Sunday, May 29, 2016

Quick tests to confirm rupture of membranes and miscarriage in markets shortly!

The definitive and quick diagnosis of rupture of membranes and miscarriage will be commercially available very shortly if data on two important and groundbreaking diagnostic tests falls in place.

The capacity to differentiate high levels of alpha fetoprotein in amniotic fluid or vaginal blood from levels in other body fluids forms the basis of both the tests. Both rely on lateral-flow immunoassay or strip test to detect and the presence of alpha-fetoprotein indicating leakage of amniotic fluid and the second test quantify the alpha-fetoprotein in vaginal blood.

Both the tests were developed by Amir Mor, MD, PhD, a third-year resident in obstetrics and gynecology at the Maimonides Medical Center in Brooklyn, New York. The pilot study was a prospective cohort study involving 52 pregnant women admitted in labor in whom urine and amniotic fluid specimens were collected. Semen specimens were collected from 17 men undergoing infertility evaluation. The study was published in February 2015 issue of Obstetrics and Gynecology.

Pads with the strip incorporated were instilled with the specimens collected to measure the levels of alpha-fetoprotein.  In other 27 pregnant women, normal vaginal discharge was collected and tested by absorbing it in the pads. It was seen that amniotic fluid has significantly higher levels of alpha-fetoprotein than semen, urine or normal vaginal discharge. Receiver operator characteristic curve analysis demonstrated 96.2% sensitivity and 100% specificity for distinguishing the presence of amniotic fluid from normal vaginal discharge on sanitary pads (cutoff 3.88 ng/mL, area under the curve 0.99).

The test can be conducted bedside or at home by the patient herself, but Dr Mor and his colleagues have the patents that prohibit anyone else from developing and marketing the technology. Dr. Mor is in negotiations with several manufactures to bring the detecting pads in the market, which he believes to be under a year.

Both the tests were presented as a poster presentation at the American Congress of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical Meeting.

In the current study 200 women with confirmed membrane rupture and 70 women with intact membranes used the pads.  All pads worn by women with confirmed rupture of membrane tested positive for alpha-fetoprotein.  While only half of the women with intact membrane activated the test and tested negative. This was expected because, they did not have enough wetness/fluid to activate the strip.

Additional pads were instilled with urine specimens obtained from the 270 women, and 40 pads were instilled with semen collected from an infertility clinic. All these tests were also negative.

Dr Mor said “Although there are several other tests designed to determine whether amniotic fluid has leaked, none are as sensitive, specific, or as fast and easy as this alpha-fetoprotein diagnostic.

Dr. Nathaniel DeNicola, MD, MSC, an obstetrician–gynecologist at the University of Pennsylvania in Philadelphia quoted “Despite the need for more study of the technology, "the excitement is real," If a diagnostic could establish rupture of membranes or a failed pregnancy at the point of care, "doctors and patients would both welcome it, but a single study will not be enough to change practice. It will have to be "verified with repeat studies with more patients."

Test for Miscarriage.


Study data dealing with detection of miscarriage was also presented by Dr. Mor at the conference, winning him the Blue Ribbon from ACOG reviewers.

Dr. Mor said “the test can identify whether the pregnancy is inside the uterus or if it's a failing pregnancy." Dr Mor explained.

At present it is difficult to determine whether the pregnancy will continue or end up in miscarriage, without sending the specimen to laboratory for presence of fetal tissue in the vaginal blood.  But with this test, the differential diagnosis can be clinched bedside.

Earlier studies have shown that levels of alpha-fetoprotein levels are 1000 times higher in fetal blood than in maternal blood in first trimester.

In a small study of 17 women who were postulated to end up in missed or incomplete abortion, Mean alpha-fetoprotein concentration in blood sampled from the vagina was 17,043 ng/mL, and from maternal serum was 116 ng/mL (P < .001).

In other nine women with threatened abortion, mean alpha-fetoprotein concentration in blood sampled from the vagina was 71 ng/mL and from maternal serum was 112 ng/mL (P = .1).

Dr Mor and his colleagues further explained that if alpha-fetoprotein levels in vaginal blood were at least 8000 times higher than the normal range seen in maternal serum, it confirmed an intrauterine pregnancy that had failed. On the other hand, women with confirmed nonheterotopic ectopic pregnancy concentrations of alpha-fetoprotein in vaginal blood were similar to maternal serum.

The concept is new and exciting, but evidence points out that it is possible to distinguish between miscarriage and viable pregnancy by this test.

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