Instructions For Use; Kit Components - Actim Partus 1ngeni Gebrauchsanweisung

Instructions for use

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Numbers - refer to illustrations on inner cover.
Structure of dipstick
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Dip area Result area Test line
Structure of cartridge
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QR code
Intended use
Actim ® Partus 1ngeni test is a quantitative immunochromatographic dipstick
test for measuring the concentration level of phosphorylated IGFBP-1 (insulin-
like growth factor binding protein-1) in cervical secretions during pregnancy.
The test is read using the Actim 1ngeni instrument. The test is intended for
professional use to help predict the risk of preterm or imminent delivery when
fetal membranes are intact. A low risk test result (phIGFBP-1 concentration less
than 10 µg/l) is a clear indication that the patient will not deliver within 7-14 days.

Kit components

Actim Partus 1ngeni kit (31931RETAC) contains 10 test packs with instructions for
use. The components of each Actim Partus 1ngeni test pack (31921RETAC) 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.
• One cartridge for reading the result with the Actim 1ngeni instrument. The
QR code on the cartridge includes information about the test (Actim Partus
1ngeni), the dipstick lot, expiry date, and lot specific calibration data.
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.
Specimen collection and sample handling
The specimen consists of cervical secretion that is extracted into the Specimen
Extraction Solution provided. A sample is obtained using a sterile polyester
swab (provided in the test pack).
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Control line
! The sample should be collected prior to performing a digital examination
and/or transvaginal ultrasound. ! Take care not to touch anything with the
swab before taking the sample.
1. A cervical secretion sample is obtained using a sterile polyester swab
(provided in the kit) from the cervical os during a sterile speculum
examination.
2. The swab should be left in the cervical os for 10-15 seconds to allow it to
absorb the secretion specimen 6 .
3. 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
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 the 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 – Patient Test
Test reaction occurs inside the instrument and results are read automatically at
5 minutes. Insertion of the cartridge into the Actim 1ngeni automatically initiates
the Actim Partus 1ngeni test procedure.
!
If the test kit is stored refrigerated, allow the test pack to reach room
temperature.
Prepare the instrument:
1.
Switch the Actim 1ngeni on (if power off). After the automatic self test,
log onto the instrument by entering your user ID either manually or with a
barcode reader.
2. Select Test icon and select Patient Test
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3.
Enter patient ID either manually or with a barcode reader.
Activate the test and start the procedure:
1. When the Actim 1ngeni screen shows "Activate and insert test", open the foil
pouch containing the dipstick.
!
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.
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. Press the swab
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