or during the test.
ADVICE
You’ll need a timer (a watch
or clock) during your test.
1 Read this instruction guide carefully.
You can also watch the swab test video
online if you need more help:
gov.uk/covid19-self-test-help
2 Clear, clean and dry a flat surface
immediately before starting the test.
3Wash or sanitise your hands. Make sure
they are dry before starting the test.
If you are testing more than one person or
repeating a void test, rewash your hands
between each test.

8Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
Check your kit contents
4In your test box you should have:
Extraction Buffer Tubes
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Extraction Buffer Tube Holder
Test Cassette in sealed pack
Extraction Buffer Tube in sealed pack Waste Bag Disposable Swab
What to do if something is damaged, broken or missing
If you notice anything damaged, broken, missing or difficult to use in the kit,
do not use it. You can give feedback by calling the customer contact centre.
Lines open every day, 7am to 11pm.
Call: 119 (free from mobiles and landlines).
We offer support in 200 languages as well as British Sign Language.
If you are harmed by a device reporting it could help others, please go to:
coronavirus-yellowcard.mhra.gov.uk
ADVICE

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ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
2. Set up your test
30
minutes
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5Take the test cassette out of the sealed
bag and place it onto a clean flat surface.
WARNING
Once opened, start the test within
30 minutes.
Take care
6Keeping the extraction buffer tube
away from your face, carefully peel off
the sealing film on the tube to avoid
spilling any fluid.
WARNING
If the liquid in the extraction buffer
tube gets onto the skin or into eyes,
wash immediately and seek medical
help if necessary.
7Insert the extraction buffer tube into the
tube holder to avoid spilling the buffer.

10 Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
8Find the swab in the sealed wrapper
and identify the soft, fabric tip.
WARNING
Do not touch the soft, fabric tip of
the swab.
Take care
9Peel open the swab packaging only
when you are ready to use. Gently take
out the swab and avoid touching the
fabric tip.

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ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
3. Take your swab sample
WARNING
ACON Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing) should be performed
using a nose sample only. Do not swab your nostril if you have a nosebleed.
Adolescents aged 12-17 can self-test with adult supervision. The adult may conduct
the test, as necessary.
If testing a child under 12 years of age, or a person who requires assistance, follow
the steps on page 12.
10 Insert the entire fabric tip of the swab
into one nostril. Using gentle rotation,
push the swab less than 2.5 cm from
the edge of the nostril.
This may feel uncomfortable. Do not
insert the swab any deeper if you feel
strong resistance or pain.
x5
11 Rotate the swab 5 times brushing
against the inside of the nostril.
x5
12 Remove the swab and insert the same
swab into the other nostril. Repeat
step 10 and step 11.

12 Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
Doing a test on someone else
ADVICE
Children under 12 years of age should be tested by an adult. Do not
conduct this test if you do not feel confident testing a child.
13 Put the fabric tip of the swab gently into
one of their nostrils until you feel some
resistance.
x5
14 Rotate the swab 5 times brushing
against the inside of the nostril.
x5
15 Remove the swab and insert the same
swab into the other nostril. Repeat
step 13 and step 14.

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ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
Doing a test on someone else 4. Process the swab sample
For best performance, test the
nasal swab as soon as possible
after swabbing your nostrils.
TIP WARNING
If the liquid in the extraction buffer
tube gets onto the skin or into eyes,
wash immediately and seek medical
help if necessary.
30
seconds
16 Pick up the extraction buffer tube and
place the fabric tip of the swab into the
tube so it is in the liquid.
Press the tip against the edge of the
extraction buffer tube with force, while
rotating it around the tube for 30
seconds.
x5 17 Rotate the swab 5 times while squeezing
the side of the tube.
This is to transfer your sample into the
liquid.
18 Pinch the extraction buffer tube against
the swab as you remove it. Make sure
you remove all liquid from the soft tip
of the swab.
Place the swab in the waste bag
provided.

14 Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
19 Attach the dropper tip firmly onto the
extraction buffer tube. Mix thoroughly
by swirling or flicking the bottom of the
tube.
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20 Ensure the test kit is on a clean and flat
surface.
Do not move the cassette during the
test.
x4
21 Gently squeeze the extraction buffer tube
to place 4 drops of the liquid into the
specimen well (S) on the test cassette.
Make sure that you are dropping liquid
and not an air bubble.
Put the extraction buffer tube in the
waste bag.
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15-30
minutes
22 Check the time and set a timer. Wait 15
minutes before you read your result.
Read the result when the timer reaches
15-30 minutes. Do not read after 30
minutes.

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ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
5. Read your result
IMPORTANT
Wait for 15 minutes to read the result.
Do not read the result after 30 minutes
Positive result
Two lines appear. One coloured line should be
in the control line region (C), and another
coloured line should be in the test line region (T)
Two lines, one next to C and one next to T,
even faint lines, shows the test is positive.
IMPORTANT
If you test positive you should self-isolate and your household should follow
government guidelines on self-isolating:
nhs.uk/conditions/coronavirus-covid-19/self-isolation-and-treatment/
Negative result
One coloured line appears in the
control line region (C). No line
appears in the test line region (T).
Void result
Control line (C) fails to appear.

16 Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
6. Report your result
You should report your positive,
negative or void results to the NHS.
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QR code
ID number
Recording all test results helps scientists spot new
virus outbreaks and advise how to respond. If
people only report a positive result, case levels
look higher than they really are.
So even if your result is negative or void, you’ll
make sure NHS information stays accurate.
You need the QR code, or the ID number under it
to report your result.
Report online (fastest)
If you live in England, Wales or Northern
Ireland visit:
www.gov.uk/report-covid19-result
If you live in Scotland visit:
www.covidtest.scot
Or report by telephone
Call 119
Lines are open every day, 7am to 11 pm, (free
from mobiles and landlines)

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Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
7. What your results mean
You've only completed your test when
you've reported your result
Positive result
If you get a positive result, it is likely you are currently infected with COVID-19
and risk infecting others. When you report your result, you will be provided
with further information on the next steps to take.
WARNING
You, anyone who lives with you, and anyone in your support bubble, should
self-isolate in accordance with current national and local guidance, which
can be found at: nhs.uk/conditions/coronavirus-covid-19/self-
isolation-and-treatment/
Negative Result
If you get a negative result, it is likely you were not infectious at the time the
test was taken. A negative test result, however, is not a guarantee that you
do not have COVID-19.
If you test negative, you should continue to follow national and local rules
and guidelines, including regular handwashing, social distancing and wearing
face coverings, where required.
If you develop symptoms of COVID-19, you and your household should self-
isolate and the guidelines are to get another test at:
gov.uk/get-coronavirus-test or by calling the customer contact centre on
119. Lines open every day, 7am to 11 pm.

18 Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
Void result
If you get a void result, this means that the test has not run correctly.
There may have not been enough specimen volume or you may not have
completed the test correctly.
You need to use another lateral flow test from the pack. Do not reuse
anything from the first kit and start the test procedure from step 1.
If the problem persists
If the problem persists, discontinue using the test kits immediately. If you do
not have another test available, you may take a different type of test through
the NHS COVID-19 app or by visiting: gov.uk/get-coronavirus-test or by
calling the customer contact centre on 119. Lines are open every day, 7am to
11 pm.
8. Safely dispose of your test kit
Once your test is complete, put all of the used test kit contents in the waste
bag provided and put this in your general household waste. Wash your
hands thoroughly after disposal.

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Report all your test results to the NHS
ACON FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5
Make a note of your test results
This is for your own records. You should still report your result to the NHS (see page
16 for information).
If you live in England, Wales or Northern Ireland visit:
www.gov.uk/report-covid19-result
If you live in Scotland visit: www.covidtest.scot
Who took the test Date Time Test result
Your kit contains
the following materials
Items
Test Cassettes
Extraction Buffer Tubes
Disposable Swabs
Waste Bags
Extraction Buffer Tube Holder
Instructions for Use (this document)
7-Pack
7
7
7
7
1
1

20 Report all your test results to the NHS
Supply of this device is only permitted as part of the DHSC deployment under the NHS Test
and Trace programme.
FlowflexTM SARS-CoV-2 Antigen
Rapid Test (Self-Testing)
ACON Biotech (Hangzhou) Co., Ltd.
No.210 Zhenzhong Road, West Lake
District, Hangzhou, P.R. China, 310030
Website: www.aconbio.com
Email: [email protected]
MedNet GmbH
Borkstrasse 10
48163 Muenster, Germany
Disposable Swabs
Jiangsu Changfeng Medical Industry Co., Ltd.
Touqiao Town, Guangling District, Yangzhou
225109, Jiangsu, P.R. China
Llins Service & Consulting GmbH
Obere Seegasse 34/2, 69124
Heidelberg, Germany
OR
Jiangsu HanHeng Medical Technology Co., Ltd.
16-B4, #1 North Qingyang Road, Tianning District,
Changzhou, 213017 Jiangsu P.R. China
Luxus Lebenswelt GmbH
Kochstr.1, 47877, Willich, Germany
Manufacturer Contains sufficient for
<n> tests Temperature limit
In vitro diagnostic
medical device Use-by date Do not reuse
Consult instructions
for use Batch code Catalogue number
Authorized representative in
the European Community Date of manufacture Keep dry
Don’t use the product when
the package is damaged Do not resterilize Keep away from sunlight
Sterilized using ethylene
oxide Recyclable Warning, please refer to the instruction
Version 1151355103 Effective date 2021-09-07
This instructions for use, relates to ACON Biotech (Hangzhou) Co., Ltd.
FlowflexTM SARS-CoV-2 Antigen Rapid Test (Self-Testing), Product Code: L031-118Y5
Report all your test results to the NHS