System and method for determining the concentration of an analyte in a sample fluid
View Patent ↗The present disclosure relates to various methods for measuring the amount of an analyte present in a biological fluid using an electrochemical testing process. Various embodiments are disclosed, including the use of AC test signals and the performance of tests having a Total Test Time within about 3.0 seconds or less, and/or having a clinically low Total System Error.
1. A method for determining a concentration of an analyte of interest in a biological sample, comprising:
a) applying the sample to a reagent film having a thickness between about 1.6 μm and about 5 μm;
b) applying a first signal to the sample;
c) measuring a first response to the first signal; and
d) determining the analyte concentration of the sample using at least the first response wherein the determination has a Total Test Time of within about 3.0 seconds or less;
wherein the first signal comprises a multi-frequency excitation waveform formed by adding a plurality of individual waveforms of different frequencies together so that the fluid sample is excited by multiple frequencies at the same time such that the first response contains measurement data collected simultaneously for all of the multiple frequencies.
2. The method of claim 1 , wherein the determination has a Total Test Time of between about 0.6 seconds and about 1.525 seconds.
3. The method of claim 1 , wherein the biological fluid is blood and the analyte of interest is glucose.
4. The method of claim 1 , further comprising the steps of:
e) applying a second signal to the sample; and
f) measuring a second response to the second signal;
wherein step (d) comprises determining the analyte concentration of the sample using at least the first response to correct the second response for the effects of at least one interferent within the sample.
5. The method of claim 4 , wherein the second signal is a DC signal.
6. The method of claim 4 ,
wherein the first response comprises response data for each of the multiple frequencies, the response data comprising correction factor information;
wherein the second response comprises a current response indicative of the analyte concentration;
wherein the first signal is applied substantially at the time the sample contacts the reagent coating for a first period of time from about 400 ms to about 800 ms;
wherein the second signal is applied substantially immediately after the period for the first signal for a second period of time from about 100 ms to about 2200 ms; and
wherein the determination has a TSE of about 9.0% or less.
7. The method of claim 6 , wherein the second period of time is from about 100 ms to about 300 ms, the Total Test Time is within about 1.1 seconds or less, and the TSE is about 8.5% or less.
8. The method of claim 1 , wherein the first signal comprises 4 simultaneously applied frequencies.