Assays and methods for detection and targeted treatment of hydrosalpinx

Abstract

A method including detecting a presence of at least one analyte in a sample from a subject wherein the at least one analyte is selected from the group consisting of: mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1, and determining the subject has hydrosalpinx if the sample comprises an increased level of mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, and/or Mucin-16 relative to a control, and/or a decreased level of GSTP1, PRDX5, TXN, PRDX6, and/or SOD1, relative to the control, is provided herein. The method may further include if the subject is determined to have hydrosalpinx, administering a hydrosalpinx therapy to the subject.

What is claimed is: 
     
         1 . A method comprising:
 detecting a presence of at least one analyte in a sample from a subject wherein the at least one analyte is selected from the group consisting of: mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-1 6, GSTP1, PRDX5, TXN, PRDX6, and SOD1;   identifying the subject as having hydrosalpinx if the sample comprises
 an increased level of mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, and/or Mucin-16 relative to a control, or comprises a hydrosalpinx control level or falls within a hydrosalpinx level range; and/or 
 a decreased level of GSTP1, PRDX5, TXN, PRDX6, and/or SOD1, relative to a control; or comprises a hydrosalpinx control level or falls within a hydrosalpinx level range; 
 and 
   if the subject is determined to have hydrosalpinx, administering a hydrosalpinx therapy to the subject.   
     
     
         2 . The method of  claim 1 , wherein the at least one analyte comprises mesothelin. 
     
     
         3 . The method of  claim 1 , wherein the at least one analyte comprises mesothelin and at least one further analyte selected from the group consisting of:
 Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1.   
     
     
         4 . The method of  claim 1 , wherein the detecting comprises subjecting the sample to one or more reagents for detecting at least one analyte of the group consisting of: mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1; 
     
     
         5 . The method of  claim 1 , wherein the sample comprises tubal fluid, blood, plasma or serum. 
     
     
         6 . The method of  claim 1 , wherein a level of the at least one analyte detected in the sample comprises a hydrosalpinx control level or falls within a hydrosalpinx level range. 
     
     
         7 . A method of treating a subject suffering from infertility, comprising:
 determining whether the subject has hydrosalpinx by detecting the presence of at least one analyte in a sample from the subject; wherein the at least one analyte is selected of the group consisting of: mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1; wherein an elevated level of mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, and/or Mucin-16 relative to a control, and/or a diminished level of GSTP1, PRDX5, TXN, PRDX6, and/or SOD1, relative to the control, or wherein a level of the at least one analyte comprises a hydrosalpinx control level or falls within a hydrosalpinx level range, indicates hydrosalpinx in the subject; and   if the subject is determined to not have hydrosalpinx; administering a fertility treatment to the subject; or   if the subject is determined to have hydrosalpinx; administering a hydrosalpinx therapy to the subject followed by a fertility treatment.   
     
     
         8 . The method of  claim 7 , wherein the at least one analyte comprises mesothelin. 
     
     
         9 . The method of  claim 7 , wherein the at least one analyte comprises mesothelin and at least one further analyte selected from the group consisting of:
 Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1.   
     
     
         10 . The method of  claim 7 , wherein the detecting comprises subjecting the sample to one or more reagents for detecting at least one analyte of the group consisting of: mesothelin, Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1. 
     
     
         11 . The method of  claim 7 , wherein the sample comprises tubal fluid, blood, plasma or serum. 
     
     
         12 . The method of  claim 7 , wherein a level of the at least one analyte detected in the sample comprises a hydrosalpinx control level or falls within a hydrosalpinx level range. 
     
     
         13 . An assay system to detect hydrosalpinx in a subject, comprising:
 a substrate to which a protein-containing sample can bind;   a first reagent that interacts with a first analyte in the protein-containing sample, said first analyte comprising mesothelin; and   a second reagent that interacts with at least a second analyte in the protein-containing sample, said second analyte comprising an analyte from the group consisting of: Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1.   
     
     
         14 . The assay system of  claim 13 , further comprising at least a third reagent that interacts with a third analyte in the protein containing sample, said third analyte comprising another analyte, other than the second analyte, from the group consisting of: Galectin-3-binding protein, Clusterin, Polymeric immunoglobulin receptor, Neutrophil gelatinase-associated lipocalin, Leucine-rich alpha-2-glycoprotein, Osteopontin, Alpha-amylase 1, WAP four-disulfide core domain protein 2, Mucin-16, GSTP1, PRDX5, TXN, PRDX6, and SOD1. 
     
     
         15 . The assay system of  claim 13 , further comprising a sample obtaining device for obtaining a sample from the subject. 
     
     
         16 . The assay system of  claim 15 , wherein the sample obtaining device is in fluid communication with the substrate. 
     
     
         17 . The assay system of  claim 15 , wherein the sample obtaining device comprises a needle, a swab, or a sample collection container. 
     
     
         18 . The assay system of  claim 13 , wherein the sample comprises tubal fluid, blood, plasma or serum.