Methods for the detection of analytes in small-volume blood samples

Patent metadata

Field	Value
Publication number	US-10156579-B2
Application number	US-201615054510-A
Country	US
Kind code	B2
Filing date	Feb 26, 2016
Priority date	Nov 14, 2006
Publication date	Dec 18, 2018
Grant date	Dec 18, 2018

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 small-volume blood sample obtained from a subject, comprising:
a) obtaining a sample of blood from a subject by lancing or pipetting, said blood sample having a volume of less than about 500 μL;
b) pre-treating the blood sample by one or more of diluting, mixing, drying, evaporating, centrifuging, and extracting;
c) introducing the blood sample into a fluidic device comprising a sample collection unit and an assay assembly, said assay assembly comprising reactants that are capable of reacting with said analyte;
d) allowing the blood sample 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 located within said fluidic device;
e) transmitting the at least one wavelength to the fluidic device from said light source, wherein said light source comprises a luminescent paint; and
f) detecting a change in absorption of light of the at least one wavelength transmitted to the fluidic device, wherein said change in absorption is indicative of the presence of the analyte in the blood sample.

2. The method of claim 1 , wherein the amount of absorption is related to the analyte concentration in the blood sample.

3. The method of claim 1 , wherein the amount of absorption is stoichiometrically related to the analyte concentration in the blood sample.

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

5. The method of claim 1 , wherein said luminescent paint is coated in said assay assembly.

6. The method of claim 1 , wherein the analyte is selected from the group consisting of drugs, drug metabolites, biomarkers indicative of a disease, tissue specific markers, and tissue specific enzymes.

7. The method of claim 1 , wherein the analyte is selected from the group consisting of HDL cholesterol, LDL cholesterol, total cholesterol, lipids, glucose, and enzymes.

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

9. The method of claim 1 , wherein said 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 i) run an enzymatic assay yielding a colored product, or ii) run an immunoassay, or iii) both i) and ii).

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

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

13. 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.

14. The method of claim 1 , wherein said introducing comprises metering a predetermined portion of said sample to be assayed in said sample collection unit, wherein said predetermined portion of the sample consists of a portion of the sample having a volume determined by the dimensions of an element of said sample collection unit.

15. The method of claim 14 , further comprising 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.

16. The method of claim 15 , wherein said predetermined portion of said sample is less than 50 ul.

17. The method of claim 15 , wherein said predetermined portion of said sample is less than 20 ul.

18. The method of claim 15 , wherein said predetermined portion of said sample is about 10 ul.

19. The method of claim 15 , further comprising filtering said diluted sample before allowing said diluted sample to react with said reactants.

Assignees

• Theranos Ip Co Llc

Inventors

• Gibbons Ian
• Roy Shaunak
• Ku Edmond

Classifications

• G01N33/92 Primary

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

• Y10T436/20

  Oxygen containing · CPC title

• B01L2300/0819

  Microarrays; Biochips · CPC title

• B01L2300/0887

  Laminated structure · CPC title

• B01L2300/0874

  Three dimensional network · CPC title