Kits, compositions and methods for detecting a biological condition

Abstract

The present invention provides kits, apparatus and methods for determining a biological condition in a mammalian subject, the method includes incubating a specimen from a patient with at least one composition in a kit for a predetermined period of time to form at least one reaction product, when the subject has said biological condition, and receiving an indication of the at least one reaction product responsive to at least one reporter element in the kit thereby providing the indication of the biological condition in the subject.

What is claimed is: 
     
         1 . A system for analyzing a sample, the system comprising:
 a test cartridge comprising:
 a) a sample composition chamber adapted for receiving the sample; 
 b) a first, second, and third blister comprising a cell lysis reagent and a diluent; 
 c) a treatment compartment adapted for fluid mixing, wherein the treatment compartment is coupled to the sample composition chamber, the first blister, the second blister, and the third blister via one or more transfer elements, wherein the one or more transfer elements are microfluidic channels that allow fluid communication between the treatment compartment and (1) the sample composition chamber, (2) the first blister, (3) the second blister, and (4) the third blister; and 
 d) an evaluation chamber fluidly connected to the treatment chamber and comprising a reading zone, wherein the reading zone allows the sample to be analyzed as it passes therethrough; and 
   the sample, wherein the sample comprises beads comprising a fluorescent tag, fluorescently tagged antibodies, and cells.   
     
     
         2 . The system of  claim 1 , further comprising a detector operably coupled to the reading zone. 
     
     
         3 . The system of  claim 2 , wherein the detector is a photomultiplier array. 
     
     
         4 . The system of  claim 3 , wherein the detector is an eight channel photomultiplier array. 
     
     
         5 . The system of  claim 1 , wherein the reading zone is configured to allow each cell passing therethrough to be analyzed individually. 
     
     
         6 . The system of  claim 1 , wherein the test cartridge comprises a pump or an air blowing element coupled to the treatment compartment. 
     
     
         7 . The system of  claim 1 , wherein the pump is a bellow pump. 
     
     
         8 . The system of  claim 1 , wherein a volume of each of the first, second, and third blister is from about 1 microliter to 1000 microliters 
     
     
         9 . The system of  claim 1 , further comprising a cartridge handling unit configured to receive the cartridge. 
     
     
         10 . The system of  claim 9 , wherein the cartridge handling unit is programmed to control actuation of the first, second, or third blister. 
     
     
         11 . The system of  claim 9 , wherein the cartridge handling unit is programmed to control mixing of the sample on the cartridge. 
     
     
         12 . The system of  claim 9 , wherein the cartridge handling unit is programmed to complete an assay running on the cartridge in a period of about 30 minutes. 
     
     
         13 . The system of  claim 9 , wherein the cartridge handling unit is operably coupled to a display. 
     
     
         14 . The system of  claim 13 , wherein the display is configured to output a graphical output of a fluorescent detection assay relating to the sample. 
     
     
         15 . The system of  claim 1 , wherein a volume of the sample is about 50 microliters or smaller. 
     
     
         16 . The system of  claim 1 , wherein the antibodies are murine monoclonal antibodies. 
     
     
         17 . The system of  claim 1 , wherein the cell lysis reagent comprises ammonium chloride. 
     
     
         18 . The system of  claim 1 , wherein the treatment compartment comprises a tortuous shaped channel. 
     
     
         19 . The system of  claim 1 , wherein the cells comprise erythrocytes or leukocytes. 
     
     
         20 . The system of  claim 1 , wherein the diluent comprises saline.