CALIBRATION OF FLUIDIC DEVICES

• US 20110104826A1
• Filed: 01/07/2011
• Published: 05/05/2011
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Wang, Chengwang, Roy, Shauank, Gibbons, Ian, Holmes, Elizabeth A.
• Granted Patent: US 9,182,388 B2
• Time in Patent Office: Days
• US Class Current: 436/536
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150763 with identification means identification means for surgical instruments A61B90/90
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/0877 : Flow chambers
• CPC Class Codes: B01L 2300/0883 : Serpentine channels
• CPC Class Codes: B01L 2300/0887 : Laminated structure
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 2500/00 : Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/50 : Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/53 : Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/5302 : Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/11 : Automated chemical analysis
• CPC Class Codes: Y10T 436/115831 : Condition or time responsive
• CPC Class Codes: Y10T 436/12 : Condition responsive control
• CPC Class Codes: Y10T 436/143333 : Saccharide [e.g., DNA, etc.]

Abstract

The present invention provides methods of calibrating a fluidic device useful for detecting an analyte of interest in a bodily fluid. The invention also provides methods for assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device. Another aspect of the invention is a method for performing a trend analysis on the concentration of an analyte in a subject using a fluidic device.

Claims

1. A method of improving the accuracy of calibrating a fluidic system, comprising:

a) providing a system for detecting an analyte in a bodily fluid from a subject comprising a fluidic device for providing said bodily fluid, said fluidic device having a calibration assembly and a reader assembly for detecting the presence of said analyte;

b) measuring one or more parameters of a calibration curve associated with said fluidic device;

c) comparing said one or more parameters with predetermined parameters associate with said fluidic device;

d) adjusting a signal output by the ratio of said one or more parameters and said predetermined parameters.

2. The method of claim 1 wherein said predetermined parameters are parameters determined at the time the fluidic device is manufactured.

3. The method of claim 2 wherein said predetermined parameters are replaced with said measured one or more parameters to be used in a calibration curve to scale a signal to determine said analyte concentration.

4. A method of improving the calibration of a fluidic system, comprising:

a) measuring a first signal in an original sample comprising a known quantity of an analyte;

b) measuring a second signal after spiking said original sample with a known quantity of said analyte;

c) plotting the difference between said first and second signals against a target value, wherein said target value is a signal expected for said known quantity of said analyte; and

d) arriving at a best fit of parameters by minimizing the sum of the square of the differences between said target value and calculated analyte values.

5. The method of claim 4 wherein said sample is provided to a fluidic device, said fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows a sample of bodily fluids to react with reactants contained within said assay assembly.

6. A method of assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device, comprising:

a) providing a system, said system comprising a fluidic device, said fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows a sample of bodily fluid to react with reactants contained within said assay assembly, for detecting the presence of an analyte in a bodily fluid from a subject, and a reader assembly for detecting the presence of said analyte;

b) sensing with a sensor a change in operation parameters under which the system normally operates.

7. The method of claim 6 further comprising improving the reliability of said assay by adjusting the operating parameters to effect normal functioning of the system.

8. The method of claim 6 wherein said sensor is associated with said fluidic device.

9. The method of claim 8 where said sensor is capable of communicating said change to said reader assembly.

10. The method of claim 6 wherein said change comprises a change in temperature.

11. The method of claim 6 wherein said change comprises a change in pressure.

12. The method of claim 6 where said sensor is associated with said reader assembly.

13. The method of claim 12 where said sensor is capable of communicating said change to an external device.

14. The method of claim 12 wherein said change comprises a change in temperature.

15. The method of claim 12 wherein said change comprises a change in pressure.

16. The method of claim 6, further comprising adjusting a calibration step of said system.

17. The method of claim 6, further comprising wirelessly communicating said change via a handheld device.

18. The method of claim 6 wherein said change is the presence of moisture in said fluidic device.

19. The method of claim 18 wherein said sensor comprises thiosyanate and iron salt.

20. A method of performing a trend analysis on the concentration of an analyte in a subject, comprising:

a) providing a fluidic device comprising at least one sample collection unit, an immunoassay assembly containing immunoassay reagents, a plurality of channels in fluid communication with said sample collection unit and/or said immunoassay assembly;

b) actuating said fluidic device and directing said immunoassay reagents within said fluidic device;

c) allowing a sample of bodily fluid of less than about 500 ul to react with said immunoassay reagents contained within said assay immunoassay assembly to yield a detectable signal indicative of the presence of said analyte in said sample;

d) detecting said detectable signal generated from said analyte collected in said sample of bodily fluid; and

e) repeating steps a) through d) for a single patient over a period of time to detect concentrations of said anayte, thereby performing said trend analysis.