Frequently Asked Questions about AmniSure ®
Q: What is AmniSure ® and how can it help?
AmniSure ® is a rapid (5-10 minutes) strip test developed by N-Dia, Inc. that can detect a rupture of the fetal membranes (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 ® makes it possible 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 a pair of specifically selected monoclonal antibodies that detect even a minimum amount of the amniotic fluid protein (PAMG-1), which is present in cervico-vaginal secretions after the rupture of the fetal membrane. To minimize the frequency of the false results, an additional monoclonal antibody against PAMG-1 is also employed to set up a predefined level of sensitivity of the test. During the test procedure, PAMG-1 from the sample sequentially binds to a monoclonal antibody conjugated with the label particles, and then to two other 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 secretions using selected pair of antibodies when the fetal membranes are intact.
Q: How accurate is the result?
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). 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 0.05-0.25 ng/ml).
Q: Is a false result possible?
A false positive result may occur in the case of bleeding in a woman with a pathological pregnancy. Conducting the test when there is a discharge of blood is not recommended. The result may turn out false negative when the sample is taken 12 or more hours after a presumed fetal membrane rupture has occurred. If there is suspicion for such scenario, other clinically available means of testing for ROM are suggested.
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 40F to 68F (+4C to +20C). It must not be frozen.
Q: How should the AmniSure ® test kit be used?
It must not be used after the expiration date stamped on the product. AmniSure ® must be used within 6 hours after opening. The test kit components must not be reused.