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instructions for use (self-test version)

instructions for use (self-test version)

instructions for use (self-test version)

Product catalog summary
Introduction
ALL IN TRIPLEX® is a self-test designed to screen for COVID-19, Influenza, and Bronchiolitis using a nasal swab. It is a single-use in-vitro diagnostic device intended for use by non-healthcare professionals in private settings or under supervision. Suitable for children over 1 month old, it can be used independently by children over 6 years old with adult supervision. Results are available in 15 minutes.
Contents of the Box
The kit includes a swab, a self-test device, a protective cap, and a holder with a buffer sachet. It is important to read the instructions carefully and ensure the kit is at room temperature before use.
Test Procedure
1. Place the self-test kit on a table and remove it from the holder.
2. Discard the protective cap.
3. Insert the self-test kit into the holder to pierce the buffer sachet.
4. Insert the swab into each nostril, rotating for 15 seconds.
5. Wait 15 minutes before reading the result.
Interpreting Results
A negative result shows one colored line on each test strip. A positive result shows at least two colored lines on one test strip. If results are inconclusive, the test must be repeated.
Principle and Performance
The test uses monoclonal antibodies to detect specific antigens. It has a high correlation with RT-PCR tests and demonstrates high specificity and sensitivity for each virus.
Precautions and Warnings
Store the kit between 2°C and 30°C. Do not reuse or use after the expiry date. Follow instructions strictly to avoid incorrect results. Dispose of the kit according to local regulations after use.
Additional Information
For further details and a demonstration video, visit www.autotest-sante.com.
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Catalog excerpts

instructions for use (self-test version)-1

ALL IN TRIPLEX® is a self-test used to screen for the virus causing COVID-19, Influenza and Bronchiolitis in a nasal swab. ALL IN TRIPLEX® is a single-use in-vitro diagnostic device. ALL IN TRIPLEX® is designed for use by non-healthcare professionals in a private setting or under the supervision of a healthcare professional. ALL IN TRIPLEX® can be carried out by an adult in children over 1 month old*. ALL IN TRIPLEX® can be used independently by children over 6 years old under adult supervision**. The self-test takes approximately 1 minute and the results are delivered in 15 minutes. Make sure you have a timer available. Read all of the instructions carefully before starting the test. *Study carried out in a French pediatric emergency department on a panel of 263 children. **Study conducted in 4 paediatric emergency units and 37 paediatric clinics in France involving a cohort of 500 children. SUITABLE FOR CHILDREN CONTENTS OF THE BOX AAZ-LMB 43, rue de Bellevue 92100 Boulogne-Billancourt - France Swab included : read the instructions carefully Humidity absorber (discard) 0459 AAZ.AVT.32-A (20240711) Instructions for use ALL IN TRIPLEX® EN NON-CONTRACTUAL PHOTO : do not reuse : expiry date Holder with buffer sachet included : in-vitro diagnostic medical device : Device for self-testing Allow the self-test kit to reach room temperature (15 - 30°C), then wash and dry your hands. 1. Insert immediately the self-test kit C with the swab D pointing downwards into the holder F placed on the table. Remove the self-test kit from the sealed sachet A immediately before carrying out the test. Blow your nose before carrying out the self-test. a. Press firmly on the self-test to pierce the buffer sachet and push it to the bottom of the holder. 1. Place the self-test kit on the table. Remove the self-test kit C from the holder F by pulling upwards. b. Check that a pink line appears within one minute. 2. Remove the protective cap E and discard it. If a pink line does not appear, press firmly once again to fully insert the self-test kit. STEP 2 1. Gently insert the swab D into the left nostril until you feel resistance (insert 1 to 2 cm into the nostril). STEP 4 1. Make a note of the time and wait 15 minutes before reading the result. DO NOT LEAVE MORE THAN 20 MIN BEFORE READING 2. Repeat the same procedure in the right nostril for 15 seconds. Rotate the swab several times in the nostril for 15 seconds by wiping the swab D against the inner wall of your nostril.

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instructions for use (self-test version)-2

INTERPRETING THE RESULTS NEGATIVE SELF-TEST If your self-test result corresponds to the three images opposite, your result is negative. POSITIVE SELF-TEST Bronchiolitis 1 coloured line present on each test strip, Control line (C) You are probably not infected with the Bronchiolitis, COVID-19 or Influenza virus. PLACE YOUR SELF-TEST KIT HERE At least 2 coloured lines on one test strip, control line (C) and test line (T) or (A) or (B) You probably are infected with the Bronchiolitis, and/or the COVID-19 and/or the Influenza virus. If your self-test result corresponds to at least one of the images...

 Open the catalog to page 2

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