Alere Partus Test Notice D'utilisation page 3

INSTRUCTIONS FOR USE
Numbers 1 - 9 refer to illustrations on inner cover.
STRUCTURE OF DIPSTICK
1 Dip area 2 Result area 3 Test line
4 Control line
INTENDED USE
The Alere Actim ® Partus test is a visually interpreted,
qualitative immunochromatographic dipstick test for
detecting the presence of phosphorylated IGFBP-1
(insulin-like growth factor binding protein-1) in
cervical secretions during pregnancy. The test is
intended for professional use to help predict the
risk of preterm or imminent delivery when fetal
membranes are intact. A negative test result is a
clear indication that the patient will not deliver within
7-14 days.
KIT COMPONENTS
The Alere Actim Partus kit 31931ETAC contains
10 test packs with instructions for use. The kit
31930ETAC contains one test pack and instructions
for use. The components of each Alere Actim Partus
test pack (31921ETAC) 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 aluminium 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
EN
for 2 months at +2...+30 °C. Use the dipsticks shortly
after their removal from the aluminum foil pouch.
SPECIMEN COLLECTION
The specimen is cervical secretion that is extracted
into the Specimen Extraction Solution provided.
The sample should be collected prior to performing
digital examination and/or transvaginal ultrasound. A
cervical secretion sample is obtained using a sterile
polyester swab (provided in the kit) from the cervical
os during a sterile speculum examination. Take care
not to touch anything with the swab before taking the
sample. The swab should be left in the cervical os
for 10-15 seconds to allow it to absorb the secretion
specimen .
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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
. Press the swab against the wall of the Specimen
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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 purple 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 sample
and hold it there until you see the liquid front
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enter the result area
. Remove the dipstick from
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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 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.
• Before performing the test ensure that the fetal
membranes are intact
(for example with the Alere Actim PROM test),
because with ruptured fetal membranes the Alere
Actim Partus test will also give a positive result.
• Patients with moderate or heavy vaginal bleeding
should not be tested. It is recommended that a
sample be taken when bleeding has stopped, and
the extract is essentially blood-free.
• The test result indicates the risk at the time of
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