IP Library Granted Patent US 11,009,516
Granted Patent B2
US 11,009,516 · App. 14/860,048 · Granted May 18, 2021

Systems and methods for multi-analysis

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Michael Chen (Sunnyvale, CA); Pey-Jiun Ko (Redwood City, CA)
Assignee: Labrador Diagnostics LLC
G01N35/0092B01L3/021B01L3/5082B01L3/50855B01L7/52B01L9/06B01L9/543C12Q1/42C12Q1/52C12Q1/6883C12Q1/70G01N15/1475G01N21/25G01N21/27G01N33/54306G01N33/54313G01N33/54366G01N33/56983G01N33/62G01N33/6827G01N33/80G01N33/92G01N35/00029G01N35/00069G01N35/00623G01N35/00871G01N35/026G01N35/04G01N35/10G01N35/1009G01N35/1011G01N35/1065G01N35/1072B01L9/52B01L2300/1827B01L2300/1855G01N33/5005G01N35/00G01N2015/008G01N2015/0073G01N2015/1006G01N2015/1486G01N2035/00138G01N2035/00148G01N2035/00237G01N2035/00306G01N2035/00326G01N2035/00356G01N2035/00366G01N2035/00425G01N2035/00435G01N2035/00495G01N2035/00633G01N2035/0449G01N2035/0474G01N2035/0486G01N2035/0491G01N2035/0493G01N2035/0494G01N2201/024G01N2201/04G01N2201/12Y10T436/111666Y10T436/113332
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Quick Facts
Patent No.
US 11,009,516
App. No.
14/860,048
Granted
May 18, 2021
Kind
B2
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.

Claims (57)

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.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 14, 2021
From: CHEN, MICHAEL; KO, PEY-JIUN
To: THERANOS, INC.
Reel/Frame 055916/0001 →
CHANGE OF NAME Recorded Apr 15, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052410/0432 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045101/0315 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2016
From: HOLMES, ELIZABETH A.
To: THERANOS, INC.
Reel/Frame 037897/0958 →
Continuity (38)
Continuation 14789930 · Jul 1, 2015
Continuation 14183500 · Feb 18, 2014
Continuation 14183503 · Feb 18, 2014
Continuation In Part 13769779 · Feb 18, 2013
Continuation In Part 13769820 · Feb 18, 2013
Continuation In Part PCTUS2012057155 · Sep 25, 2012
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Continuation In Part 13244949 · Sep 26, 2011
Continuation In Part 13244956 · Sep 26, 2011
Continuation In Part 13244952 · Sep 26, 2011
Continuation In Part 13244950 · Sep 26, 2011
Continuation In Part 13244953 · Sep 26, 2011
Continuation In Part 13244954 · Sep 26, 2011
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947
Continuation In Part 13244946
Continuation In Part PCTUS2012057155 · Sep 25, 2012
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947
Continuation In Part 13244946
Continuation In Part 13244949
Continuation In Part 13244956
Continuation In Part 13244952
Continuation In Part 13244950
Continuation In Part 13244953
Continuation In Part 13244954
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947
Continuation In Part 13244946
Provisional Application 61766113 · Feb 18, 2013
Provisional Application 61766119 · Feb 18, 2013
Related Publication 20160011215A1 · Jan 14, 2016
Cited By (1)
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