Systems and methods for sample use maximization

Patent metadata

Field	Value
Publication number	US-9677993-B2
Application number	US-201514789967-A
Country	US
Kind code	B2
Filing date	Jul 1, 2015
Priority date	Jan 21, 2011
Publication date	Jun 13, 2017
Grant date	Jun 13, 2017

Abstract

The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.

First claim

What is claimed is:

1. A method for handling a bodily fluid sample, the method comprising:
receiving in an instrument a cartridge, wherein the cartridge contains the bodily fluid sample, wherein:
the bodily fluid sample has a volume of 250 microliters or less;
the instrument comprises: i) a centrifuge comprising at least a first bucket, and ii) a pipette comprising a nozzle, and
the cartridge further contains: i) a first tip, ii) a second tip, and iii) a tip seal,
wherein the first tip and second tip each have a first open end and a second open end, wherein the first open end of each tip is configured to engage with the nozzle of the pipette and the second open end of each tip is configured to permit the movement of fluid into or out of the tip;

engaging the first open end of the first tip with the nozzle of the pipette;
aspirating at least a portion of the bodily fluid sample into the engaged first tip through the second open end of the first tip;
pressing with the pipette the second open end of the engaged first tip containing the at least a portion of the bodily fluid sample into the tip seal such that the second open end of the first tip is capped with and sealed by the tip seal;
inserting with the pipette the sealed first tip into the bucket of the centrifuge and disconnecting the sealed first tip from the pipette nozzle; and
centrifuging the sealed first tip in the bucket of the centrifuge.

2. The method of claim 1 , wherein the bodily fluid sample is a blood sample obtained from a fingerstick.

3. The method of claim 1 , wherein upon centrifuging the sealed first tip, the sample in the sealed first tip is separated into a supernatant and a pellet.

4. The method of claim 3 , wherein the method further comprises:
engaging the first open end of the second tip with the nozzle of the pipette; and
aspirating at least a portion of the supernatant from the sealed first tip into the second tip.

5. The method of claim 4 , wherein the supernatant comprises blood plasma or blood serum.

6. The method of claim 5 , further comprising using at least a portion of the supernatant to perform at least one assay for an analyte.

7. The method of claim 3 , wherein the pellet contains red blood cells and white blood cells.

8. The method of claim 7 , further comprising:
imaging at least a portion of the sealed first tip, wherein the imaged portion of the sealed first tip contains the pellet; and
determining the hematocrit of the sample.

9. The method of claim 7 , further comprising:
removing the supernatant from the sample in the sealed first tip; and
resuspending the pellet in a reagent which acts as a lysing agent for the red blood cells.

10. The method of claim 9 , further comprising:
centrifuging the sealed first tip comprising the resuspended pellet, such that upon centrifuging the sealed first tip, the resuspended pellet is separated into a supernatant comprising lysed red blood cells and a pellet comprising white blood cells.

11. A method for handling a bodily fluid sample, the method comprising:
receiving in an instrument a cartridge, wherein the cartridge contains the bodily fluid sample, wherein:
the bodily fluid sample has a volume of 250 microliters or less;
the instrument comprises: i) a centrifuge comprising at least a first bucket, and ii) a pipette comprising a nozzle, and
the cartridge further contains: i) a first tip, ii) a second tip, and iii) a tube having an open end and an opposing closed end, wherein the first tip and second tip each have a first open end and a second open end, wherein the first open end of each tip is configured to engage with the nozzle of the pipette and the second open end of each tip is configured to permit the movement of fluid into or out of the tip, and wherein the open end of the tube is configured to engage with the nozzle of the pipette;

engaging the first open end of the first tip with the nozzle of the pipette;
aspirating at least a portion of the bodily fluid sample into the engaged first tip through the second open end of the first tip;
dispensing the at least a portion of the fluid sample from the engaged first tip into the tube;
disengaging the engaged first tip from the pipette nozzle;
engaging the open end of the tube comprising the at least a portion of the fluid sample with the pipette nozzle;
inserting with the pipette the tube comprising the at least a portion of the fluid sample into the first bucket of the centrifuge and disconnecting the tube from the pipette nozzle; and
centrifuging the tube in the bucket of the centrifuge.

12. The method of claim 11 , wherein the bodily fluid sample is a blood sample obtained from a fingerstick.

13. The method of claim 11 , wherein upon centrifuging the tube, the sample in the tube is separated into a supernatant and a pellet.

14. The method of claim 13 , wherein the method further comprises:
engaging the first open end of the second tip with the nozzle of the pipette; and
aspirating at least a portion of the supernatant from the tube into the second tip.

15. The method of claim 14 , wherein the supernatant comprises blood plasma or blood serum.

16. The method of claim 15 , further comprising using at least a portion of the supernatant to perform at least one assay for an analyte.

17. The method of claim 13 , wherein the pellet contains red blood cells and white blood cells.

18. The method of claim 17 , further comprising:
imaging at least a portion of the tube, wherein the imaged portion of the tube contains the pellet; and
determining the hematocrit of the sample.

19. The method of claim 17 , further comprising:
removing the supernatant from the sample in the tube; and
resuspending the pellet in a reagent which acts as a lysing agent for the red blood cells.

20. The method of claim 19 , further comprising:
centrifuging the tube comprising the resuspended pellet, such that upon centrifuging the tube, the resuspended pellet is separated into a supernatant comprising lysed red blood cells and a pellet comprising white blood cells.

21. An instrument comprising:
i) a centrifuge comprising at least a first bucket, ii) a pipette comprising a nozzle, and iii) a housing, wherein:
the centrifuge and pipette are within the housing,
the housing comprises a door through which a cartridge containing a tip or tube may be inserted, the pipette is configured to, upon the insertion of a cartridge containing a tip or tube into the housing of the instrument: i) engage with its nozzle a tip or tube in the cartridge, ii) move the engaged tip or tube from the cartridge to the centrifuge, iii) insert the engaged tip or tube into the bucket of the centrifuge, and iv) disconnect the engaged tip or tube from the nozzle into the bucket of the centrifuge, such that the tip or tube is parked in the bucket of the centrifuge.

22. The instrument of claim 21 , the instrument further comprising:
iv) the cartridge, wherein the cartridge contains: A) a first tip, B) a second tip, and C) a tip seal,
wherein the first tip and second tip each have a first open end and a second open end, wherein the first open end of each tip is configured to engage with the nozzle of the pipette and the second open end of each tip is configured to permit the movement of fluid into or out of the tip.

23. The instrument of claim 21 , the instrument further comprising:
iv) the cartridge, wherein the cartridge contains: A) a first tip, B) a second tip, and C) a tube

Assignees

• Theranos Inc

Inventors

• Nugent Anthony
• Young Daniel
• Holmes Elizabeth A
• Siegel Michael
• Wistort Ryan

Classifications

• C12Q1/6809

  Methods for determination or identification of nucleic acids involving differential detection · CPC title

• G01N2333/96463

  Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups · CPC title

• G01N2035/1018

  Detecting inhomogeneities, e.g. foam, bubbles, clots · CPC title

• G01N2001/4083

  sedimentation · CPC title

• G01N21/0303 Primary

  Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment (G01N21/031 - G01N21/15 take precedence) · CPC title