Standardized Calibration for Analyte Concentration Determination

Abstract

A biosensor system measurement device for determining the presence and / or concentration of an analyte in a sample includes normalized calibration information that causes the device to generate an output signal in response to the analyte concentration of the sample with a previously determined reference sample analysis linked to the concentration of the substance. The measurement device uses this normalized calibration information to relate one or more output signals from electrochemical or optical analysis of the sample to the presence and / or concentration of one or more analytes in the sample. The normalized calibration information includes a normalized relationship that normalizes the output signal measured by the measurement device of the biosensor system and at least one normalized reference correlation that relates the normalized output signal to a reference sample analyte concentration.

Description

[0001] References to related applications [0002] This application claims the benefit of US Provisional Application No. 61 / 782,520, filed March 14, 2013, entitled "Calibration of Analyte Concentration Determination," the entire contents of which are incorporated herein by reference. Background technique [0003] Biosensor systems provide analysis of biological fluid samples such as blood, serum, plasma, urine, saliva, intercellular or intracellular fluids. Typically, the system includes a measurement device that analyzes the sample present in the test sensor. The sample is usually in liquid form and, in addition to being a biological fluid, can also be a derivative of a biological fluid, such as an extract, dilution, filtrate or reconstituted pellet. Analyses performed by biosensor systems determine biological fluids such as ethanol, glucose, uric acid, lactate, cholesterol, bilirubin, free fatty acids, triglycerides, proteins, ketones, phenylalanine, or enzymes or the pres...

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Problems solved by technology

[0032] If the measurement setup is calibrated with too many or non-optimal error parameters, points of diminishing effect or even poorer measurement performance may result

Furthermore, the more parameters are considered in the calibration, the less useful the calibration information stored in the measuring device may be for the compensation of subsequent analyzes from error parameters determined during the analysis

These calibration issues are compounded when the ongoing analysis includes multiple output signals, including analyte concentration responses (primary output signals) and / or non-analyte response signals (secondary output signals)

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