Cartridges for oral fluid analysis and methods of use

Abstract

A disposable cartridge can be used for biofluid sample collection, preparation, and mixing with reagents. After sample collection, the cartridge can be inserted into a reader for sample analysis. This system can be used for detecting and measuring analytes, such as drugs, in saliva for example. This is useful for point of test detection of drugs in applications such as workplace drug testing and driving under the influence of drugs testing.

What is claimed is: 
     
         1 . A cartridge for testing a subject's saliva for a drug using a reader device, the cartridge comprising:
 a cartridge body;   a photonic chip comprising a plurality of waveguides having an exposed edge on one end of the cartridge body, further comprising the drug bound to the waveguide surface;   a diluted sample cavity configured to hold a diluted saliva sample;   a metering channel within the cartridge body in fluid communication with the diluted sample cavity;   a serpentine mixing channel in fluid communication with the metering channel at a fist end and in fluid communication with the photonic chip at a second end;   a plurality of openings through the cartridge body in fluid communication with the diluted sample cavity and metering channel, wherein the plurality of openings are configured to be shut by a valve on a reader device;   a diaphragm in the cartridge body, the diaphragm having a neutral position, a first displaced position extending a fist distance from the neutral position and a second displaced position extending a second distance from the neutral position that is greater than the first distance; and   wherein displacement of the diaphragm by an external push rod on the reader device to the second distance pushes fluid through the serpentine mixing channel in a first direction and further wherein releasing the diaphragm to the neutral position pulls fluid through the serpentine mixing channel in a second direction.   
     
     
         2 . The cartridge of  claim 1 , further comprising a lyophilized and fluorescently-marked antibody in fluid communication with the metering channel. 
     
     
         3 . The cartridge of  claim 1 , further comprising a waste channel fluidly connected to a waste chamber and in fluid communication with the photonic chip. 
     
     
         4 . The cartridge of  claim 1 , further comprising a second serpentine mixing channel in fluid communication with the photonic chip in fluid connection with a second metering channel coupled to a source of control fluid. 
     
     
         5 . The cartridge of  claim 1 , further comprising a blister pack containing a buffer solution. 
     
     
         6 . The cartridge of  claim 1 , further comprising a saliva collection body extending distally from the cartridge body, and configured to collect and dilute a saliva sample from the subject. 
     
     
         7 . The cartridge of  claim 6 , wherein the saliva collection body comprises a first swab piston extending distally from the collection body, the first swab piston comprising a first internal channel configured to wick saliva from an open distal end of the first swab piston; and a second swab piston extending distally from the collection body, the second swab piston comprising a second internal channel configured to wick saliva from an open distal end of the second swab piston. 
     
     
         8 . The cartridge of  claim 7 , further comprising a cap having a first tube configured to receive the first swab piston and a second tube configured to receive the second channel piston; a dilution buffer within the first tube and covered by a first frangible cover that is configured to be pierced by the first swab piston when the cap is attached to the collection body; and a preservation solution, having a different composition than the dilution buffer, within the second tube and covered by a second frangible cover that is configured to be pierced by the second swab piston when the cap is attached to the collection body. 
     
     
         9 . The cartridge of  claim 8 , further comprising a fastener configured to secure the cap to the collection body when a predetermined amount of force is applied, wherein the first swab piston and first tube are configured so that securing the cap to the collection body drives the dilution buffer through the first internal channel to mix and dilute any saliva within the first internal channel and to push the mixed and diluted saliva into the diluted sample cavity. 
     
     
         10 . The cartridge of  claim 1 , wherein the drug comprises one or more drugs of addiction. 
     
     
         11 . The cartridge of  claim 1 , wherein the drug comprises one or more of; cocaine, THC, an opiate, and benzodiazepine. 
     
     
         12 . A cartridge for testing a subject's saliva for a drug using a reader device, the cartridge comprising:
 a cartridge body;   a photonic chip comprising a plurality of waveguides having an exposed edge on one end of the cartridge body, further comprising the drug bound to a surface of the photonic chip above the plurality of waveguides;   a diluted sample cavity configured to hold a diluted saliva sample;   a metering channel within the cartridge body in fluid communication with the diluted sample cavity;   a lyophilized and fluorescently-marked antibody in fluid communication with the metering channel;   a serpentine mixing channel in fluid communication with the metering channel at a fist end and in fluid communication with the photonic chip at a second end;   a waste channel fluidly connected to a waste chamber and in fluid communication with the photonic chip;   a second serpentine mixing channel in fluid communication with the photonic chip in fluid connection with a second metering channel coupled to a source of control fluid;   a plurality of openings through the cartridge body in fluid communication with the diluted sample cavity and metering channel, wherein the plurality of openings are configured to be shut by a valve on a reader device;   a diaphragm in the cartridge body, the diaphragm having a neutral position, a first displaced position extending a fist distance from the neutral position and a second displaced position extending a second distance from the neutral position that is greater than the first distance; and   wherein displacement of the diaphragm by an external push rod on the reader device to the second distance pushes fluid through the serpentine mixing channel in a first direction and further wherein releasing the diaphragm to the neutral position pulls fluid through the serpentine mixing channel in a second direction.   
     
     
         13 . The cartridge of  claim 12 , further comprising a blister pack containing a buffer solution. 
     
     
         14 . The cartridge of  claim 12 , further comprising a saliva collection body extending distally from the cartridge body, and configured to collect and dilute a saliva sample from the subject. 
     
     
         15 . The cartridge of  claim 14 , wherein the saliva collection body comprises a first swab piston extending distally from the collection body, the first swab piston comprising a first internal channel configured to wick saliva from an open distal end of the first swab piston; and a second swab piston extending distally from the collection body, the second swab piston comprising a second internal channel configured to wick saliva from an open distal end of the second swab piston. 
     
     
         16 . The cartridge of  claim 12 , further comprising a cap having a first tube configured to receive the first swab piston and a second tube configured to receive the second channel piston; a dilution buffer within the first tube and covered by a first frangible cover that is configured to be pierced by the first swab piston when the cap is attached to the collection body; and a preservation solution, having a different composition than the dilution buffer, within the second tube and covered by a second frangible cover that is configured to be pierced by the second swab piston when the cap is attached to the collection body. 
     
     
         17 . The cartridge of  claim 16 , further comprising a fastener configured to secure the cap to the collection body when a predetermined amount of force is applied, wherein the first swab piston and first tube are configured so that securing the cap to the collection body drives the dilution buffer through the first internal channel to mix and dilute any saliva within the first internal channel and to push the mixed and diluted saliva into the diluted sample cavity. 
     
     
         18 . The cartridge of  claim 12 , wherein the drug comprises one or more drugs of addiction. 
     
     
         19 . The cartridge of  claim 12 , wherein the drug comprises one or more of; cocaine, THC, an opiate, and benzodiazepine. 
     
     
         20 . A method of testing a subject's saliva for a drug, the method comprising:
 inserting a cartridge into a reader so that: an outer edge of a photonic chip in the cartridge is aligned with an optical sensor in the reader, a piston in the reader aligns with a diaphragm on the cartridge, and a plurality of openings in the cartridge each align with individual valves in the reader configured to open or close the openings in the cartridge;   pushing, using the piston, on a diaphragm on the cartridge to displace the diaphragm from a neutral position to a first deflected position while a first opening in the cartridge is open;   closing the first opening and opening a second opening in the cartridge;   partially releasing the diaphragm by withdrawing the piston to pull fluid from a diluted sample cavity in the cartridge into a metering well wherein the second opening is in fluid communication with the diluted sample cavity distal to the metering well;   closing the second opening and opening a third opening that is in fluid communication with a region between the metering well and the diluted sample cavity;   releasing the diaphragm further by further withdrawing the piston to pull fluid into the metering well and to introduce air between the metering well and the diluted sample cavity;   alternatively pushing and releasing the piston to push and pull fluid from the metering well within a serpentine mixing channel in fluid communication with the mixing well;   releasing the piston to pull the fluid from the serpentine mixing channel onto a surface of the photonic chip; and   reading an evanescent optical signal from a waveguide of the photonic chip.