Intended Use; Kit Components; Test Procedure - Actim SARS-COV-2 Notice D'utilisation

Instructions for use
[1] [13]
Numbers - refer to illustrations on inner cover.
Structure of dipstick
Actim SARS-CoV-2
[1] [2] [3]
Dip area Result area Test line
Actim Influenza A&B
[5] Dip area [6] Result area [7] Test lines

Intended use

Actim SARS-CoV-2
The Actim SARS-CoV-2 is a visually interpreted, in vitro diagnostic
immunochromatographic rapid test for the qualitative detection of SARS-CoV-2
virus antigens in nasal or nasopharyngeal swab samples. The test is intended
for professional use to help diagnose acute COVID-19 infection.
Actim Influenza A&B
The Actim Influenza A&B test is a visually interpreted, qualitative
immunochromatographic rapid test for detection of influenza type A and type B
virus antigens in respiratory samples. The test is intended for professional use
to help diagnose acute influenza infections.

Kit components

The components of the Actim SARS-CoV-2 + Actim Influenza A&B kit 36031ETAC
are:
• 10 individually packed dipsticks of Actim SARS-CoV-2 (35523ETAC) and Actim
Influenza A&B (32801ETAC) in sealed aluminum foil pouches with desiccant.
• 10 Swab Extraction Buffer tubes (35524ETAC) needed for sample extraction.
Each tube contains 0.3ml of buffer, which contains detergents, bovine serum
albumin (BSA) and preservatives.
• 10 swabs for swab sample collection.
• Instructions for use.
Materials required but not provided: Clock/Timer, Personal protective
equipment.
[4]
Control line
[8] Control line
Storage
Store the test kit at +2...+30 °C. Stored unopened, each component can be used
until the expiry date marked on the component. Use the dipsticks shortly after
their removal from the aluminum foil pouch.
Specimen collection and handling
Collect a nasal [9a] or nasopharyngeal
place and rotate slowly five (5) times against the nasal wall and gently remove
from nose. This should take approximately 10-15 seconds.
The samples should be tested as soon as possible after collection but in any case,
no more than 1 hour after specimen collection and extraction.
Open the Swab Extraction Buffer tube and put it in a vertical position. The
specimen is extracted immediately from the swab by swirling the swab
vigorously in the extraction solution for 10–15 seconds [10]. Press the swab
against the wall of the Swab Extraction Buffer tube to remove any remaining
liquid from the swab. Discard the swab after extraction.
Note! Do not leave the swab to the tube.

Test procedure

1. Allow the aluminum foil pouches to reach room temperature if stored
refrigerated. Open the foil pouches containing the dipsticks by tearing. Do not
touch the yellow dip area at the lower part of the dipsticks. Identifying marks
may be written on the upper light and dark blue part of the dipsticks. The
dipsticks must be used shortly after its removal from the foil pouch.
2. Place the yellow dip areas (the lower end of the dipsticks) backsides facing
each other into the test tube with extracted sample, and leave those there
until reading [11].
Interpretation of the result
The test lines are read at two different timepoints: at 10 minutes (Actim
Influenza A&B) and at 15 minutes (Actim SARS-CoV-2).
Actim Influenza A&B (light blue dipstick)
Read the result at 10 minutes. A result can be interpreted as positive as soon as
one or two blue and one black line become visible in the result area. If only one
black line appears within 10 minutes, the result is interpreted as negative [12a].
Appearance of a black control line confirms that the test has been performed
properly.
[9b] swab sample. Keep the swab in
3
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