US2023173490A1PendingUtilityA1

Multi-chambered assay devices and associated methods, systems and apparatuses thereof for detection of analytes

Assignee: ORBIS DIAGNOSTICS LTDPriority: Mar 20, 2020Filed: Jan 30, 2023Published: Jun 8, 2023
Est. expiryMar 20, 2040(~13.7 yrs left)· nominal 20-yr term from priority
B01L 2200/0668B01L 2300/0803G01N 33/543B01L 3/50273B01L 2400/0688B01L 2400/06B01L 2200/16B01L 2400/0409G01N 21/65G01N 33/743B01F 33/304B01L 2300/161B01F 35/71725B01L 2400/0487B01L 2200/0684B01F 35/331B01L 3/502715B01L 2300/0654B01F 31/10B01L 3/502761
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Claims

Abstract

Accordingly, in some embodiments of the disclosure, a multi-chambered assay device is provided, which is configured for arrangement on a disc, as well as configured to process an individual sample. A plurality of such assay devices can be arranged along a periphery of the disc at a distance/radius from the center, such that a plurality of individual samples can be processed, e.g., one per assay device. In addition, in an arrangement that a plurality of assay devices are used, they can be spaced apart such that they balance the disc during rotation (which can be with samples contained in one or more of the assay devices, a plurality, a majority, or all of the assay devices).

Claims

exact text as granted — not AI-modified
What is currently claimed: 
     
         1 . An assay device configured for arrangement on a disc, and configured to process an individual sample, the assay device positioned along a periphery of the disc at a predetermined radius in a spaced apart arrangement, the assay device comprising:
 a plurality of peripheral chambers each configured to receive one or more fluids via a respective inlet area;   a resuspension chamber including a scaffold for at least one of drying and retaining at least one reagent;   and   a main chamber having a mixing area and at least one bead therein   
     
     
         2 . The device of  claim 1 , wherein the plurality of chambers comprise at least one of a first peripheral chamber, a second peripheral chamber, and a third peripheral chamber. 
     
     
         3 . The device of  claim 1 , wherein each peripheral chamber includes a corresponding inlet area. 
     
     
         4 . The device of  claim 5 , wherein each inlet area is configured to flow or otherwise transfer a fluid to a respective peripheral chamber via a microfluidic channel. 
     
     
         5 . The device of  claim 1 , wherein the plurality of peripheral chambers comprise at least two of:
 a first peripheral chamber having an associated first inlet area, the first inlet area in fluid communication with the first peripheral chamber via a first microchannel,   wherein fluid received in the first inlet area flows into the first peripheral chamber;   a second peripheral chamber having an associated second inlet area, the second inlet area in fluid communication with the second peripheral chamber via a second microchannel, wherein fluid received in the second inlet area flows into the second peripheral chamber;   and a third peripheral chamber having an associated third inlet area, the third inlet area in fluid communication with the third peripheral chamber via a third microchannel, wherein fluid received in the third inlet area flows into the third peripheral chamber.   
     
     
         6 . The device of  claim 1 , wherein the resuspension chamber is in fluid communication with at least one of the peripheral chambers via an associated microfluidic channel. 
     
     
         7 . The device of  claim 1 , wherein the scaffold material comprises a mesh. 
     
     
         8 . The device of  claim 7 , wherein the mesh configured as a geometric shape. 
     
     
         9 . The device of  claim 10 , wherein the geometric shape comprises a circular disc between 1-6 mm in diameter. 
     
     
         10 . The device of  claim 7 , wherein the mesh includes a mesh or pore size selected from the group consisting of between: 10-250 pm, between 10-20 pm, between 20-40 pm, 40-60 pm, 60-80 pm, 80-100 pm, 100-120 pm, 120-140, 140-160, 160-180, 180-200, 200-220, 220-240, 240-250. 
     
     
         11 . The device of  claim 1 , wherein the mixing area is arranged distally to the main chamber towards an edge of the disc. 
     
     
         12 . The device of  claim 11 , wherein the mixing chamber includes one or more pre-stored reagents. 
     
     
         13 . The device of  claim 1 , wherein the main chamber is configured to receive fluid from each of plurality of peripheral chambers via associated microfluidic channels. 
     
     
         14 . The device of  claim 1 , wherein the mixing chamber is configured as a detection window. 
     
     
         15 . The device of  claim 1 , wherein the missing chamber is configured to stabilize the bead during measurements. 
     
     
         16 . The device of  claim 1 , wherein the bead includes at least one capture reagent establishing a plurality of binding sites thereon. 
     
     
         17 . The device of  claim 16 , wherein the capture reagent of the bead comprises at least one of one or more antibodies and antigens. 
     
     
         18 . The device of  claim 16 , wherein the reagent covers a percentage of the surface of the at least one bead. 
     
     
         19 . The device of  claim 1 , wherein the at least one bead includes a diameter of between 100 pm-2500 pm. 
     
     
         20 . The device of  claim 1 , further comprising a first siphon channel and an associated valve configured to at least one of time and mix a dried reagent for resuspension of the dried reagent in the resuspension chamber. 
     
     
         21 . The device of  claim 1 , further comprising at least one siphon channel. 
     
     
         22 . The device of  claim 21 , wherein the siphon channel includes at least one microfluidic capillary valve being in fluid communication with the resuspension chamber and the main chamber. 
     
     
         23 . The device of  claim 1 , further comprising a microfluidic pressure release capillary valve in communication with the main chamber. 
     
     
         24 . The device of  claim 21 , further comprising a second siphon channel and an associated valve configured to provide at least one of a timing and mixing in the main chamber. 
     
     
         25 . The device of  claim 26 , wherein the second siphon includes at least one microfluidic capillary valve. 
     
     
         26 . The device of  claim 1 , further comprising a waste chamber in communication with the main chamber via at least one siphon. 
     
     
         27 . The device of  claim 26 , further comprising a pressure release outlet in fluid communication with the waste chamber via a microfluid channel. 
     
     
         28 . The device of  claim 1 , further comprising at least one microfluidic capillary valve including a dried hydrophobic material configured to decrease wettability at a specific area such that fluid flow/transitions via the capillary valve is based on a rotational speed of the disc. 
     
     
         29 . The device of  claim 28 , wherein each capillary valve includes at least one of a surface modification of a contact angle at an entrance thereof so as to prevent fluid uncontrolled bridging of the capillary valve, and an increase in pressure to open the valve. 
     
     
         30 . An assay device configured for arrangement on a disc, and configured to process an individual sample, the assay device positioned along a periphery of the disc at a predetermined radius in a spaced apart arrangement, the assay device comprising:
 a plurality of peripheral chambers each configured to receive one or more fluids via a respective inlet area;   a resuspension chamber including a scaffold for at least one of drying and retaining at least one reagent;   a main chamber;   at least one bead;   and   a mixing chamber arranged at a distal end of the main chamber toward the periphery of the disc, wherein the mixing chamber is sized and/or shaped so as to contain the at least one bead at rest such that when at rest, the at least one bead is removed from the mixing chamber.

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