Systems and methods for multi-analysis

Patent metadata

Field	Value
Publication number	US-10018643-B2
Application number	US-201514848775-A
Country	US
Kind code	B2
Filing date	Sep 9, 2015
Priority date	Sep 25, 2011
Publication date	Jul 10, 2018
Grant date	Jul 10, 2018

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.

First claim

What is claimed is:

1. A point of care biological sample processing system for performing assays with two or more different types of biological samples obtained from at least one subject comprising:
an insertable and removable cartridge comprising (i) a first location for receiving a first biological sample obtained from the at least one subject; (ii) a second location for receiving a second biological sample obtained from the at least one subject, wherein the first biological sample is a blood sample and the second biological sample is a non-blood sample; (iii) a first cuvette for performing a first assay on the first biological sample to detect a first analyte, wherein the first assay comprises a thermocycling nucleic acid amplification assay; (iv) a second cuvette for performing a second assay on the second biological sample to detect a second analyte, wherein the second assay is a culture assay for detecting a microorganism; and (v) all reagents for performing the first and second assays, the cartridge has a multi-layer design wherein at least some cartridge assay components are located below one of said first cuvette or said second cuvette and are accessible only after the first cuvette or second cuvette is detached from the cartridge;
and
a sample processing device comprising a cartridge receiving location for receiving the insertable and removable cartridge, a thermocycler for performing the nucleic acid amplification assay, a cytometer, and at least one automated sample handling device comprising a first pipette head and a second pipette head, wherein the first pipette head and the second pipette head are mounted on a common support structure and are independently movable and independently controllable in relation to the other.

2. The system of claim 1 , wherein the at least one automated sample handling device is configured to transfer (i) the first biological sample to the first cuvette; (ii) the second biological sample to the second cuvette; and (iii) the first cuvette to the thermocycler and the second cuvette to the cytometer.

3. The system of claim 1 , wherein the sample processing device comprises (i) a first automated sample handling device comprising the first pipette head and the second pipette head, wherein the first pipette head and the second pipette head are mounted on a first common support structure and are independently moveable and independently controllable in relation to the other, and wherein the first automated handling device is configured to transfer at least a portion of the first biological sample to the first cuvette and the first cuvette to the thermocycler; and (ii) a second automated sample handling device comprising a third pipette head and a fourth pipette head, wherein the third pipette head and the fourth pipette head are mounted on a second common support structure and are independently movable and independently controllable in relation to the other, and wherein the second automated sample handling device is configured to transfer at least a portion of the second biological sample to the second cuvette and the second cuvette to the cytometer.

4. The system of claim 1 , wherein the system comprises a first sample vessel for collecting the first biological sample and a second sample vessel for collecting the second biological sample, and the first and second sample vessels are different.

5. The system of claim 1 , wherein the first and second cuvettes are each fluidically isolated and movable.

6. The system of claim 1 , wherein the second biological sample is obtained on a swab.

7. A method for performing assays with two or more different types of biological samples obtained from at least one subject, comprising:
receiving in the sample processing device of the system of claim 1 the insertable and removable cartridge;
wherein the cartridge comprises the first and second biological samples and the sample processing device performs the first and second assays and detects the first and second analytes.

8. A point of care biological sample processing system for performing assays with two or more different types of biological samples obtained from at least one subject comprising:
a first insertable and removable cartridge comprising (i) a first location for receiving a first biological sample obtained from the at least one subject, wherein the first biological sample is a blood sample; (ii) a first cuvette for performing a first assay on the first biological sample to detect a first analyte, wherein the first assay comprises a thermocycling nucleic acid amplification assay; and (iii) all reagents for performing the first assay;
a second insertable and removable cartridge comprising (iv) a second location for receiving a second biological sample obtained from the at least one subject, wherein the second biological sample is a non-blood sample; (v) a second cuvette for performing a second assay on the second biological sample to detect a second analyte, wherein the second assay is a culture assay for detecting a microorganism; and (vi) all reagents for performing the second assay; and
a sample processing device comprising (a) at least one cartridge receiving location for receiving at least one insertable and removable cartridge, (b) a thermocycler for performing the nucleic acid amplification assay, (c) a cytometer, and (d) at least one automated sample handling device comprising a first pipette head and a second pipette head, wherein the first pipette head and the second pipette head are mounted on a common support structure and are independently movable and independently controllable.

9. The system of claim 8 , wherein the at least one automated sample handling device is configured to transfer (i) the first biological sample to the first cuvette; (ii) the second biological sample to the second cuvette; and (iii) the first cuvette to the thermocycler and the second cuvette to the cytometer.

10. The system of claim 8 , wherein the sample processing device comprises (i) a first automated sample handling device comprising the first pipette head and the second pipette head, wherein the first pipette head and the second pipette head are mounted on a first common support structure and are independently movable and independently controllable, and wherein the first automated sample handling device is configured to transfer the first biological sample to the first cuvette and the first cuvette to the thermocycler; and (ii) a second automated sample handling device comprising a third pipette head and a fourth pipette head, wherein the third pipette head and the fourth pipette head are mounted on a second common support structure and are independently movable and independently controllable, and wherein the second automated sample handling device is configured to transfer the second biological sample to the second cuvette and the second cuvette to the cytometer.

11. The system of claim 8 , wherein the sample processing device comprises one cartridge receiving location for receiving the first and second insertable and removable cartridges.

12. The system of claim 8 , wherein the sample processing device comprises a first and second module, wherein the first module comprises a first cartridge receiving location for receiving the first insertable and removable cartridge, and the second module comprises a second cartridge location for receiving the second insertable and removable cartridge.

13. The system of claim 12 , wherein the first module comprises the thermocycler and the second module comprises the cytometer.

14. The system of claim 8 , wherein the first and second cuvettes are each fluidically isolated and movable.

Assignees

• Theranos Inc
• Theranos Ip Co Llc

Inventors

• Holmes Elizabeth A
• Pangarkar Chinmay
• Anekal Samartha
• Frankovich John K
• Chen Michael
• Smith Timothy

Classifications

• G01N35/0092 Primary

  Scheduling · CPC title

• G01N33/54313

  the carrier being characterised by its particulate form · CPC title

• B01L3/5082

  Test tubes per se · CPC title

• Y10T436/113332

  with conveyance of sample along a test line in a container or rack · CPC title

• G01N2035/00425

  Heating or cooling means associated with pipettes or the like, e.g. for supplying sample/reagent at given temperature · CPC title