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What is AmniSure® and how can it help?

AmniSure® is a rapid test that aids in detecting Rupture Of [fetal] Membranes (ROM) in women with signs and symptoms suggestive of ROM. ROM presents the risks of infection, fetal distress, prolapse of the umbilical cord, postnatal endometritis and abruptio placenta.1,3 Premature ROM could also lead to premature delivery. All these consequences increase the likelihood of fetal and maternal morbidity and mortality. AmniSure® can help diagnose ROM in a timely and accurate manner, so that appropriate and opportune measures can be taken.

Under what conditions and when is the use of AmniSure® recommended?

The test is for use by healthcare professionals (Rx only) to aid in the detection of fetal membranes rupture in pregnant women when they report signs, symptoms, or complaints suggestive of such a rupture. AmniSure® should be used in sites or by qualified personnel (physicians, certified nurse-midwives, or labor and delivery nurses certified to evaluate ROM) similar to those of clinical trials that were performed on the product. AmniSure® can therefore be used in a variety of settings, from OB/GYN clinics and doctors' offices to outpatient clinics and labor admitting rooms.

How does the test work?

AmniSure® is a one-step immunochromatographic device. The test is based on the use of several, specifically selected, monoclonal antibodies that detect trace amounts of the amniotic fluid protein PAMG-1, which is present in cervico-vaginal discharge after the rupture of the fetal membranes. During the test procedure, PAMG-1 from the sample sequentially binds to a monoclonal antibody conjugated with the label particles, and then to antibodies immobilized on an insoluble carrier.

What is PAMG-1?

Placental alpha microglobulin-1 is a protein expressed by the cells of the decidual part of the placenta. During pregnancy, PAMG-1 is secreted into the amniotic fluid.

What is the benefit of PAMG-1 over other antigens?

PAMG-1 was selected as a marker of fetal membranes rupture due to its extremely low background level in the presence of intact fetal membranes, when measured in cervico-vaginal discharge.

How accurate are the test results?

Based on published data, the AmniSure® test is ~99% accurate.1-5 In clinical trials, an AmniSure® test correlated with the clinical diagnosis obtained through the combined usage of three routinely used tests—nitrazine, ferning, and pooling. The simplicity of the test provides for equally accurate results when the test is conducted in OB/GYN clinics and exam rooms. The diagnostic accuracy of the AmniSure® test relies on its sensitivity threshold, which is set at the low level of 5 ng/ml (while the background cervico-vaginal concentration of PAMG-1 is only 0.05-0.22 ng/ml).

Can samples be stored for subsequent testing?

Whenever possible, the AmniSure® test should be performed immediately after sample collection. If necessary, however, samples can be stored in a refrigerator (at +4°C) for six hours.

Is a false result possible?

In cases where trace amounts of blood are present on the swab, the test functions properly. When there is a significant presence of blood on the swab, the test can malfunction and its use is not recommended. In such cases, a separate sample without considerable amounts of blood should be taken and tested. The test result may be negative when the sample is taken 12 or more hours after a presumed fetal membrane rupture has occurred (i.e. due to a possible “resealed” rupture or the temporary obstruction of leakage).

Will medical procedures affect the results of the test?

Yes. AmniSure® should not be used within 6 hours after the removal of any disinfectant solutions or medications from the vagina.

How should the AmniSure® test kit be stored?

A sealed AmniSure® test must be stored in a dry place, at 40°F to 75°F (+4°C to +24°C). The test should not be frozen or used beyond the expiration date stamped on the product. AmniSure® must be used within 6 hours after opening and the test kit components should not be reused.