![]() However, accurate diagnosis of PROM remains a challenge for obstetrics. Therefore, a correct and timely diagnosis of this disorder by the clinician is crucial. On the other hand, a false diagnosis of PROM can lead to inappropriate interventions (e.g. neonatal sepsis occurs if PROM is detected more than 32 hours after initial occurance). ![]() Failure to diagnose patients with PROM may result in the failure to implement salutary obstetric measures (e.g. Detection of PROM with a simple rapid test usable at the point of care enables an immediate decision-making. In amniotic fluid (diamine oxidase, alpha feto protein, fibronectin or IGFBP-1). Of alkalinization of vaginal secretion (an easy-to-carry-out, sensitive, inexpensive procedure, but with poor specificity) or on the detection of molecules present in high concentrations Biological tests are based on the detection In some cases, biological tests are required to confirm the suspicion of PROM. Conventional clinicalĮxaminations cannot always detect a leakage of amniotic fluid. It may lead to premature delivery and fetal infection. Premature rupture of membranes (PROM) is relatively frequent and occurs in 5 to 10% of all pregnancies. The test is intended as an aid in the diagnosis of the rupture of fetal membranes in pregnant women and designed for professional ![]() ![]() Marker of the amniotic fluid, in a vaginal swab. The result is read visually by the presence of one or two lines in the test region of the strip.The NADAL® PROM Amniotic Fluid Test is an immunochromatographic rapid test for the qualitative detection of IGFBP-1 (Insulin-like Growth Factor Binding Protein 1), a major protein PAMG-1 is then detected in the sample through an amniotic fluid test strip (lateral flow device). A sample of cervicovaginal discharge (collected by vaginal swab) is placed into a vial with solvent for extraction. To minimize the frequency of false results, two monoclonal antibodies were selected to set the sensitivity threshold of the AmniSure ROM Test at the optimal low level of 5 ng/ ml.The maximum background concentration of PAMG-1 in cervicovaginal discharge is slightly lower than the sensitivity cut-off of the AmniSure ROM Test, reducing false results and allowing for ~99% accuracy (2). PAMG-1 was selected as a marker of fetal membranes rupture due to its high level in amniotic fluid, low level in blood, and extremely low background level in cervicovaginal discharge when fetal membranes are intact. The test employs highly sensitive monoclonal antibodies that detect even a minimal amount of PAMG-1, which is present in cervicovaginal discharge after rupture of fetal membranes. The AmniSure ROM Test uses the principles of immunochromatography to detect human PAMG-1 protein present in amniotic fluid. As an alternative to conventional methods of ROM detection, the AmniSure test has a 99% sensitivity and 98% specificity to support accuracy of negative and positive ROM clinical results. ![]() The AmniSure ROM Test is a rapid, non-invasive, amniotic fluid test that can aid in the detection of ROM, providing rapid, easy-to-interpret and timely results. Other available tests have limitations or are in some degree invasive (2). Accurate diagnosis of membranes rupture, however, remains a frequent clinical problem in obstetrics (2-4). Therefore the correct and timely diagnosis of ROM is of crucial importance for the clinician (2). Failure to identify patients with ROM can result in the failure to intervene appropriately.Ĭonversely, the false diagnosis of ROM can lead to inappropriate interventions (e.g., hospitalization or induction of labor). The AmniSure ROM Test kit is a self-contained system that can serve as part of your overall clinical evaluation of PROM, which is crucial to ensure appropriate obstetric measures are taken in the event of a rupture. All of these consequences significantly increase risk of fetal and maternal morbidity and mortality. Complications of pPROM include infectious morbidity in the mother and fetus, pulmonary hypoplasia of the fetus, prolapse of the umbilical cord, development of fetal deformities, and postnatal endometritis (2). pPROM accounts for 20% to 40% of PROM cases, and is associated with 20% to 50% of premature births. Risks of PROM at term are related to serious neonatal consequences such as pre-term delivery, fetal distress, prolapsed cord, abruptio placentae and infection (2). Management of patients with PROM and pPROM (pre-term PROM, occurring before 37 weeks gestation) is expensive and remains an important perinatal dilemma as the clinician attempts to balance the risk of prolonging gestation against the risks of infection (2). Premature rupture of fetal membranes (PROM) occurs in about 10% of pregnancies and poses one of the most important therapeutic dilemmas in current obstetric practice (2). ![]()
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