Systems and methods for multi-analysis

Patent metadata

Field	Value
Publication number	US-10627418-B2
Application number	US-201615161533-A
Country	US
Kind code	B2
Filing date	May 23, 2016
Priority date	Sep 25, 2011
Publication date	Apr 21, 2020
Grant date	Apr 21, 2020

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 method of performing three or more assays for detecting a plurality of analytes in a biological sample from a subject, comprising:
providing a cartridge in a refrigerated condition at a temperature less than room temperature,
receiving the biological sample and the cartridge in a biological sample processing system, wherein:
a) the cartridge comprises:
a plurality of components including sample vessels, reagent units, and at least three assay units for performing the three or more assays to detect a plurality of analytes in the biological sample; and

b) the biological sample processing system comprises:
a sample handling system including a pipette; and
at least two detection units;

heating at least one portion of the cartridge using a movable heater on the biological sample processing system, wherein said heating comprises moving said movable heater from a first position to a second position wherein in the second position, at least a portion of the cartridge is inside the heater to pre-heat reagent units or assay units that are in the cartridge when the cartridge is in the biological sample processing system;
using said sample handling system for aliquoting at least a diluted portion of the sample into one of the plurality of said components while the cartridge remains inside the biological sample processing system;
decoupling one or more of said plurality of components from the cartridge while the cartridge remains inside the biological sample processing system to form one or more decoupled components;
performing in the biological sample processing system the three or more assays, wherein the three or more assays are performed at least partially in parallel and comprises leaving one or more of the one or more decoupled components of the cartridge at a location in the device separate from the cartridge;
detecting the plurality of analytes with at least one of the at least two detection unit in the biological sample processing system; and
after detecting the plurality of analytes, returning any decoupled components back to the cartridge while the cartridge remains inside the biological sample processing system;
wherein each of the reagent units is a container, a tube, a pipette tip, or a vessel;
wherein each of the assay units is a cuvette, a container, a tube, a pipette tip, or a vessel.

2. The method of claim 1 , wherein the biological sample is a blood sample.

3. The method of claim 2 , wherein the blood sample obtained from the subject is about 500 μl or less.

4. The method of claim 2 , wherein the three or more assays are performed from a single blood sample obtained from the subject.

5. The method of claim 2 , wherein the blood sample is a plasma sample.

6. The method of claim 1 , wherein the biological sample processing system comprises at least four assay units and performs four or more assays at least partially in parallel, wherein the four or more assays comprise a nucleic acid amplification, and immunoassay, and wherein the plurality of analytes comprise an antibody, antigen, nucleic acid, and cell.

7. The method of claim 6 , further comprising performing a cytometric assay and wherein the biological sample processing system further comprises a cytometer.

8. The method of claim 1 , wherein the biological sample processing system further comprises a centrifuge.

9. The method of claim 1 , wherein the biological sample processing system further comprises a housing.

10. The method of claim 9 , wherein the cartridge comprises the at least three assay units and all reagents for performing the three or more assays, and the housing comprises the sample handling system, the heater and the at least one of said at least two detection units.

11. The method of claim 10 , wherein the cartridge further comprises at least one tip and the sample handling system comprises at least one pipette nozzle, wherein the pipette nozzle is configured to engage with the at least one tip.

12. The method of claim 1 , where the cartridge in the refrigerated condition has temperature in the range of about 0° C. to about 8° C.

13. The method of claim 1 , where the cartridge in the refrigerated condition has temperature in the range of about −20° C. to about 8° C.

14. The method of claim 1 , wherein the heater comprises a thermoelectric device.

15. The method of claim 14 , wherein the heater further comprises a fan.

16. The method of claim 14 , wherein the heater further comprises a plurality of holes sized to engage portions of vessels in the cartridge.

17. The method of claim 14 , wherein the heater is located to direct heat towards an underside of the cartridge when the cartridge is in a cartridge receiving location.

18. The method of claim 14 , wherein heater is located to direct heat directly towards only a portion of an underside of the cartridge when the cartridge is in a cartridge receiving location.

19. A method of performing three or more assays for detecting a plurality of analytes in a biological sample from a subject, comprising:
providing a cartridge in a refrigerated condition at a temperature less than room temperature,
receiving the biological sample and the cartridge in a biological sample processing system, wherein:
b) the cartridge comprises:
a plurality of components including sample vessels, reagent units, and at least three assay units for performing the three or more assays to detect a plurality of analytes in the biological sample; and

b) the biological sample processing system comprises:
a sample handling system including a pipette; and
at least two detection units;

heating at least one portion of the cartridge using a movable heater on the biological sample processing system, wherein said heating comprises moving said movable heater from a first position to a second position wherein in the second position, at least a portion of the cartridge is inside the heater to pre-heat reagent units or assay units that are in the cartridge when the cartridge is in the biological sample processing system;
using said sample handling system for aliquoting at least a diluted portion of the sample into one of the plurality of said components while the cartridge remains inside the biological sample processing system;
decoupling one or more of said plurality of components from the cartridge while the cartridge remains inside the biological sample processing system to form one or more decoupled components;
performing in the biological sample processing system the three or more assays, wherein the three or more assays are performed at least partially in parallel and comprises leaving one or more of the one or more decoupled components of the cartridge at a location in the device separate from the cartridge;
detecting the plurality of analytes with at least one of the at least two detection unit in the biological sample processing system; and
after detecting the plurality of analytes, returning any decoupled components back to the cartridge while the cartridge remains inside the biological sample processing system;
wherein each of the reagent units is a container, a tube, a pipette tip, or a vessel;
wherein each of the assay units is a cuvette, a container, a tube, a pipette tip, or a vessel;
where the cartridge in the refrigerated condition has temperature in the range of about 2° C. to about 8° C.

20. A method of performing three or more assays for detecting a plurality of analytes in a biological sample from a subject, comprising:
providing a cartridge in a refrigerated

Assignees

• Theranos Inc
• Theranos Ip Co Llc

Inventors

• Wasson James
• Ko Pey-Jiun
• Roy Joy
• Holmes Elizabeth A

Classifications

• B01L9/543

  for disposable pipette tips, e.g. racks or cassettes · CPC title

• G01N35/00623

  of instruments · CPC title

• G01N21/27

  using photo-electric detection (G01N21/31 takes precedence){; circuits for computing concentration (logarithmic circuits G06G7/24; photometric circuits in general G01J)} · CPC title

• G01N35/00069

  whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk · CPC title

• G01N33/54366

  Apparatus specially adapted for solid-phase testing · CPC title