Systems and methods for analyte testing and laboratory oversight

• US 10,401,373 B1
• Filed: 05/02/2017
• Issued: 09/03/2019
• Est. Priority Date: 02/18/2013
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos IP Company, LLC
• Inventors: Holmes, Elizabeth A., Smith, Timothy, Loo, Alexander, Young, Daniel
• Primary Examiner(s): Hixson, Christopher Adam
• Application Number:
  US15/584,374
• Time in Patent Office: 854 Days
• CPC Class Codes: G01N 2035/1048 using the transfer device for another function
• CPC Class Codes: G01N 2035/1058 for mixing
• CPC Class Codes: G01N 21/00 Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light G01N3/00 - G01N19/00 take precedence
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 35/0098 involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C
• CPC Class Codes: G01N 35/1065 Multiple transfer devices
• CPC Class Codes: G01N 35/1072 with provision for selective pipetting of individual channels

Abstract

In one embodiment, a method is provided comprising analyte testing on one or more types of samples.

Claims

1. A method comprising:

providing a sample processing device,

providing a cartridge containing at least two types of reagents and at least two types of vessels;

inserting the cartridge into the sample processing device;

using a magnet tool that resides inside the sample processing device that is picked up using a pipette nozzle of a pipette of the sample processing device, wherein the magnet tool is partially retracted inside of the pipette nozzle;

coupling a magnet tool sleeve from the cartridge to the pipette nozzle; and

extending the magnet tool into the magnet tool sleeve and inserting into a vessel to capture magnet beads inside the vessel on an exterior of the magnet tool sleeve.

2. A method comprising:

inserting a cartridge into a sample processing device;

breaking through a foil seal barrier on the cartridge to access a sample therein;

mixing the sample in a sample vessel;

adding lysis buffer and functionalized magnetic beads to the sample from reagent storage locations on the cartridge;

moving a vessel with the sample to a sonicator probe location, and the vessel is sonicated in order to lyse open the cells to release the nucleic acids

adding binding buffer to help the nucleic acids bind to the functionalized magnetic beads

using a magnet tool that resides inside the sample processing device that is picked up using a pipette nozzle of a pipette of the sample processing device, wherein the magnet tool is partially retracted inside of the pipette nozzle;

coupling a magnet tool sleeve from the cartridge to the pipette nozzle; and

extending the magnet tool to the magnet tool sleeve and inserting into the vessel to capture the magnet beads on an exterior of the magnet tool sleeve.

3. The method of claim 2 wherein the magnet tool comprises a magnetized rod.

4. The method of claim 2 wherein a piston of the pipette nozzle extends outward from the pipette nozzle to engage the magnet tool to pick up the magnet tool from the cartridge.

5. The method of claim 4 wherein the piston of the pipette nozzle retracts inward to remove the magnet tool from the magnet tool sleeve.

6. The method of claim 4 wherein pipette nozzle used with the magnet tool is larger than other pipette nozzles of the pipette.

7. The method of claim 2 wherein magnetic beads with captured nucleic acids are held on a tip of the sleeve and are transported into a well of the cartridge containing wash buffer.

8. The method of claim 7 further comprising retracting the magnet tool into the pipette nozzle, and the pipette nozzle is moved in vertical directions for several cycles to release the beads and mixed by fluid displacement the well of wash buffer.

9. The method of claim 8 further comprising extending the magnet tool back into the magnet tool sleeve and inserted into the well of wash buffer to capture washed magnet beads and transport them on the magnet tool sleeve.

10. The method of claim 9 further comprising moving the magnet tool and its sleeve carrying captured magnetic beads with purified nucleic acid sample into an elution buffer well.

11. The method of claim 10 further comprising retracting the magnet tool, covered by the magnet tool sleeve, into the pipette nozzle by moving a piston motor of the pipette, and the pipette nozzle with the magnet tool sleeve is moved in a vertical direction multiple times to release the beads and mix them with fluid of the elution buffer well.

12. The method of claim 11 further comprising incubating beads in the elution well.

13. The method of claim 12 further comprising extending the magnet tool back into the magnet tool sleeve and inserting into the elution buffer well to capture the magnetic beads.

14. The method of claim 13 further comprising discarding the magnet tool sleeve into its original location on the cartridge.

15. The method of claim 14 comprising returning the magnet tool to its location on the sample processing device.