Disposable cartridge for reagent storage systems and methods using the same

Abstract

In general, the present application is directed to cartridge assemblies which can be used for reagent storage and systems and methods using the same. Aspects of the present disclosure can include disposable cartridge assemblies that are intended for single-use only. For instance, example cartridge assemblies can include interlocking features that can couple to a to an assay system (e.g., a chip assembly) in an irreversible manner.

What is claimed is: 
     
         1 . A system for conducting an assay comprising:
 a cartridge assembly, wherein the cartridge assembly comprises:
 a first surface having a first seal, 
 a second surface having a second seal, and 
 one or more reservoirs positioned between the first surface and the second surface, 
 the reservoirs defining a volume, and wherein at least one of the one or more reservoirs contains a wet reagent; and 
   a chip assembly, wherein the chip assembly comprises:
 a microfluidic channel, and 
 one or more puncture elements configured to pierce the second seal to provide the wet reagent to the chip assembly. 
   
     
     
         2 . The system of  claim 1 , wherein the first seal comprises:
 a non-reactive layer enclosing the one or more reservoirs, and   a flexible layer in contact with the non-reactive layer.   
     
     
         3 . The system of  claim 2 , wherein the second seal comprises:
 an inert layer enclosing the cone or more reservoirs, and   a compressible layer in contact with the inert layer.   
     
     
         4 . The system of  claim 3 , wherein the cartridge assembly and the chip assembly are oriented so that engaging the cartridge assembly and the chip assembly causes the one or more puncture elements to pierce the second seal and the compressible layer to contact the chip assembly to fluidically seal the microfluidic channel. 
     
     
         5 . The system of  claim 1 , wherein the chip assembly further comprises an optically transparent seal, and wherein the optically transparent seal forms a bottom to the microfluidic channel. 
     
     
         6 . The system of  claim 5 , wherein the cartridge assembly and the chip assembly are oriented so that engaging the cartridge assembly and the chip assembly causes the one or more puncture elements to pierce the second seal and the compressible layer to contact the chip assembly to fluidically seal a top of the microfluidic channel. 
     
     
         7 . The system of  claim 1 , wherein the cartridge assembly further comprises a mechanism configured to prevent the cartridge assembly from engaging the chip assembly until the mechanism is activated. 
     
     
         8 . The system of  claim 1 , wherein the cartridge assembly and/or the chip assembly further comprise a sample port for providing a biological sample. 
     
     
         9 . The system of  claim 8 , wherein the chip assembly further comprises a plurality of metal beads configured to interact with RNA present in the biological sample. 
     
     
         10 . The system of  claim 1 , wherein the cartridge assembly further comprises one or more one-way clips that are configured to irreversibly engage portions of the chip. 
     
     
         11 . The system of  claim 1 , wherein the one or more reservoirs comprise:
 a first reservoir containing a wash and a second reservoir containing a master mix, wherein the master mix comprises at least one polymerase.   
     
     
         12 . The system of  claim 1 , wherein the assay comprises polymerase chain reaction (PCR). 
     
     
         13 . The system of  claim 1 , wherein the volume is 5 μL to 30 μL. 
     
     
         14 . A method for conducting an assay, the method comprising:
 providing a biological sample to a cartridge assembly, wherein the cartridge assembly comprises:
 a first surface having a first seal, 
 a second surface having a second seal, and 
 one or more reservoirs positioned between the first surface and the second surface, the reservoirs defining a volume, and wherein at least one of the one or more reservoirs contains a wet reagent; 
   engaging the cartridge assembly with a chip assembly to transfer the biological sample to the chip assembly, wherein the chip assembly comprises:
 a microfluidic channel, and 
 one or more puncture elements configured to pierce the second seal to provide the wet reagent to the chip assembly; and 
   moving the biological sample through the microfluidic channel, wherein   after engaging the cartridge assembly with the chip assembly, the one or more reservoirs become fluidically connected to the microfluidic channel.   
     
     
         15 . The method of  claim 14 , wherein moving the biological sample through the microfluidic channel comprises:
 applying pressure to one or more regions of the first seal, whereby the pressure is fluidically communicated to the biological sample.   
     
     
         16 . The method of  claim 14 , wherein after engaging the cartridge assembly with the chip assembly the wet reagent mixes with the biological sample to produce a liquid biological sample. 
     
     
         17 . The method of  claim 15 , wherein the microfluidic channel comprises a first serpentine region held at a first temperature, a second serpentine region held at a second temperature, and a detection volume positioned between the first serpentine region and the second serpentine region, wherein the second temperature is different from the first temperature, and wherein moving the biological sample through the microfluidic channel comprises:
 inducing a fluid flow by applying pressure to at least one region of the first seal, wherein the fluid flow moves the biological sample directionally from the first serpentine region to the detection volume and the second serpentine region; and   reversing the fluid flow by removing pressure to said at least one region of the first seal, applying pressure to another region of the first seal, or both, wherein said another region of the first seal is different from said at least one region of the first seal, and wherein reversing the fluid flow moves the biological sample directionally from the second serpentine region to the detection volume and the first serpentine region.   
     
     
         18 . The method of  claim 17 , further comprising iteratively repeating inducing the fluid flow and reversing the fluid flow over a number of cycles. 
     
     
         19 . The method of  claim 14 , further comprising:
 detecting a signal from the biological sample, wherein detecting the signal is performed while moving the biological sample through the microfluidic channel.   
     
     
         20 . The method of  claim 14 , wherein the one or more reservoirs comprise:
 a first reservoir containing a wash and a second reservoir containing a master mix, wherein the master mix comprises at least one polymerase.   
     
     
         21 . The method of  claim 14 , wherein the assay comprises polymerase chain reaction (PCR). 
     
     
         22 . The method of  claim 14 , wherein the volume is 5 μL to 30 μL. 
     
     
         23 . A cartridge assembly for storing wet reagents, wherein the cartridge assembly comprises:
 a first surface having a first seal,   a second surface having a second seal, and   one or more reservoirs positioned between the first surface and the second surface,   the reservoirs defining a volume, and wherein at least one of the one or more reservoirs contains a polymerase.   
     
     
         24 . The cartridge assembly of  claim 23 , wherein the first seal and the second seal, respectively provide a top and a bottom enclosing the volume defined by the reservoirs. 
     
     
         25 . The cartridge assembly of  claim 23 , wherein the first seal comprises a non-reactive layer facing the one or more reservoirs, and a compressible layer adhered to the non-reactive layer. 
     
     
         26 . The cartridge assembly of  claim 25 , wherein the second seal comprises an inert layer facing the one or more reservoirs, and a flexible layer in contact with the inert layer. 
     
     
         27 . The cartridge assembly of  claim 26 , wherein the inert layer, the non-reactive layer, or both comprise: a metal foil, a fluorinated polymer, or combinations thereof. 
     
     
         28 . The cartridge assembly of  claim 27 , wherein the fluorinated polymer is polytetrafluoroethylene.