iGFBP-1 Rapid Test Device / Strip
PRINCIPLE
The iGFBP‐1 (vaginal secretion) has been designed to detect iGFBP‐1 thrisough visual
interpretation of color development in the internal strip. The membrane was immobilized with
anti‐iGFBP‐1 antibodies on the test region. During the test, the specimen is allowed to react with
colored anti‐iGFBP‐1 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 iGFBP‐1 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.
PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15-
30°C) before use.
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 dilute tube, rotate for 20 times. Then press the
swab against the side of the tube and squeeze the bottom of the tube as the
swab is withdrawn. Discard the swab.
3) Fit the cap of the tube. Remove the top part of the cap. Place the test device
on a clean and level surface. Add 3 full drops of solution (approx. 100 µL)
to the specimen well (S) and then start the timer.
4) 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 RESULT:
* A colored band appears in the control band region (C) and another colored band appears in the T band region.
NEGATIVE RESULT:
One colored band appears in the control band region(C). No band appears in the test band region (T).
INVALID RESULT:
Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists,
discontinue using the kit immediately and contact your local distributor.
NOTE：
1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
