Diagnostic systems and cartridges

Abstract

A clinical diagnostic system is disclosed, including a clinical diagnostic instrument with a disposable cartridge. The disposable cartridge is capable of performing diagnostic and analytical functions including filtering samples such as plasma from whole blood and running assays and collecting measurements of analytes or biomarkers. Methods of storing dry and liquid reagents together on the disposable cartridge are also disclosed.

What is claimed is: 
     
         1 . A method of storing dry and liquid reagents together on a cartridge, comprising:
 storing in the cartridge at least one liquid in at least one fluid-containing compartment of the cartridge;   storing in the cartridge at least one dry reagent in at least one dry reagent-containing compartment, wherein the at least one fluid-containing compartment is adjacent to the at least one dry reagent-containing compartment on the cartridge, and
 wherein the cartridge has a pathway connecting the at least one dry reagent to at least one vapor from the liquid; and 
   sealing a cartridge in an airtight package with a moisture-absorbent material, wherein the moisture-absorbent material out-competes the at least one dry reagent for water absorption that slowly diffuses from the liquid through a wall of the at least one fluid-containing compartment.   
     
     
         2 . The method of  claim 1 , wherein the wall of the at least one fluid-containing compartment is made from a material having a low moisture vapor transmission rate. 
     
     
         3 . The method of  claim 1 , wherein the wall of the at least one fluid-containing compartment is made from cyclic olefin copolymer. 
     
     
         4 . The method of  claim 1 , wherein the moisture-absorbent material is a desiccant. 
     
     
         5 . The method of  claim 1 , wherein the desiccant is DRIERITE®. 
     
     
         6 . The method of  claim 1 , wherein the package is a foil pouch. 
     
     
         7 . A desiccating system for a cartridge that has both stored liquids and dry reagents, comprising:
 storing in the cartridge at least one liquid in at least one fluid-containing compartment of the cartridge;   storing in the cartridge at least one dry reagent in at least one dry reagent-containing compartment; and   sealing a cartridge in an airtight package with a desiccant, wherein the cartridge has at least one passageway connecting the dry reagent and the cartridge exterior where a desiccant is located.   
     
     
         8 . The desiccating system of  claim 7 , wherein the at least one fluid-containing compartment is adjacent to the at least one dry reagent-containing compartment on the cartridge. 
     
     
         9 . The desiccating system of  claim 7 , wherein the at least one fluid-containing compartment is separated from the at least one dry reagent-containing compartment by a wall within the cartridge. 
     
     
         10 . The desiccating system of  claim 7 , wherein the at least one fluid-containing compartment is separated from the at least one dry reagent-containing compartment by a wall made of cyclic olefin copolymer. 
     
     
         11 . The desiccating system of  claim 7 , wherein the desiccant absorbs more water than the at least one dry reagent. 
     
     
         12 . The desiccating system of  claim 7 , wherein the rate of transport of water vapor to the desiccant is greater than the rate of transport of water vapor to the at least one dry reagent-containing compartment on the cartridge. 
     
     
         13 . The desiccating system of  claim 7 , wherein the desiccant comprises at least one molecular sieve. 
     
     
         14 . The desiccating system of  claim 7 , wherein the desiccant is silica. 
     
     
         15 . The desiccating system of  claim 7 , the cartridge further comprising:
 structural members;   a body and a cover, wherein the body and the cover mate together;   at least one reagent handling station formed from the body;   a septum seal between the body and cover capable of establishing a liquid and air-tight seal for the at least one reagent handling station and capable of establishing a fluidic connection with at least one probe of a diagnostic instrument in the diagnostic system;   a bottom seal adjacent to the body;   at least one fluidic channel formed from the body and sealed by the bottom seal, wherein the bottom seal defines in part the volume of the at least one fluidic channel;   a blood filtration module in fluidic communication with the blood collection tube mount; and   a plasma cache; and   a mounting apparatus for mounting a blood collection tube to the cartridge, the mounting apparatus comprising:
 a framework comprising of at least one of the structural members of the cartridge; and 
 at least one needle capable of establishing a fluidic connection between the cartridge and the blood collection tube when the at least one needle pierces a septum of the blood collection tube, wherein the framework is configured to guide the blood collection tube into a position such that the blood collection tube is capable of being fixed at an angle ranging from about 45° to about 5° from a horizontal axis of the cartridge; 
   wherein the at least one reagent handling station is part of a closed fluidic pathway.   
     
     
         16 . A desiccating system for a cartridge containing both liquid and dry reagents, comprising:
 the cartridge comprising:
 structural members; 
 a body and a cover, wherein the body and the cover mate together; 
 at least one dry reagent-containing compartment formed from the body configured to store at least one dry reagent; 
 at least one reagent handling station formed from the body, wherein the at least one reagent handling station is part of a closed fluidic pathway and wherein the cartridge is configured to store at least one liquid in the at least one reagent handling station; 
 a septum seal between the body and cover capable of establishing a liquid and air-tight seal for the at least one reagent handling station and capable of establishing a fluidic connection with at least one probe of a diagnostic instrument in the diagnostic system; 
 a bottom seal adjacent to the body; 
 at least one fluidic channel formed from the body and sealed by the bottom seal, wherein the bottom seal defines in part the volume of the at least one fluidic channel; and 
 a mounting apparatus for mounting a blood collection tube to the cartridge, the mounting apparatus comprising:
 a framework comprising of at least one of the structural members of the cartridge; and 
 at least one needle capable of establishing a fluidic connection between the cartridge and the blood collection tube when the at least one needle pierces a septum of the blood collection tube, wherein the framework is configured to guide the blood collection tube into a position such that the blood collection tube is capable of being fixed at an angle ranging from about 45° to about 5° from a horizontal axis of the cartridge; and 
 
   an airtight package configured to hold the cartridge, wherein the cartridge is sealed within the airtight package with a moisture-absorbent material, and wherein the cartridge has at least one passageway connecting the dry reagent and the cartridge exterior where the moisture-absorbent material is located.   
     
     
         17 . The desiccating system of  claim 16 , wherein the at least one reagent handling station is adjacent to the at least one dry reagent-containing compartment on the cartridge. 
     
     
         18 . The desiccating system of  claim 16 , wherein the at least one reagent handling station is separated from the at least one dry reagent-containing compartment by a wall within the body of the cartridge. 
     
     
         19 . The desiccating system of  claim 16 , wherein the at least one reagent handling station is separated from the at least one dry reagent-containing compartment by a wall made of cyclic olefin copolymer. 
     
     
         20 . The desiccating system of  claim 16 , wherein the moisture-absorbent material absorbs more water than the at least one dry reagent. 
     
     
         21 . The desiccating system of  claim 16 , wherein the rate of transport of water vapor to the moisture-absorbent material is greater than the rate of transport of water vapor to the at least one dry reagent-containing compartment on the cartridge. 
     
     
         22 . The desiccating system of  claim 16 , wherein the moisture-absorbent material is a desiccant. 
     
     
         23 . The desiccating system of  claim 22 , wherein the desiccant comprises at least one molecular sieve. 
     
     
         24 . A desiccating system of  claim 22 , wherein the desiccant is silica.