Point-of-care fluidic systems and uses thereof

• US 20060264782A1
• Filed: 03/24/2006
• Published: 11/23/2006
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Gibbons, Ian, Holmes, Elizabeth A., Roy, Shaunak, Wang, Chengwang, Howard, John, Qi, Shize Daniel, Kemp, Timothy M.
• Granted Patent: US 7,635,594 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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, comprising:

a) a fluidic device, said fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows a sample of bodily fluid to react with reactants contained within said assay assembly based on a protocol transmitted from an external device to yield a detectable signal indicative of the presence of said analyte;

b) a reader assembly comprising a detection assembly for detecting said detectable signal; and

c) a communication assembly for transmitting said detected signal to said external device.

2. The system of claim 1, wherein said protocol is transmitted wirelessly from an external device.

3. The system of claim 1, wherein said fluidic device further comprises an identifier to provide the identity of said fluidic device that is adapted to trigger the transmission of said protocol.

4. The system of claim 1, wherein said protocol varies depending on the identify of said fluidic device that is recognizable by an identifier detector.

5. The system of claim 1, wherein said sample of bodily fluid is less than about 500 ul.

7. The system of claim 1 or claim 6, wherein said reactants comprise immunoassay reagents.

8. The system of claim 7, wherein the immunoassay reagents detect a microorganism selected from the group consisting of bacterium, virus, fungus, and protozoa.

10. The system of claim 7, wherein the immunoassay reagents detect a member selected from the group consisting of drug, drug metabolite, biomarker indicative of a disease, tissue specific marker, and biomarker specific for a cell or cell type.

11. The system of claim 1 or claim 6, wherein said fluidic device detects a plurality of analytes and said fluidic device comprises immunoassay reagents for said plurality of analytes.

12. The system of claim 11, wherein the plurality of analytes are identified by distinct signals detectable over a range of 3 orders of magnitude.

13. The system of claim of claim 7, wherein the detectable signal is a luminescent signal.

14. The system of claim of claim 1 or 6, wherein the fluidic device further comprises a microneedle for obtaining the sample of bodily fluid.

15. A method for detecting an analyte in a bodily fluid of a subject, comprising:

a) providing a system of claim 1 or 6;

b) allowing a sample of bodily fluid to react with the reactants contained within said assay assembly to yield a detectable signal indicative of the presence of said analyte; and

c) detecting said detectable signal.

16. The method of claim 15, further comprising the step of quantifying the amount of said analyte present in said bodily fluid.

17. The method of claim 16, further comprising the step of comparing the amount of said analyte present in said biologic fluid to a predetermined amount of said analyte.

18. The method of claim 15 further comprising the step of taking a medical action when the amount of said analyte present in said bodily fluid is statistically different than said predetermined amount.

19. The method of claim 18, wherein the medical action comprises notifying a pharmacy that a prescription for such subject needs to be altered.

20. The method of claim 19, wherein the notification is electronically transimitted.

21. The method of claim 19, wherein the notification is wirelessly transmitted

22. The method of claim 18, wherein the medical action comprises altering a subject'"'"'s dosage of a therapeutic agent.

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

a) a fluidic device, said fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows a sample of bodily fluid of less than 500 ul to react with reactants contained within said assay assembly to yield a detectable signal indicative of the presence of said analyte collected in said sample of bodily fluid;

b) a reader assembly comprising a detection assembly for detecting said detectable signal; and

c) a communication assembly for transmitting said detected signal to an external device.

9. The system of 7, wherein the immunoassay reagents detect a polypeptide glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.

23. A method of detecting an analyte in a bodily fluid from a subject, comprising:

a) providing a fluidic device comprising at least one sample collection unit, an immunoassay assembly containing immunoassay reagents, a plurality of channels in fluid communication with said sample collection unit and/or said immunoassay assembly;

b) actuating said fluidic device and directing said immunoassay reagents within said fluidic device;

c) allowing a sample of bodily fluid of less than about 500 ul to react with said immunoassay reagents contained within said assay immunoassay assembly to yield a detectable signal indicative of the presence of said analyte in said sample; and

d) detecting said detectable signal generated from said analyte collected in said sample of bodily fluid.

24. The method of claim 23, wherein said directing is effected by a mechanism selected from the group consisting of capillary action, vacuum suction, pulling, and a combination thereof.

25. The method of claim 23, wherein said fluidic device detects a plurality of analytes and said fluidic device comprises immunoassay reagents for said plurality of analytes.

26. The method of claim 23, wherein said sample of bodily fluid and said immunassay reagents remain in said fluidic device after said detecting step.

27. The method of claim 23, wherein said immunoassay is indicative of a pharmacokinetic parameter.

28. The method of claim 23, wherein said immunoassay is indicative of a pharmacodynamic parameter.

29. The method of claim 23, wherein said fluidic device communicates data relating to said signal via a wireless transmitter.

30. The method of claim 23, where a wireless device transfers an immunassay protocol to be run on said fluidic device.

31. The method of claim 23, wherein said immunoassay protocol varies dependent upon an identity of said fluidic device.

32. The method of claim 23, wherein said fluidic device is identified and an expiration date of said fluidic device is registered.

33. The method of claim 23, wherein said immunoassay is an assay for a disease marker, a drug metabolite and a disease agent.

34. The method of claim 23, wherein the detectable signal is a chemiluminescent signal.

35. The method of claim 23, wherein the immunoassay reagents comprise an alkaline phosphatase or a horseradish peroxidase.

36. The method of claim 23, wherein a CCD is used for said detecting said detectable signal.

37. The method of claim 23, wherein said fluidic device further comprises at least one waste disposal unit.

38. The method of claim 23, wherein a pin diode connected to an amplifier is used for detecting said detectable signal.

39. The method of claim 23, wherein said immunoassay assembly comprises a plurality of immunoassays.

40. The method of claim 23, wherein the fluidic device further comprises a microneedle for obtaining the sample of bodily fluid.