Analytical test device and method of use

Abstract

The present invention provides an analytical test device for conducting assays of biological fluids. Methods for carrying out the assays with the disclosed analytical test device are also provided.

I claim:  
     
         1 . An analytical test device, comprising: 
 (a) a top having one or more display ports and, optionally, a receiving port and a vertical bar;    (b) a bottom, optionally having the receiving port, an upper plane, a slope and a lower plane;    (c) a strip comprising an absorbent membrane, a reaction membrane having one or more reagents that form a reaction complex with an analyte in a fluid sample and, optionally, a collecting pad;    (d) an absorbent sample pad in a container; and    (e) a stopping means,    wherein the absorbent membrane, the reaction membrane and the collecting pad, when present, are in fluid flow contact with one another; the strip is placed on the bottom such that the reaction membrane is visible through the display port and the absorbent membrane is towards the receiving port; the top or the bottom have the receiving port or together the top and the bottom form the receiving port; and in the assembled top and bottom the absorbent sample pad is slidably insertable through the receiving port until stopped by the stopping means, which places the absorbent sample pad in fluid flow contact with the absorbent membrane.    
     
     
         2 . The analytical test device of  claim 1 , further comprising the top having the optional vertical bar, wherein the vertical bar deflects the absorbent membrane to follow the contour of the slope and further comprising the bottom having the optional upper plane, slope and lower plane.  
     
     
         3 . The analytical test device of  claim 1 , wherein the stopping means is the container contacting the outside of the assembled top and bottom.  
     
     
         4 . The analytical test device of  claim 1 , further comprising a bottom having a horizontal bar, wherein the horizontal bar is inside the assembled top and bottom and is the stopping means.  
     
     
         5 . The analytical test device of  claim 4 , wherein the stopping means is the horizontal bar contacting the container.  
     
     
         6 . The analytical test device of  claim 1 , wherein the edge of the absorbent sample pad that contacts the absorbent membrane is orthogonal to the absorbent membrane.  
     
     
         7 . The analytical test device of  claim 1 , wherein the one or more reagents is a diffusively bound labeled reagent bound to the absorbent membrane at a point spatially separated from the point at which the absorbent sample pad first contacts the absorbent membrane.  
     
     
         8 . The analytical test device of  claim 7 , wherein bound to the reaction membrane is: 
 (a) a non-diffusively bound reagent complementary to an analyte in the fluid sample at a point beneath the display port; and    (b) a non-diffusively bound control reagent complementary to the diffusively bound labeled reagent at a point beneath the display port spatially separated from the point at which the non-diffusively bound reagent is bound.    
     
     
         9 . The analytical test device according to  claim 8 , further comprising a first display port and a second display port, wherein the non-diffusively bound reagent is positioned beneath the first display port and the non-diffusively bound control reagent is positioned beneath the second display port.  
     
     
         10 . The analytical test device of  claim 7 , wherein bound to the reaction membrane at a point beneath the display port is a non-diffusively bound reagent, wherein the analyte and the diffusively bound labeled reagent compete for binding to the non-diffusively bound reagent.  
     
     
         11 . A method for detecting an analyte in a fluid sample, comprising the steps of: 
 (a) adding fluid sample to the absorbent sample pad of the analytical test device of  claim 1;     (b) inserting the absorbent sample pad into the receiving port until the absorbent sample pad is stopped by the stopping means;    (c) detecting the analyte by observing the reaction complex through the display port.    
     
     
         12 . The method according to  claim 11 , wherein the reaction complex is visible.