IP Library Granted Patent US 10,920,284
Granted Patent B2
US 10,920,284 · App. 15/159,399 · Granted Feb 16, 2021

Pathogen and antimicrobial resistance testing

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Chandan Shee (Palo Alto, CA); Clarissa Lui (Menlo Park, CA)
Assignee: Labrador Diagnostics LLC
C12Q1/689C12Q1/04G01N33/53G01N33/56911C12Q2600/156C12Q2600/158G01N2469/10G01N2469/20
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Quick Facts
Patent No.
US 10,920,284
App. No.
15/159,399
Granted
Feb 16, 2021
Kind
B2
Abstract

Systems and methods for determining pathogens and antimicrobial resistance of pathogens in a sample are provided.

Claims (53)

1. An insertable cartridge for being received in a slot of a sample analysis device for analysis of a sample, said cartridge comprising:

at least one pipette tip;

a plurality of vessels;

a support frame with openings for holding said vessels and said at least one pipette tip;

at least a first of said vessels containing an antimicrobial;

at least a second of said vessels containing a microorganism growth medium;

at least a third of said vessels containing at least one reagent selected from the group consisting of: a metabolic indicator, a reagent for a nucleic acid amplification reaction, and a reagent for a nucleic acid probe-based assay;

at least a first opening for holding a first type of sample vessel; and

at least a second opening for holding a second type of sample vessel different from the first type of sample vessel;

wherein at least one of said vessels is detachable from the support frame;

a microscopy cuvette coupled to said support frame;

a cap-removal tip coupled to said support frame; and

reagent in said vessels to support at least another type of assay different from nucleic acid amplification, said another type of assay selected from the following: metabolic/biochemical assay, immunoassay, or cytometry;

wherein said support frame is configured to engage a matching slot at a cartridge receiving location in the sample processing device, and wherein the cartridge is ejectable from the sample processing device after assay processing.

2. The cartridge of claim 1 , wherein the first type of sample vessel further comprises the sample.

3. The cartridge of claim 2 , wherein the sample is a blood sample obtained from a subject.

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

5. The cartridge of claim 1 , wherein the at least one reagent is the metabolic indicator.

6. The cartridge of claim 5 , wherein the metabolic indicator is resazurin.

7. A system for analysis of a sample, comprising:

an insertable cartridge comprising:

at least one pipette tip;

a plurality of vessels;

a support frame for holding said vessels and said at least one pipette tip;

at least a first of said vessels containing an antimicrobial;

at least a second of said vessels containing a microorganism growth medium;

at least a third of said vessels containing at least one reagent selected from the group consisting of: a metabolic indicator, a reagent for a nucleic acid amplification reaction, and a reagent for a nucleic acid probe-based assay;

at least a first opening for holding a first type of sample vessel; and

at least a second opening for holding a second type of sample vessel different from the first type of sample vessel; and

a microscopy cuvette coupled to said support frame;

a cap-removal tip coupled to said support frame; and

reagent in said vessels to support at least another type of assay different from nucleic acid amplification, said another type of assay selected from the following: metabolic/biochemical assay, immunoassay, or cytometry;

a sample processing device for receiving the cartridge, wherein the sample processing device comprises a fluid handling system and at least one detector, wherein the cartridge is configured to engage a matching slot at a cartridge receiving location in the sample processing device, and wherein the cartridge is configured to be ejected from the sample processing device when done.

8. The system of claim 7 , wherein the sample is a blood sample obtained from a subject.

9. The system of claim 8 , wherein the blood sample obtained from the subject is about 500 μl or less.

10. The system of claim 7 , wherein the at least one reagent is the metabolic indicator.

11. The system of claim 7 , wherein the metabolic indicator is selected from resazurin, 5-cyano-2,3-ditolyl tetrazolium chloride (CTC), carboxyfluorescein diacetate succinimidyl ester (CFDA-SE), and luciferin.

12. The system of claim 11 , wherein the metabolic indicator is resazurin.

13. An insertable cartridge for being received in a slot of a sample analysis device for analysis of a sample, said cartridge comprising:

at least one pipette tip;

a plurality of vessels;

a support frame with openings for holding said vessels and said at least one pipette tip;

at least a first of said vessels containing an antimicrobial;

at least a second of said vessels containing a microorganism growth medium;

at least a third of said vessels containing at least one reagent selected from the group consisting of: a metabolic indicator, a reagent for a nucleic acid amplification reaction, and a reagent for a nucleic acid probe-based assay;

at least a first opening for holding a first type of sample vessel; and

at least a second opening for holding a second type of sample vessel different from the first type of sample vessel;

wherein at least one of said vessels is detachable from the support frame;

a microscopy cuvette coupled to said support frame;

a cap-removal tip coupled to said support frame; and

reagent in said vessels to support at least another type of assay different from nucleic acid amplification, said another type of assay selected from the following: metabolic/biochemical assay, immunoassay, or cytometry;

wherein said support frame is configured to engage a matching slot at a cartridge receiving location in the sample processing device, and wherein the cartridge is ejectable from the sample processing device after assay processing;

wherein the metabolic indicator is selected from one of the following: 5-cyano-2,3-ditolyl tetrazolium chloride (CTC), carboxyfluorescein diacetate succinimidyl ester (CFDA-SE), or luciferin.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 13, 2021
From: LUI, CLARISSA
To: THERANOS, INC.
Reel/Frame 054911/0488 →
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 045075/0310 →
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 Nov 28, 2017
From: HOLMES, ELIZABETH A.; SHEE, CHANDAN
To: THERANOS, INC.
Reel/Frame 044242/0230 →
Continuity (4)
Continuation PCTUS2015048533 · Sep 4, 2015
Provisional Application 62046135 · Sep 4, 2014
Provisional Application 62061093 · Oct 7, 2014
Related Publication 20160281143A1 · Sep 29, 2016