Actim PROM 1ngeni Gebrauchsanweisung Seite 5

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.
• A negative test result is an indication on the present condition and cannot be
used to predict the forthcoming.
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 PROM 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.
• The availability of the workflow and read only modes is dependent on the
administrator settings.
• A test must always be read in read only mode in case the test reaction has
occurred outside the instrument.
• 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 delayed reading of the
dipstick 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.
• If the procedural control line is not detected by the Actim 1ngeni instrument,
the result will be declared indeterminate and the test should be repeated.
• The result must not be visually inspected after analysing it with the
instrument.
• Do not re-analyse a test with the instrument.
• For additional information, please refer to the Actim 1ngeni instrument
manual.
• A positive Actim PROM test result, although detecting the presence of
amniotic fluid in the sample, does not locate the site of the rupture.
• As with all diagnostic tests, results must be interpreted in the light of other
clinical findings.
• All biological specimens and materials must be treated as potentially
hazardous, and disposed of in accordance with local authority guidelines.
Principle of the test
The concentration of IGFBP-1 (insulin-like growth factor binding protein-1) in
amniotic fluid is 100 to 1,000 times higher than in maternal serum. IGFBP-1 is
not usually present in the vagina, but after rupture of fetal membranes, amniotic
fluid with a high concentration of IGFBP-1 mixes with vaginal secretions. In Actim
PROM test, a specimen of vaginal secretion is taken with a sterile polyester swab
and the specimen is extracted into Specimen Extraction Solution. The presence
of IGFBP-1 in the solution is detected using a dipstick.
The test is based on immunochromatography. It uses two monoclonal antibodies
to human IGFBP-1. One is bound to blue latex particles (the detecting label). The
other is immobilized on a carrier membrane to catch the complex of antigen
and latex-labeled antibody and indicate a positive result. When the dip area of
the dipstick is placed in an extracted sample, the dipstick absorbs liquid, which
starts to flow up the dipstick. If the sample contains IGFBP-1 it binds to the
antibody labeled with latex particles. The particles are carried by the liquid flow
and, if IGFBP-1 is bound to them, they bind to the catching antibody. Actim 1ngeni
instrument will recognize a blue line (test line) if the concentration of IGFBP-1 in
the sample exceeds the detection limit of the test. A second blue line detected by
the instrument, the control line, confirms correct performance of the test.
Performance of the test
Analytical Sensitivity
The analytical sensitivity of Actim PROM 1ngeni was evaluated using samples
with different concentrations of IGFBP-1. The samples were tested using three
replicates. The analytical sensitivity (detection limit) is approximately 25 µg/l for
Actim PROM 1ngeni test and the results remain positive at least to 500,000 µg/l.
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