Medix Biochemica Actim PROM 1ngeni Notice D'utilisation page 4

2. Activate the test by placing the yellow dip area of the test into the extracted
and hold it there until you see the liquid front enter the result area
sample 10
11.
3. Immediately remove the dipstick from the solution, place it in the cartridge
(reading area forward and coloured side facing up) and insert the cartridge
inside the Actim 1ngeni (QR code forward and facing up) until the cartridge
clicks into place 12 . Follow and respond to any information on the screen.
!
Use only the cartridge included in the test pack.
firmly inside the cartridge. ! Ensure that the timer appears on the screen.
Proceed to section "Results".
TEST PROCEDURE – PATIENT TEST, READ ONLY
In the read only-procedure, the test reaction occurs outside Actim 1ngeni. The
user is responsible for the timing and for starting the analysis. Insertion of the
cartridge into Actim 1ngeni automatically initiates the reading of the test result.
! As the test must be read at 5 minutes, ensure that Actim 1ngeni is
available for analysis before activating the test.
refrigeration, 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 8 and select Patient Test, Read only.
3.
Enter the patient ID either manually or with a barcode reader.
Activate the test and start the procedure:
!
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.
4. When the Actim 1ngeni screen shows "Insert test", open the foil pouch
containing the dipstick.
5. Activate the test by placing the yellow dip area of the test into the extracted
sample 10 and hold it there until you see the liquid front enter the result area
11.
6. Immediately remove the dipstick from the solution, place it in the cartridge
(reading area forward and coloured side facing up) and place the cartridge
in a horizontal position and start your external timer for 5 minutes.
7. Start the analysis: Immediately at 5 minutes, insert the cartridge inside
the Actim 1ngeni (QR code forward and facing up) until the cartridge clicks
into place
"Analysing" screen appears.
!
Use only the cartridge included in the test pack.
firmly inside the cartridge.
Proceed to section "Results".
RESULTS
! Ensure that the dipstick is
The Actim 1ngeni automatically reports and saves the result.
!
Do not visually interpret the result under any circumstances after removing
the test from the instrument because the test is optimised for the Actim 1ngeni.
• When the test result is visible on the screen, remove and discard the dipstick and
the cartridge. The result can be either printed or exported into a USB stick or
stored in the Actim 1ngeni for later use. Refer to the instrument manual for details.
• Log off when leaving the instrument.
Positive and negative results with additional test-related information are shown
on the screen 13. If problems have occurred during the test process, an error is
! If the test kit is stored in
reported and no result is shown.
QUALITY CONTROL AND CALIBRATION
Test calibration and quality control
Each Actim PROM 1ngeni test kit lot has been calibrated and quality controlled
during manufacturing to give reproducible results with the Actim 1ngeni
instrument. QR code on the cartridge contains the lot specific calibration data.
Depending on local hospital practices and the local administrator for the Actim
1ngeni instrument, quality control for the Actim PROM 1ngeni test system using
liquid controls may be advised. Refer to Actim PROM controls (30800ETAC)
for details. There are no daily requirements for controlling the instrument
performance using liquid controls.
Actim 1ngeni instrument
The Actim 1ngeni instrument has various levels of quality control procedures
available. Refer to Actim 1ngeni instrument manual for details.
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.
12 . Follow and respond to any information on the screen until the
4
EN
!
Ensure that the dipstick is