| 主权项 |
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 α1-microglobulin (PAMG-1), wherein at least one of the two monoclonal antibodies binds to the PAMG-1 when present in the sample to form a PAMG-1/monoclonal antibody complex, wherein said first and second PAMG-1-specific monoclonal antibodies are selected from the group consisting of M271, produced by hybridoma N271, deposited with the Russian National Collection of Industrial Microorganisms (VKPM) Depository and assigned accession number VKPM-93; M52, produced by hybridoma N52, deposited with the VKPM and assigned accession number VKPM-92; and M42, produced by hybridoma N42, deposited with the VKPM and assigned accession number VKPM-94; (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. |
