Systems and methods for detecting a biological condition

Abstract

The present invention provides self-contained systems, apparatus and methods for determining a chemical state, the system includes a stationary cartridge for performing the assay therein, the cartridge adapted to house at least one reagent adapted to react with a sample; and at least one reporter functionality adapted to report a reaction of the at least one reagent with the sample to report a result of the assay, a mechanical controller including a first urging means adapted to apply a force externally onto the cartridge to release the at least one reagent; and at least one second urging means adapted to apply a removable force to induce fluidic movement in a first direction in the cartridge and upon removal of the force causing fluidic movement in an opposite direction to the first direction, an optical reader adapted to detect the reaction and a processor adapted to receive data from the optical reader and to process the data to determine said chemical state.

1 . A self-contained system for performing an assay for determining a chemical state, the system comprising:
 a) a stationary cartridge for performing the assay therein, the cartridge adapted to house at least one reagent adapted to react with a sample; and at least one reporter functionality adapted to report a reaction of said at least one reagent with said sample to report a result of said assay; wherein said cartridge further comprises an alignment means adapted to align a reading channel on said cartridge for a detection of said least one reporter functionality;   b) a mechanical controller comprising;
 i. a first urging means adapted to apply a force externally onto said cartridge to release said at least one reagent; 
 ii. at least one second urging means adapted to apply a removable force to induce fluidic movement in a first direction in said cartridge and upon removal of said force causing fluidic movement in an opposite direction to said first direction; 
   c) an optical reader adapted to detect said reaction; and   d) a processor adapted to receive data from said optical reader and to process said data to determine said chemical state.   
     
     
         2 . (canceled) 
     
     
         3 . A system according to  claim 1 , further comprising a plurality of fluidic open channels, all said channels in liquid communication with each other. 
     
     
         4 . A system according to  claim 3 , wherein said cartridge is adapted to be sealed after receiving a fluid specimen and to pass a predetermined quantity of said sample through at least part of said plurality of fluidic open channels. 
     
     
         5 . A system according to  claim 4 , wherein said cartridge further comprises at least one inflatable deformable elastic chamber adapted to apply at least one of a negative pressure and a positive pressure in said fluidic channels. 
     
     
         6 . A system according to  claim 5 , wherein said at least one deformable elastic chamber is adapted to further contact said at least one reagent stored in a sealed on-board storage chamber with a predetermined quantity of said sample in a reaction chamber to induce said reaction. 
     
     
         7 . A system according to  claim 6 , wherein said a first urging means is disposed proximal to said on-board storage chamber such that upon movement is adapted to break a frangible seal on said storage chamber. 
     
     
         8 . A system according to  claim 7 , wherein said alignment means adapted to align with a reading channel on said cartridge for a detection of a reaction in said predetermined quantity of said sample. 
     
     
         9 . A system according to  claim 7 , wherein some of said plurality of fluidic open channels are of a cross-section of 0.1 to 2 mm 2 . 
     
     
         10 . A system according to  claim 8 , wherein said predetermined quantity is of a volume of 10 to 500 microliters. 
     
     
         11 . (canceled) 
     
     
         12 . A system according to  claim 1 , wherein said cartridge is adapted to induce cascaded sequential reactions of a plurality of on-board reagents, with said at least one of said sample and a reaction product. 
     
     
         13 . A system according to  claim 1 , wherein said cartridge comprises at least one reaction chamber of a volume of 200 to 10000 microliters. 
     
     
         14 . A system according to  claim 1 , further comprising a temperature control device external to said cartridge, said device being adapted to control a temperature of said reaction. 
     
     
         15 .- 23 . (canceled) 
     
     
         24 . A system according to  claim 1 , wherein said cartridge is a disposable microfluidics cartridge. 
     
     
         25 . A system according to  claim 1 , wherein said sample is introduced to said cartridge via capillary action. 
     
     
         26 .- 29 . (canceled) 
     
     
         30 . A system according to  claim 1 , wherein said at least one reagent disposed in said cartridge comprises at least one sepsis biomarker. 
     
     
         31 .- 58 . (canceled)