Methods of scaling data used to construct biosensor algorithms as well as devices, apparatuses and systems incorporating the same

摘要

Methods are disclosed for scaling body fluid analysis data to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature, variations in electrode conductivity or combinations thereof before providing an analyte concentration. The scaling methods utilize current response data obtained from an AC block applied prior to a DC block to minimize the impact of such confounding variables upon the observed DC current response before creating descriptors or algorithms. The scaling methods therefore compensate the measured DC current by using data from the AC block made on the same sample. Also disclosed are devices, apparatuses and systems incorporating the various scaling methods.

主权项

1. A method of scaling amperometric data obtained during an electrochemical analysis of an analyte of interest to compensate for variations in electrode conductivity, the method comprising the steps of:
applying an electrical test sequence to a body fluid sample in an electrochemical biosensor, the biosensor comprising: an electrode system, a reagent in electrical communication with the electrode system, and a receptacle configured to contact the fluid sample provided to the biosensor,wherein the test sequence comprises at least one AC block of low-amplitude signals and at least one DC block, and wherein the body fluid sample comprises the analyte of interest;
measuring AC and DC current responses to an electro-active species indicative of the analyte of interest; measuring at least two loop resistances of the electrode system of the biosensor, wherein a first loop resistance is measured between two contact pads associated with a trace of a working electrode, and wherein a second loop resistance is measured between two contact pads associated with a trace of a counter electrode; normalizing the at least two loop resistances (Rconductor) by dividing a first loop resistance by a first constant and by dividing a second loop resistance by a second constant to obtain normalized loop resistances; scaling the amperometric data by incorporating the lowest normalized loop resistance into an algorithm for determining an analyte concentration or a failsafe calculation.