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.
References:
I am Mary rick, i want to share my testimony with all my views , I was marriage for good ten year with out child so my husband send out this house so i was crying and i went to a friend of my who live in London who help me out pail , she went to a man of God who enable to help my life today and him bring my husbandman black to me , now i am with one king and pregnancy . thank for man of God who make me to enjoy my life today, places if you are have any problem now yours try and contact him for a solution to your problem, him we do it for you , contact email prophetmercyland@gmail.com or watch him television marcylandtv com or +23470551766175
ReplyDelete