SYSTEMS AND METHODS OF FLUIDIC SAMPLE PROCESSING

• US 20120258472A1
• Filed: 03/30/2012
• Published: 10/11/2012
• Est. Priority Date: 08/06/2007
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Roy, Shaunak, Takahashi, Malissa, Gibbons, Ian, Ku, Edmond, Dang, Thanh, Burd, Tammy, Vollmer, Adam, Holmes, Elizabeth A.
• Granted Patent: US 8,883,518 B2
• Time in Patent Office: Days
• US Class Current: 435/7.9
• CPC Class Codes: G01N 2201/12746 Calibration values determination
• CPC Class Codes: G01N 27/06 of a liquid involving electrolysis G01N27/26
• CPC Class Codes: G01N 27/07 Construction of measuring vessels; Electrodes therefor
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control

Abstract

The present invention provides fluidic devices and systems 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

1-26. -26. (canceled)

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

a) providing a fluidic device comprising a sample collection unit, an assay assembly, and a calibration unit, wherein,

i) said sample collection unit is configured to a collect a sample of the bodily fluid from said subject;

ii) said assay assembly comprises at least one reaction site containing a reactant configured to react with said analyte to yield a detectable signal indicative of the presence of said analyte; and

iii) said calibration unit is configured to provide a measurement of said sample used for calibrating said detectable signal;

b) allowing a portion of said sample to react with assay reagents contained within said assay assembly to yield a signal indicative of the presence of said analyte in said sample; and

c) detecting said signal generated from said analyte collected in said sample of bodily fluid.

28. The method of claim 27 further comprising calibrating the measurement of said signal generated from said analyte based upon a measurement by said calibration unit.

29. The method of claim 27 further comprising the step of quantifying the amount of said analyte present in said bodily fluid based on the measurement provided by the calibration unit.

30. The method of claim 27, wherein said fluidic device detects a plurality of analytes and said fluidic device comprises immunoassay reagents for said plurality of analytes.

31. A method of measuring plasma concentration of a blood sample, comprising:

a) providing a plasma sample substantially free of removing red blood cells;

b) passing a current through said plasma sample; and

c) measuring at least one of conductivity or impedance of said plasma sample, thereby measuring the plasma concentration of said blood sample.

32. The method of claim 31, wherein the blood sample is diluted with a 3iluents prior to step b).

33. The method of claim 31, wherein said measuring of plasma concentration occurs in a fluidic channel.

34. The method of claim 31 further comprising comparing the measured conductivity to a set of predetermined values showing relationship of conductivity values and plasma concentrations.

35. The method of claim 31 further comprising comparing the measured conductivity to a set of predetermined values showing relationship of conductivity values and dilution ratios that are employed to dilute the blood sample.

36. The method of claim 35 further comprising normalizing a calibration curve.

37. The method of claim 36, wherein said normalizing accounts for at least one factor selected from the group consisting of surface area of an electrode, temperature of said sample, gain of a circuit wherein said circuit delivers said current to said sample, volume of said sample, and red blood cell quantity of said sample.

38-48. -48. (canceled)