Detection of influenza virus

Abstract

The present application describes methods for detecting influenza A and/or influenza B and/or distinguishing between pathogenic and seasonal influenza A subtypes. Many of these preferred formats employ pan-specific antibodies (i.e., that react with all or at least multiple strains within an influenza type) to detect presence of influenza A and/or influenza B and PDZ domains in combination with panspecific antibodies to influenza A to distinguish pathogenic and seasonal influenza A subtypes.

1 - 29 . (canceled) 
     
     
         30 . A kit for determining the presence and/or amount and/or subtype of an influenza A virus in a human subject, comprising:
 (a) a first capture reagent immobilized upon a solid support, and comprising at least one binding agent that specifically binds to influenzavirus non-structural protein (NS1),   (b) a second detector reagent comprising a label that can be optically detected by eye and at least one binding agent that specifically binds to NS1.   
     
     
         31 . The kit of  claim 30 , further comprising a means for collecting a clinical sample from a human subject. 
     
     
         32 . The kit of  claim 31 , wherein the solid support is a lateral flow assay device. 
     
     
         33 . The kit of  claim 30 , wherein the label is a colorimetric label and comprises gold or colored latex particles. 
     
     
         34 . The kit of  claim 30 , wherein the first or second reagent comprises a PDZ polypeptide or antibody that specifically binds to one or more subtypes of NS1. 
     
     
         35 . The kit of  claim 30 , wherein the first or the second reagent binds pan-specifically to NS1. 
     
     
         36 . The kit of  claim 30 , wherein the first or second reagent comprises a first binding agent specifically binds in a subtype-specific manner to a first subtype of NS1. 
     
     
         37 . The kit of  claim 36 , wherein said first or second reagent comprises a second binding agent different from the first binding agent, wherein the second binding agent specifically binds to NS1. 
     
     
         38 . The kit of  claim 37 , wherein the second binding agent specifically binds in a subtype-specific manner to a second subtype of NS1. 
     
     
         39 . The kit of  claim 38 , wherein the second subtype of NS1 is different from the first subtype. 
     
     
         40 . The kit of  claim 39 , wherein the second binding agent does not specifically bind to the first subtype of NS1. 
     
     
         41 . The kit of  claim 36 , wherein the first subtype is pathogenic and the second subtype is seasonal, or vice versa. 
     
     
         42 . The kit of  claim 41 , wherein the first or second subtype is H5N1 or H1N1 or H3N2. 
     
     
         43 . The kit of  claim 37 , wherein the second binding agent binds pan-specifically to NS1. 
     
     
         44 . The kit of  claim 37 , wherein first reagent comprises both the first and second binding agent. 
     
     
         45 . The kit of  claim 44 , wherein the first reagent comprises said first and second binding agents organized in an array. 
     
     
         46 . The kit of  claim 30 , further comprising at least one sample of an influenza virus NS1 protein as control. 
     
     
         47 . A kit comprising a capture reagent and a detection reagent, wherein:
 (a) the capture reagent comprises at least one capture antibody that specifically binds to influenza A virus non-structural protein (NS1)   (b) the detection reagent comprises at least one detection antibody that specifically binds NS1 at a different site from the at least one capture antibody,   (c) the at least one capture antibody is immobilized upon a solid support within a lateral flow assay device,   (d) the at least one detection antibody is attached to a label which emits a visually detectable signal, and   (e) the capture reagent comprises a first and second capture antibody that specifically bind to NS1 organized in an array, wherein the first capture antibody specifically binds to a first subtype of NS1 that is not bound by the second capture antibody.   
     
     
         48 . The method of  claim 47 , wherein the first capture antibody binds in a subtype-specific manner to NS1. 
     
     
         49 . The method of  claim 47 , wherein both the first capture antibody and the second capture antibody specifically bind to a second subtype of NS1.