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

Patent metadata

Field	Value
Publication number	US-10634667-B2
Application number	US-201514848032-A
Country	US
Kind code	B2
Filing date	Sep 8, 2015
Priority date	Oct 2, 2007
Publication date	Apr 28, 2020
Grant date	Apr 28, 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 system for detection of an analyte in a biological sample, comprising:
i) a fluidic device comprising a sample collection unit configured to receive the biological sample, a diluent unit configured to contain a diluent and a reagent unit configured to contain a cartridge reagent for running an assay;
ii) an addressable assay unit comprising an interior reaction site having thereon an immobilized binding reagent that is configured to yield a detectable intensity of a signal indicative of the presence of the analyte;
iii) a fluid transfer device configured to transport the diluent to the sample collection unit to form a diluted sample, the diluted sample to the addressable assay unit, and the cartridge reagent to the addressable assay unit;
iv) a device stage configured to move the fluidic device into fluidic communication with the addressable assay unit; and
v) a detection assembly comprising a detector configured to detect the detectable intensity of a signal indicative of the presence of the analyte.

2. The system of claim 1 , wherein the analyte is selected from the group of analyte types consisting of protein analytes, nucleic acid analytes, organic analytes, and inorganic analytes.

3. The system of claim 1 , further comprising a reader assembly configured to engage said fluidic device.

4. The system of claim 1 , wherein at least one of the sample collection unit or the reagent unit is configured to be moved into fluid communication with the addressable assay unit.

5. The system of claim 1 , wherein said detection assembly comprises an optical detector.

6. The system of claim 5 , wherein said optical detector comprises a photodiode, an avalanche photodiode, a photomultiplier (PMT), a photon counting detector, a charge-coupled device, or a pin diode.

7. The system of claim 1 , wherein said detection assembly comprises a plurality of detectors.

8. The system of claim 1 , wherein said detection assembly is configured to detect a signal from a nucleic acid assay, a signal from an immunoassay, or both.

9. The system of claim 1 , wherein said system comprises a system selected from one or more of: a point of care system for detecting analytes in a biological sample; a portable system for detecting analytes in a biological sample; a desk-top system for detecting analytes in a biological sample; and a bench-top system for detecting analytes in a biological sample.

10. The system of claim 1 , wherein said biological sample is selected from the group consisting of blood, serum, plasma, saliva, urine, tears, gastric fluid, digestive fluid, bone marrow, cerebrospinal fluid, stool, semen, vaginal fluid, and liquid extracted from tissue.

11. The system of claim 1 , wherein said biological sample comprises a volume about 1 μL to 100 μL.

12. The system of claim 1 , further comprising a pretreatment unit configured to separate, process, or retrieve a portion of said biological sample, or combinations thereof.

13. The system of claim 1 , wherein the fluid transfer device comprises a pipette head comprising a nozzle.

14. The system of claim 13 , wherein said nozzle is configured to engage a pipette tip.

15. The system of claim 1 , wherein the fluid transfer device is configured to operate according to a protocol.

16. The system of claim 15 , wherein said protocol is configured to be adjustable without requiring modification of the system.

17. The system of claim 1 , wherein the fluid transfer device is configured for automated operation.

18. The system of claim 1 , further comprising a communication assembly, wherein said communication assembly is configured to transmit information.

19. The system of claim 1 , further comprising a communication assembly, wherein said communication assembly is configured to receive information.

20. The system of claim 19 , wherein operation of said system comprises operation according to a protocol, wherein said protocol is configured to incorporate information received by said communication assembly.

21. The system of claim 20 , wherein said protocol is configured to be adjustable without requiring modification of the system.

22. The system of claim 1 , comprising a plurality of addressable assay units and a plurality of diluent units configured to perform at least two assays in parallel.

Assignees

• Theranos Ip Co Llc

Inventors

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

Classifications

• G01N2800/60

  Complex ways of combining multiple protein biomarkers for diagnosis · CPC title

• B01L2300/0829

  Multi-well plates; Microtitration plates · CPC title

• B01L9/543

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

• B01J2219/00315

  Microtiter plates · CPC title

• B01J2219/00369

  in multiple or parallel arrangements · CPC title