Diagnostic sanitary test strip

Abstract

An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.

1 - 28 . (canceled) 
     
     
         29 . A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:
 a first support layer having a first interior surface;   a second support layer having a second interior surface;   a separating layer pretreated with a separating agent; and   a membrane pretreated with a reagent and a conditioning solution to produce a color change in response to the analyte of interest;   wherein the separating layer and the membrane are supported between and in contact with the first and second interior surfaces of the first and second support layers, respectively.   
     
     
         30 . The diagnostic test strip of  claim 29 , wherein the separating layer removes substantially all red blood cells from the fluid sample. 
     
     
         31 . The diagnostic test strip of  claim 30 , wherein the membrane removes the remaining red blood cells from the fluid sample. 
     
     
         32 . The diagnostic test strip of  claim 29 , wherein the membrane is isotropic. 
     
     
         33 . The diagnostic test strip of  claim 29 , wherein the first support layer includes a sample receiving port, and the second support layer includes a reaction viewing port. 
     
     
         34 . The diagnostic test strip of  claim 33 , wherein the separating layer is in vertical alignment with the sample receiving port, and the membrane is in vertical alignment with the reaction viewing port. 
     
     
         35 . The diagnostic test strip of  claim 29 , wherein the separating layer filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the membrane. 
     
     
         36 . The diagnostic test strip of  claim 29 , wherein the separating layer is a woven fabric including a plurality of mesh openings. 
     
     
         37 . The diagnostic test strip of  claim 29 , wherein the color change in the reagent corresponds to an amount of the analyte of interest present. 
     
     
         38 . A diagnostic test strip for measuring an analyte of interest in a heterogeneous fluid sample, the test strip comprising:
 a first support layer including a sample receiving port for receiving the fluid sample and having a first interior surface;   a second support layer including a reaction viewing port for displaying the measurement and having a second interior surface;   a separating layer pretreated with a separating agent; and   a membrane pretreated with a reagent for reacting with the analyte of interest to produce a measurable change in color for display in the reaction viewing port;   wherein the separating layer and the membrane are supported between and in contact with the first and second interior surfaces of the first and second support layers, respectively, and   wherein the separating agent filters at least one undesirable element from the fluid sample prior to passing the fluid sample to the membrane.   
     
     
         39 . The diagnostic test strip of  claim 38 , wherein the separating layer includes a plurality of mesh openings. 
     
     
         40 . The diagnostic test strip of  claim 38 , wherein the separating layer is in vertical alignment with the sample receiving port, and the membrane is in vertical alignment with the reaction viewing port. 
     
     
         41 . The diagnostic test strip of  claim 38 , wherein the measurable change in the reagent corresponds to an amount of the analyte of interest present.