Devices And Methods For Detecting Amniotic Fluid In Vaginal Secretions
AssigneeN-Dia, Inc.
InventorsBoris Fuks, Dmitrii D. Petrunin, Evgeny I. Zaraisky, Marina N. Boltovskaya, Svetlana V. Nazimova, Nelly A. Starosvetskaya, Alexandr Konstantinov, Margarita I. Marshiskaia
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Abstract
The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.
Claims20
A method for diagnosing rupture of fetal membranes (ROM) with 100% negative predictive value in a pregnant woman, the method comprising:
- (a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and which are each specific for the same amniotic protein, wherein at least one of the two monoclonal antibodies binds to the amniotic protein when present in the sample to form an amniotic protein/monoclonal antibody complex;
- (b) detecting the presence of the amniotic protein/monoclonal antibody complex in the sample, only when the concentration of the amniotic protein in the sample exceeds a predefined detection threshold, wherein the predefined detection threshold is set at a level that eliminates 100% of false positive results;
- and
- (c) diagnosing ROM with 100% negative predictive value if the amniotic protein is detected in the sample.
A method for diagnosing rupture of fetal membranes (ROM) with at least 99% positive predictive value in a pregnant woman, the method comprising:
- (a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and which are each specific for the same amniotic protein, wherein at least one of the two monoclonal antibodies binds to the amniotic protein when present in the sample to form an amniotic protein/monoclonal antibody complex;
- (b) detecting the presence of the amniotic protein/monoclonal antibody complex in the sample, only when the concentration of the amniotic protein in the sample exceeds a predefined detection threshold that is set at a level that reduces false positive results such that at least 99% positive predictive value is achieved;
- and
- (c) diagnosing ROM with at least 99% positive predictive value if the amniotic protein is detected in the sample.
A method for diagnosing rupture of fetal membranes (ROM) in a pregnant woman with at least 99% specificity and 100% sensitivity, the method comprising:
- a) contacting a vaginal fluid sample obtained from the pregnant woman with a first and a second monoclonal antibody that do not cross-react with each other and which are each specific for the same amniotic protein, wherein at least one of the two monoclonal antibodies binds to the amniotic protein when present in the sample to form an amniotic protein/monoclonal antibody complex;
- (b) detecting the presence of the amniotic protein/monoclonal antibody complex in the sample, only when the concentration of the amniotic protein in the sample exceeds a predefined detection threshold;
- and
- (c) diagnosing ROM with at least 99% specificity and 100% sensitivity if the amniotic protein is detected in the sample.
(canceled)
Dependencies are inferred from the claim text.