Calibration of fluidic devices
AssigneeLabrador Diagnostics LLC
InventorsIan Gibbons (deceased), Chengwang Wang, Shaunak Roy, Elizabeth A. Holmes
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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.
Claims20
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.
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.
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.
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.
Dependencies are inferred from the claim text.