nal von minden COVID-19 Ag Test Instructions D'utilisation page 8

ENGLISH
Storage & Stability
Test kits should be stored at 2-30°C until the indicated expiry
date. Test cassettes are stable until the expiry date printed on
the foil pouches. Test cassettes must remain in the sealed foil
pouches until use. Do not freeze the test kit. Do not use tests
beyond the expiry date indicated on the packaging. Care
should be taken to protect test kit components from
contamination. Do not use test kit components if there is
evidence of microbial contamination or precipitation.
Biological contamination of dispensing equipment, containers
or reagents can lead to inaccurate results.
Warnings and Precautions
 For professional in-vitro diagnostic use only.
 Carefully read through the test procedure prior to testing.
 Do not use the test beyond the expiration date indicated on
the packaging.
 Do not use test kit components if the primary packaging is
damaged.
 Tests are for single use only.
 Do not add specimens to the reaction area (result area).
 In order to avoid contamination, do not touch the reaction
area (result area).
 Avoid cross-contamination of specimens by using a new
extraction tube for each specimen obtained.
 Do not substitute or mix components from different test
kits.
 Do not use the buffer if it is discoloured or turbid.
Discolouration or turbidity may be a sign of microbial
contamination.
 Do not eat, drink or smoke in the area where specimens
and test kits are handled.
 Wear appropriate personal protective equipment, such as
face mask, isolation gown, gloves and eye protection during
specimen collection, preparation and test procedure.
 Handle all specimens as if they contain infectious agents.
Observe established precautions for microbiological risks
throughout all procedures and standard guidelines for the
appropriate disposal of specimens.
 Further specimen processing and patient management
should follow local COVID-19 guidelines and regulations.
 The test kit contains products of animal origin. Certified
knowledge of the origin and/or sanitary state of the animals
does not completely guarantee the absence of transmissible
pathogenic agents. It is therefore recommended that these
products be treated as potentially infectious and handled in
accordance with usual safety precautions (e.g., do not
ingest or inhale).
 Temperature can adversely affect test results.
 Used testing materials should be disposed of according to
local regulations.
Specimen Collection and Preparation
Oropharyngeal specimen:
 Gently insert a sterile swab into the pharynx and collect
secretions by brushing the swab several times against the
reddened posterior pharyngeal wall and both tonsillar
pillars. Avoid touching the tongue, teeth and gums.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 Ag Test
(Ref. 243103N-20)
Nasopharyngeal specimen:
 Insert the swab into the nostril, parallel to the palate (not
upwards) until resistance is encountered or the distance is
equivalent to that from the ear to the nostril of the patient,
indicating contact with the nasopharynx.
 Gently rub and roll the swab. Leave swab in place for
several seconds to absorb secretions.
 Slowly remove the swab while rotating it. Specimens can be
collected from both nostrils using the same swab, but it is
not necessary to collect specimens from both sides if the tip
is saturated with fluid from the first collection.
Note:
 Use only synthetic fibre swabs with plastic shafts. Do not
use calcium alginate swabs or swabs with wooden shafts, as
they may contain substances that inactivate some viruses
and inhibit further testing.
 Swab specimens should be tested immediately after
collection. Use freshly collected specimens for best test
performance.
 If not tested immediately, swab specimens can be stored in
viral transport media (VTM) without denaturing agents
at 2-8°C for 24 hours after collection.
 Viral transport media (VTM) without denaturing agents as
well as VTM containing virus-inactivating agents and
evaluated with the test can be used during specimen
storage for the subsequent antigen detection using the
NADAL® COVID-19 Ag Test. In order to influence the
sensitivity as little as possible, a low volume of VTM (max.
1 mL) is recommended. The test procedure when using viral
transport media (VTM) is available separately:
 under the following link:
https://www.nal-vonminden.com/en/vtm-ifu
 by request at +49 941 29010-0 or
info@nal-vonminden.com
 Do not use specimens that are obviously contaminated with
blood, as it may interfere with the flow of specimens and
lead to inaccurate test results.
Test Procedure
Bring tests, specimens, buffer and/or controls to room
temperature (15-30°C) prior to testing.
1. Place a clean extraction tube labeled with the patient or
control identification into the designated area of the
reagent holder.
2. Gently mix the buffer by carefully
swiveling the bottle.
3. Holding the buffer bottle vertically
and without touching the edge of
the tube, add 10 drops to the
extraction tube.
4. Insert the swab with the collected
specimen into the tube. Swirl the
swab and squeeze it 10-15 times by
compressing the wall
extraction tube against the swab to
extract the antigens contained in the
swab.
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