IGFBP-1 Home Fertility Testing Kits , Vaginal Secretion Pregnancy Detection Kit

iGFBP-1 Home Fertility Testing Kits, self test use at home, individual package or professional package

INTENDED USE:

The Insulin-like growth factor-binding protein 1 (iGFBP-1) rapid test (vaginal secretion) is a visually interpreted, qualitative immunochromatographic test device for detection of iGFBP-1 in vaginal secretions during pregnancy, which is a major protein marker of the amniotic fluid in a vaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.

TEST PRINCIPLE

The iGFBP-1 (vaginal secretion) has been designed to detect iGFBP-1 through 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.

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

Performance

Sensitivity and Specificity

The iGFBP-1 Rapid Test Cassette (vaginal secretion) has been tested with a leading commercial iGFBP-1 Rapid Test using clinical specimens.

Relative Sensitivity: 98.1% (95%CI:*93.2%-99.8%)

Relative Specificity: 98.0% (95%CI:*94.3%-99.6%)

Overall Accuracy: 98.0% (95%CI:*95.5%-99.4%)

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.