CALIBRATION OF FLUIDIC DEVICES

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 thiocyanate 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.