![]() Tay-Sachs disease, a disease that destroys nerve cells, causes mental and physical problems, and often death in early childhood (uncommon).Sickle cell disease, a group of red blood cell disorders that can cause anemia and other health problems.Cystic fibrosis, a disease of the mucus and sweat glands that causes thick sticky mucus, which can lead to problems with breathing and digestion.Down syndrome, a disorder that causes intellectual disabilities and other health problems.Genetic and chromosomal disorders, including:. ![]() If a screening test shows your baby could have a problem, your health care provider may recommend amniocentesis or another diagnostic test to find out for sure.Īmniocentesis is used to diagnose certain health problems in an unborn baby. They can only show if your baby might have a health problem. Prenatal screening tests have no risks for you or your baby, but they don't diagnose problems. Diagnostic tests are different from prenatal screening tests for genetic disorders. That means it will tell you whether your baby has a specific health problem, and the results are almost always accurate. The fluid contains cells that provide important information about your unborn baby's health.Īmniocentesis is a diagnostic test. Amniotic fluid is a clear or pale yellow liquid that surrounds and protects an unborn baby throughout pregnancy. The test is usually done between weeks 15 and 20 of pregnancy.Īmniocentesis looks at a sample of amniotic fluid. The result is read visually by the presence of one or two lines in the test region of the strip.Amniocentesis is a test done during pregnancy to diagnose certain genetic disorders, birth defects, and other conditions in an unborn baby. 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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