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Publication Number
US-10605759-B2
Publication Date
2020-03-31
Expiration Date
Abstract
A method of verifying operation of a meter for reading electrochemical test devices, includes obtaining a reference output signal indicative of a response generated at an electrochemical test device when the electrochemical test device reacts with a reference test fluid; applying with the meter an algorithm to the reference output signal so as to obtain a reference test result, wherein the algorithm is for use in estimating an unknown concentration of an analyte in a sample of the reference test fluid; and determining whether the reference test result is valid so as to verify operation of the meter.
Core Innovation
The invention provides a method of verifying operation of a meter for reading electrochemical test devices. The method obtains a reference transient indicative of a current vs time response generated at an electrochemical test device when the electrochemical test device reacts with a reference test fluid, wherein the reference test fluid is a bodily fluid sample and a non-control fluid, and the electrochemical test device comprises at least one working electrode. The reference transient is stored in a memory of the meter.
The method applies, with the meter, an algorithm to the reference transient to obtain a reference test result. The algorithm is for estimating an unknown concentration of an analyte in a sample of the reference test fluid, and the method determines whether the reference test result is valid based on a predetermined range of acceptable readings, thereby verifying operation of the meter.
The disclosure further describes detecting anomalies related to stored reference transients and algorithm outputs. It describes identifying a condition where the reference test result is not valid and, in such cases, determining an anomaly in the reference transient and an error in the algorithm, as well as determining corruption of a meter memory that stores a reference transient and/or an algorithm. A complementary control-solution check is also described using a calibration code and comparing an estimated analyte concentration to an expected range.
Claims Coverage
The independent claims are clm-00001, clm-00014, and clm-00015, covering the method, the meter apparatus, and a non-transitory data carrier. Across these claims, the core coverage repeatedly uses a stored reference transient from a bodily fluid non-control reference test fluid, applies an analyte-concentration estimation algorithm to produce a reference test result, and validates the result against a predetermined range of acceptable readings to verify meter operation; the claims also require storing the reference transient in meter memory.
Reference transient from bodily fluid non-control fluid
Obtaining a reference transient indicative of a current vs time response generated at an electrochemical test device when the electrochemical test device reacts with a reference test fluid, wherein the reference test fluid is a bodily fluid sample and a non-control fluid, and wherein the electrochemical test device comprises at least one working electrode.
Algorithm estimation of unknown analyte concentration
Applying an algorithm to the reference transient so as to obtain a reference test result, wherein the algorithm is for use in estimating an unknown concentration of an analyte in a sample of the reference test fluid.
Validity determination using predetermined range of acceptable readings
Determining whether the reference test result is valid on the basis of a predetermined range of acceptable readings so as to verify operation of the meter.
Storing the reference transient in meter memory
Storing the reference transient in a memory of the meter.
Meter with memories, algorithm, and processor to verify operation
A meter comprising one or more memories storing the reference transient and the algorithm, and a processor configured to apply the algorithm to the reference transient, determine validity on the basis of a predetermined range of acceptable readings to verify operation of the meter, and store the reference transient in a memory of the meter.
Non-transitory data carrier with processor control code
A non-transitory data carrier having a processor control code stored thereon configured, when read by a computer, to obtain the reference transient, apply the algorithm to obtain the reference test result, determine validity based on a predetermined range of acceptable readings to verify operation of the meter, and store the reference transient in a memory of the meter.
Overall, the independent claims consistently cover verifying meter operation by using a reference transient from an electrochemical test device reacted with a bodily fluid non-control fluid, applying an algorithm to estimate an unknown analyte concentration to obtain a reference test result, validating the reference test result using a predetermined range of acceptable readings, and storing the reference transient in meter memory.
Stated Advantages
Verifies operation of the meter for reading electrochemical test devices by validating a reference test result against a predetermined range of acceptable readings.
Supports diagnosis by determining whether a reference test result is valid and, when not valid, identifying an anomaly in the reference transient and an error in the algorithm.
Supports detection of corruption by determining corruption of meter memory that stores a reference transient and/or an algorithm.
Provides complementary verification using a control-solution check with a calibration code and comparing an estimated analyte concentration to an expected range.
Documented Applications
Verification of meter operation for reading electrochemical test devices using a reference transient generated at an electrochemical test device when reacted with a reference test fluid that is a bodily fluid sample and a non-control fluid.
Use of the reference transient approach in combination with optional anomaly detection when the reference test result is not valid.
Control-solution verification using a calibration code and an expected range for an estimated analyte concentration.
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