Detection and quantification of analytes in bodily fluids

Patent metadata

Field	Value
Publication number	US-9303286-B2
Application number	US-201414285562-A
Country	US
Kind code	B2
Filing date	May 22, 2014
Priority date	Nov 14, 2006
Publication date	Apr 5, 2016
Grant date	Apr 5, 2016

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.

First claim

What is claimed is:

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 μL.

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

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 μL.

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

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

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.

Assignees

• Theranos Inc

Inventors

• Gibbons Ian
• Roy Shaunak
• Ku Edmond

Classifications

• B01L3/502753

  characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation · CPC title

• B01L2300/0887

  Laminated structure · CPC title

• G01N33/92 Primary

  involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)} · CPC title

• G01N33/525

  Multi-layer analytical elements · CPC title

• B01L2200/0605

  Metering of fluids · CPC title