Devices and methods for detecting amniotic fluid in vaginal secretions
AssigneeN-Dia, Inc.
InventorsBoris Fuks, Dmitrii Dmitrievich Petrunin, Evgeny I. Zaraisky, Marina Nikolayevna Boltovskaya, Svetlana Vladimirovna Nazimova, Nelly Andronikovna Starosvetskaya, Alexandr Konstantinov, Margarita Igorevna 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.
Claims8
A method of detecting amniotic fluid in a sample comprising a vaginal secretion of a pregnant woman using a combination of at least three PAMG-1-specific monoclonal antibodies, the method comprising:
- (a) contacting said sample with said at least three PAMG-1-specific monoclonal antibodies,
- wherein at least one antibody of the three has a lower PAMG-1 binding specificity than at least one other antibody of the three;
- and
- wherein the binding specificity of each of said three antibodies and specific combination thereof are selected to detect PAMG-1 in the sample when present at least in a predefined threshold amount that is greater than the regular background level of PAMG-1 in vaginal secretions of pregnant women in the absence of amniotic fluid and less than the level present in amniotic fluid;
- (b) detecting a PAMG-1/antibody complex;
- and
- (c) determining that said sample contains amniotic fluid if said PAMG-1/antibody complex is detected in step (b).
Dependencies are inferred from the claim text.