Alere PROM Test Notice D'utilisation page 3

INSTRUCTIONS FOR USE
1 9
Numbers - refer to illustrations on inner cover.
STRUCTURE OF DIPSTICK
Dip area Result area Test line
1 2 3
4 Control line
INTENDED USE
The Alere Actim ® PROM test is a visually interpreted,
qualitative immunochromatographic dipstick test for
detection of amniotic fluid in vaginal secretions during
pregnancy. Alere Actim PROM detects IGFBP-1, which
is a major protein in amniotic fluid and a marker of the
amniotic fluid in a vaginal sample. The test is intended
for professional use to help diagnose the rupture of
fetal membranes (ROM) in pregnant women.
KIT COMPONENTS
The Alere Actim PROM kit 30831ETAC contains 10
and the kit 30832ETAC contains 20 test packs with
instructions for use. The kit 30830ETAC contains one
test pack and instructions for use.
The components of each Alere Actim PROM test pack
(30821ETAC) are:
• One sterile polyester swab for specimen collection.
• One tube of Specimen Extraction Solution (0.5 ml).
This phosphate-buffered solution contains bovine
serum albumin (BSA), protease inhibitors and
preservatives.
• One dipstick in a sealed aluminum foil pouch with
desiccant.
STORAGE
Store the test kit at +2...+25 °C. Stored unopened,
each component can be used until the expiry date
marked on the component. The kit can also be stored
for 2 months at +2...+30 °C. Use the dipsticks shortly
after their removal from the aluminum foil pouch.
EN
SPECIMEN COLLECTION
The specimen is vaginal secretion that is extracted
into the Specimen Extraction Solution provided. A
sample is obtained using a sterile polyester swab
(provided in the kit). The sample should be collected
prior to performing digital examination and/or
transvaginal ultrasound. Take care not to touch
anything with the swab before taking the sample.
Separate the labia and carefully insert the tip of the
swab into the vagina toward the posterior fornix
until resistance is met. Alternatively the sample can
be taken from the posterior fornix during a sterile
speculum examination. The swab should be left in
the vagina for 10–15 seconds to allow it to absorb the
vaginal secretion 5 .
Open the Specimen Extraction Solution 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 6 . Press the swab against the wall of the
Specimen Extraction Solution tube to remove any
remaining liquid from the swab. Discard the swab.
Specimens should be tested as soon as possible after
extraction but in any case no more than 4 hours after
specimen collection and extraction. If a specimen
cannot be tested within this time it should be frozen.
After thawing, the specimens should be mixed and
tested as described below.
TEST PROCEDURE AND INTERPRETATION OF
THE RESULTS
1. If stored refrigerated, allow the aluminum foil pouch
and the Extraction Solution tube to reach room
temperature. Open the foil pouch containing the
dipstick by tearing. Do not touch the yellow dip area
at the lower part of the dipstick. Identifying marks
may be written on the upper turquoise part of the
dipstick. The dipstick must be used shortly after its
removal from the foil pouch.
2.
Place the yellow dip area into the extracted
and hold it there until you see the liquid
sample 7
front enter the result area
. Remove the dipstick
8
from the solution and place it in a horizontal
position.
3. The result can be interpreted as positive as soon
as two blue lines become visible in the result area.
Negative result should be read at 5 minutes
Do not pay attention to any lines appearing later
than 5 minutes.
4. If two blue lines, the test line and the control line,
appear, the test
result is positive. If one blue line, the control line,
appears, the test result is negative.
If the control line does not appear, the test is
invalid
LIMITATIONS OF THE TEST
• The test is intended for in vitro diagnostic use only.
• If rupture of fetal membranes has occurred but
the leakage of amniotic fluid has ceased more
than 12 hours before the specimen is taken,
IGFBP-1 may have been degraded by proteases in
the vagina and the test may give a negative result.
• A negative test result is an indication on the
present condition and cannot be used to predict
the forthcoming.
NOTES
• No quantitative interpretation should be made
based on the test results.
• The test requires about 150 μl of extracted sample
to ensure proper performance of the test.
9 .
3