Systems and methods for multi-analysis

Patent metadata

Field	Value
Publication number	US-9719990-B2
Application number	US-201514859064-A
Country	US
Kind code	B2
Filing date	Sep 18, 2015
Priority date	Sep 25, 2011
Publication date	Aug 1, 2017
Grant date	Aug 1, 2017

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 a plurality of general chemistry assays on a blood sample obtained from a subject, comprising:
(i) receiving in a biological sample processing device a cartridge comprising the blood sample obtained from a subject, wherein the blood sample is about 200 μl or less and the cartridge further comprises:
at least 14 cuvettes for performing at least 14 general chemistry assays to detect at least 14 different analytes, wherein at least one general chemistry assay is performed in each of the cuvettes; and
all reagents for performing the at least 14 general chemistry assays, wherein the all reagents comprises at least an inert liquid and a chromogen for each of the at least 14 general chemistry assays, and wherein the inert liquid is immiscible with and has a lower density than the sample;

wherein the biological sample processing device comprises:
at least one detection unit selected from a luminometer and a spectrophotometer; and
a pipette comprising a plurality of pipette heads, wherein at least one pipette head is (a) capable of engaging with at least one pipette tip and aspirating and dispensing a fluid and (b) capable of engaging with at least one cuvette and moving the at least one cuvette from a first location to a second location within the device;

(ii) aspirating at least a portion of the biological sample with the pipette and dispensing the at least a portion of the biological sample to each of the at least 14 cuvettes with the pipette;
(iii) aspirating a chromogen with the pipette and dispensing the chromogen to a cuvette with the pipette, and repeating the aspirating and dispensing step with the remaining chromogens, wherein each of the at least 14 cuvettes comprises the inert liquid and the inert liquid forms a layer on top of the sample and chromogen;
(iv) engaging the at least one pipette head with at least one of the at least 14 cuvettes and moving with the pipette head the at least one cuvette from the cartridge to the at least one detection unit;
and
(v) detecting signals indicative of the presence or absence of the at least 14 different analytes with the at least one detection unit;
wherein the at least 14 general chemistry assays do not use an antibody and do not assay for a nucleic acid, and the at least 14 different analytes comprise glucose, calcium, albumin, total protein, sodium, potassium, chloride, carbon dioxide, creatinine, blood urea nitrogen (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate aminotransferase LAST/GOT), and total bilirubin.

2. The method of claim 1 , wherein the device further comprises a centrifuge.

3. The method of claim 1 , wherein the cartridge further comprises the at least one pipette tip, and wherein the at least one pipette head engages with the at least one pipette tip for aspirating at least a portion of the blood sample and dispensing the at least a portion of the blood sample to the at least 14 cuvettes.

4. The method of claim 1 , wherein the blood sample is a blood sample obtained by a fingerstick.

5. The method of claim 2 , wherein the method comprises centrifuging the blood sample in the centrifuge in the biological sample processing device and obtaining a plasma or serum sample.

6. The method of claim 1 , wherein the cartridge further comprises at least one diluent for diluting the blood sample and the method further comprises diluting by the pipette the blood sample with the diluent.

7. The method of claim 1 , wherein the at least one detection unit is a luminometer.

8. The method of claim 1 , wherein the at least one detection unit is a spectrophotometer.

9. The method of claim 1 , wherein the biological sample processing device comprises at least two detection units, wherein a first detection unit is a luminometer and a second detection unit is a spectrophotometer.

10. The method of claim 1 , wherein the method comprises detecting the signal indicative of the presence of a first analyte with the luminometer and the signal indicative of the presence of a second analyte with the spectrophotometer.

11. The method of claim 1 , wherein the method comprises incubating the at least 14 different general chemistry assays at a temperature of about 37° C.

12. The method of claim 1 , wherein the method further comprises performing at least four additional general chemistry assays on the blood sample in the device to detect at least four additional different analytes, wherein the at least four additional different analytes comprises low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.

13. A sample processing system for performing a plurality of general chemistry assays on a blood sample obtained from a subject, comprising:
an insertable and removable cartridge comprising (i) at least one receptacle for receiving the blood sample, wherein the at least one receptacle holds a sample of about 200 μl or less (ii) at least 14 cuvettes for performing at least 14 general chemistry assays to detect at least 14 different analytes; and (iii) all reagents for performing the at least 14 general chemistry assays, wherein the all reagents comprises at least an inert liquid and a chromogen for each of the at least 14 general chemistry assays, and wherein the inert liquid is immiscible with and has a lower density than the sample;
and a biological sample processing device comprising a cartridge receiving location, at least one detection unit selected from a luminometer and a spectrophotometer, and a pipette comprising a plurality of pipette heads, wherein at least one pipette head is (a) capable of engaging with at least one pipette tip and aspirating and dispensing a fluid and (b) capable of engaging with at least one cuvette and moving the at least one cuvette from a first location to a second location within the device
wherein the at least 14 general chemistry assays do not use an antibody and do not assay for a nucleic acid, and the at least 14 different analytes comprise glucose, calcium, albumin, total protein, sodium, potassium, chloride, carbon dioxide, creatinine, blood urea nitrogen (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate aminotransferase (AST/GOT), and total bilirubin.

14. The system of claim 13 , wherein the biological sample processing device further comprises a centrifuge.

15. The system of claim 13 , wherein the at least one detection unit is a luminometer.

16. The system of claim 13 , wherein the at least one detection unit is a spectrophotometer.

17. The system of claim 13 , wherein the biological sample processing device comprises at least two detection units, wherein a first detection unit is a luminometer and a second detection unit is a spectrophotometer.

18. The system of claim 13 , wherein the cartridge further comprises the at least one pipette tip.

19. The system of claim 13 , wherein the cartridge further comprises at least one diluent for diluting the biological sample.

20. The system of claim 13 , wherein the cartridge further comprises at least four additional cuvettes for performing at least four additional general chemistry assays on the blood sample to detect at least four additional different analytes, wherein the at least four additional different analytes comprise low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.

21. The method of 1 , wherein a plurality of the at least

Assignees

• Theranos Inc

Inventors

• Holmes Elizabeth A
• Gibbons Ian
• Patel Paul
• Anekal Samartha

Classifications

• G01N35/04 Primary

  Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)} · CPC title

• G01N2035/0474

  Details of actuating means for conveyors or pipettes · CPC title

• Y10T436/111666

  Utilizing a centrifuge or compartmented rotor · CPC title

• G01N2035/0449

  using centrifugal transport of liquid · CPC title

• G01N2015/1486

  Counting the particles · CPC title