DETECTION AND QUANTIFICATION OF ANALYTES IN BODILY FLUIDS

• US 20100248277A1
• Filed: 03/30/2010
• Published: 09/30/2010
• Est. Priority Date: 11/14/2006
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos Incorporated
• Inventors: Ku, Edmond, Gibbons, Ian, Roy, Shaunak
• Granted Patent: US 8,778,665 B2
• Time in Patent Office: Days
• US Class Current: 435/11
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0631 Purification arrangements, e.g. solid phase extraction [SPE]
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0819 Microarrays; Biochips
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/0874 Three dimensional network
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/168 Specific optical properties, e.g. reflective coatings
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502753 characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: C12Q 1/60 involving cholesterol
• CPC Class Codes: G01N 21/27 using photo-electric detection G01N21/31 takes precedence; circuits for computing concentration logarithmic circuits G06G7/24; photometric circuits in general G01J
• CPC Class Codes: G01N 21/31 Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry G01N21/72 takes precedence
• CPC Class Codes: G01N 2201/061 Sources
• CPC Class Codes: G01N 2201/062 LED's
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: Y10T 436/20 : Oxygen containing

Abstract

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow 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 comprising a cartridge, said cartridge 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 to yield a colored product having an absorbance spectrum corresponding to at least one wavelength from a light source;

b) a light source transmitting the at least one wavelength to the assay assembly; and

c) a detector that detects absorption of light of the at least one wavelength, wherein said absorption is indicative of the presence of the analyte in said bodily fluid.

3. The system of claim 1, wherein the amount of absorption is stoichiometrically related to the concentration of the analyte in said bodily fluid.

6. The system of claim 1, wherein the light source comprises a light emitting diode.

13. The system of claim 1, wherein the assay assembly is configured to run an immunoassay or an enzymatic assay yielding a colored product.

16. The system of claim 1, wherein the wavelength is in a range of about 400 to about 800 nm.

18. The system of claim 1, wherein said sample of bodily fluid is less than about 50 ul.

2. (canceled)

4-5. -5. (canceled)

7-12. -12. (canceled)

14-15. -15. (canceled)

17. (canceled)

19. (canceled)

20. A fluidic device for detecting the presence or absence of an analyte in a bodily fluid from a subject, comprising:

a cartridge, said cartridge comprising a sample collection unit, an assay assembly; and

a light source, wherein said sample collection unit is configured to collect a sample of bodily fluid from said subject and wherein said assay assembly comprises at least one reaction site containing a reactant that reacts with said analyte to yield a colored product having an absorbance spectrum corresponding to at least one wavelength from said light source.

21. The fluidic device of claim 20, wherein said light source is luminescent paint coated in said assay assembly.

23. The fluidic device of claim 20, wherein said sample collection unit comprises a sample collection well, a metering channel, and a dilution chamber in fluidic communication with said metering channel, wherein said dilution chamber is configured to store a diluent.

24. The fluidic device of claim 23, wherein said sample collection unit further comprises a mixing chamber that is configured to mix a predetermined portion of the sample with the diluent to yield a diluted sample.

25. The fluidic device of claim 24, wherein the sample collection unit further comprises a filter configured to filter the diluted sample before it is assayed.

22. (canceled)

26-32. -32. (canceled)

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

a) introducing a sample of bodily fluid into a fluidic device comprising

a sample collection unit including a metering assembly, and

an assay assembly, said assay assembly comprising reactants that are capable of reacting with said analyte;

b) allowing said sample of bodily fluid to react with said reactants contained within said assay assembly to yield a colored product having an absorbance spectrum corresponding to at least one wavelength from a light source;

c) transmitting the at least one wavelength to the fluidic device from said light source; and

d) detecting absorption of light of the at least one wavelength transmitted to the fluidic device, wherein said absorption is indicative of the presence of the analyte in said bodily fluid.

35. The method of claim 33, wherein the amount of absorption is stoichiometrically and linearly related to the concentration of the analyte in said bodily fluid.

37. The method of claim 33, wherein the light source comprises a light emitting diode or luminescent paint coated in said assay assembly.

39. The method of claim 33, wherein the analyte is selected from the group consisting of drug, drug metabolite, biomarker indicative of a disease, tissue specific marker, tissue specific enzyme, HDL cholesterol, LDL cholesterol, total cholesterol, lipids, glucose, and enzymes.

41. The method of claim 33, wherein the wavelength is in a range of about 400 to about 800 nm.

43. The method of claim 33, wherein said assay assembly is configured to run an enzymatic assay yielding a colored product or an immunoassay.

49. The method of claim 33, wherein said introducing comprises metering a predetermined portion of said sample using a metering channel, to be assayed in said sample collection unit;

diluting and mixing said predetermined portion of said sample with a diluent in said fluidic device after the metering step to yield a diluted sample, and filtering said diluted sample before allowing said diluted sample to react with said reactants.

52. The method of claim 49 wherein said predetermined portion of said sample is less than 20 ul.

55. The method of claim 49, wherein the sample collection unit includes a diluent chamber and the predetermined portion of said sample is mixed with the diluent wherein the diluent is stored in a diluent chamber and the portion and diluent are mixed in a mixing chamber.

34. (canceled)

36. (canceled)

38. (canceled)

40. (canceled)

42. (canceled)

44-48. -48. (canceled)

50-51. -51. (canceled)

53-54. -54. (canceled)