Multilayer reagent test strips and methods for using the same to quantify glycated protein in a physiological sample

Abstract

Multilayer reagent test strips for quantitating glycated protein in a fluid sample, as well as methods for using the same, are provided. The subject multilayer test strips include at least a filter layer, a proteinase layer and a ketoamine oxidase signal producing and fluid flow control system layer. In using the subject test strips, a fluid sample is applied to the test strip and a signal is generated that can be employed to quantitate the glycated protein level in the sample. The quantitated glycated protein level can then be employed to determine the amount of glycated protein in the fluid sample. Also provided are kits and systems that include the subject test strips and find use in practicing the subject methods. The subject compositions and methods find use in glycated protein monitoring applications, among other utilities.

1 - 17 . (canceled)  
     
     
         18 . A method for quantifying the amount of glycated protein in a physiological sample, said method comprising: 
 providing a multilayer test strip comprising: 
 a blood separation element for separating red blood cells from plasma;  
 a protease layer in fluid communication with said blood separation element; and  
 a ketoamine oxidase signal producing system layer in fluid communication with said protease layer;  
   applying said physiological sample to a said multilayer test strip    detecting a signal produced on said test strip to quantify the amount of glycated protein in said physiological sample.    
     
     
         19 . The method according to  claim 18 , wherein said physiological sample is whole blood.  
     
     
         20 . The method according to  claim 18 , wherein said detecting step is performed by an automated instrument.  
     
     
         21 - 25 . (canceled)