One Step fetal fibronectin (fFN) rapid test, Home fertility testing
kits, high accuracy
INTENDED USE:
The fetal fibronectin (fFN) rapid test (vaginal secretion) is a
visually interpreted, qualitative immunochromatographic test device
for detection of fFN in vaginal secretions during pregnancy, which
is a special protein that literally holds your baby in place in the
womb. The test is intended for professional use to help diagnose
the rupture of fetal membranes (ROM) in pregnant women.
TEST PRINCIPLE
The fFN (vaginal secretion) has been designed to detect fFN
thrisough visual interpretation of color development in the
internal Device. The membrane was immobilized with anti-fFN
antibodies on the test region. During the test, the specimen is
allowed to react with colored anti-fFN antibodies colloidal gold
conjugates, which were precoated on the sample pad of the test. The
mixture then moves on the membrane by a capillary action, and
interact with reagents on the membrane. If there were enough fFN in
specimens, a colored band will form at the T region of the
membrane. Presence of colored band indicates a positive result,
while its absence indicates a negative result. Appearance of a
colored band at the control region serves as a procedural control.
This indicates that proper volume of specimen has been added and
membrane wicking has occurred.
TEST PROCEDURE
1. Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. To obtain a best result, the assay should be
performed within one hour.
2. Insert the swab into the specimen tube containing 1ml of assay
diluent.
3. add the Vaginal secretion into the specimen tube containing
1000ml of assay diluent using the dropper.
4. Mix the swab samples with assay diluent to extract well.
5. Hold the dropper vertically and transfer 3 full drops of
specimen (approx. 100 uL) to the specimen well (S) of the test
device, and then start the timer. Avoid trapping air bubbles in the
specimen well (S).
6. Wait for the colored band to appear. The result should be read
at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Two distinct colored lines are visible, and the line in the test
line region (T) is the same as or darker than the line in the
control line region (C). A positive result indicates that the FSH
level is higher than normal and the subject may be experiencing
perimenopause.
NEGATIVE: Two colored lines are visible, but the line in the test line
region (T) is lighter than the line in the control line region (C),
or there is no line in the test line region (T). A negative result
indicates that the subject is probably not experiencing
perimenopause in this cycle.
INVALID: Control line fails to appear. Insufficient specimen volume or
incorrect test performance are the most likely reasons for an
invalid result. Review the procedure and repeat with a new test. If
the problem persists, discontinue using the test kit immediately
and contact your local distributor.
Kit Components
| Individually packed test Devices | Each Device contains colored conjugates and reactive reagents
pre-spreaded at the corresponding regions. |
| Specimens collection swab | For specimens collection use. |
| Specimens dilution tube with buffer | 0.1 M Phosphate buffered saline (PBS) and preservative |
| Package insert | For operation instruction. |
| |
NOTE: Insufficient specimen volume or incorrect procedural techniques
are the most
likely reasons for control line failure. Review the procedure and
repeat the test with a new test device. If the problem persists,
please contact your local distributor.
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
