Kits And Devices For Detecting Analytes

Abstract

The invention provides devices that improve tests for detecting specific cellular, viral, and molecular targets in clinical, industrial, or environmental samples. The invention permits efficient detection of individual microscopic targets at low magnification for highly sensitive testing. The invention does not require washing steps and thus allows sensitive and specific detection while simplifying manual operation and lowering costs and complexity in automated operation. In short, the invention provides devices that can deliver rapid, accurate, and quantitative, easy-to-use, and cost-effective tests.

1 . A device for analyzing a sample potentially containing a target, wherein said device comprises
 a. a housing comprising an inlet for the sample;   b. an imaging well having a depth of ≥2 mm and comprising a detection area with a shortest linear dimension of ≥1 mm;   c. a reservoir disposed in the housing for selection moieties and/or signaling moieties fluidically connected to the imaging well or selection moieties and/or signaling moieties disposed in the imaging well in liquid or dry form;   d. features for positioning or registration of the imagining well with an imaging analyzer,   wherein the imaging well is disposed in the housing to allow for external illumination of the detection area and/or detection of light emitted from the imaging well, wherein the inlet is fluidically connected to the imaging well, and wherein the detection area is transparent at wavelengths corresponding to the signal signature of said signaling moieties.   
     
     
         2 . The device of  claim 1 , further comprising capture molecules that are bound to the imaging well and that specifically bind the target. 
     
     
         3 . The device of  claim 1 , wherein a detection surface defining the detection area is non-fluorescent at the wavelengths corresponding to said signal signature. 
     
     
         4 . The device of  claim 1 , wherein the imaging well is integral with the housing. 
     
     
         5 . The device of  claim 1 , wherein the imaging well is separable from the housing. 
     
     
         6 . The device of  claim 1 , wherein the inlet accepts a sampling device 
     
     
         7 . The device of  claim 6 , wherein the sampling device is a sample swab or pipette. 
     
     
         8 . The device of  claim 1 , wherein the housing comprises stabilizers for vertical stacking of multiple devices. 
     
     
         9 . The device of  claim 1 , further comprising a seal for the inlet, which is engaged after the sample is introduced into the inlet. 
     
     
         10 . The device of  claim 9 , wherein engaging the seal results in movement of the sample from the inlet towards the imagining well. 
     
     
         11 . The device of  claim 10 , wherein the seal comprises a plunger. 
     
     
         12 . The device of  claim 9 , wherein the seal is capable of being variably moved relative to the inlet. 
     
     
         13 . The device of  claim 12 , wherein the seal is threaded and screwing of the seal into the device results in movement of the sample. 
     
     
         14 . The device of  claim 1 , further comprising a meter for the volume of the sample introduced into the device via the inlet. 
     
     
         15 . The device of  claim 1 , further comprising a second reservoir disposed in the housing and containing a cushion or dried reagents that produce the cushion upon solvation, wherein the cushion has a density greater than an overlying liquid layer following said solvation and wherein the second reservoir is fluidically connected to the imaging well. 
     
     
         16 . The device of  claim 1 , wherein the imaging well further comprises a cushion or dried reagents that produce the cushion upon solvation, wherein the cushion has a density greater than an overlying liquid layer comprising solvated target signaling moieties and selection moieties following said solvation. 
     
     
         17 . The device of  claim 1 , further comprising a third reservoir disposed in the housing and containing a dye that interferes with the production or transmission of light to or from the signaling moieties, wherein the third reservoir is fluidically connected to the imaging well. 
     
     
         18 . The device of  claim 17 , wherein the third reservoir further comprises a cushion or dried reagents that produce the cushion upon solvation, wherein the cushion has a density greater than an overlying liquid layer comprising solvated target signaling moieties and selection moieties following said solvation. 
     
     
         19 . The device of  claim 1 , wherein the imaging well further comprises a dye that interferes with the production or transmission of light to or from the signaling moieties. 
     
     
         20 . The device of  claim 19 , wherein the imaging well further comprises a cushion or dried reagents that produce the cushion upon solvation, wherein the cushion has a density greater than an overlying liquid layer liquid layer comprising solvated target signaling moieties and selection moieties following said solvation.