Alere Partus Test Notice D'utilisation page 4

EN
sampling and changes in the patient's condition
may later affect the final outcome of the
pregnancy.
NOTES
• No quantitative interpretation should be made
based on the test results.
• The test requires about 150 μl of extracted sample
to ensure proper performance of the test.
• Care must be taken 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 colouring
in the result area before testing.
• Do not use the dipstick if its aluminium foil pouch
or the seals of the pouch are not intact.
• Use only the swab provided with the kit.
• Improper sampling may lead to false negative
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.
• If the control line does not appear, the test is
invalid, and should be repeated using another
dipstick.
• If the test result cannot be interpreted clearly it is
recommended that the test be repeated.
• At five minutes the appearance of any faint-to-dark
blue test line along with a control line indicates a
positive result. However, do not pay attention to any
lines appearing after 5 minutes.
• If only the control line is visible, the result should
be interpreted as negative only after 5 minutes
have elapsed.
• 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
Decidual cells synthesize the phosphorylated
forms of IGFBP-1 (phIGFBP-1) while amniotic fluid
contains substantial quantities of non- and less
phosphorylated forms of IGFBP-1. When delivery
is approaching, fetal membranes begin to detach
from the decidua parietalis, and small amounts of
phIGFBP-1 begin to leak into cervical secretions.
In the Alere Actim Partus test a cervical specimen
sample is taken with a sterile polyester swab during
sterile speculum examination and extracted into
the Specimen Extraction Solution. The presence of
phIGFBP-1 in the solution is detected using a dipstick.
The test is based on immunochromatography.
It involves 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
phIGFBP-1 it binds to the antibody labeled with latex
particles. The particles are carried by the liquid flow
and, if phIGFBP-1 is bound to them, they bind to the
catching antibody. A blue line (test line) will appear
in the result area if the concentration of phIGFBP-1
in the sample exceeds the detection limit of the test.
A second blue line (control line) confirms correct
performance of the test.
PERFORMANCE OF THE TEST
Analytical Sensitivity
The analytical sensitivity (detection limit) of the
Alere Actim Partus test was identified by evaluating
different concentrations of IGFBP-1 in extracted
samples on three different lots of the Alere Actim
Partus test.
Two different operators each interpreted ten devices
run at each concentration under various lighting
conditions for a total of 60 determinations per level.
The Alere Actim Partus test limit of detection is
approximately 10 µg/l in extracted sample. The
measuring range of the Alere Actim Partus test is
approximately 10-8000 µg/l in extracted sample.
Analytical Specificity
Analytical specificity (cross-reactivity) was tested
with human IGFBP proteins at a concentration level
of 5000 µg/l of IGFBP-2, -4, -5 and -6 proteins, and
at 50000 µg/l of IGFBP-3 protein using one lot of the
Alere Actim Partus test. No cross-reactivity was seen
using human IGFBP-2, -3, -4, -5 and -6 proteins. The
Alere Actim Partus test is specific to human IGFBP-1.
Repeatability
Two panels of specimens consisting of samples
of different IGFBP-1 concentration levels were
evaluated for intra-assay precision. Two different
operators each interpreted one panel of specimens
with 10 replicates during the same day using three
different lots of the Alere Actim Partus test for a total
of 60 determinations per level. Repeatable results
were obtained.
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