Patent ID: 9568479
Date: 2017-02-14
CPC Classifications: G01N,Y10S

Claim:
1. 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 placental α (b) detecting the presence of the PAMG-1/monoclonal antibody complex in the sample, only when the concentration of the PAMG-1 in the sample exceeds a predefined detection threshold of 5 ng/ml, 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 PAMG-1 is detected in the sample.