Methods and kits for assays of analytes of interest in tears

Abstract

The invention, in one aspect, provides a strip for tear collection. The strip has a first end and an opposite second end and preferably has substantially uniform cross-sections from the first end to the second end. The strip is made of a hydrogel material in substantially dry state. The strip is characterized by having a substantially uniform swelling along the hydrogel strip from the first end to the second end when fully wicked by a tear fluid and by having a correlation between the volume of tear uptake by said strip and the length of the wicked end portion of said strip. A strip of the invention is useful for assay of an analyte of interest in a tear fluid. The invention also provides a method and kits for assaying an analyte of interest (e.g., lactoferrin, glucose, herpes simplex virus, hormones, etc.).

1 - 31 . (canceled)  
     
     
         32 . A strip for tear collection, having a first end and an opposite second end, wherein said strip is made of a hydrogel material in substantially dry state, wherein said hydrogel material is obtained by polymerization or copolymerization of at least one hydrophilic monomer in the presence of or in the absence of additional monomers and/or macromers and is selected from the group consisting of poly(vinyl alcohol), modified polyvinylalcohol, poly(hydroxyethyl methacrylate), poly(vinyl pyrrolidone), poly(vinyl alcohol) with polycarboxylic acids, polyacrylamide, polymethacrylamide, silicone-containing hydrogels, polyurethane, polyurea, and mixtures thereof, wherein said strip is characterized by having a substantially uniform swelling along the hydrogel strip from the first end to the second end when fully wicked by the tear fluid during tear collection-and characterized by having a defined correlation between the volume of tear uptake by said strip and the length of a tear-wicked end portion of said strip.  
     
     
         33 . A strip of  claim 32 , wherein said strip has substantially uniform cross-sections from the first end to the second end.  
     
     
         34 . A strip of  claim 33 , wherein the cross-section of said strip has a rectangular shape.  
     
     
         35 . A strip of  claim 34 , wherein the cross-section of said strip has a width of from about 1 mm to about 3 mm and a height of from 0.5 mm to 1.5 mm.  
     
     
         36 . A strip of  claim 34 , wherein the cross-section of said strip has a width of from 1.5 mm to 2 mm and a height of from 0.8 mm to 1.2 mm.  
     
     
         37 . A strip of  claim 33 , wherein the cross-section of said strip is circular, and wherein the diameter of the circular cross-section is from 1 mm to 3 mm.  
     
     
         38 . A strip of  claim 32 , wherein said defined correlation between the volume of tear uptake by said strip and the length of the tear-wicked end portion of said strip is a substantially linear relationship.  
     
     
         39 . A strip of  claim 32 , wherein said strip has noticeable marks thereon, wherein each of the marks indicates a volume of the tear fluid absorbed by the end portion up to that mark of said strip.