Systems and methods for multi-analysis

• US 9,250,229 B2
• Filed: 02/18/2013
• Issued: 02/02/2016
• Est. Priority Date: 09/25/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A.
• Primary Examiner(s): HIXSON, CHRISTOPHER
• Application Number:
  US13/769,779
• Publication Number:
  US 20140073043A1
• Time in Patent Office: 1,079 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 2035/00326 Analysers with modular structure
• CPC Class Codes: G01N 2035/00495 Centrifuges
• CPC Class Codes: G01N 33/5005 involving human or animal cells immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025
• CPC Class Codes: G01N 35/00 Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
• CPC Class Codes: G01N 35/0092 Scheduling

Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Claims

1. A biological sample processing device comprising:

a) a pipette comprising at least a first nozzle and a second nozzle;

b) a detection station comprising an optical sensor;

c) a cytometry station comprising an imaging device and a stage for receiving a microscopy cuvette, and

d) a cartridge supporting multiple components comprising i) a biological sample and ii) at least a first, a second, and a third fluidically isolated assay unit,

wherein the first assay unit and second assay unit each comprise a pipette tip;

wherein the third assay unit comprises a microscopy cuvette configured to interface with the stage, and the third assay unit further comprises a first pipette interface and a second pipette interface, and

wherein the pipette is configured to i) transfer at least a portion of the biological sample to the first assay unit, the second assay unit, and the third assay unit;

ii) transfer the first and second assay units containing biological sample to the detection station; and

iii) engage the third assay unit at the first pipette interface with the first nozzle and at the second pipette interface with the second nozzle, and, while the third assay unit is engaged with the first nozzle and second nozzle, transfer the third assay unit containing biological sample to the cytometry station.

2. The sample processing device of claim 1, wherein the pipette further comprises a third nozzle.

3. The sample processing device of claim 2, wherein the second nozzle and third nozzle have different shapes.

4. The sample processing device of claim 1, wherein the biological sample has a volume of no greater than 250 microliters.

5. The sample processing device of claim 1, wherein the biological sample is whole blood.

6. The sample processing device of claim 1, wherein the optical sensor is a photomultiplier tube (PMT) or photodiode.

7. The sample processing device of claim 1, wherein the detection station further comprises a light source.

8. The sample processing device of claim 7, wherein the light source comprises a light emitting diode (LED) or a laser.

9. The sample processing device of claim 1, wherein the cartridge further comprises an absorbent pad.

10. The sample processing device of claim 1, wherein the imaging device is a camera.

11. The sample processing device of claim 10, wherein the camera comprises a CMOS or CCD sensor.

12. The sample processing device of claim 1, wherein the sample processing device further comprises a centrifuge, wherein the cartridge further comprises a centrifuge vessel, and wherein the pipette is further configured to transfer at least a portion of the biological sample to the centrifuge vessel and to transfer the centrifuge vessel to the centrifuge.

13. The sample processing device of claim 1, wherein the pipette tip of each of the second and third assay units comprises an interior volume, and wherein the interior volume of each of the pipette tips comprises 150 microliters or less.

14. The sample processing device of claim 1 further comprising a housing, wherein the housing encloses the device.

15. The sample processing device of claim 5, wherein the biological sample is a first biological sample, wherein the cartridge further supports a second biological sample.

16. The sample processing device of claim 1, wherein the cartridge further comprises a heater.

17. The sample processing device of claim 1 wherein the cartridge is configured to be insertable into and removable from the device.

18. The sample processing device of claim 15, wherein the second biological sample is saliva.

19. The sample processing device of claim 15, wherein the second biological sample is urine.