Modular point-of-care devices, systems, and uses thereof

Patent metadata

Field	Value
Publication number	US-10670588-B2
Application number	US-201615217207-A
Country	US
Kind code	B2
Filing date	Jul 22, 2016
Priority date	Oct 2, 2007
Publication date	Jun 2, 2020
Grant date	Jun 2, 2020

Abstract

The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

First claim

What is claimed is:

1. A method of measuring a volume of a liquid sample, comprising:
reacting a known quantity of a control analyte in the liquid sample with a reagent to yield a detectable signal indicative of the quantity of the control analyte; and
comparing the detectable signal indicative of the quantity of the control analyte with an expected signal,
wherein the expected signal is indicative of an expected volume of the liquid sample, and
wherein the comparison provides a measurement of the volume of the liquid sample being measured.

2. The method of claim 1 , wherein the control analyte is normally not present in the liquid sample in a detectable amount.

3. The method of claim 1 , further comprising verifying the volume of the liquid sample when the measurement of the volume of the liquid sample is within about 50% of the expected volume of the liquid sample.

4. The method of claim 1 , further comprising:
reacting the liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and
measuring the quantity of the target analyte in the liquid sample based on the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

5. The method of claim 1 , wherein the liquid sample comprises a bodily fluid sample.

6. The method of claim 4 , wherein the control analyte does not react with the target analyte in the liquid sample.

7. The method of claim 4 , further comprising:
reacting a second liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and
measuring the quantity of the target analyte in the second liquid sample based on the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

8. The method of claim 1 , wherein the control analyte is selected from the group consisting of: albumin, fluorescein, IgG, protein C, fluorescein-labeled albumin, fluorescein labeled IgG, anti-fluorescein, antidigoxigenin, digoxigenin-labeled albumin, digoxigenin-labeled IgG, biotinylated proteins, and non-human IgG.

9. The method of claim 1 , further comprising:
placing, by a fluid transfer device, the liquid sample in an addressable reagent unit of a removable cartridge to create a control solution, the addressable reagent unit including the control analyte;
transferring, by the fluid transfer device, the control solution to an addressable assay unit having a reaction site, wherein the reagent is disposed on the reaction site; and
detecting, by a detection assembly, the detectable signal indicative of the quantity of the control analyte.

10. A method of measuring a volume of a liquid sample using a bench-top, point-of-care system including an assay assembly, a fluid transfer device, and a detection assembly, the method comprising:
reacting a known quantity of a control analyte in the liquid sample with a reagent to yield a detectable signal indicative of the quantity of the control analyte; and
comparing the detectable signal indicative of the quantity of the control analyte with an expected signal, wherein the expected signal is indicative of an expected volume of the liquid sample; and
determining the volume of the liquid sample based on comparing the expected signal and the detectable signal.

11. The method of claim 10 , wherein reacting the known quantity of the control analyte in the liquid sample, comprises:
placing, by the fluid transfer device, the liquid sample in an addressable reagent unit of a removable cartridge to create a control solution, the addressable reagent unit including the control analyte;
transferring, by the fluid transfer device, the control solution to an addressable assay unit having a reaction site, wherein the reagent is disposed on the reaction site; and
detecting, by the detection assembly, the detectable signal indicative of the quantity of the control analyte.

12. The method of claim 10 , wherein the control analyte is normally not present in the liquid sample in a detectable amount.

13. The method of claim 10 , further comprising verifying the volume of the sample when the measurement of the volume of the liquid sample is within about 50% of the expected volume of the liquid sample.

14. The method of claim 10 , further comprising:
reacting the liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and
measuring the quantity of the target analyte in the liquid sample based on of the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

15. The method of claim 14 , wherein the control analyte does not react with the target analyte in the liquid sample.

16. The method of claim 14 , further comprising
reacting a second liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and
measuring the quantity of the target analyte in the second liquid sample based the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

17. The method of claim 10 , wherein the control analyte is selected from the group consisting of: albumin, fluorescein, IgG, protein C, fluorescein-labeled albumin, fluorescein labeled IgG, anti-fluorescein, antidigoxigenin, digoxigenin-labeled albumin, digoxigenin-labeled IgG, biotinylated proteins, and non-human IgG.

Assignees

• Labrador Diagnostics Llc
• Theranos Ip Co Llc

Inventors

• Burd Tammy
• Gibbons Ian
• Holmes Elizabeth A
• Frenzel Gary
• Nugent Anthony Joseph

Classifications

• B01J2219/00702

  Processes involving means for analysing and characterising the products · CPC title

• A61B10/0038

  Devices for taking faeces samples; Faecal examination devices (anal receptacles A61F5/451) · CPC title

• B01L9/543

  for disposable pipette tips, e.g. racks or cassettes · CPC title

• G01N33/54386

  Analytical elements · CPC title

• B01J2219/00292

  in the shape of pipette tips · CPC title