Qiagen, ASSKNE100, AmniSure ROM Test Ext Starter Kit

For the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant women.

Features

- 99% sensitive and 98% specific to support accuracy of negative and positive ROM clinical results
- No gestational age limit
- Not affected by urine, semen, vaginal infections and trace amounts of blood on the swab (1)

Product Details

The AmniSure ROM (Rupture Of [fetal] Membranes) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women. The AmniSure ROM Test uses amniotic fluid test strips to detect the PAMG-1 protein marker of the amniotic fluid in vaginal discharge. The amniotic fluid test is used by health care professionals to aid in the detection of ROM in pregnant women reporting signs, symptoms, or complaints suggestive of ROM. Want to try this solution for the first time? Speak to a specialist .

Watch the AmniSure training video here .

Performance

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). 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).

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). pPROM accounts for 20% to 40% of PROM cases, and is associated with 20% to 50% of premature births. 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). All of these consequences significantly increase risk of fetal and maternal morbidity and mortality.

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. Failure to identify patients with ROM can result in the failure to intervene appropriately.

Conversely, the false diagnosis of ROM can lead to inappropriate interventions (e.g., hospitalization or induction of labor). Therefore the correct and timely diagnosis of ROM is of crucial importance for the clinician (2). Accurate diagnosis of [fetal] membranes rupture, however, remains a frequent clinical problem in obstetrics (2-4).

Procedure

- Collect sample of vaginal discharge with sterile collection swab (no speculum required).
- Rinse specimen swab in solvent vial. Discard swab.
- Insert amniotic fluid test strip into vial and remove if 2 lines are visible, or at 10 minutes sharp.
- Results are observed and recorded.

The simple 4-step test procedure* detects placental alpha microglobulin-1 (PAMG-1) a protein found in high concentrations in amniotic fluid and low concentration in cervicovaginal fluid (4).

*Please refer to package insert for complete instructions for use.

Applications

The AmniSure test is for use by healthcare professionals to aid in the detection of fetal membranes rupture in pregnant women when they report signs, symptoms, or complaints suggestive of such a rupture.