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Acon Flowflex L031-118Y5 Step-By-Step Manual

Sars-cov-2 antigen rapid test (selftesting)
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Read this whole guide carefully before you start the
test. This test may be different from those you have
used before.
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
Your step-by-step guide for
ACON Flowflex
Antigen Rapid Test (Self-
Antigen Rapid Test (Self-Testing)
Testing)
These instructions for use relate to ACON Flowflex
Test (Self-Testing), product code: L031-118Y5 only.
Report all your test results to the NHS
The guide explains how to test yourself or another person for COVID-19, and report
SARS-CoV-2
™
ABC12345678
SARS-CoV-2 Antigen Rapid
TM

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Summary of Contents for Acon Flowflex L031-118Y5

  • Page 1 Antigen Rapid Test (Self- Antigen Rapid Test (Self-Testing) Testing) ABC12345678 These instructions for use relate to ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), product code: L031-118Y5 only. Report all your test results to the NHS The guide explains how to test yourself or another person for COVID-19, and report...
  • Page 2 These instructions for use relate to ACON Flowflex™ 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...

  • Page 3: What You Need To Do

    What you need to do Your step-by-step guide ACON Flowflex™ 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.
  • Page 4 5. Read your result page 22 6. Report your result page 24 7. What your results mean page 25 8. Safely dispose of your test kit page 27 Around 1 in 3 people with COVID-19 do not know they have it. Advice about taking the test Precautions •...

  • Page 5: Storage And Handling

    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.
  • Page 6 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.
  • Page 7 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.
  • Page 8 Where to find extra support Get more self-test information at: gov.uk/covid19-self- test-help This instructions booklet only refers to ACON Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing), Product code: L031-118Y5. Report all your test results to the NHS...
  • Page 9 Prepare your test area 1. Prepare your test area 1. Prepare your test area Do not eat, drink, smoke or vape 30 minutes prior to or during the test. ADVICE Advice ADVICE Do not eat, drink, smoke or vape 30 You’ll need a timer (a watch You’ll need a timer (a watch or clock) during your test.
  • Page 10 If you are testing more than one between each test. person or repeating a void test, rewash your hands between each ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 test. Report all your test results to the NHS Report all your test results to the NHS...
  • Page 11 Check your kit contents 4. In your test box you should have: ABC12345678 Test Cassette in sealed pack Extraction Buffer Tube Holder Extraction Buffer Tubes Extraction Buffer Tube in Waste Bag Disposable sealed pack Swab Report all your test results to the NHS...
  • Page 12 Advice 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.
  • Page 13 Insert the extraction buffer tube into the tube holder to avoid spilling the buffer. WARNING ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 Take care If the liquid in the extraction buffer Report all your test results to the NHS...
  • Page 14 Insert the extraction buffer tube into the tube holder to avoid spilling the buffer. ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 Report all your test results to the NHS 8. Find the swab in the sealed wrapper...
  • Page 15 WARNING supervision. The adult may conduct the test, as necessary. 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. If testing a child under 12 years of age, or a person who Adolescents aged 12-17 can self-test with adult supervision.
  • Page 16 Remove the swab and insert the same Repeat step 10 and step 11. swab into the other nostril. Repeat step 10 and step 11. ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 Report all your test results to the NHS ACON Flowflex...
  • Page 17 Doing a test on someone else Doing a test on someone else Doing a test on someone else Advice Children under 12 years of age should be tested by an ADVICE adult. Do not conduct this test if you do not feel confident ADVICE Children under 12 years of age should be tested by an adult.
  • Page 18 Repeat step 13 and step 14. swab into the other nostril. Repeat step 13 and step 14. ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 Report all your test results to the NHS Report all your test results to the NHS...
  • Page 19 Process the swab sample For best performance, test the nasal swab as soon as possible after swabbing your nostrils. 4. Process the swab sample Warning If the liquid in the extraction buffer tube gets onto the skin WARNING or into eyes, wash immediately and seek medical help if If the liquid in the extraction buffer For best performance, test the necessary.
  • Page 20 Place the swab in the waste bag provided. Place the swab in the waste bag ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 provided. Report all your test results to the NHS ACON Flowflex...
  • Page 21 Check the time and set a timer. Wait 15 Wait 15 minutes before you read ABC12345678 minutes before you read your result. ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 your result. Read the result when...
  • Page 22 Read your result 5. Read your result 5. Read your result Important IMPORTANT Wait for 15 minutes to read the result. Wait for 15 minutes to read the result. Do not read the result after 30 minutes. Do not read the result after 30 minutes IMPORTANT Wait for 15 minutes to read the result.
  • Page 23 (T). even faint lines, shows the test is positive. appears in the test line region (T). ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), Report all your test results to the -isolate and your household should follow...
  • Page 24 If you live in Scotland visit: covidtest.scot Or report by telephone Call 119 Lines are open every day, 7am to 11pm, (free from mobiles and landlines) ACON Flowflex SARS-CoV-2 An ACON Flowflex SARS-CoV-2 An Report all your t Report all your t...
  • Page 25 A negative test result, however, is not a guarantee that you do not have result Void result ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), L031-118Y5 COVID-19. ne appears in the Control line (C) fails to appear.
  • Page 26 If you develop symptoms you should self-isolate and get the current recommended test at: gov.uk/get-coronavirus- test or by calling the customer contact centre on 119. Lines open every day, 7 am to 11 pm. You and your household should follow national guidelines. Void result Void result Control line (C) fails to appear.
  • Page 27 Wash your hands thoroughly after disposal. hands thoroughly after disposal. ACON Flowflex SARS-CoV-2 Antigen Rapid T Report all your test resu Report all your test results to the NHS...
  • Page 28 Make a note of your test results This is for your own records. You should still report your result to the NHS (see page 24 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...
  • Page 29 Your kit contains the following materials Items 7-Pack Test cassettes Extraction Buffer Tubes Disposable Swabs Waste Bags Extraction Buffer Tube Holder Instructions for Use (this document) Report all your test results to the NHS...
  • Page 30 Supply of this device is only permitted as part of ACON Biotech (Hangzhou) Co., Ltd. and Trace programme. No.210 Zhenzhong Road, West Lake District, Hangzhou, P.R. China, 310030 Supply of this device is only permitted as part of the DHSC deployment Supply of this device is only permitted as part of the DHSC deployment under the NHS Test and Trace programme.

  • Page 31: Medical Device

    Email: COVID19selftest@aconlab.com.cn MedNet GmbH Disposable Swabs Borkstrasse 10 48163 Muenster, Germany Jiangsu Changfeng Medical Industry Co., L Jiangsu HanHeng Medical Technology Co., Ltd. 16-B4, #1 North Qingyang Road, Tianning Touqiao Town, Guangling District, Yangzhou District, Changzhou, 213017 Jiangsu P.R. China Llins Service &...
  • Page 32 Warning, please Recyclable refer to the instruction Version 1151355105 Effective date 2021-10-08 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...