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

Patent metadata

Field	Value
Publication number	US-9435793-B2
Application number	US-201113326023-A
Country	US
Kind code	B2
Filing date	Dec 14, 2011
Priority date	Oct 2, 2007
Publication date	Sep 6, 2016
Grant date	Sep 6, 2016

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 retrieving plasma from a blood sample comprising:
a. mixing a blood sample in the presence of magnetizable particles in a sample collection unit,
wherein the magnetizable particles comprise an antibody capture surface for binding to non-plasma portions of the blood sample; and
b. applying a magnetic field above a plasma collection area to the mixed blood sample to effect suspension of the non-plasma portions of the blood sample on top of the plasma collection area,
wherein said method is carried out in a system for automated detection of an analyte, said system comprising:
i) a cartridge for automated detection of an analyte, the cartridge comprising:
the sample collection unit, wherein the sample collection unit comprises the sample;
an array of assay units configured to receive a portion of the sample from the sample collection unit and run a chemical reaction that yields a detectable signal indicative of the presence of the analyte in the sample; and
an array of reagent units containing reagents for running the chemical reaction;
wherein an individual assay unit of the array of assay units and an individual reagent unit of the array of reagent units are configured to be movable into fluid communication such that reagents for running the chemical reaction are brought to contact with the portion of the sample in the assay unit; and

ii) a detection assembly for detecting the detectable signal indicative of the presence or absence of the analyte.

2. The method of claim 1 , wherein the sample collection unit is a capillary tube.

3. The method of claim 1 , wherein the blood sample is less than about 20 microliters.

4. The method of claim 1 , wherein the plasma retrieved is less than about 10 microliters.

5. The method of claim 1 , wherein the blood sample is not diluted.

6. The method of claim 1 , wherein the mixing occurs in the presence of antibodies unbound to a solid surface.

7. The method of claim 1 , wherein the mixing comprises mixing by syringe action.

8. The method of claim 1 , wherein the magnetizable particles comprise an antibody to a red cell antigen or to an adaptor molecule.

9. The method of claim 8 , wherein the adaptor molecule is biotin, digoxigenin, or fluorescein.

10. The method of claim 1 , wherein the sample collection unit is a sample tip, and the magnetic field and sample tip are moved simultaneously.

11. The method of claim 1 , wherein 25% to 60% of the blood sample is plasma which can be separated.

12. The method of claim 1 , wherein the sample collection unit is a sample tip comprising an opening, wherein the plasma collection area is adjacent to the opening of the sample tip, wherein the plasma collection area comprises plasma, and wherein while the non-plasma portions of the blood sample are suspended on top of the plasma collection area, the plasma is allowed to exit the tip into a well.

13. The method of claim 12 , wherein the plasma is collected from the well by a plasma collection tip.

14. The method of claim 13 , wherein the plasma is distributed from the plasma collection tip into a diluent.

15. A method of retrieving plasma from a blood sample comprising:
a. mixing a blood sample in the presence of magnetizable particles in a sample collection unit,
wherein the magnetizable particles comprise an antibody capture surface for binding to non-plasma portions of the blood sample; and
b. applying a magnetic field above a plasma collection area to the mixed blood sample to effect suspension of the non-plasma portions of the blood sample on top of the plasma collection area,
wherein the sample collection unit is a sample tip comprising an opening, and the plasma collection area is adjacent to the opening of the sample tip, wherein the plasma collection area comprises plasma, and while the non-plasma portions of the blood sample are suspended on top of the plasma collection area, the plasma is allowed to exit the tip by gravity.

16. The method of claim 15 , wherein the plasma exits the tip by gravity and by vacuum or pressure.

17. The method of claim 15 , wherein the plasma exits the tip into a microtiter plate.

Assignees

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

Inventors

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

Classifications

• G16H10/40

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title

• G01N33/5758

  involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites · CPC title

• B01L3/5025

  for parallel transport of multiple samples · CPC title

• G01N33/6803

  General methods of protein analysis not limited to specific proteins or families of proteins · CPC title

• A61B2010/0077

  Cerebrospinal fluid · CPC title