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• 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.
8. Specimen Collection and Preparation
Nasal specimen:
• It is important to obtain as much secretion as possible.
Insert the swab into the nostril.
• Gently push the swab until resistance is met at the level of
the turbinate (up to 2.5 cm into the nostril).
• Rotate the swab 5 times against nasal wall to ensure that
both mucus and cells are collected.
• Slowly withdraw the swab while continuing to rotate it.
• Repeat this process for the other nostril using the same
swab in order to ensure that sufficient specimen volume is
collected from both nasal cavities.
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
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 Ag plus Test
(Ref. 243104N-20)
not necessary to collect specimens from both sides if the tip
is saturated with fluid from the first collection.
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.
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 the test cannot be carried out immediately
after specimen collection, the swab can be stored for up to a
maximum of one hour in a clean, dry and sealed tube.
• 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.
9. 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
identification into the designated area
of the reagent holder.
2. Detach one buffer ampoule.
3. Open the ampoule by twisting the tip
off.
4. Hold the buffer ampoule vertically over
the tube to ensure that the entire
buffer solution flows into the bottom
part. Squeeze the buffer ampoule and
add the entire buffer solution to the
extraction tube without touching the
edge of the tube.
5. Insert the swab with the collected
specimen into the tube. Swirl the swab
and squeeze it at least 5 times by
compressing the wall of the extraction
tube against the swab to extract the
antigens contained in the swab.
6. Remove the swab, pressing it firmly
against the wall of the tube to release
as much liquid as possible. Dispose of
the swab in accordance with guidelines
for the handling of infectious agents.
Note: If the dropper cap is attached,
the extracted specimen can be stored
in the extraction tube for up to a
maximum of 1 hour until the removal
of the test cassette from its foil pouch.
7. Remove the test cassette from the foil
pouch and use it as soon as possible.
The best results will be obtained if the
test is performed immediately after
opening the foil pouch. Label the test
or
control
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