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

Patent metadata

Field	Value
Publication number	US-11092593-B2
Application number	US-201514848084-A
Country	US
Kind code	B2
Filing date	Sep 8, 2015
Priority date	Oct 2, 2007
Publication date	Aug 17, 2021
Grant date	Aug 17, 2021

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 point-of-care system configured for detecting a plurality of different analytes in a blood sample, the system comprising:
a cartridge comprising a sample unit for containing the blood sample, and a plurality of addressable reagent units for containing reagents for carrying out an assay to detect an analyte, wherein the sample unit and the plurality of addressable reagent units are arranged in a grid-like pattern, the plurality of addressable reagent units are isolated and independent from one another, and the cartridge contains all reagents for performing the assay to detect the analyte;
an assay assembly comprising an assay unit and an assembly tip, wherein the assembly tip comprises an opening for transferring the blood sample and a reagent from a reagent unit of the plurality of addressable reagent units into the assay unit, wherein the assay unit comprises a capture surface on which an antibody is immobilized such that a reaction occurs within the assay unit which is configured to yield a signal indicative of a presence of the analyte; and
a reader assembly configured to receive the cartridge and the assay assembly, the reader assembly comprising:
a translational stage configured to receive the cartridge thereon and movably position the cartridge within the reader assembly relative to the assay assembly to place the blood sample in fluid communication with the assay unit via the assembly tip;
a fluid transfer device comprising a programmable processor configured to direct fluid transfer of the blood sample and the reagent from the plurality of addressable reagent units into the assay unit via the assembly tip according to a protocol for performing the assay on the blood sample to detect the analyte; and
a detector assembly configured to detect the signal indicative of the presence of the analyte within the assay assembly.

2. The system of claim 1 , wherein the blood sample has a volume of about 1 μL to about 50 μL.

3. The system of claim 1 , wherein the blood sample is whole blood, plasma, or serum.

4. The system of claim 1 , wherein the plurality of addressable reagent units are pre-filled with the reagents for performing the assay.

5. The system of claim 1 , wherein the plurality of addressable reagent units are configured as cylindrical cups.

6. The system of claim 1 , wherein the plurality of addressable reagent units are covered by a seal.

7. The system of claim 1 , wherein the fluid transfer device comprises a pump configured to aspirate and eject one of the blood sample and the reagents.

8. The system of claim 1 , wherein the blood sample and the reagents are transferred to the assay unit in an order and combination determined by the protocol.

9. The system of claim 1 , wherein the reader assembly further comprises a communication assembly; and wherein the protocol is transferred to the reader assembly via the communication assembly from an external device.

10. The system of claim 1 , wherein the reader assembly further comprises a heating unit configured to control a temperature of the assay unit.

11. The system of claim 1 , wherein the fluid transfer device is configured to effect dilution of the blood sample by transferring the blood sample from the sample unit to the assay unit via the assembly tip, and subsequently transferring a reagent that is a diluent from the plurality of addressable reagent units to the assay unit via the assembly tip.

12. The system of claim 1 , wherein the cartridge contains a reagent in a reagent unit of the plurality of addressable reagent units configured to amplify the signal indicative of the presence of the analyte.

13. The system of claim 1 , wherein the antibody is bound to the capture surface by a linkage selected from the group of a streptavidin- or avidin-biotin linkage, a carbamate linkage, and an ester linkage.

14. A point-of-care system configured for detecting an analyte in a blood sample, the system comprising:
a cartridge comprising a sample unit for receiving the blood sample, a plurality of reagent units containing reagents for performing an assay to detect the analyte, and a cartridge identifier, wherein the sample unit and the plurality of reagent units are arranged in a grid-like pattern, the plurality of reagent units are isolated and independent from one another, and the cartridge contains all reagents for performing the assay to detect the analyte;
an assay assembly comprising an assay unit and an assembly tip, wherein the assembly tip comprises an opening for transferring the blood sample and a reagent from a reagent unit of the plurality of reagent units into the assay unit, wherein the assay unit comprises a capture surface on which an antibody is immobilized such that a reaction occurs within the assay unit which is configured to yield a signal indicative of a presence of the analyte;
a reader assembly configured to receive the cartridge and the assay assembly, wherein the reader assembly comprises:
a translational stage configured to movably position the cartridge within the reader assembly so as to place the blood sample in fluid communication with the assay assembly via the assembly tip of the assay assembly,
a fluid transfer device comprising a programmable processor configured to direct fluid transfer of the blood sample and a reagent of the plurality of reagent units to the assay unit of the assay assembly based on a protocol, wherein a reaction occurs within the assay unit that yields a detectable signal indicative of the presence of the analyte, and
a detection assembly configured to detect the signal indicative of the presence of the analyte within the assay unit; and

an external device which stores protocols for performing assays to detect analytes, wherein the external device is in communication with the reader assembly, and wherein the reader assembly detects the cartridge based on the cartridge identifier, and the external device communicates a protocol corresponding to the cartridge identifier to the reader assembly for running the assay to detect the analyte.

15. The system of claim 14 , wherein the blood sample has a volume of about 1 μL to about 50 μL.

16. The system of claim 14 , wherein the blood sample is whole blood, plasma, or serum.

17. The system of claim 14 , wherein the cartridge is pre-filled with the reagents for performing the assay.

18. The system of claim 14 , wherein the detection assembly comprises a light source.

19. The system of claim 14 , wherein the reader assembly is further configured to communicate the detectable signal to the external device.

20. The system of claim 14 , wherein the external device is a server comprising a user interface.

21. The system of claim 14 , wherein the analyte is a biomarker associated with a disease or a disease stage.

Assignees

• Labrador Diagnostics Llc

Inventors

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

Classifications

• 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

• G01N33/54386

  Analytical elements · CPC title

• B01L3/0275

  Interchangeable or disposable dispensing tips · CPC title

• G01N35/1065

  Multiple transfer devices · CPC title

• G01N2035/103

  using disposable tips · CPC title