Frequently Asked Questions about AmniSure®

Q: 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. It may be the cause of premature delivery. All these consequences increase the chances of fetal and maternal morbidity and mortality. AmniSure® can help to diagnose ROM in a timely and accurate manner, so that appropriate measures can be taken.

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

The test is for use by health care 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. AmniSure® should be used in sites or by qualified personnel (physicians, certified nurse midwives, or labor and delivery nurse 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.

Q: 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 even a minimum amount of the amniotic fluid protein (PAMG-1), which is present in cervico-vaginal discharge after the rupture of the fetal membrane. 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.

Q: What is PAMG-1?

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

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

PAMG-1 was selected as a marker of fetal membrane rupture due to its unique characteristics, i.e., its extremely low background level measured in cervico-vaginal discharge using selected pair of antibodies when the fetal membranes are intact.

Q: How accurate are the test results?

Based on published data, the AmniSure test is ~99% accurate. In clinical trials, one AmniSure® test correlated with clinical diagnosis obtained through the combined usage of three other 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 the 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).

Q: Is a false result possible?

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

Q: Will medical treatments affect the results of the test?

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

Q: How should AmniSure® test kit be stored?

The kit must be stored in a dry place at 40°F to 75°F (+4°C to +24°C). Do not freeze. Do not use beyond the expiration date stamped on the product. AmniSure® must be used within 6 hours after opening. Do not reuse the test kit components.