ENGLISH
NADAL® PROM Amniotic Fluid Test
(Ref. 431006N-01/431006N-03/431006N-10/431006N-20)
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • [email protected] • www.nal-vonminden.com
7
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 swap caps between different tubes with extraction
buffer.
Do not eat, drink or smoke in the area where specimens
and test kits are handled.
Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when specimens are
being assayed.
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.
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).
Do not use swabs from damaged pouches.
Humidity and temperature can adversely affect test results.
Used testing materials should be discarded according to
local regulations.
8.
Specimen Collection and Preparation
Use a sterile Copan flocked swab to collect a sample of vaginal
secretions from the vaginal wall. Carefully insert a swab into
the vagina approximately 5 cm deep for 1 minute. Specimen
collection from the cervix should be avoided.
Alternatively, a speculum can be used and vaginal secretion
can be collected by placing the swab in contact with the
vaginal wall at the level of the posterior fornix for 15 seconds.
9.
Test Procedure
Ensure that the test components and samples are at room
temperature (15-30°C) prior to testing.
1.
Hold
the
collection
tube
containing extraction buffer on
the lid and shake it thoroughly so
that the whole liquid reaches the
bottom of the tube. Open the
collection tube and place it
vertically on a flat, horizontal
surface. Use the tube holder as an
aid.
2.
Dip a swab into the tube and
rotate it for 10 seconds. Press the
swab against the tube walls in
order to squeeze as much liquid
as possible from it. Discard the
swab.
3.
Dip a strip vertically into the tube,
ensuring the arrows are pointing
downwards, so that it touches the
bottom of the tube. This will
enhance migration of the sample.
Leave the test strip in this
position.
4.
Remove the test strip after 5
minutes. Read the results by
placing the test strip on a clean,
dry and flat surface. Do not
interpret test results after more
than 10 minutes.
Note:
For a sample collected during a strong leakage of
amniotic fluid, a positive result can become visible
earlier, while for a sample collected during a very small
leakage, it will take the full 10 minutes for a positive
result to appear.
10.
Result Interpretation
Positive
Two coloured lines appear on the
membrane. One line appears in the
control line region (C) and the other line
appears in the test line region (T). The
result indicates that the concentration of
IGFBP-1 is above the detection limit of the
test.
Negative
A coloured line appears in the control line
region (C). No apparent coloured line
appears in the test line region (T). The
result indicates that the concentration of
IGFBP-1 is below the detection limit of the
test.
Invalid
The control line (C) fails to appear. Results
from any test which has not produced a
control line at the specified reading time
must be discarded. Please review the
procedure and repeat the test with a new
test strip. If the problem persists,
discontinue using the test kit immediately
and contact your local distributor.
Note:
The colour intensity in the test line region (T) may vary
depending on the concentration of the analyte present in the
specimen. Therefore, any shade of colour in the test line
region should be considered positive. Note that this is a
qualitative test only and it cannot determine the concen-
tration of the analyte in the specimen.
Insufficient specimen volume, incorrect operating procedure
or expired tests are the most likely reasons for the control line
failure.
11.
Quality Control
An internal procedural control is included in the test strip:
A coloured line appearing in the control line region (C) is
considered an internal procedural control. It confirms
sufficient specimen volume, adequate membrane wicking and
correct procedural technique.
Good laboratory practice
(GLP)
recommends the use of
control materials to ensure proper test kit performance.
