Homogenous Assay Device and Apparatus

Abstract

Among other things, the present disclosure is related to devices and methods of performing biological and chemical assays, such as but not limited to immunoassays and nucleic assay acid, particularly a homogeneous assay that does not use a wash step and that is fast (e.g., 60 seconds from dropping a sample to displaying results). The present disclosure is related to both competitive and non-competitive homogeneous assays.

What is claimed is: 
     
         1 . A device for performing a homogenous assay of an analyte that is or is suspected of being in a sample, comprising:
 (a) one bead that have a capture agent attached onto the surface of the one or more beads, wherein the capture agent binds to the analyte;   (b) a labeled detection agent, wherein the labeled detection agent binds to either the capture agent or the analyte but not both;   (s) a first plate and a second plate, wherein the first and second plates are configured to make at least a part of the sample into a thin layer of a thickness of 200 um or less between the two plates, and wherein the beads and the labeled detection agent are in the at least a part of the sample.   
     
     
         2 . An apparatus for performing a homogenous assay of an analyte that is or is suspected of being in a sample, comprising:
 (a) the device of  claim 1 ;   (b) an imager that is configured to take at least two images, including a first image and a second image, of a common area of the sample layer, wherein the common area of the sample layer is an area of the sample that contains the bead, wherein the first image is a direct image for measuring topology of the sample including a position and geometry of the bead; and the second image is a signal image for measuring a signal from the labeled detection agent; and   (c) a computer readable medium that contain an algorithm that compares and analyzes the first image and the second image to identify the signal at the bead.   
     
     
         3 . A method for performing a homogenous assay of an analyte that is or is suspected of being in a sample, comprising:
 (a) providing a sample that contains or is suspected of containing an analyte;   (b) providing one bead that have a capture agent attached onto the surface of the one or more beads, wherein the capture agent binds to the analyte;   (c) providing a labeled detection agent, wherein the labeled detection agent binds to either the capture agent or the analyte but not both;   (d) providing a sample holder that is configured to make at least a part of the sample into a sample layer of a thickness of 200 um or less;   (e) having the sample in the sample holder, wherein the bead and the labeled detection agent are mixed with the sample in the sample layer;   (f) taking, after step (e), without washing the sample, at least two images, including a first image and a second image, of a common area of the sample layer, wherein the common area of the sample layer is an area of the sample that contains the bead, wherein the first image is a direct image for measuring topology of the sample including a position and geometry of the bead; and the second image is a signal image for measuring a signal from the labeled detection agent;   (g) after (f), comparing and analyzing, using an algorithm, the first image and the second image to identify the signal at the bead.