Underfill management system for a biosensor

• US 10,175,194 B2
• Filed: 11/19/2015
• Issued: 01/08/2019
• Est. Priority Date: 06/07/2010
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Wu, Huan-Ping, Maurer, Eric A.
• Primary Examiner(s): Kaur, Gurpreet
• Assistant Examiner(s): Rosenwald, Steven E
• Application Number:
  US14/946,570
• Publication Number:
  US 20160077050A1
• Time in Patent Office: 1,146 Days
• Field of Search: None
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A biosensor system including the underfill management system determines the analyte concentration in a sample from the at least one analytic output signal value. The underfill management system includes an underfill recognition system and an underfill compensation system. The underfill recognition system determines whether the test sensor initially is substantially full-filled or underfilled, indicates when the sample volume is underfilled so that additional sample may be added to the test sensor, and starts or stops the sample analysis in response to the sample volume. The underfill recognition system also may determine the initial degree of underfill. After the underfill recognition system determines the initial fill state of the test sensor, the underfill compensation system compensates the analysis based on the initial fill state of the test sensor to improve the measurement performance of the biosensor system for initially underfilled test sensors.

Claims

1. A biosensor system for determining an analyte concentration in a sample, the biosensor system comprising:

a test sensor having a sample interface and a reservoir, the sample interface being in electrical communication with the reservoir, the reservoir including a counter electrode and a working electrode, the sample interface having conductors connected to the counter electrode and the working electrode;

a portable measurement device having a processor, a sensor interface, and a storage medium, the sensor interface being in electrical or optical communication with the sample interface of the test sensor, the processor being connected to the sensor interface and in electrical communication with the storage medium, the storage medium storing at least one reference correlation pre-determined with a reference instrument, the processor being programmed to;

apply a potential across the working electrode and the counter electrode,

based on the applied potential, determine an initial fill state of the test sensor to be an initial underfill state in which an insufficient volume of sample is present in the reservoir,

signal for adding sample in the reservoir until the test sensor has a sufficient volume of sample, the sufficient volume of sample changing the initial underfill state of the test sensor to a subsequent substantially full-fill state,

apply an analytic test excitation signal to the sufficient volume of sample,

generate at least one analytic output signal value responsive to the concentration of the analyte in the sufficient volume of sample and the analytic test excitation signal,

compensate for underfill error in the at least one analytic output signal value in response to the initial underfill state and the subsequent substantially full-fill state of the test sensor, wherein the compensating for the underfill error includes;

adjust the reference correlation with a compensation system, the compensation system including at least one index function previously determined from an error parameter, the compensation system applying one or more compensation equations in response to the initial underfill state and the subsequent substantially full-fill state of the test sensor, and

determine an analyte concentration in the sample from the at least one analytic output signal value and the adjusting of the reference correlation; and

a display communicatively coupled to the processor for displaying an error signal when there is an insufficient volume of sample, the display further displaying a numerical reading indicative of the analyte concentration in the sample.

2. The biosensor system of claim 1, wherein the processor is further programmed to detect sample presence in the test sensor before determining the initial fill state of the test sensor.

3. The biosensor system of claim 1, wherein, to determine the initial fill state of the test sensor, the processor is further programmed to:

apply a polling sequence to the insufficient volume of sample, the polling sequence including regular and extended polling sequences and the extended polling sequence includes at least one different extended input pulse;

or

sequentially detect sample filling.

4. The biosensor system of claim 3, wherein the extended polling sequence includes two or more different extended input pulses of decreasing amplitude.

5. The biosensor system of claim 3, wherein the sequentially detecting includes determining when two different pairs of electrodes of the test sensor are contacted by the insufficient volume of sample.

6. The biosensor system of claim 3, wherein the processor is further programmed to select the error parameter in response to the polling sequence or the sequentially detecting, the error parameter being a value responsive to a volume threshold.

7. The biosensor system of claim 6, wherein the error parameter is a value corresponding to a duration.

8. The biosensor system of claim 1, wherein the at least one index function is responsive to a slope deviation between the reference correlation and a hypothetical sample analyte concentration, the hypothetical sample analyte concentration indicating the analyte concentration in the sample without error.

9. The biosensor system of claim 1, wherein, to compensate for underfill error, the processor is further programmed to compensate in response to the initial fill state of the test sensor with a primary function for compensating primary errors in a total error of the subsequent substantially full-fill state, the primary function being different than a primary function otherwise used in compensating errors if the initial fill state was an initial substantially full-fill state, the primary function being a complex index function including at least two terms wherein each term is modified by a weighing coefficient.

10. The biosensor system of claim 1, wherein, to compensate for underfill error, the processor is further programmed to compensate with an initial low volume underfill compensation system including a first residual function for compensating residual errors in a total error, the first residual function being different than a residual function otherwise used if the initial fill state was an initial substantially full-fill state.

11. The biosensor system of claim 10, wherein the initial low volume underfill compensation system further includes a primary function for compensating primary errors in a total error of the subsequent substantially full-fill state.

12. The biosensor system of claim 1, wherein, to compensate for underfill error, the processor is further programmed to compensate with an initial high volume underfill compensation equation including a primary function for compensating primary errors in a total error, the primary function being different than a primary function otherwise used if the initial fill state was an initial substantially full-fill state.

13. The biosensor system of claim 1, wherein the sufficient volume of sample is whole blood including red blood cells and the analyte is glucose, and greater than 95% of the glucose concentrations determined for 600 or fewer analyses fall within a ±

10% percent bias limit.

14. The biosensor system of claim 1, wherein the greater than 95% of the glucose concentrations determined for 600 or fewer analyses fall within a ±

10% percent bias limit when a test sensor is initially underfilled and subsequently substantial full-filled within 35 seconds or less from the initial fill.

15. The biosensor system of claim 1, wherein the sufficient volume of sample is whole blood including red blood cells and the analyte is glucose, and greater than 75% of the glucose concentrations determined for 600 or fewer analyses fall within a ±

5% percent bias limit.

16. The biosensor system of claim 1, wherein the sufficient volume of sample is whole blood including red blood cells and the analyte is glucose, and the glucose concentrations determined for 600 or fewer analyses provide a percent bias standard deviation of less than 5.

17. A biosensor measurement device for determining an analyte concentration in a sample, the biosensor measurement device comprising:

a sample interface in electrical communication with a reservoir in which a sample is received;

a counter electrode and a working electrode positioned in the reservoir;

a sensor interface in electrical communication with the sample interface;

a storage medium storing at least one reference correlation pre-determined with a reference instrument;

a processor connected to the sensor interface and in electrical communication with the storage medium, the processor being programmed to;

apply a potential across the working electrode and the counter electrode, based on the applied potential, determine an initial fill state of the reservoir to be an initial underfill state in which an insufficient volume of sample is present,

signal for adding sample until the reservoir has a sufficient volume of sample, the sufficient volume of sample changing the initial underfill state of the test sensor to a subsequent substantially full-fill state,

apply an analytic test excitation signal to the sufficient volume of sample,

generate at least one analytic output signal value responsive to the concentration of the analyte in the sufficient volume of sample and the analytic test excitation signal,

compensate for underfill error in the at least one analytic output signal value in response to the initial underfill state and the subsequent substantially full-fill state of the reservoir, wherein the compensating for the underfill error includes;

adjust the reference correlation with a compensation system, the compensation system including at least one index function previously determined from an error parameter, wherein the compensation system applies one or more compensation equations in response to the initial underfill state and the subsequent substantially full-fill state of the reservoir, and

determine an analyte concentration in the sample from the at least one analytic output signal value and the adjusting of the reference correlation; and

a display communicatively coupled to the processor for displaying an error signal when there is an insufficient volume of sample, the display further displaying a numerical reading indicative of the analyte concentration in the sample.

18. A biosensor system for determining an analyte concentration in a sample, the biosensor system comprising:

a test sensor having a sample interface and a reservoir, the sample interface being in electrical communication with the reservoir, the test sensor further having a counter electrode and a working electrode positioned in the reservoir, the sample interface having conductors connected to the counter electrode and the working electrode;

a biosensor measurement device having a sensor interface and a storage medium, the storage medium storing the reference correlation, the reference correlation being pre-determined with a reference instrument, a processor being located in the biosensor measurement device such that the processor is connected to the sensor interface and in electrical communication with the storage medium, the processor being communicatively coupled to the sample interface and programmed to;

apply a potential across the working electrode and the counter electrode,

based on the applied potential, determine an initial fill state of the test sensor to be an initial underfill state in which an insufficient volume of sample is present in the reservoir,

signal for adding sample in the reservoir until the test sensor has a sufficient volume of sample, the sufficient volume of sample changing the initial underfill state of the test sensor to a subsequent substantially full-fill state,

apply an analytic test excitation signal to the sufficient volume of sample,

generate at least one analytic output signal value responsive to the concentration of the analyte in the sufficient volume of sample and the analytic test excitation signal,

compensate for underfill error in the at least one analytic output signal value in response to the initial underfill state and the subsequent substantially full-fill state of the test sensor, wherein the compensating for the underfill error includes;

adjust at least one reference correlation with a compensation system, the compensation system including at least one index function previously determined from an error parameter, wherein the compensation system applies one or more compensation equations in response to the initial underfill state and the subsequent substantially full-fill state of the test sensor, and

determine an analyte concentration in the sample from the at least one analytic output signal value and the adjusting of the reference correlation; and

a display communicatively coupled to the processor for displaying an error signal when there is an insufficient volume of sample, the display further displaying a numerical reading indicative of the analyte concentration in the sample.