Assay modules having assay reagents and methods of making using same

Abstract

We describe assay modules (e.g., assay plates, cartridges, multi-well assay plates, reaction vessels, etc.), processes for their preparation, and method of their use for conducting assays. Reagents may be present in free form or supported on solid phases including the surfaces of compartments (e.g., chambers, channels, flow cells, wells, etc.) in the assay modules or the surface of colloids, beads, or other particulate supports. In particular, dry reagents can be incorporated into the compartments of these assay modules and reconstituted prior to their use in accordance with the assay methods. A desiccant material may be used to maintain and stabilize these reagents in a dry state.

1 - 41 . (canceled) 
     
     
         42 . A method of carrying out an assay in a multi-well assay plate, the multi-well assay plate comprising a plate body with a plurality of wells defined therein comprising: (a) a plurality of detection wells, wherein each detection well comprises a binding surface having a capture reagent immobilized thereon and (b) a plurality of reagent reconstitution wells, wherein each reagent reconstitution well comprises a reconstitutable labeled detection reagent, wherein at least one detection well and one reagent reconstitution well comprise matched capture and detection reagents for measuring an analyte of interest, the method comprising:
 (a) adding a sample to one of said reagent reconstitution wells,   (b) reconstituting reconstitutable dry labeled detection reagents in said reconstitution well to form one or more reaction mixture(s),   (c) transferring an aliquot of said reaction mixture to one or more detection wells,   (d) incubating said reaction mixture in said detection well(s) under conditions that promote binding of said capture and detection reagents to their corresponding binding partners, and   (e) measuring formation of complexes comprising said immobilized capture reagents and said labeled binding reagent.   
     
     
         43 . The method of  claim 42 , wherein said multi-well assay plate can be divided into a plurality of sets of wells consisting of one first reagent well and one or more second reagent wells, and said method further comprises repeating the process of (a)-(d) for each of said set of wells. 
     
     
         44 - 47 . (canceled) 
     
     
         48 . A method of carrying out an assay in a multi-well assay plate comprising a plate body with a plurality of wells defined therein comprising: (a) a plurality of first reagent wells holding a reconstitutable first dry reagent and (b) a plurality of second reagent wells holding a second dry reagent, wherein said first and second reagents are matched reagents for conducting an assay, the method comprising:
 (a) adding a sample to one of said first reagent wells,   (b) reconstituting reconstitutable dry labeled detection reagents in said first reagent well to form a reaction mixture,   (c) transferring an aliquot of said reaction mixture to one or more of said second reagent wells, and   (d) incubating said reaction mixture in said second reagent well(s) so as to carry out said assay on said sample.   
     
     
         49 . The method of claim  66 , wherein said multi-well assay plate can be divided into a plurality of sets of wells consisting of one first reagent well and one or more second reagent wells, and said method further comprises repeating the process of (a)-(d) for each of said set of wells. 
     
     
         50 . A multi-well assay plate comprising a plate body with a plurality of wells defined therein having well floors and well walls that extend from said floors to a height hw above said floors, wherein said walls are shaped so as to provide shelf elements at a height h s , wherein 0<h s <h w . 
     
     
         51 . The multi-well assay plate of  claim 50 , wherein 0.05 h w <h s <0.25 h w . 
     
     
         52 . The multi-well plate of  claim 50 , wherein 0.2 mm<h s <5 mm. 
     
     
         53 . The multi-well plate of  claim 50 , wherein said plate body is a one-piece injection-molded part. 
     
     
         54 . The multi-well plate of  claim 50 , wherein said plate body comprises a plate top having a plurality of through-holes that define said well walls and a plate bottom that is sealed against said plate top, and said plate bottom defines said well floors. 
     
     
         55 . The multi-well plate of  claim 54 , wherein said plate bottom provides conductive electrode surfaces that are exposed to the interior volume of the wells. 
     
     
         56 . The multi-well assay plate of  claim 50 , wherein said plate defines wells arranged in a 4×6, 8×12, 16×24, or 32×48 array. 
     
     
         57 - 69 . (canceled) 
     
     
         70 . A multi-well assay plate comprising:
 (a) a plate body with a plurality of wells defined therein containing a dry assay reagent, said plate body comprising a plate top having a plurality of through-holes that define well walls and a plate bottom that is sealed against said plate top and defines well floors,   (b) a plate seal sealed against said plate body, thereby isolating said plurality of wells from the external environment, and   (c) a dessicant material.   
     
     
         71 . The multi-well plate of  claim 70 , wherein said plate seal comprises said desiccant material. 
     
     
         72 . The multi-well plate of  claim 70  further comprising a gasket layer between said plate seal and said plate body, wherein said gasket layer comprises said desiccant material. 
     
     
         73 . The multi-well plate of  claim 70 , wherein said plate top is impregnated with said desiccant material. 
     
     
         74 . The multi-well plate of  claim 70  further comprising a gasket layer between said plate top and said plate bottom, wherein said gasket layer comprises said desiccant material. 
     
     
         75 . The multi-well plate of  claim 70 , wherein said plate bottom comprises said desiccant material. 
     
     
         76 . The multi-well plate of  claim 70 , wherein said plate body defines one or more additional wells, and said additional wells hold said desiccant material. 
     
     
         77 . The multi-well plate of  claim 70 , wherein said plate bottom provides conductive electrode surfaces that are exposed to the interior volume of the wells. 
     
     
         78 . The multi-well assay plate of  claim 70 , wherein said assay well comprises an binding surface having a capture reagent immobilized thereon and a reconstitutable dry labeled detection reagent. 
     
     
         79 . The multi-well assay plate of  claim 78 , wherein said assay well further comprises one or more additional immobilized capture reagents, said capture reagent and additional capture reagents form a patterned array of binding domains on said binding surface, and said binding domains differ in specificity or affinity for binding partners. 
     
     
         80 . The multi-well assay plate of  claim 79 , wherein said reconstitutable dry reagent further comprises one or more additional labeled detection reagents, and said detection reagent and additional detection reagents differ in specificity or affinity for binding partners. 
     
     
         81 . The multi-well assay plate of  claim 70 , wherein said binding surface is suitable for use as an electrode in an electrochemiluminescence assay. 
     
     
         82 . The multi-well assay plate of  claim 70 , wherein said plate defines wells arranged in a 4×6, 8×12, 16×24, or 32×48 array.