Multiplex bead array assay

Abstract

The present disclosure relates to a system, method, and kit for particle detection and analysis. Devices disclosed herein may include at least an optical source, a fluidic chip containing a multiplex bead array, and a detection module, wherein the sample flows within the fluidic chip past a detection window, where the cells or particles are imaged by an image acquisition and analysis module that may include an optical detector. The image acquisition and analysis module counts the labeled particles and software allows for analysis of bead population.

What is claimed is: 
     
         1 . A system for detecting analytes in a sample comprising:
 a. one or more housing units;   b. a bead array, wherein the bead array comprises at least one detection bead labelled with a detectable signal and a capture probe attached to the detection bead surface and wherein the bead array is capable of detecting at least two unique analytes in a sample;   c. an analyte detection molecule;   d. a fluidic chip, the fluidic chip incorporating at least one microfluidic channel that one or more detection beads flows through within the fluidic chip;   e. a detection window incorporated in one of the one or more housings, the detection window being operable to facilitate the capture of one or more images of one or more detection beads flowing within the detection window; and   f. a detection module, the detection module comprising an optical imaging system and software for image analysis, that allows communication to and from a central database.   
     
     
         2 . The system of  claim 1 , wherein the bead array comprises fluorescent detection beads, wherein each detection bead is coupled with a capture probe. 
     
     
         3 . The system of  claim 2 , wherein the bead array comprises detection beads having at least one of varying fluorescent wavelengths and intensities. 
     
     
         4 . The system of  claim 1 , wherein the detection beads comprise a magnetic microbead core. 
     
     
         5 . The system of  claim 1 , wherein the detection beads comprise quantum dots. 
     
     
         6 . The system of  claim 2 , wherein the capture probe is an antibody. 
     
     
         7 . The system of  claim 2 , wherein the capture probe is an oligonucleotide probe. 
     
     
         8 . The system of  claim 1 , wherein all reagents required for the detection are supplied and sealed in a cartridge. 
     
     
         9 . The system of  claim 1 , wherein the reagents are dried, lyophilized, or slow dried on the fluidic chip. 
     
     
         10 . The system of  claim 1 , wherein the detection module further comprises:
 a. the optical imaging system comprising a light source and detector;   b. the software for image analysis, that allows communication to and from the central database;   c. a display;   d. an input/output means;   e. CPU;   f. storage or memory means;   g. power control; and   h. communication means.   
     
     
         11 . The detection module of  claim 10 , wherein the dimensions of the detection module do not exceed 25×15×5 cm. 
     
     
         12 . The detection module of  claim 10 , wherein the software maintains privacy standards equivalent to HIPAA when displaying, storing, and transmitting patient data.