Insulin-like Growth Factor-binding Protein 1 (iGFBP-1) Rapid Test Cassette

Applications:

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.

Description:

Insulin-like growth factor-binding protein 1 (IBP-1) known as placental protein 12 (PP12) is a protein that in humans is encoded by the IGFBP1 gene. IGF-binding proteins (IGFBPs) is believed to be important in the regulation of fetal and neonatal growth. We previously reported that the profiles of IGFBPs in fetal cord serum (FCS) were dependent on the growth/metabolic status of the fetus. It can be detected in cervical secretions of pregnant women with preterm uterine contractions, and whether their presence predicts an increased risk of preterm delivery.

The abundance of insulin-like growth factor binding protein-1 at the maternal-fetal interface in severely preeclamptic pregnancies suggests that the binding protein may participate in the pathogenesis of the shallow placental invasion observed in this disorder. Low circulating insulin-like growth factor-I and elevated insulin-like growth factor binding protein-1 levels may contribute to restricted placental and therefore fetal growth.

How to use?

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 Then press the swab against the side of the tube and squeeze the bottom of the tube as the swab is withdrawn.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 5 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE:
* A colored band appears in the control band region (C) and another colored band appears in the T band region.

NEGATIVE:
One colored band appears in the control band region (C). No band appears in the test band region (T).

INVALID:
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.