Systems and methods for multi-analysis

Patent metadata

Field	Value
Publication number	US-11009516-B2
Application number	US-201514860048-A
Country	US
Kind code	B2
Filing date	Sep 21, 2015
Priority date	Sep 25, 2011
Publication date	May 18, 2021
Grant date	May 18, 2021

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 an assay on a blood sample, comprising:
receiving in a biological sample processing device a cartridge comprising a whole blood sample obtained from a subject, wherein the whole blood sample is about 200 μl or less and the cartridge further comprises:
a first processing vessel for receiving a first processed blood sample obtained from the whole blood sample;
all reagents for performing a first assay on the first processed blood sample to detect a first analyte;
a second processing vessel for receiving a second processed blood sample obtained from the whole blood sample; and
all reagents for performing a second assay on the second processed blood sample to detect a second analyte;
wherein the cartridge has a multi-layer configuration wherein a single cuvette covers a plurality of detachable processing vessels and wherein the detachable processing vessels become accessible after the cuvette is lifted out of the cartridge;

and wherein the biological sample processing device comprises:
an automated pipette;
at least one optical detector; and
a centrifuge;

centrifuging in the centrifuge of the biological sample processing device the whole blood sample and obtaining the first and second processed blood samples; wherein the first and second processed blood samples are selected from at least one type of the following: plasma, serum, and cells, and wherein the first and second processed blood samples are different in type;
transferring with the automated pipette the first processed blood sample to the first processing vessel and the second processed blood sample to the second processing vessel;
performing in the biological sample processing device the first assay on the first processed blood sample to detect the first analyte and the second assay on the second processed blood sample to detect the second analyte; and
detecting the first and second analytes with the at least one optical detector.

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

3. The method of claim 1 , wherein the cartridge further comprises at least one pipette tip and the automated pipette comprises at least one pipette head configured to engage with the at least one pipette tip to transfer the first processed blood sample to the first processing vessel.

4. The method of claim 1 , wherein the first processed blood sample is plasma comprising an anticoagulant and the second processed blood sample is serum.

5. A biological sample processing system comprising:
a cartridge comprising:
one or more receptacles for receiving a whole blood sample obtained from a subject, wherein the whole blood sample is about 200 μl or less;
a first processing vessel for receiving a first processed blood sample obtained from the whole blood sample;
all reagents for performing a first assay on the first processed blood sample to detect a first analyte;
a second processing vessel for receiving a second processed blood sample obtained from the whole blood sample; and
all reagents for performing a second assay on the second processed blood sample to detect a second analyte;
wherein the first and second processed blood samples are selected from at least one type of the following: plasma, serum, and cells, and wherein the first and second processed blood samples are different in type;
wherein the cartridge has a multi-layer configuration wherein a single cuvette covers a plurality of processing vessels and wherein the processing vessels become accessible after the cuvette is lifted out of the cartridge;

and a biological sample processing device comprising:
an automated pipette;
a centrifuge; and
at least one optical detector for detecting the first analyte and the second analyte, wherein the automated pipette is configured to transport samples from the centrifuge.

6. The system of claim 5 , wherein the cartridge further comprises at least one pipette tip and the automated pipette comprises at least one pipette head configured to engage with the at least one pipette tip to transfer the first processed blood sample to the first processing vessel.

7. The method of claim 1 , wherein the first processed blood sample is plasma and the second processed blood sample is cells.

8. The method of claim 1 , wherein the first processed sample and the second processed blood sample comprise an anticoagulant.

9. The method of claim 1 , wherein (i) the centrifuge comprises a base and one or more buckets for receiving a sample or a sample vessel, and (ii) the one or more buckets has a first orientation when the base is not rotating and a second orientation when the base is rotating, and the first orientation and the second orientation are different.

10. The system of claim 5 , wherein (i) the centrifuge comprises a base and one or more buckets for receiving a sample or a sample vessel, and (ii) the one or more buckets has a first orientation when the base is not rotating and a second orientation when the base is rotating, and the first orientation and the second orientation are different.

11. The method of claim 1 , wherein the centrifuge has a footprint of about 200 cm 2 or less.

12. The system of claim 5 , wherein the centrifuge has a footprint of about 200 cm 2 or less.

13. The method of claim 9 , wherein each of the one or more buckets is configured to accept about 200 μl or less of the sample.

14. The system of claim 10 , wherein the each of the one or more buckets is configured to accept about 200 μl or less of the sample.

15. The method of claim 1 , wherein the centrifuge is capable of withstanding g-forces of about 1200 m/s 2 .

16. The system of claim 5 , wherein the centrifuge is capable of withstanding g-forces of about 1200 m/s 2 .

17. The system of claim 5 wherein the cuvette is a cytometry cuvette.

18. A biological sample processing system comprising:
a cartridge comprising:
one or more receptacles for receiving a whole blood sample obtained from a subject, wherein the whole blood sample is about 200 μ 1 or less;
a first processing vessel for receiving a first processed blood sample obtained from the whole blood sample;
all reagents for performing a first assay on the first processed blood sample to detect a first analyte;
a second processing vessel for receiving a second processed blood sample obtained from the whole blood sample; and
all reagents for performing a second assay on the second processed blood sample to detect a second analyte;
wherein the first and second processed blood samples are selected from at least one type of the following: plasma, serum, and cells, and wherein the first and second processed blood samples are different in type;
wherein the cartridge has a multi-layer configuration wherein a single cuvette covers a plurality of processing vessels and wherein the processing vessels become accessible after the cuvette is lifted out of the cartridge;

and a biological sample processing device comprising:
an automated pipette;
a centrifuge; and
at least one optical detector for detecting the first analyte and the second analyte, wherein the automated pipette is configured to transport samples from the centrifuge;

wherein said processing vessels are detachable from the cartridge.

Assignees

• Theranos Inc
• Labrador Diagnostics Llc

Inventors

• Holmes Elizabeth A
• Chen Michael
• Ko Pey-Jiun

Classifications

• G01N35/04 Primary

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

• G01N33/56972

  White blood cells · CPC title

• B01L3/5027

  by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip · CPC title

• G01N33/54313

  the carrier being characterised by its particulate form · CPC title

• G01N35/10

  Devices for transferring samples {or any liquids} to, in, or from, the analysis apparatus, e.g. suction devices, injection devices {(G01N35/0099 takes precedence)} · CPC title