Actim Partus 1ngeni Gebrauchsanweisung Seite 4

2. 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.
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 . Follow and respond to any information on the screen.
12
!
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".
Results
The Actim 1ngeni automatically reports and saves the result. Result is reported
as a low risk result when the phIGFBP-1 concentration is less than 10 µg/l and
as an elevated risk result when the phIGFBP-1 concentration is equal or more
than 10 µg/l.
!
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.
Test result with additional test-related information are shown on the screen 13.
If problems have occurred during the test process, an error is reported and no
result is shown.
Quality control and Calibration
Test calibration and quality control
Each Actim Partus 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 Partus 1ngeni test system using
liquid controls may be advised. Refer to Actim Partus Controls (31900ETAC)
for details. There are no daily requirements for controlling the instrument
performance using liquid controls.
4
EN
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.
• Before performing the test ensure that the fetal membranes are intact (for
example with Actim PROM test), because with ruptured fetal membranes
! Ensure that the dipstick is
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 sampling and changes in the
patient's condition may later affect the final outcome of the pregnancy.
Notes
• The test requires approximately 150 μl of extracted sample to ensure proper
performance of the test.
• Use care when placing the dipstick in the sample tube. The upper part of the
dipstick must stay dry.
• Do not use a dipstick that has become wet before use because moisture
damages the dipstick.
• Do not use a dipstick if you notice a blue coloring in the result area before
testing.
• Do not use the dipstick if its aluminum foil pouch or the seals of the pouch are
not intact.
• Use only the swab provided with the Actim Partus kit.
• Improper sampling may lead to false result.
• When dipping, be careful to hold the dipstick in position (with the dip area in
the sample extract) until the sample liquid front reaches the result area.
• Do not insert anything other than the cartridges provided with Actim 1ngeni
tests into the instrument.
• Proper timing of reading the dipstick is essential. A delay in inserting the
dipstick into the instrument can have an effect on the test results. In these
cases the test should be repeated.
• Ensure that the dipstick is firmly inside the cartridge and does not slip out
when placed into the reader.