DEVICES, SYSTEMS, METHODS, AND KITS FOR RECEIVING A SWAB

• US 20160243543A1
• Filed: 02/11/2016
• Published: 08/25/2016
• Est. Priority Date: 09/06/2013
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Lui, Clarissa, Holmes, Elizabeth A.
• Granted Patent: US 10,391,496 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: B01L 1/52 Transportable laboratories; Field kits
• CPC Class Codes: B01L 2200/02 Adapting objects or devices to another
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/0858 Side walls
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 1/02 Devices for withdrawing samples sampling of foundation soil E02D1/04; collecting or conveying radioactive samples G01T7/00, e.g. G01T7/02, G01T7/08
• CPC Class Codes: G01N 1/10 in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising

Abstract

Methods, devices, systems, and kits useful for the collection and analysis of samples obtained by swabs are disclosed. Swab containers configured for receiving a swab containing a sample; cartridges for holding one or more of: a swab container, a swab, assay units, pipette tips, vessels, transport units, and implements; systems (which may include a sample processing device); kits; and methods for their use are disclosed. A swab container may include an entry port; an assay chamber having an assay port; a conduit comprising an interior channel connecting the entry port; and an interior channel providing fluidic communication between the entry port and assay chamber. An interior channel may be configured to squeeze a portion of a swab placed in or through the conduit. A cartridge may include a cartridge frame configured to receive one or more of swab containers, assay units, transport units, pipette tips, vessels or implements.

Claims

1. A container for receiving a swab, comprising:

at least one entry port, said entry port configured to receive at least one swab having a handle;

an assay chamber having an port, said assay chamber being configured to receive at least a portion of a swab;

a conduit comprising an interior channel connecting said entry port with said assay chamber, said conduit being configured to accept at least a portion of said swab handle therein;

wherein said conduit provides fluidic communication between said entry port and said assay chamber effective that passing a swab through said entry port into said conduit allows at least a portion of the swab to be placed within said assay chamber.

2. The container for receiving a swab of claim 1, wherein said conduit interior channel is configured to squeeze a portion of a swab placed in or through said conduit interior channel portion adjacent to said assay chamber.

3. The container for receiving a swab of claim 1, wherein said conduit interior channel comprises interior dimensions, wherein said interior dimension near said entry port is greater than said interior dimension near said assay chamber.

4. The container for receiving a swab of claim 1, wherein said conduit interior channel comprises a cross-section having a cross-sectional shape selected from round, oval, square, rectangular, rhomboid, and triangular.

5. The container for receiving a swab of claim 1, wherein said conduit connects with said assay chamber at a contact angle, wherein said contact angle comprises between about 10°

to about 90°

, or between about 40°

to about 85°

, or between about 70°

to about 80°

.

6. The container for receiving a swab of claim 1, wherein said assay chamber comprises a cross-sectional dimension, wherein said cross-sectional dimension comprises between about 3 millimeters (mm) to about 30 mm, or between about 4 mm to about 20 mm, or between about 5 mm to about 15 mm.

7. The container for receiving a swab of claim 1, comprising a material selected from polypropylene, polycarbonate, polystyrene, polyurethane, polyethylene, polyacrylamide, polyacrylate, polymethacrylate, polymethylmethacrylate (PMMA), poly(4-methylbutene), other acrylic, polydimethysiloxanes (PDMS), polyvinylchloride (PVC), poly(vinyl butyrate)polysulfone, acrylonitrile-butadiene-styrene (ABS), poly(ethylene terephthalate), a fluorocarbon polymer (e.g., polytetrafluoroethylene (PTFE or Teflon®

)), nylon, a co-polymer, and combinations thereof.

8. The container for receiving a swab of claim 1, comprising a cover configured to cover said entry port, a cover configured to cover said assay port, or both.

9. The container for receiving a swab of claim 8, comprising a pierceable cover.

10. The container for receiving a swab of claim 8, comprising a cover that is flexibly connected to said assay chamber, assay port, conduit, or entry port, and that is configured to cover said assay port or said entry port in a first position and to be disposed away from said assay port or entry port in a second position.

11. The container for receiving a swab of claim 1, wherein said conduit interior channel comprises a length sufficient to contain at least a portion of said handle when a swab having a handle is disposed within said interior channel of the conduit.

12. The container for receiving a swab of claim 1, wherein said contact angle comprises an angle of between about 70°

to about 80°

, and said conduit interior channel comprises a length, wherein said length is between about 50 millimeters (mm) and about 150 mm.

13. The container for receiving a swab of claim 1, wherein said swab container contains a reagent for bathing a swab, wherein said reagent for bathing a swab is effective to receive sample material from said swab into said reagent.

14. The container for receiving a swab of claim 1, comprising a conduit having a plurality of interior channels or a plurality of conduits each of which comprise at least one interior channel, wherein each of said interior channels provides fluidic communication between an entry port and said assay chamber effective that passing a swab through said entry port into said conduit allows at least a portion of the swab to be placed within said assay chamber.

15. The container for receiving a swab of claim 14, wherein one entry port is in fluidic communication with more than one interior channel.

16. The container for receiving a swab of claim 14, comprising a plurality of entry ports, wherein each interior channel is in fluidic communication with a single entry port.

66. The container for receiving a swab of claim 13, comprising a volume of reagent for bathing a swab, wherein said volume of reagent is selected from the group of volumes of less than about 1 mL, or less than about 500 μ

L, or less than about 250 μ

L, or less than 150 μ

L, or less than about 100 μ

L, or less than about 50 μ

L, or less than about 25 μ

L, or less than about 10 μ

L, or less than about 5 μ

L, or less than about 1 μ

L.

86. The container of claim 13, wherein said reagent comprises an extraction buffer.

17-65. -65. (canceled)

67-85. -85. (canceled)

87-100. -100. (canceled)

101. A swab container, said swab container being configured for receiving a swab, comprising:

at least one entry port, said entry port configured to receive at least one swab having a handle;

an assay chamber having an port, said assay chamber being configured to receive at least a portion of a swab;

a conduit comprising an interior channel connecting said entry port with said assay chamber, said conduit being configured to accept at least a portion of said swab handle therein;

wherein said conduit provides fluidic communication between said entry port and said assay chamber effective that passing a swab through said entry port into said conduit allows at least a portion of the swab to be placed within said assay chamber, and wherein said interior channel of said conduit is configured to squeeze a portion of a swab placed in or through said conduit interior channel portion adjacent to said assay chamber.

109. The swab container of claim 101, comprising a plurality of interior channels each providing fluidic communication between an entry port and said assay chamber effective that passing a swab through said entry port into said conduit allows at least a portion of the swab to be placed within said assay chamber, wherein said plurality of interior channels are selected from i) two or more interior channels within a conduit;

ii) two or more conduits each having an interior channel; and

iii) combinations thereof.

102-108. -108. (canceled)

110-130. -130. (canceled)