Prewetting lateral flow test strip

Abstract

A test strip and method for detecting an analyte present in a sample. The test strip comprising: a buffer addition zone to which a buffer may be added; an absorbent zone proximal to the buffer addition zone; one or more test zones distal to the buffer addition zone, at least one of the test zones including a first analyte binding agent immobilized therein which is capable of binding to the analyte to be detected; a terminal buffer flow zone distal to the one or more test zones, the absorbent zone being positioned relative to the buffer addition zone and having an absorption capacity relative to the other zones of the test strip such that when a volume of buffer within a predetermined buffer volume range for the test strip is added to the buffer addition zone, a distal diffusion front of the buffer diffuses from the buffer addition zone to a distal diffusion point within the terminal buffer flow zone and then diffuses proximal relative to the one or more test zones; and a sample addition zone distal to the terminal buffer flow zone to which a sample may be added.

1 . (canceled) 
     
     
         2 . A test strip characterized in that:
 said test strip is a lateral flow test strip adapted to receive a sample for performance of an assay to detect an analyte in said sample; and   said test strip reduces performance variability during the performance of said assay.   
     
     
         3 . The test strip of  claim 2 , wherein said performance variability is reduced by reducing absolute amount of either an analyte binding agent or a control binding agent that binds to region on said test strip. 
     
     
         4 . The test strip of  claim 2 , wherein said performance variability is reduced by reducing variations in liquid flow rates across said test strip. 
     
     
         5 . The test strip of  claim 4 , wherein said performance variability is reduced by equilibrating said liquid flow rate so that said sample, once added, moves across said test strip at a uniform rate. 
     
     
         6 . The test strip of  claim 2 , wherein said performance variability is reduced by prewetting said test strip prior to addition of said sample. 
     
     
         7 . The test strip of  claim 3 , wherein said region on said test strip comprises a test zone, a control zone, or both. 
     
     
         8 . The test strip of  claim 6 , wherein said test strip is prewet with buffer, wherein said buffer may, optionally, comprises a control agent. 
     
     
         9 . The test strip of  claim 8 , wherein said buffer is added to a region of said test strip comprising a buffer addition zone. 
     
     
         10 . The test strip of  claim 9 , wherein said buffer flows across said test zone, control zone, or both, and then independently flows back toward said buffer addition zone. 
     
     
         11 . The test strip of  claim 10 , wherein said buffer flows back toward said buffer addition zone independent of any user intervention. 
     
     
         12 . The test strip of  claim 8 , wherein said buffer is added to said test strip within a predetermined volume range designed for said test strip. 
     
     
         13 . The test strip of  claim 12 , wherein said predetermined volume range is between about 10 μl and about 250 μl.