POINT-OF-CARE FLUIDIC SYSTEMS AND USES THEREOF

• US 20130115685A1
• Filed: 10/08/2012
• Published: 05/09/2013
• Est. Priority Date: 05/09/2005
• Status: Active Application

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Inventors: Holmes, Elizabeth A., Roy, Shaunak, Howard, John, Wang, Chengwang, Gibbons, Ian, Kemp, Timothy M., Qi, Shize Daniel
• Application Number:
  US13/647,325
• Publication Number:
  US 20130115685A1
• Time in Patent Office: Days
• US Class Current: 435/287.2
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150763 with identification means identification means for surgical instruments A61B90/90
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/0877 : Flow chambers
• CPC Class Codes: B01L 2300/0883 : Serpentine channels
• CPC Class Codes: B01L 2300/0887 : Laminated structure
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 2500/00 : Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/50 : Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/53 : Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/5302 : Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/11 : Automated chemical analysis
• CPC Class Codes: Y10T 436/115831 : Condition or time responsive
• CPC Class Codes: Y10T 436/12 : Condition responsive control
• CPC Class Codes: Y10T 436/143333 : Saccharide [e.g., DNA, etc.]

Abstract

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Claims

1. A system for detecting an analyte in a bodily fluid from a subject, the system comprising:

a reader assembly comprising at least one communication interface operable to receive an assay protocol from an external device; and

an assay device configured to be coupled to the reader assembly, said assay device comprising;

i) at least one structure for receiving at least a portion of the bodily fluid;

ii) at least one reactant that reacts with the bodily fluid based on the assay protocol transmitted from said external device to yield a detectable signal indicative of said analyte; and

iii) an information storage unit;

wherein the reader assembly comprises a detection assembly for detecting the detectable signal;

wherein the assay protocol effects selection of a detection method for detecting said signal;

wherein the information storage unit has information to be used in selection of the assay protocol.

2. A system as in claim 1 wherein the communication interface is configured to receive said protocol wirelessly from said external device.

3. A system as in claim 1 wherein the communication interface is configured to receive said protocol via a wired connection from said external device.

4. A system as in claim 1 wherein the assay device comprises a cartridge.

5. A system as in claim 1 wherein said reactant comprises an immunoassay or a nucleic acid reagent immobilized within the assay device.

6. A system as in claim 1 wherein the information storage unit comprise a bar code.

7. A system as in claim 1 wherein the information storage unit comprise a semiconductor memory device.

8. A system as in claim 1 wherein the information comprises an identifier for the assay unit.

9. A system as in claim 1 wherein the reader assembly is configured to detect a plurality of analytes and said assay device comprises immunoassay or nucleic acid reagents for said plurality of analytes.

10. A system as in claim 11 wherein the detection assembly is configured to detect a plurality of analytes that generate distinct signals, wherein the intensities of said distinct signals vary over a range of 3 orders of magnitude.

11. A system as in claim 1 wherein the detection assembly is configured to detect luminescent signals from said plurality of reactions.

12. A system as in claim 1 wherein the detection assembly is configured to detect chemiluminescent signals from said plurality of reactions.

13. A system as in claim 1 wherein the detection assembly comprises sensors from one or more of the following sensor types:

temperature, conductivity, potentiometric, or amperometric.

14. A system as in claim 1 wherein the reader assembly further comprises a controller having computer-executable commands for performing the reaction at a designated point-of-care location remote from a location of the external device.

15. A system as in claim 1 wherein the reader assembly further comprises a controller configured for executing having computer-executable commands for performing on-board calibration of said reader assembly.

16. A system as in claim 1 wherein said reader assembly comprises an identifier detector that detects an identifier from the information storage unit on the assay device.

17. A system as in claim 1 wherein the assay device is configured to run a plurality of types of assays.

18. A system as in claim 1 wherein the reader assembly comprises a communication assembly for transmitting data regarding the detectable signal.

19. A system as in claim 1 wherein the system has a programmable processor that compares the amount of said analyte determined from the detectable signal to a predetermined amount of said analyte.

20. A system as in claim 1 wherein the protocol dictates the actuation of one or more elements of the device, thereby directing fluid movement.