IP Library Granted Patent US 11,162,936
Granted Patent B2
US 11,162,936 · App. 15/595,489 · Granted Nov 2, 2021

Systems and methods for multi-analysis

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Daniel Young (San Francisco, CA); Timothy Smith (San Ramon, CA); Joy Roy (San Jose, CA); Alexander Loo (Redwood City, CA)
Assignee: Labrador Diagnostics LLC
G01N33/50G01N21/07G01N21/51G01N21/76G01N35/00G01N35/0092G01N21/6428G01N30/88G01N2015/1006G01N2021/513G01N2021/6417G01N2021/6441G01N2035/00326G01N2035/00495
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Quick Facts
Patent No.
US 11,162,936
App. No.
15/595,489
Granted
Nov 2, 2021
Kind
B2
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 (51)

1. A method for performing multiple assays with a biological sample, the method comprising:

providing a point-of-service, benchtop biological sample processing device comprising a housing containing therein:

an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle;

a cartridge comprising a microscopy cuvette, a pipette tip, a reagent, a diluent, a vessel, and a microfluidic cartridge, said microfluidic cartridge having a planar configuration and is removable from the cartridge by the fluid handling apparatus so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use, wherein said nozzle of the fluid handling apparatus configured to: a) engage and hold a pipette tip and b) to engage and hold a microscopy cuvette, wherein said microscopy cuvette is configured to engage said pipette nozzle;

a first detection station comprising an electronic optical sensor;

a second detection station comprising a light source and an electronic optical sensor; and

a nucleic acid assay station,

transferring, by the fluid handling apparatus of the automated sample handling system, the microfluidic cartridge from the cartridge, so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use;

transferring by the automated sample handling system at least a portion of the biological sample to each of a first unit, second assay unit, and third assay unit of the cartridge;

transferring by the automated sample handling system the first assay unit containing biological sample to the first detection station;

transferring by the automated sample handling system the second assay unit containing biological sample to the second detection station;

transferring by the automated sample handling system the third assay unit containing biological sample to the nucleic acid assay station; and

transferring from the cartridge to the first assay unit, second assay unit, and third assay unit, respectively, all reagents required for the performance of first, second, and third assays to the respective assay units.

2. The method of claim 1 , wherein the biological sample has a volume of no greater than 500 microliters.

3. The method of claim 1 , wherein a turbidimetric assay is performed in the second assay unit, and wherein the turbidity of the turbidimetric assay is measured over a period of time.

4. The method of claim 1 , wherein the electronic optical sensor is selected from the group of electronic optical sensors consisting of photodiodes, photomultiplier tubes (PMTs), Charge-Coupled Devices (CCDs), super-cooled CCD arrays, CMOS sensors, photodetectors, photon counting detectors, avalanche photodiodes, avalanche photodiode arrays, pin diodes, spectrophotometers, and electronic cameras.

5. The method of claim 1 , wherein the biological sample is from a subject, and wherein prior to insertion of the cartridge into the biological sample processing device, the subject's insurance coverage is checked.

6. The method of claim 1 , wherein the biological sample processing device further comprises a third detection station, wherein the cartridge further contains a fourth assay unit, wherein the fourth assay unit comprises gear teeth, and wherein the method further comprises transporting the fourth assay unit to the third detection station by rotation of a gear mechanism, wherein rotation of the gear mechanism engages the gear teeth in the fourth assay unit and moves the fourth assay unit into the third detection station.

7. The method of claim 1 , wherein the cartridge comprises a lid and a locking feature, wherein the lid comprises an engagement feature which is configured to optionally engage the locking feature in the cartridge, and wherein the engagement feature does not engage the locking feature in the cartridge upon insertion of the cartridge into the sample processing device.

8. The method of claim 1 , wherein the second detection station comprises a cytometry station, wherein the light source and electronic optical sensor or sensing device of the second detection station are contained within the cytometry station.

9. The method of claim 1 wherein the nucleic acid assay station comprises a heater.

10. A method for performing multiple assays with a biological sample, the method comprising:

providing a point-of-service, benchtop biological sample processing device comprising a housing containing therein:

an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle;

a cartridge comprising a microscopy cuvette, a pipette tip, a reagent, a diluent, a vessel, and a microfluidic cartridge;

a first detection station comprising an electronic optical sensor;

a second detection station comprising a light source and an electronic optical sensor; and

a nucleic acid assay station,

transferring, by the fluid handling apparatus of the automated sample handling system, the microfluidic cartridge from the cartridge, so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use;

transferring by the automated sample handling system at least a portion of the biological sample to the vessel;

transferring by the automated sample handling system the vessel containing biological sample to the first detection station.

11. The method of claim 10 , wherein the biological sample has a volume of no greater than 500 microliters.

12. The method of claim 10 , wherein the electronic optical sensor is selected from the group of electronic optical sensors consisting of photodiodes, photomultiplier tubes (PMTs), Charge-Coupled Devices (CCDs), super-cooled CCD arrays, CMOS sensors, photodetectors, photon counting detectors, avalanche photodiodes, avalanche photodiode arrays, pin diodes, spectrophotometers, and electronic cameras.

13. The method of claim 10 , wherein the biological sample is from a subject, and wherein prior to insertion of the cartridge into the biological sample processing device, the subject's insurance coverage is checked.

14. The method of claim 10 , wherein the biological sample processing device further comprises a third detection station.

15. The method of claim 10 , wherein the cartridge comprises a lid and a locking feature, wherein the lid comprises an engagement feature which is configured to optionally engage the locking feature in the cartridge, and wherein the engagement feature does not engage the locking feature in the cartridge upon insertion of the cartridge into the sample processing device.

16. The method of claim 10 , wherein the second detection station comprises a cytometry station, wherein the light source and electronic optical sensor or sensing device of the second detection station are contained within the cytometry station.

17. The method of claim 10 wherein the nucleic acid assay station comprises a heater.

18. A method for performing multiple assays with a biological sample, the method comprising:

providing a point-of-service, benchtop biological sample processing device comprising a housing containing therein:

an automated sample handling system comprising a fluid handling apparatus comprising a pipette having a nozzle;

a cartridge comprising a microscopy cuvette, a pipette tip, a reagent, a diluent, a vessel, and a microfluidic cartridge;

a first detection station comprising an electronic optical sensor;

a second detection station comprising a light source and an electronic optical sensor; and

a nucleic acid assay station,

transferring, by the fluid handling apparatus of the automated sample handling system, the microfluidic cartridge from the cartridge, so that at least one of said reagent, diluent, pipette tip, or vessel housed below the microfluidic cartridge become accessible for use;

transferring, by the automated sample handling system, at least a portion of the biological sample to the vessel;

transferring, by the automated sample handling system, the vessel containing biological sample to the nucleic acid assay station; and

performing nucleic acid amplification using said nucleic acid assay station.

19. The method of claim 18 , wherein said nucleic acid amplification uses isothermal heating.

20. The method of claim 18 , wherein said nucleic acid amplification uses thermocycling.

Assignments (5)
CHANGE OF NAME Recorded Apr 15, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052410/0432 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045205/0686 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2018
From: HOLMES, ELIZABETH A.; YOUNG, DANIEL; SMITH, TIMOTHY; ROY, JOY; LOO, ALEXANDER
To: THERANOS, INC.
Reel/Frame 045178/0672 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
Continuity (14)
Continuation 13769820 · Feb 18, 2013
Continuation In Part PCTUS2012057155 · Sep 25, 2012
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part 13769820 · Feb 18, 2013
Continuation In Part 13244949 · Sep 26, 2011
Continuation In Part 13244956 · Sep 26, 2011
Continuation In Part 13244952 · Sep 26, 2011
Continuation In Part 13244950 · Sep 26, 2011
Continuation In Part 13244953 · Sep 26, 2011
Continuation In Part 13244954 · Sep 26, 2011
Related Publication 20170350878A1 · Dec 7, 2017
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