Secreted P-glycoprotein is a Non-Invasive Biomarker of Chronic Rhinosinusitis

Abstract

Methods for identifying and optionally treating subjects, e.g., subjects who have Chronic Rhinosinusitis (CRS), based on the detection of elevated levels of soluble P-glycoprotein in nasal secretions. The methods of treatment can include administration of a therapeutically effective amount of a P-glycoprotein inhibitor.

1 .- 20 . (canceled) 
     
     
         21 . A kit for use in a method of diagnosing and/or treating Chronic Rhinosinusitis (CRS) in a subject, the method comprising:
 providing a sample comprising nasal secretions, preferably comprising nasal secretions comprising secreted p-glycoprotein (P-gp) from the subject;   detecting the level of secreted p-glycoprotein (P-gp) in the sample;   comparing the level of P-gp in the sample to a reference level of P-gp, wherein the level of P-gp in the sample above the reference level indicates that the subject has CRS; and   identifying the subject as having CRS,   said kit comprising:
 an antibody or antigen-binding fragment thereof that binds specifically to P-glycoprotein, and one or more of: a sponge for sample collection; a delivery device for placing the sponge; a collection container comprising a protease inhibitor and/or RNAse inhibitor for sample preservation; sterile saline; and a cold or freezer pack for specimen preservation during shipment. 
   
     
     
         22 . The kit of  claim 21 , wherein the kit comprises a sample comprising a known amount of P-glycoprotein. 
     
     
         23 . The kit of  claim 21 , comprising a sponge for sample collection. 
     
     
         24 . The kit of  claim 23 , comprising a delivery device for placing the sponge. 
     
     
         25 . The kit of  claim 21 , comprising a collection container comprising a protease inhibitor and/or a RNAse inhibitor. 
     
     
         26 . The kit of  claim 25 , wherein the container comprises a protease inhibitor. 
     
     
         27 . The kit of  claim 25 , wherein the container comprises a RNAse inhibitor. 
     
     
         28 . The kit of  claim 25 , wherein the container comprises a protease inhibitor and an RNAse inhibitor. 
     
     
         29 . The kit of  claim 21 , comprising sterile saline. 
     
     
         30 . The kit of  claim 21 , comprising a cold or freezer pack for specimen preservation during shipment. 
     
     
         31 . The kit of  claim 30 , comprising a cold pack. 
     
     
         32 . The kit of  claim 30 , comprising a freezer pack. 
     
     
         33 . The kit of  claim 21 , comprising a sample comprising a known amount of P-glycoprotein, a sponge for sample collection, a delivery device for placing the sponge, and a collection container comprising a protease inhibitor and/or a RNAse inhibitor. 
     
     
         34 . The kit of  claim 33 , comprising sterile saline. 
     
     
         35 . The kit of  claim 34 , comprising a cold pack or freezer pack. 
     
     
         36 . The kit of  claim 21 , wherein the antibody or antigen-binding fragment thereof that binds specifically to P-glycoprotein is a first antibody that binds specifically to P-glycoprotein (P-gp), further comprising a second, different antibody which binds to either P-gp or to the first antibody and is conjugated to a detectable agent. 
     
     
         37 . The kit of  claim 36 , wherein the first antibody is attached to a solid support. 
     
     
         38 . The kit of  claim 36 , further comprising a test strip. 
     
     
         39 . The kit of  claim 38 , wherein the test strip is a lateral-flow test strip.