Rapid bedside test for detection of IGFBP-1 (Insulin Growth Factor Binding Protein 1) from a vaginal swab sample in pregnant women with suspected Premature Rupture of Membranes (PROM)

AMNIOQUICK® offers a convenient solution to obstetricians and midwives for accurate diagnostic of PROM. AMNIOQUICK® is a rapid test based on the detection in vaginal samples of IGFBP-1 (Insulin-Like Growth Factor Binding Protein-1), which is found in high concentration in amniotic fluid. A pair of monoclonal antibodies anti-IGFBP-1 is used for the detection of IGFBP-1. One is immobilized on the nitrocellulose membrane at the level of the test line: it corresponds to the capture antibody. Another one is labelled with colloidal gold for the subsequent manifestation. During the sample migration, IGFBP-1, if present in the sample, will form antigen antibody complexes with the labelled antibodies. These complexes will be caught by the capture antibodies on the test line, creating one purple colored line generated by gold nanoparticles. The presence of a purple internal control line in the upper part of the membrane indicates that the result is valid and that the followed procedure is correct. AMNIOQUICK® can be used from the early stages of pregnancy to near term women. It is an easy-to-use rapid test that allows better management of PROM.

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Product code: 0524_K10 (10 tests)

Product description

Rupture of fetal membranes that occurs before the onset of labor is known as Premature Rupture of Membranes or PROM. PROM occurs relatively frequent and concerns 5 to 10 % of pregnancy cases. It might lead to fetal infection and preterm delivery. Appropriate management of PROM is important to reduce the consequences to neonatal health. The leakage of amniotic liquid is not always detectable by conventional clinical examination and therefore confirmatory biological test can be very useful. Biological tests are based on detection of alkalinisation of vaginal fluid (easy to proceed, sensitive and inexpensive, but poorly specific) or presence of a molecule which is physiologically present in high concentration in amniotic fluid such as insulin-like growth factor binding protein-1 (IGFBP-1).

IGFBP-1, also known as placental protein 12 (PP12) is the major insulin-like growth factor binding protein in the amniotic fluid, which gradually increases in the second trimester and remains higher throughout pregnancy in comparison to its plasma levels. Its concentration in amniotic fluid is 100–1000 times higher than the concentration in other bodily fluids. IGFBP-1 phosphorylated isoform is mainly secreted in the decidua cells and human liver, whereas the non-phosphorylated isoform is mainly found in the amniotic fluid. Detection of IGFBP-1 in the cervical–vaginal secretions has been shown to be a reliable method in the diagnosis of ruptured amniotic membrane in cases in which the clinical diagnosis is uncertain3.

1.    The American College of Obstetricians and Gynecologists: practice bulletin clinical management guidelines for obstetrician- gynecologists, number 139 October 2013.
2.    Beckman et al, Hospital versus outpatient care for preterm pre-labour rupture of membranes, Australian and New Zealand Journal of Obstetrics and Gynaecology 2013; 53: 119–124
3.    Rutanen et al, Comment on: Guidelines for the management of spontaneous preterm labor: identification of spontaneous preterm labor, diagnosis of preterm premature rupture of membranes, and preventive tools for preterm birth, The Journal of Maternal-Fetal and Neonatal Medicine, 2012; 25(5): 546–549
© 2012 Informa UK, Ltd

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