Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1995-09-07
1998-07-21
Achutamurthy, Ponnathapura
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
4241841, 435 4, 435 791, 435 792, 530350, 5303871, 5303881, 530412, 530416, 530417, 530806, 530851, G01N 3353, A61K 3900, C07K 1600, C07K 1400
Patent
active
057833966
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to the method of detecting rupture of the amniotic membranes in pregnant mammals including humans using an immunoassay and reagents useful in such an assay. The method describes how to prepare a suitable protein antigen from amniotic fluid, gives criteria for the selection of this protein from the mixture of proteins present in amniotic fluid using the techniques of protein purification, gives criteria for assessing a sufficient degree of antigen purity for raising antibodies to the antigen and shows how the resultant antibodies can be used in immunoassays to detect the presence of amniotic fluid in the vagina and consequently to detect rupture of the amniotic membranes. The method also relates to the detection of amniotic fluid in other situations.
BACKGROUND OF THE INVENTION
1. RUPTURE OF THE AMNIOTIC MEMBRANES IN MAMMALS
Premature rupture of the fetal membranes was observed in 14-16% of all pregnancies (Polansky, G. H., et al., J. Reprod. Med. 30:189 (1985); Trap, P., et al., Gynecol. Obstet. Invest. 28:14 (1989)), while another study found the rupture of fetal membranes in 3-14% of all pregnancies was not followed by labour (Larsen, L., Br. Med. J. 1:1165 (1979). On rupture of the membranes, Duff (Obstet. Gynecol. 63:697 (1984)) observed that spontaneous labour followed within 24 hours in 80% of patients, with 10% remaining undelivered after a period of 48 hours. The perinatal mortality doubles after a latent period of 24 hours and again after 48 hours (Overstreet & Romney, Am. J. Obstet. Gynaecol. 90:1036 (1966)). Delayed onset of labour carries with it an increased risk of maternal and perinatal infection and mortality (Kapeller-Adler, R. et al., Biochim. Biophys. Acta. 67:542-565 (1963); Overstreet, above). Therefore the accurate detection of ruptured membranes is an important diagnostic aid.
In the mature fetus therefore, early diagnosis of membrane rupture allows for expediting the delivery thereby reducing infection risk to mother and baby. In the premature infant, accurate diagnosis of membrane rupture is even more important particularly if labour needs to be induced. A reliable, easy method of diagnosis of membrane rupture would be clinically useful to the obstetrician (Davidson, K. M., Clin. Obstet. Gynecol. 34:715-722 (1991); Gregg, A. R., Obstet. Gynecol. Clin. North Am. 19:241-249 (1992) and also cost saving by reducing the need for prolonged and unnecessary hospitalisation. The benefit to those patients resident in the country areas and facing transfer to a tertiary care centre for prolonged periods of hospitalisation away from home and family environment on suspicion of having premature rupture of the membranes would be considerable.
2. DETECTION OF RUPTURE OF THE AMNIOTIC MEMBRANES IN MAMMALS
Besides physical examination, current techniques for establishing the diagnosis of ruptured fetal membranes are: Fenniae. 47:22 (1927); Scand. 16:249 (1936); Gynok. 53:1618 (1929), Bourgeois, G. A., Am. J. Obstet. Gynecol. 44:80 (1942); et al., Gynaecologica 149:151 (1960), Borten, M., et al., Am. J. Obstet. Gynecol. 154:628 (1986); J. Obst. Gynecol. Brit. Commonw. 81:361 (1974), Gahl, W. A., et al., Obstet. Gynecol. 60:297 (1982a), Bank, C. M., et al., Eur. J. Clin. Chem. Biochem. 29:742 (1992); (1990), Garite, T. J. et al., Am. J. Perinatol. 7:276 (1990); (1991); Reprod. Biol. 43:173 (1992), Lockwood, C. J. et al., New Engl. J. Med. 325:669 (1991); E. A. Bol. med. Hosp. Infant Mex. 41:P341 (1984), Davidson, K. M., Clin. Obstet. Gynecol. 34:715 (1991)); J. Ultrasound. Med. 11:109 (1992), Hellemans, P., et al., Eur. J. Obstet. Gynecol. Reprod. Biol. 43:173 (1992); (1991).
Methods 1-4
In accordance with Friedman, M. L., et al., (Am. J. Obstet. Gynaecol. 48:172 (1976) any three of the abovementioned methods taken together provide an accuracy of 93% although false-positive and false-negative results are frequent with all laboratory techniques which are applied in diagnosing rupture of the membranes (Larsen, L., above).
Method 5- DAO Activity
REFERENCES:
patent: 5281522 (1994-01-01), Sentei et al.
patent: 5514598 (1996-05-01), Doody
patent: 5554504 (1996-09-01), Rutanen
Lelle, Ralph J. et al. "Measurement of CEA, TPA, Neopterin, CA125, CA153 and CA199 in Sera of Pregnant Women, Umbilical Cord Blood and Amniotic Fluid" Gynecol Obstet Invest vol. 27 (issued 1989) (S Karger AG, Basel) see p. 137 to 142.
Cowley David Michael
Voroteliak Victor
LandOfFree
Method of detecting rupture of the amniotic membranes in pregnan does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method of detecting rupture of the amniotic membranes in pregnan, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method of detecting rupture of the amniotic membranes in pregnan will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1645906