Detection and quantification of analytes in bodily fluids

• US 9,303,286 B2
• Filed: 05/22/2014
• Issued: 04/05/2016
• Est. Priority Date: 11/14/2006
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Gibbons, Ian, Roy, Shaunak, Ku, Edmond
• Primary Examiner(s): Nguyen, Bao Thuy L
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US14/285,562
• Publication Number:
  US 20140308689A1
• Time in Patent Office: 684 Days
• Field of Search: None
• US Class Current: 1/1
• 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 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, a light source having an emission spectrum, said light source comprising luminescent paint, 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 within said emission spectrum of said light source;

c) transmitting the at least one wavelength to the fluidic device from the 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.

2. The method of claim 1, wherein the amount of absorption is related to the concentration of the analyte in said bodily fluid.

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

4. The method of claim 1, wherein the light source further comprises a light emitting diode.

5. The method of claim 1, wherein the light source comprises a coating of luminescent paint.

6. The method of claim 5, wherein said luminescent paint is coated in said assay assembly.

7. The method of claim 1, wherein the analyte is selected from the group consisting of HDL cholesterol, LDL cholesterol, total cholesterol, lipids, glucose, enzymes, drug, drug metabolite, biomarker indicative of a disease, tissue specific marker, and tissue specific enzyme.

8. The method of claim 1, wherein the at least one wavelength is in a range of about 400 to about 800 nm.

9. The method of claim 1, wherein the fluidic device detects a plurality of analytes and said fluidic device comprises reactants for said plurality of analytes.

10. The method of claim 1, wherein said assay assembly is configured to run an enzymatic assay yielding a colored product, is configured to run an immunoassay, or both.

11. The method of claim 1, wherein the reactants are selected from the group of enzymes, substrates, and combinations thereof.

12. The method of claim 1, wherein the volume of the sample of bodily fluid is less than about 500 μ

L.

13. The method of claim 1, wherein the volume of the sample of bodily fluid is less than about 50 μ

L.

14. The method of claim 1, further comprising the step of quantifying the amount of said analyte present in said bodily fluid after said detecting step.

15. The method of claim 1, wherein said fluidic device comprises a metering assembly, and wherein said introducing comprises metering a predetermined portion of said sample to be assayed in said sample collection unit.

16. The method of claim 15, further comprising diluting and mixing said predetermined portion of said sample with a diluent in said fluidic device to yield a diluted sample.

17. The method of claim 16, wherein the volume of said predetermined portion of said sample is less than about 50 μ

L.

18. The method of claim 16, wherein the volume of said predetermined portion of said sample is less than about 20 μ

L.

19. The method of claim 16, wherein the volume of said predetermined portion of said sample is less than about 10 μ

L.

20. The method of claim 16, further comprising filtering said diluted sample before allowing said diluted sample to react with said reactants.

21. The method of claim 15, wherein the fluidic device comprises 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.