nal von minden NADAL Strep A Test Instructions D'utilisation page 7

ENGLISH
 Store and transport the test device always at 2-30°C (36-
86°F)
8. Specimen Collection and Preparation
Collect throat swab specimens by standard clinical methods
such as those described by Facklam (1) and Ross (5). Use only
Dacron or Rayon tipped sterile swabs with plastic shafts such
as those provided. Do not use calcium alginate, cotton tipped,
or wooden shafted swabs.
Push the patient's tongue down with a spatula or a spoon.
Attention must be paid when taking the throat swab sample,
that the tongue, the inside of the mouth and the gums do not
come in contact with the swab to avoid contamination with
physiological mouth flora bacteria. Do not repetitively rub the
tip of the swab over the throat, the tonsils, or other inflamed,
infected or purulent areas. It is recommended that swabs
specimens be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed
into a sterile, dry, tightly capped tube or bottle and refrigerat-
ed. If a liquid transport method is employed, use Modified
Stuart's Transport Media as outlined in the manufacture's
instructions. Do not use transport media formulas including
charcoal or agar. Swabs can be stored at room temperature
(15-30°C) up to 4 hours, or refrigerated (2-8°C) up to 3 days. If
a bacteria culture is desired, lightly stroke the swab on a 5%
sheep blood agar plate before using it in the NADAL® Strep A
Test. Extraction reagents kill the bacteria on the swabs and
make them impossible to culture. Alternatively, a subsequent
second swab sample may be taken for culture procedure.
9. Procedure of the Test
Procedural Notes
If specimen swabs or the NADAL® Strep A Test reagents have
been refrigerated, allow them to equilibrate to room tempera-
ture (15-30°C) before testing. To avoid cross contamination,
do not allow the tips of the reagent bottles to come in contact
with sample swabs and extraction tubes.
Extraction Procedure
1. Add four (4) drops of extraction re-
agent #1 (bottle with white cap) to
the extraction tube. Add four (4)
drops of extraction reagent #2 (bottle
with red cap) to the extraction tube.
2. Immediately place the throat swab
specimen in the extraction tube and
press against the side. Use a circular
motion to roll the swab against the
side of the extraction tube so that the
liquid is expressed from the swab and
reabsorbed. Repeat 5 times.
3. Let the swab stand in the extraction
tube for a minimum of 1 minute at
room temperature and maximum of
15 minutes. Press the swab against
the side of the extraction tube that all
the liquid is expressed. When throw-
ing the swab away, firmly compress
the extraction tube.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® Strep A Test (test cassette)
(Ref. 222001A)
Test Procedure
4. Remove the NADAL® Strep A test
cassette and the disposable pipette
from the foil packaging and place the
cassette on a level surface. Take the
disposable pipette between thumb
and index finger and squeeze the
pipette balloon. Dip the pipette in the
extraction tube and withdraw by slow
release of pressure on the balloon
extraction solution.
5. Add three (3) drops from the pipette
into the sample well of the test cas-
sette.
6. The result can be interpreted within 5
minutes. Depending on the organism
concentration in the solution, a line
can appear after 1 minute. For the
confirmation of a negative result, the
full development time has to be
awaited. Do not interpret any result
after 10 minutes.
10. Interpretation of the Results
Positive
In additional to a pink-coloured line in the control (C) region, a
pink-coloured line will appear in the test (T) region. These
lines can differ in colour intensity depending on amount of
antigen in the sample. This indicates that specimen contains
Strep A antigen.
Negative
A pink-coloured line appears in the
control (C) region. No pink-coloured
line is visible in the test (T) region.
This indicates that NO Strep A antigen
has been detected.
Invalid
No line appears in the control (C)
region. This indicates possible error in
performing the test. A new test
should be performed.
11. Quality Control
Good laboratory practice recommends the use of control
materials to ensure proper kit performance. A positive control
containing heat-inactivated Group A Streptococcus is provided
with each kit.
Test procedure of positive control
Add four (4) drops of extraction reagent #1 and four (4) drops
of extraction reagent #2 to the extraction tube. Shake the
positive control bottle before use to ensure well mixed and
add one (1) drop to the extraction tube. Mix the solution well
with a sterile swab.
7