![]() For example, pH 6.0 (indicative of an intact membrane) is an olive green while pH 6.5 (indicative of a possible ruptured membrane) is a dark green. The colour squares on the card are only examples always use the colour description found in the IFU in combination with the colour squares as part of your interpretation. A colour interpretation card is included with each box of AmnioTest™. A possible ruptured membrane is indicated if the swab has a pH of 6.5 to pH 7.5 turning the swab dark green to navy blue. AmnioTest™ is a sterile swab impregnated with nitrazine yellow dye that when brought into contact with the upper vagina will absorb fluid and develops a colour to correlate with the pH of the absorbed fluid ranging from pH 5.0 to pH 7.5. Thus, the presence of amniotic fluid elevates the pH of the upper vagina. Rupture of fetal membranes can result in small amounts of amniotic fluid leaking into the upper vagina. Education PowerPoint available for staff training to meet POC requirements Click here for documents.Easy to QC with available buffers to match colour interpretation card.The test is usually done between weeks 15 and 20 of pregnancy and has a very small risk of miscarriage. It involves taking a sample of amniotic fluid from the baby's sac. The result is read visually by the presence of one or two lines in the test region of the strip. Amniocentesis is a diagnostic test done during pregnancy to diagnose certain genetic disorders, birth defects, and other conditions in an unborn baby. Strong leakage of amniotic fluid may make the results visible early (within minutes), while a very small leak will take the full 5 minutes. 7 Dip the white end of the test strip (marked with arrows) into the vial with solvent. PAMG-1 is then detected in the sample through an amniotic fluid test strip (lateral flow device). Tear open the foil pouch at the tear notches and remove the AmniSure ROM Test strip. Amer J Dis Child 120 : 17-21, Jul 70 ANTIBODIES / ANTIBODY FORMATION. ![]() A sample of cervicovaginal discharge (collected by vaginal swab) is placed into a vial with solvent for extraction. AMNIOTIC FLUID, analysis / BILIRUBIN, analysis / FEMALE / HUMAN. 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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