Intended Use; Kit Components - Medix Biochemica Actim PROM 1ngeni Notice D'utilisation

INSTRUCTIONS FOR USE
Numbers 1 - 13 refer to illustrations on inner cover.
STRUCTURE OF DIPSTICK
1 2 3
Dip area Result area Test line
STRUCTURE OF CARTRIDGE
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QR code

INTENDED USE

The Actim PROM 1ngeni test is a qualitative immunochromatographic dipstick
test for the detection of amniotic fluid in vaginal secretions during pregnancy.
Actim PROM 1ngeni 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

Actim PROM 1ngeni kit (30831RETAC) contains 10 test packs with instructions for
use. The components of each Actim PROM 1ngeni test pack (30821RETAC) 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 PROM
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 vaginal 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. !
swab before taking the sample.
1.
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.
2. Leave the swab in the vagina for 10-15 seconds to allow it to absorb the
vaginal secretion 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
In this procedure, 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 PROM 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.
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2. Select Test icon and select Patient Test
!
Do not choose [Patient test, Read only]. See below "Test procedure – read only".
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 turquoise part of the dipstick. The
dipstick must be used shortly after its removal from the foil pouch.
Take care not to touch anything with the
7 . Press the swab
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.
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