Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1993-06-30
1996-09-10
Chan, Christina Y.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 79, 435 792, 435 794, 436510, 436518, 436548, 436 65, 436 87, 436814, G01N 3353, G01N 33543, G01N 33577
Patent
active
055545041
DESCRIPTION:
BRIEF SUMMARY
This application is a 37/of PCT/FI91/00413 filed Dec. 30, 1991.
The present invention relates to a diagnostic method for detecting the rupture of fetal membranes, said method being based on the determination of a protein present in a vaginal secretion sample of a pregnant woman, and a test kit for the diagnosis of the rupture of fetal membranes.
The term "premature rupture of fetal membranes" (PROM) refers to the spontaneous rupture of the membranes at least 24 hours before the onset of labor at term or preterm. It occurs in about 5-10% of deliveries and is the cause of about 10% of perinatal deaths. About 30-50% of the premature ruptures of membranes occur when the gestational age is less than 37 weeks, and thus is not fullterm. In this case the diagnosis is extremely important because the rupture of membranes is associated with a significantly increased risk of an intrauterine infection. The risk of an infection is greater the longer time has elapsed between the rupture of membranes and the delivery. Infections increase both maternal and perinatal mortality.
In spite of the problem being so common and severe, no absolute diagnostic method has been known for detecting the rupture of membranes in cases when the rupture is not clinically evident.
Because of the lack of a definitive method, several unsatisfactory methods have been used when trying to determine the presence of amniotic fluid in the vagina. Known methods are described by, inter alia, Friedman, M. L. and McElin, T. W., Diagnosis of ruptured fetal membranes. Am. J. Obstet. Gynec. 1969; 104: 544-550. The amniotic fluid crystallization test is based on observing a characteristic arborization or "fern" pattern on a slide, which pattern differs from that of normal vaginal secretions.
In the dye tests, an attempt is made to detect the difference by dyeing the secretion on a slide with, e.g., Nile Blue, Acridin Orange or Bromthymol Blue. An altered pH in the vaginal secretion can be detected by a Nitrazin test. In the above mentioned article a method is also described wherein amniotic fluid is dyed with a fluorescent compound and its leakage is visually observed in UV light.
These methods are not satisfactory because false positive or false negative results are too often obtained, Or they are sensitive to interfering substances or are associated with a risk to patient health. The test result can be erroneous if there is a vaginal infection, or if a long time has elapsed since the rupture of membranes.
It has also been suggested that, in order to detect premature rupture of fetal membranes,i it could be useful to determine such a compound in the vaginal fluid the concentration of which is high in amniotic fluid compared to the concentration of said compound in those other secretions that could possibly be present in the vagina. Compounds like this have been described: Alpha-fetoprotein (AFP) (Rochelson et al., Rapid assay--possible application in the diagnosis of premature rupture of the membranes. Obstet Gynecol. 1983; 62: 414-418) and prolactin (PRL) (Koninckx et al., Prolactin concentration in vaginal fluid: a new method for diagnosing ruptured membranes. Br. J. Obstet. Gynecol. 1981; 88: 607-610). The concentration of both compounds in amniotic fluid is clearly higher than in the blood of a pregnant person. However, in a situation where the vaginal fluid sample contains blood, it is difficult to detect the presence of a small amount of amniotic fluid by determining these compounds.
Consequently, it is evident that there is a need for developing a simple and reliable diagnostic method for detecting the rupture of fetal membranes. In the situation when the test is performed, it is extremely important to obtain the test result rapidly. The ideal test for this purpose is simple to perform and rapid (result obtained within at least 30 minutes), and can preferably be performed as a bed-side test immediately on site.
An object of the present invention is thus to provide a new and improved method for detecting the rupture of fetal membranes, the method bei
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Chan Christina Y.
Grun James L.
Oy Medix Biochemica AB
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