Biological sample measuring device and method for measuring biological sample using same

• US 9,316,649 B2
• Filed: 05/10/2012
• Issued: 04/19/2016
• Est. Priority Date: 05/10/2011
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Healthcare Holdings Co., Ltd.
• Inventors: Mizuoka, Daiki, Tokunaga, Hiroyuki, Takahashi, Tsuyoshi
• Primary Examiner(s): Fritchman, Rebecca M
• Application Number:
  US14/003,090
• Publication Number:
  US 20130337571A1
• Time in Patent Office: 1,440 Days
• Field of Search: 436/95, 422/82.01, 205/775, 204/403.1
• US Class Current: 1/1
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• 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 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

With this biological sample measuring device, the determination section performs measurement at specific intervals in a first measurement period from the start of measurement until a first time, and performs measurement at specific intervals in a second measurement period that comes after the first measurement period, calculates the difference between the measurement values in corresponding specific periods, and finds a plurality of first difference determination values, on the basis of a plurality of current values measured in the first measurement period and a plurality of current values measured in the second measurement period, finds a second difference determination value by finding the difference at specific intervals in the plurality of first difference determination values, and determines whether or not a reagent movement error and/or exposure error of the biological sample measurement sensor has occurred, on the basis of the first and second difference determination values.

Claims

1. A biological sample measuring device, comprising:

a sensor mounting section to which a biological sample measurement sensor is mounted, wherein a reagent is to be placed on the biological sample measurement sensor;

a main body case having the sensor mounting section;

a measurement section that is connected to the sensor mounting section;

a controller that is connected to the measurement section; and

a determination section, a calculating unit, and a display section that are connected to the controller; and

a memory section that stores a first upper threshold, a first lower threshold, a second upper threshold, and a second lower threshold, the memory section is connected to the determination section;

wherein the measurement section is programmed to measure current values at intervals in a first measurement period, and is programmed to measure at intervals in a second measurement period that comes after the first measurement period, and

the calculating unit is programmed to;

calculate a plurality of first difference determination values by subtracting the current values measured at the intervals in the first measurement period from a plurality of current values measured at the intervals in the second measurement period, respectively, and

calculate a second difference determination value by subtracting one of the first difference determination values from another of the first difference determination values; and

the determining section is programmed to;

compare the plurality of first difference determination values with both the first upper threshold and the first lower threshold to determine a first comparison result,

compare the second difference determination value with both the second upper threshold and the second lower threshold to determine a second comparison result, and

determine that an error exists if the first comparison result fails to satisfy a first condition and the second comparison result fails to satisfy a second condition, and

if an error is determined to exist, determine that the error is an exposure error if the first comparison result satisfies a third condition and the second comparison result satisfies a fourth condition, and determine that the error is a reagent movement error if the error is not determined to be an exposure error.

2. The biological sample measuring device according to claim 1,

wherein the determination section finds first and second measurement values obtained at specific intervals in the first measurement period, and finds third and fourth measurement values obtained at specific intervals in the second measurement period, and

the difference obtained by subtracting the first measurement value from the third measurement value, and the difference obtained by subtracting the second measurement value from the fourth measurement value are used as the plurality of first difference determination values.

3. The biological sample measuring device according to claim 1,

wherein the absolute value of the second lower threshold is less than the absolute value of the first upper threshold and the first lower threshold.

4. The biological sample measuring device according to claim 1,

wherein it is determined that a reagent movement error of the biological sample measurement sensor has occurred if none of the plurality of first difference determination values or the second difference determination value satisfies the following conditions (1) and (2):

(1) at least one of the plurality of first difference determination values is less than the first lower threshold, and at least one of the plurality of first difference determination values is at or under the first upper threshold, and at least one of the second difference determination values is at or over the second lower threshold,

(2) the plurality of first difference determination values are at or above the first lower threshold and at or below the first upper threshold, and the second difference determination value is at or above the second lower threshold and at or below the second upper threshold.

5. The biological sample measuring device according to claim 4,

wherein the absolute values of the second upper threshold and the second lower threshold are less than the absolute values of the first upper threshold and the first lower threshold.

6. The biological sample measuring device according to claim 1,

wherein the controller displays the occurrence of an error on the display section when it is determined by the determination section that the exposure error or the reagent movement error has occurred.

7. The biological sample measuring device according to claim 6,

wherein the controller displays information about what to do after the occurrence of the exposure error or the reagent movement error on the display section.

8. The biological sample measuring device according to claim 1,

wherein the measurement involves measuring the oxidation or reduction current value between a working electrode and a counter electrode provided to the biological sample measurement sensor.

9. The biological sample measuring device according to claim 1, wherein the determination section switches the first threshold and/or the second threshold.

10. The biological sample measuring device according to claim 9,

wherein the determination section switches at least one of the first threshold and/or second threshold according to the concentration of a specimen, the ambient temperature during measurement, or the Hct value.