Detection and quantification of analytes in bodily fluids

• US 8,778,665 B2
• Filed: 03/30/2010
• Issued: 07/15/2014
• 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): Chin, Chris L
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US12/750,518
• Publication Number:
  US 20100248277A1
• Time in Patent Office: 1,568 Days
• US Class Current: 435/287.2
• 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 at least one analyte in a bodily fluid from a subject, the system comprising:

a light source comprising a coating of luminescent paint and having an emission spectrum;

an assay assembly having one or more reactants to react with the bodily fluid to yield a colored product having an absorbance spectrum encompassing at least one wavelength within the emission spectrum from the light source; and

a detector that detects absorption of the at least one wavelength of light directed through the colored product, wherein said absorption of said at least one wavelength through the colored product is indicative of the presence of the analyte in said bodily fluid.

2. The system of claim 1 wherein the detector is configured to detect at least two different analytes in the 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.

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

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

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

7. The system of claim 1 wherein the light source comprises a monochromatic light source having a wavelength that is encompassed by the absorbance spectrum.

8. The system of claim 1 wherein the light source comprises a filter having a wavelength that is encompassed by the absorbance spectrum.

9. The system of claim 1 wherein the analyte is specifically bound by an antibody that is detected by a secondary enzyme-linked antibody that catalyzes a color-producing reaction.

10. The system of claim 1 wherein the analyte is converted chemically to the colored product via a color-producing reaction.

11. The system of claim 1 wherein the analyte catalyzes the formation of the colored product from said reactants.

12. The system of claim 1 further comprising a chemical reagent that bind the analyte binds with an agent that participates in a color-producing reaction.

13. The system of claim 3 wherein the amount of absorption is linearly related to the concentration of the analyte in said bodily fluid.

14. The system of claim 1 wherein the volume of bodily fluid is less than about 50 μ

l.

20. The system of claim 1 wherein the detector is configured to detect the absorption of the at least one wavelength of light at a reaction site where the reactants react with the bodily fluid within the assay assembly.

21. The system of claim 1 wherein the detector is configured to detect the absorption of the at least one wavelength of light at a detection site after the colored product has been transported from a reaction site where the reactants react with the bodily fluid within the assay assembly.

22. The system of claim 1 wherein the assay assembly comprises at least one well in which the reactants react with the bodily fluid.

23. The system of claim 22 wherein the well is cylindrical in shape and includes a defined length between two opposed flat surfaces, wherein at least one of the flat surfaces is transparent.

24. The system of claim 23 wherein the light source and the detector are on the same side of the well where the one or more reactants react with the bodily fluid.

25. The system of claim 23 wherein the light source and the detector are on opposite sides of the well where the one or more reactants react with the bodily fluid.

26. The system of claim 1 wherein the assay assembly comprises multiple reaction sites where one or more reactants react with the bodily fluid, the multiple reaction sites comprising different reactants to detect different analytes in the bodily fluid.

27. The system of claim 26 wherein the multiple reaction sites and the detector are movable relative to one another.

15. A fluidic device for detecting the presence or absence of at least one analyte in a bodily fluid from a subject, the device comprising:

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

wherein said light source comprises luminescent paint coated in said assay assembly, and

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 of light directed through the colored product by said light source.

16. The fluidic device of claim 15, 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.

17. The fluidic device of claim 16, 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.

18. The fluidic device of claim 17, wherein the sample collection unit further comprises a filter configured to filter the diluted sample before it is assayed.

19. The fluidic device of claim 15, wherein the absorbance spectrum of the colored product overlaps by at least 70% with an emission spectrum from the light source.