JusChek ROM Amniotic Fluid Leakage Test (25 pcs box)


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The Insulin-like growth factor-binding protein 1 (iGFBP-1) rapid test cassette (vaginal secretion) is a visually interpreted, qualitative immunochromatographic test 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.


For professional in vitro diagnostic use only.

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Insulin-like growth factor-binding protein 1 (iGFBP-1) known as placental protein 12 (PP12) is a protein that in humans is encoded by the IGFBP-1 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, 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.

The iGFBP-1 Rapid Test Cassette is a rapid test that qualitatively detects the presence of iGFBP-1 in vaginal secretion specimen at the sensitivity of 25ng/ml.


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 interacts with reagents on the membrane. If there was enough iGFBP-1 in specimens, a colored band will form in 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 in the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.


Materials provided

- Individually packed test cassettes
- Specimens collection swabs
- Package insert
- Specimens dilution tubes with buffer

Materials Required But Not Provided

- Timer

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Product Details

Data sheet

25 ng/ml
Over 99%
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